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Medicare Part B Prior Authorization and Step Therapy Criteria — November 2026

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Coverage review, prior authorization, and step therapy requirements for Priority Health Medicare Part B provider-administered injectable and infused drugs.

Policy Summary

PayerPriority Health Medicare

PolicyMedicare Part B Prior Authorization and Step Therapy Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the applicable Medicare Part B prior authorization form or web form with supporting medical records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Part BBenefit

2Actemra IV step products

6 monthsAdakveo hydroxyurea trial

<10%Adzynma ADAMTS13 threshold

1 doseCasgevy lifetime limit

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CurrentPriority Health MedicarePolicy N/A

Medicare Part B Prior Authorization and Step Therapy Criteria — November 2026

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Coverage review, prior authorization, and step therapy requirements for Priority Health Medicare Part B provider-administered injectable and infused drugs.

Policy Summary

PayerPriority Health Medicare

PolicyMedicare Part B Prior Authorization and Step Therapy Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the applicable Medicare Part B prior authorization form or web form with supporting medical records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Part BBenefit

2Actemra IV step products

6 monthsAdakveo hydroxyurea trial

<10%Adzynma ADAMTS13 threshold

1 doseCasgevy lifetime limit

≥150 or ≥300Cinqair eosinophil threshold

Coverage Criteria

Actemra IV Initial Authorization

Covered when all of the following are met:

ALL of the following

Covered use is a medically accepted indication not otherwise excluded.
Medical records supporting the request, including documentation of prior therapies and responses, are provided.
The prescriber is a specialist or has consulted with a specialist for the condition being treated.
Actemra is not used in combination with other biologic drugs, Otezla, or Janus kinase inhibitors (JAK inhibitors). SSc-ILD is not approved for intravenous administration.
The patient has first tried Tyenne and Avtozma.
Dose is consistent with FDA-approved labeling or accepted standards of practice.

Adakveo Initial Coverage

Covered when all of the following are met:

ALL of the following

Adakveo is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request are provided.
The patient has tried hydroxyurea for 6 months, or has an intolerance or contraindication to hydroxyurea.
Dose is consistent with FDA-approved labeling or accepted standards of practice.

Adzynma Initial and Continuation Therapy

Covered when all applicable criteria are met:

ALL of the following

Adzynma is used for an FDA-approved indication not otherwise excluded.
Genetic testing confirms congenital thrombotic thrombocytopenic purpura (cTTP).
ADAMTS13 activity is less than 10%.
Medical records, including the patient's current weight for dosing, are provided.
The initial prophylactic dosing frequency is every 2 weeks; frequency may be adjusted to once weekly based on prior prophylactic dosing or clinical response with supporting documentation.

Alhemo Reauthorization

Reauthorization requires all of the following:

ALL of the following

The patient continues to use Alhemo for routine prophylaxis to prevent or reduce bleeding episodes.
Documentation of clinical benefit is provided, such as fewer bleeding episodes or less use of factor VIII/factor IX replacement therapy or bypassing agents.

Alyglo Part B Criteria

Covered when all applicable Part B criteria are met:

ALL of the following

Alyglo is used for a medically accepted indication not otherwise excluded.
The request is determined to be a Part B benefit.
The patient has first tried two preferred IVIG products, such as Gammagard Liquid, Gamunex-C, or Privigen.
Medical records supporting the request, including prior therapies and responses, are provided.
Additional criteria required by LCD L34771 may apply.

Alymsys Criteria

Covered when all of the following are met:

ALL of the following

Alymsys is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Mvasi and Zirabev.
Criteria are applied consistent with LCD L37205.

Amvuttra General Requirements

Covered when all applicable requirements are met:

ALL of the following

Amvuttra is used for an FDA-approved indication not otherwise excluded.
Amvuttra is not used with TTR stabilizers, such as tafamidis, or TTR-lowering agents, such as Onpattro.
The patient is at least 18 years of age.
Amvuttra is not used for primary (light-chain) amyloidosis.
Dose is consistent with FDA-approved labeling or accepted standards of practice.

Initial hATTR-PN

Initial hATTR-PN coverage requires all of the following:

ALL of the following

The patient has a transthyretin mutation, such as V30M.
Baseline polyneuropathy disability score is less than or equal to IIIb.
The patient has clinical signs and symptoms, such as motor disability or peripheral/autonomic neuropathy.
Medical records supporting the request are provided.

Initial ATTR-CM

Initial ATTR-CM coverage requires all of the following:

ALL of the following

The patient has NYHA class 1, 2, or 3 heart failure with current clinical manifestations or prior hospitalization for heart failure.
ECHO or CMR demonstrates cardiac involvement, including increased left ventricular wall thickness.
Diagnosis is confirmed by tissue biopsy, genetic testing, or radionuclide imaging.
If confirmed by radionuclide imaging, documentation shows Grade 2 or 3 cardiac uptake.
The patient has tried and failed tafamidis (Vyndamax or Vyndaqel).

Amvuttra Reauthorization

Reauthorization requires documentation of a positive clinical response to Amvuttra compared with baseline.

hATTR-PN response

Improved neuropathy symptoms.
Improved motor function.
Improved quality of life.
Slowing of disease progression.

ATTR-CM response

Reduced cardiovascular-related hospitalizations.

Aralast NP Coverage Criteria

Covered when all of the following are met:

ALL of the following

Diagnosis of alpha-1-antitrypsin deficiency with phenotype PiZZ, PiZ (null), Pi (null, null), or another phenotype associated with reduced serum alpha-1-antitrypsin concentration.
Serum AAT level is less than 11 micromoles/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry).
The patient has symptomatic emphysema.
Medical records supporting the request are provided.

Armlupeg

Covered when all of the following are met:

ALL of the following

Armlupeg is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Neulasta and Fulphila.

Asceniv

Covered when all applicable criteria are met:

ALL of the following

Asceniv is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The request is determined to be a Part B benefit.
The patient has first tried two preferred IVIG products, such as Gammagard Liquid, Gamunex-C, or Privigen.
Additional criteria required by LCD L34771 may apply.

Aukelso

Covered when all of the following are met:

ALL of the following

Aukelso is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Wyost, Xtrenbo, and Bilprevda.

Avastin Chemotherapy

Covered when all of the following are met:

ALL of the following

Avastin is used for a medically accepted indication not otherwise excluded and billed as chemotherapy (J9035 only).
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Mvasi and Zirabev.
Criteria are applied consistent with LCD L37205.

Aveed Hypogonadism

Covered when all of the following are met:

ALL of the following

For hypogonadism: the patient has tried and failed generic testosterone cypionate or enanthate and a generic topical testosterone therapy.
For hypogonadism: two pretreatment morning total testosterone levels on separate days are below 300 ng/dL or below the laboratory reference range.
For hypogonadism: clinical signs and symptoms consistent with testosterone deficiency are present, other than erectile dysfunction or decreased libido, and the patient was assigned male at birth.
For gender dysphoria: the patient has tried and failed generic testosterone cypionate or enanthate and a generic topical testosterone therapy.
Medical records supporting the applicable request are provided.

Aveed Gender Dysphoria

For gender dysphoria, coverage requires all of the following:

ALL of the following

The patient has tried and failed generic testosterone cypionate or generic testosterone enanthate.
The patient has tried and failed a generic topical testosterone therapy.
Medical records supporting the request are provided.

Avgemsi Initial Therapy

Covered when all of the following are met:

ALL of the following

Avgemsi is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried generic gemcitabine injection (Gemzar).

Avtozma Coverage

Covered when all applicable requirements are met:

ALL of the following

Avtozma is used for a medically accepted indication not otherwise excluded.
Avtozma is not used with other biologic drugs, Otezla, or JAK inhibitors.
Medical records supporting the request, including prior therapies and responses, are provided.
The prescriber is a specialist or has consulted with a specialist.
Dose is consistent with FDA-approved labeling or accepted standards of practice.

Avtozma Coverage Requirements

For medically accepted indications other than cytokine release syndrome, giant cell arteritis, and COVID-19, coverage additionally requires all of the following:

ALL of the following

The patient has first tried Avsola or Renflexis.
The requested indication is medically accepted.

Axtle Coverage

Covered when all of the following are met:

ALL of the following

Axtle is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried generic pemetrexed.

Azmiro Coverage

Covered when all applicable criteria are met:

ALL of the following

Azmiro is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request are provided.
For hypogonadism: the patient has tried and failed generic testosterone cypionate, has two separate pretreatment morning total testosterone levels below 300 ng/dL or laboratory reference range, has compatible clinical signs and symptoms other than erectile dysfunction or decreased libido, and was assigned male at birth.
For gender dysphoria: the patient has tried and failed generic testosterone cypionate.

Beizray

Covered when all of the following are met:

ALL of the following

Beizray is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request are provided.
The patient has first tried generic docetaxel (Taxotere, J9171).

Beizray Kit

Covered when all of the following are met:

ALL of the following

Beizray kit is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request are provided.
The patient has first tried generic docetaxel (Taxotere, J9171).

Benlysta IV Initial Coverage

Initial IV coverage requires all applicable criteria:

ALL of the following

Benlysta IV is used for a medically accepted indication not otherwise excluded.
Benlysta IV is not used with another biologic drug or Lupkynis.
Medical records supporting the request, including prior therapies and responses, are provided.
The prescriber is a specialist or has consulted with a specialist.
For SLE, SELENA-SLEDAI score is at least 6 and either anti-dsDNA antibody is greater than 30 IU/mL or ANA is greater than 1:80.

Benlysta IV Reauthorization

Reauthorization requires documented clinical improvement since starting Benlysta, including improved or stable eGFR for lupus nephritis.

ALL of the following

The patient demonstrates clinical improvement since starting Benlysta.
For lupus nephritis, eGFR is improved or stable.

Benlysta Initial SLE Therapy

Initial SLE therapy requires all of the following:

ALL of the following

SELENA-SLEDAI score is at least 6 before starting Benlysta.
Anti-dsDNA antibody is greater than 30 IU/mL or ANA is greater than 1:80.
Standard of care includes two of a steroid, immunosuppressant, or hydroxychloroquine, each for at least 12 weeks.

Benlysta SLE Reauthorization

Reauthorization requires evidence of clinical improvement since starting Benlysta.

The patient demonstrates clinical improvement since starting Benlysta.

Benlysta Lupus Nephritis Initial Therapy

Initial lupus nephritis therapy requires all of the following:

ALL of the following

The patient has a confirmed diagnosis of SLE.
Kidney biopsy confirms class 3, 4, and/or 5 disease.
The patient receives standard therapy for lupus nephritis, such as mycophenolate or azathioprine plus a steroid.

Benlysta Lupus Nephritis Reauthorization

Reauthorization requires all of the following:

ALL of the following

The patient demonstrates clinical improvement.
eGFR is improved or stable.

Bivigam Medically Accepted Use

Covered when all applicable criteria are met:

ALL of the following

Bivigam is used for a medically accepted indication not otherwise excluded.
The request is determined to be a Part B benefit.
The patient has first tried two preferred IVIG products, such as Gammagard Liquid, Gamunex-C, or Privigen.
Medical records supporting the request, including prior therapies and responses, are provided.
Additional criteria required by LCD L34771 may apply.

Bkemv Reauthorization Criteria

Reauthorization requires continued noncombination use and documented benefit for the applicable indication.

ALL of the following

For NMOSD, Bkemv is not used with Ultomiris, Uplizna, Enspryng, or other NMOSD medications and relapse rate has decreased.
For PNH, Bkemv is not used with Fabhalta, Ultomiris, Empaveli, or other complement therapy, and PNH symptoms and laboratory measures have improved.
For aHUS, thrombotic microangiopathy signs have decreased, such as normalized platelet and LDH levels or reduced serum creatinine.
For myasthenia gravis, Bkemv is not used with chronic immune globulin therapy, Vyvgart, Ultomiris, Rystiggo, or Zilbrysq, and MG-ADL score has improved from baseline.
Medical records supporting the request are provided.

Bomyntra Coverage

Covered when all of the following are met:

ALL of the following

Bomyntra is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Wyost, Xtrenbo, and Bilprevda.

Boruzu Coverage

Covered when all of the following are met:

ALL of the following

Boruzu is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried one generic injectable bortezomib product, such as an HCPCS J9049 or J9041 product.

Bosaya Coverage

Covered when all of the following are met:

ALL of the following

Bosaya is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Jubbonti, Enoby, and Bildyos.

Casgevy Initial Therapy — Sickle Cell Disease

Casgevy initial coverage for sickle cell disease requires all of the following:

ALL of the following

Medical records supporting the request are provided.
The patient has sickle cell disease with βS/βS, βS/β0, or βS/β+ genotype confirmed by genetic testing.
The patient has a history of at least 2 severe vaso-occlusive events per year in each of the previous 2 years.
The patient's current weight is provided.
The patient has adequate organ function and is eligible for hematopoietic stem cell transplantation (HSCT).

Casgevy Initial Therapy — Beta Thalassemia

Casgevy initial coverage for beta thalassemia requires all of the following:

ALL of the following

Medical records supporting the request are provided.
The patient has transfusion-dependent beta thalassemia, defined as a history of at least 100 mL/kg/year or 10 units/year of packed red blood cells during the previous 2 years.
The patient does not have a known and available HLA-matched donor, as determined by the hematologist and/or transplant specialist.
The provider attests that, absent a known or available HLA-matched family donor, the patient would otherwise be clinically stable and eligible to undergo HSCT.
The patient is at least 2 years of age.

Cimzia Medically Accepted Use

Covered when all applicable criteria are met:

ALL of the following

Cimzia is used for a medically accepted indication not otherwise excluded.
Cimzia is not used with another biologic drug, Otezla, or a JAK inhibitor.
The prescriber is a specialist or has consulted with a specialist.
The patient has tried and failed two drugs with supported use for the requested condition from: a preferred adalimumab product, Rinvoq, Skyrizi, Tyenne, Cosentyx, Otezla, Xeljanz, Xeljanz XR, Yesintek/Selarsdi, or Enbrel.
Medical records supporting the request, including prior therapies and responses, are provided.

Cinqair Coverage Criteria

Covered when all applicable criteria are met:

ALL of the following

Cinqair is used for a medically accepted indication not otherwise excluded and is not used with another biologic drug.
Medical records, current weight, and prior therapy responses are provided.
For initial severe eosinophilic asthma coverage, eosinophils are at least 150 cells/mcL at therapy start or at least 300 cells/mcL during the prior 12 months.
The prescriber is a specialist or has consulted with a specialist.
The patient has tried and failed an ICS/LABA inhaler combined with another asthma controller during the prior 6 months; failure means intolerance or inability to improve after at least 4 weeks.

Cinryze Coverage Criteria

Covered when all of the following are met:

ALL of the following

Cinryze is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Haegarda.

Conexxence Coverage

Covered when all of the following are met:

ALL of the following

Conexxence is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has first tried Jubbonti, Enoby, and Bildyos.

Cosentyx IV Coverage

Covered when all of the following are met:

ALL of the following

Cosentyx IV is used for a medically accepted indication not otherwise excluded.
Cosentyx IV is not used with another biologic drug, Otezla, or a JAK inhibitor.
Medical records supporting the request, including prior therapies and responses, are provided.
The prescriber is a specialist or has consulted with a specialist.
The patient has first tried Avsola, Renflexis, or Simponi Aria.

Docivyx Coverage

Covered when all of the following are met:

ALL of the following

Docivyx is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request are provided.
The patient has first tried generic docetaxel (Taxotere, J9171).

Durysta Coverage

Covered when all of the following are met:

ALL of the following

Durysta is used for a medically accepted indication not otherwise excluded.
Medical records supporting the request, including prior therapies and responses, are provided.
The patient has tried two of latanoprost, bimatoprost, or travoprost.

Durysta Prior Therapies

Prior therapy requirement:

TWO of the following

Latanoprost.
Bimatoprost.
Travoprost.

Elevidys

Covered when all of the following are met:

ALL of the following

Duchenne muscular dystrophy is confirmed by a genetic mutation in the DMD gene that is not a deletion in exon 8 or exon 9.
Anti-AAVrh74 titer is less than 1:400.
The prescriber is, or has consulted with, a neurologist or specialist experienced in treating DMD.
Medical records supporting the request are provided.

Emblaveo

Covered when all of the following are met:

ALL of the following

Culture and sensitivity results are provided, or the suspected organism(s) being treated are specified if results are unavailable.
The prescriber is an infectious disease specialist or has consulted with one.
The patient has tried all other generic, susceptible antibiotics identified by culture and sensitivity or appropriate for empiric therapy.

Encelto Initial Coverage

Initial coverage requires all of the following:

ALL of the following

There has been no previous Encelto implant.
MacTel type 2 is supported by test results such as FA or OCT.
IS/OS PR loss in the EZ is between 0.16 and 2.00 mm2c.
BCVA is 54 letters or better (20/80 Snellen equivalent) on the ETDRS chart.
There is no evidence of neovascular MacTel type 2.
The patient is at least 18 years old.

Enjaymo Initial Therapy

Initial therapy requires documentation of all of the following:

ALL of the following

Confirmed diagnosis of cold agglutinin disease (CAD).
At least one blood transfusion within 6 months before starting Enjaymo.
One or more CAD-associated symptoms, such as symptomatic anemia, acrocyanosis, Raynaud phenomenon, hemoglobinuria, disabling circulatory symptoms, or a major adverse vascular event.
A documented trial and failure of a rituximab-containing regimen.

Enjaymo Continuation Therapy

Reauthorization requires documented clinical benefit compared with baseline.

ALL of the following

Hemoglobin level has increased.
Blood transfusions have decreased.

Entyvio Coverage

Covered when all of the following are met:

ALL of the following

Entyvio is used for a medically accepted indication not otherwise excluded.
Entyvio is not used with another biologic drug, Otezla, or a JAK inhibitor.
Medical records supporting the request, including prior therapies and responses, are provided.
The prescriber is a specialist or has consulted with a specialist for the condition being treated.

Coding and Thresholds

Avastin ChemotherapyHCPCSCovered

J9035

Avastin chemotherapy only

Avastin chemotherapy codeHCPCS

J9035

Avastin chemotherapy

Required generic docetaxel stepHCPCS

J9171

Generic docetaxel (Taxotere)

Example HCPCS codes for generic injectable bortezomibHCPCS

J9049	Healthcare Common Procedure Coding System code identified as an example for a generic bortezomib injectable product.
J9041	Healthcare Common Procedure Coding System code identified as an example for a generic bortezomib injectable product.

Required step-therapy product codeHCPCS

J9171

Generic docetaxel (Taxotere)

Prior Authorization and Provider Requirements

Prior Authorization

Submit a Part B prior authorization request

Submit the applicable Medicare Medical (Part B) Prior Authorization form or web form when prior authorization is required. PA may determine coverage under the Medicare Part B medical benefit, Part D pharmacy benefit, or other Medical Drug List limits.

Prior Authorization

Actemra IV authorization requirements

For Actemra IV, submit medical records documenting the medically accepted indication, prior therapies and responses, and specialist involvement. Both Tyenne and Avtozma must be tried first; dosing must follow FDA-approved labeling or accepted standards of practice.

Coverage duration: 2 years.

Initial Therapy Criteria

Initial Actemra IV authorization

Continuation requires ongoing eligibility.

Use remains medically accepted and non-excluded and continues to follow FDA-approved labeling or accepted standards.2 years

Adakveo initial authorization

All initial criteria apply.

Medically accepted indication; supporting records; and hydroxyurea tried for 6 months unless contraindicated or not tolerated.6 months

Adzynma initial authorization

All initial criteria apply.

Continuation and Reauthorization Criteria

Actemra IV continuation

Continuation requires ongoing eligibility.

The indication remains medically accepted and non-excluded and dosing remains within FDA labeling or accepted standards.2 years

Adzynma reauthorization

Reauthorization requires ongoing medical necessity and response.

Supporting records including current weight; specialist prescriber or consultation; and beneficial response such as fewer TTP events, improved platelets, or fewer hemolytic anemia episodes.12 months

Alhemo continuation therapy

All continuation criteria are required.

Required Step Therapy

Step	Required prior therapy	Notes
1	Tyenne and Avtozma	Both products must be tried before Actemra IV.

Step	Required prior therapy	Notes
1	Hydroxyurea	Try for 6 months, unless contraindicated or not tolerated.

Step	Required prior therapy	Notes
1	Hemlibra	Must be tried and failed before initial Alhemo approval for hemophilia A.

Step	Required prior therapy	Notes
1	Two preferred IVIG products	For requests determined to be a Part B benefit; examples include Gammagard Liquid, Gamunex-C, and Privigen.

Step	Required prior therapy	Notes
1	Mvasi and Zirabev	Both products must be tried before Alymsys.

Step	Required prior therapy	Notes
1	Tafamidis (Vyndamax or Vyndaqel)	For ATTR-CM; tafamidis must be tried and failed before Amvuttra.

Step	Required prior therapy	Notes
1	Neulasta and Fulphila	Both products must be tried before Armlupeg.

Step	Required prior therapy	Notes
1	Two preferred IVIG products	For requests determined to be a Part B benefit; examples include Gammagard Liquid, Gamunex-C, and Privigen.

Step	Required prior therapy	Notes
1	Wyost, Xtrenbo, and Bilprevda	All three products must be tried before Aukelso.

Step	Required prior therapy	Notes
1	Mvasi and Zirabev	Both products must be tried before Avastin intravenous chemotherapy coverage under J9035.

Step	Required prior therapy	Notes
1	Mvasi and Zirabev	Both products must be tried before Avastin.

Step	Required prior therapy	Notes
1	Generic testosterone cypionate or enanthate; then generic topical testosterone	Both therapies must be tried and failed; failure means inability to improve symptoms or testosterone levels.

Step	Required prior therapy	Notes
1	Generic gemcitabine injection (Gemzar)	Must be tried before Avgemsi.

Step	Required prior therapy	Notes
1	Avsola or Renflexis	Required for medically accepted indications except cytokine release syndrome, giant cell arteritis, and COVID-19 treatment.

Step	Required prior therapy	Notes
1	Generic pemetrexed	Must be tried before Axtle.

Step	Required prior therapy	Notes
1	Generic testosterone cypionate	Must be tried and failed before Azmiro for hypogonadism or gender dysphoria.

Step	Required prior therapy	Notes
1	Generic docetaxel (Taxotere; J9171)	Must be tried before Beizray.

Step	Required prior therapy	Notes
1	Generic docetaxel (Taxotere; J9171)	Must be tried before Beizray kit.

Step	Required prior therapy	Notes
1	Two preferred IVIG products	When the request is a Part B benefit; examples include Gammagard Liquid, Gamunex-C, and Privigen.

Step	Required prior therapy	Notes
1	Epysqli	Must be tried and failed for NMOSD, PNH, aHUS, and generalized myasthenia gravis.

Step	Required prior therapy	Notes
2	Vyvgart or Vyvgart Hytrulo	Also required for generalized AChR-antibody-positive myasthenia gravis; intolerance or inadequate response is required.

Step	Required prior therapy	Notes
1	Wyost, Xtrenbo, and Bilprevda	All three products must be tried before Bomyntra.

Step	Required prior therapy	Notes
1	One generic bortezomib injectable product	Examples include products billed with HCPCS J9049 or J9041.

Step	Required prior therapy	Notes
1	Jubbonti, Enoby, and Bildyos	All three products must be tried before Bosaya.

Step	Required prior therapy	Notes
1	Hydroxyurea or an alternative SCD treatment	For sickle cell disease, try and fail hydroxyurea; if not tolerated, try and fail at least one other SCD treatment, such as Endari.

Step	Required prior therapy	Notes
1	Two supported-use therapies	Try and fail two listed options, such as a preferred adalimumab product, Rinvoq, Skyrizi, Tyenne, Cosentyx, Otezla, Xeljanz, Xeljanz XR, Yesintek/Selarsdi, or Enbrel.

Step	Required prior therapy	Notes
1	One ICS/LABA inhaler plus one other asthma controller	Try and fail during the past 6 months; required therapy must be used for at least 4 weeks.

Step	Required prior therapy	Notes
1	Haegarda	Must be tried before Cinryze.

Step	Required prior therapy	Notes
1	Jubbonti, Enoby, and Bildyos	All three products must be tried before Conexxence.

Step	Required prior therapy	Notes
1	Avsola, Renflexis, or Simponi Aria	At least one listed product must be tried before Cosentyx IV.

Step	Required prior therapy	Notes
1	Generic docetaxel (Taxotere; J9171)	Must be tried before Docivyx.

Step	Required prior therapy	Notes
1	Two of: latanoprost, bimatoprost, or travoprost	Two listed prostaglandin agents must be tried before Durysta.

Step	Required prior therapy	Notes
1	All other generic, susceptible antibiotics	Try all other suitable generic antibiotics identified by culture and sensitivity or appropriate for empiric therapy.

Step	Required prior therapy	Notes
1	Rituximab-containing therapy	A documented trial and failure are required before Enjaymo coverage.

Quantity and Lifetime Limits

Casgevy quantity limits

DrugCasgevy

Lifetime quantity limitOne dose (treatment) per lifetime

Authorization duration6 months

Encelto quantity limits

DrugEncelto

Lifetime implant limit1 implant per affected eye per lifetime

Approval duration6 months

Site of Care and Administration

Billing Rule

Actemra IV infusion center and billing location

Actemra IV is an infusion-administered Part B drug. Include the place of administration on the request for billing and coverage review.

Note

Enjaymo infusion administration

Enjaymo is administered by intravenous infusion. The policy does not specify a required infusion setting.

Policy Summary

PayerPriority Health Medicare

PolicyMedicare Part B Prior Authorization and Step Therapy Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the applicable Medicare Part B prior authorization form or web form with supporting medical records.

SourceLink

On This Page

The prescriber is, or has consulted with, a specialist for the disease state.

For reauthorization

Medical records, including the patient's current weight for dosing, are provided.
The patient demonstrates beneficial response, such as decreased acute or subacute TTP events, improved platelet count from baseline, or fewer microangiopathic hemolytic anemia episodes.

Medical records supporting the request are provided.

Improved quality of life.

For lupus nephritis, SLE is confirmed and kidney biopsy shows class 3, 4, and/or 5 disease.

For SLE, standard of care includes two of a steroid, immunosuppressant, or hydroxychloroquine, each used for at least 12 weeks.

For lupus nephritis, the patient receives standard therapy, such as mycophenolate or azathioprine plus a steroid.

The patient has no contraindication to any product or procedure required for successful gene therapy treatment.

The patient has tried and failed hydroxyurea or, if not tolerated, at least one other SCD treatment such as Endari (L-glutamine).

The patient is at least 2 years of age.

The prescriber is, or has consulted with, a hematologist or other clinically appropriate provider.

For reauthorization, clinical benefit is documented, such as fewer exacerbations, improved symptoms, or reduced oral steroid use.

The prescriber is, or has consulted with, an ophthalmologist.

Medical records supporting the request are provided.

Documentation Required

Specialist involvement

The prescribing provider must be a specialist or must have consulted with a specialist for the condition being treated.

Prior Authorization

Adakveo prior authorization

Adakveo requires Medicare Part B prior authorization. Complete the Medicare Part B Non-Oncology drug request form or Web Form and submit supporting medical records.

Prior Authorization

Adzynma prior authorization

Submit prior authorization documentation for the diagnosis and laboratory criteria, including genetic confirmation of congenital TTP and ADAMTS13 activity below 10%. The drug must be prescribed by or in consultation with a disease-state specialist.

Initial and reauthorization approvals: 12 months each.
Initial prophylactic dosing is every 2 weeks unless a documented adjustment is supported.

Prior Authorization

Alhemo prior authorization

Submit prior authorization records documenting the applicable hemophilia A or B criteria. Alhemo must be prescribed by or in consultation with a hematologist or other specialist, and dosing must follow FDA-approved labeling or accepted standards of practice.

Patient must be at least 12 years old.
Hemophilia A requests require documented Hemlibra trial and failure.

Prior Authorization

Alyglo prior authorization

Submit the prior authorization request with a Part B versus Part D benefit determination and medical records documenting prior therapies and responses. Dosing must follow FDA-approved labeling or accepted standards of practice.

For requests determined to be a Part B benefit, two preferred IVIG products must be tried first.

Prior Authorization

Alymsys prior authorization

Submit prior authorization with medical records documenting prior therapies and responses. Dosing must follow FDA-approved labeling or accepted standards of practice, and criteria are applied consistent with LCD L37205.

Prior Authorization

Amvuttra prior authorization

Submit Medicare Part B prior authorization for Amvuttra with the applicable hATTR-PN or ATTR-CM records. Initial authorization and reauthorization are each for 1 year, and dosing must follow FDA-approved labeling or accepted standards of practice.

For ATTR-CM, document the required clinical findings and failed tafamidis trial.

Prior Authorization

Aralast NP prior authorization

Submit Medicare Part B prior authorization for Aralast NP with records supporting the qualifying alpha-1 antitrypsin deficiency, serum AAT level, and symptomatic emphysema. Authorization is for 2 years, with dosing according to FDA-approved labeling or accepted standards of practice.

Prior Authorization

Armlupeg prior authorization

Complete the Medicare Part B Non-Oncology drug request form or Web Form and document prior therapies and responses. Armlupeg coverage is authorized for 1 year when criteria are met, with dosing according to FDA-approved labeling or accepted standards of practice.

Prior Authorization

Asceniv prior authorization

Complete the Medicare Part B Non-Oncology drug request form or Web Form and submit supporting records. Asceniv coverage is authorized for 2 years when criteria are met, with dosing according to FDA-approved labeling or accepted standards of practice.

Complete the Part B versus Part D determination.
For a Part B benefit, two preferred IVIG products must be tried first.

Prior Authorization

Aukelso prior authorization

Complete the Medicare Part B Non-Oncology drug request form or Web Form and submit records documenting prior therapies and responses. Aukelso may be authorized for up to 2 years, with dosing according to FDA-approved labeling or accepted standards of practice.

Prior Authorization

Avastin chemotherapy prior authorization

Complete the Medicare Part B Oncology (Cancer Therapy) drug request form or Web Form for Avastin intravenous chemotherapy code J9035. Coverage may be authorized for up to 1 year when criteria are met.

Dosing must follow FDA-approved labeling or accepted standards of practice.
Apply LCD L37205 criteria.

Prior Authorization

Avastin prior authorization

Avastin intravenous requires prior authorization through the Medicare Part B Oncology drug process. Submit medical records and use dosing consistent with FDA-approved labeling or accepted standards of practice.

Coverage may be authorized for up to 1 year.
For chemotherapy code J9035, apply LCD L37205 criteria.

Prior Authorization

Aveed prior authorization

Submit Aveed through the Medicare Part B Non-Oncology drug process with medical records supporting the applicable hypogonadism or gender dysphoria criteria. Coverage may be authorized for up to 2 years when criteria are met.

Dosing must follow FDA-approved labeling or accepted standards of practice.

Prior Authorization

Avgemsi prior authorization

Submit Avgemsi through the Medicare Part B Non-Oncology drug process with medical records documenting prior therapies and responses. Coverage may be authorized for up to 1 year, with dosing according to FDA-approved labeling or accepted standards of practice.

Prior Authorization

Avtozma prior authorization

Submit Avtozma through the Medicare Part B Non-Oncology drug process with medical records documenting prior therapies and responses. Dosing must follow FDA-approved labeling or accepted standards of practice.

Coverage is for medically accepted indications not otherwise excluded.
Specialist involvement is required.

Billing Rule

Non-oncology request form

For applicable non-oncology requests, complete the Medicare Part B Non-Oncology drug request form or Web Form and provide the information required for review and billing.

Billing Rule

Oncology request form

For applicable oncology requests, complete the Medicare Part B Oncology (Cancer Therapy) drug request form or Web Form.

Prior Authorization

Avtozma authorization

Avtozma requires prior authorization with medical records, specialist involvement, and dosing consistent with FDA-approved labeling or accepted standards of practice. Coverage may be authorized for up to 2 years.

Prior Authorization

Axtle authorization

Submit Axtle prior authorization with supporting medical records and dosing consistent with FDA-approved labeling or accepted standards of practice. Coverage duration is 1 year.

Prior Authorization

Azmiro authorization

Submit Azmiro prior authorization with indication-specific medical records and dosing consistent with FDA-approved labeling or accepted standards of practice. Coverage may be authorized for up to 2 years.

Hypogonadism requests require two separate low morning testosterone levels and compatible clinical signs or symptoms.
Generic testosterone cypionate must be tried and failed.

Billing Rule

Oncology Part B request form

Complete the Medicare Part B Oncology (Cancer Therapy) drug request form or Web Form for Beizray and Beizray kit requests.

Billing Rule

Non-oncology Part B request form

Complete the Medicare Part B Non-Oncology drug request form or Web Form for Benlysta IV requests.

Documentation Required

Benlysta specialist involvement

Benlysta IV must be prescribed by a specialist in treating the condition or by a prescriber who has consulted with a specialist.

Prior Authorization

Submit the Part B drug request form

For the listed Part B drug requests, use the Medicare Part B Non-Oncology drug request form or Web Form and submit supporting medical records.

Note

Dose and authorization duration

Dose approval for Benlysta and Bkemv follows FDA-approved labeling or accepted standards of medical practice. Initial coverage is 1 year and reauthorization is 2 years for both products.

Prior Authorization

Bivigam authorization parameters

Bivigam is available for medically accepted indications not otherwise excluded when the request is determined to be a Part B benefit. Coverage is authorized for 2 years and dosing follows FDA-approved labeling or accepted standards of practice.

Two preferred IVIG products must be tried first for a Part B benefit.
Additional criteria may apply under LCD L34771.

Prior Authorization

Bomyntra prior authorization

Bomyntra requires prior authorization. Complete the Medicare Part B Non-Oncology drug request form or Web Form and submit supporting medical records.

Prior Authorization

Boruzu prior authorization

Boruzu requires prior authorization. Complete the Medicare Part B Oncology (Cancer Therapy) drug request form or Web Form and submit supporting medical records.

Prior Authorization

Bosaya prior authorization

Bosaya requires prior authorization. Complete the Medicare Part B Non-Oncology drug request form or Web Form and submit supporting medical records.

Prior Authorization

Casgevy prior authorization

Casgevy requires prior authorization. Submit the Medicare Part B Non-Oncology drug request form or Web Form and provide the indication-specific records for sickle cell disease or transfusion-dependent beta thalassemia.

Casgevy is not covered after prior HSCT or prior gene therapy.
The prescriber must be or consult with a hematologist or other clinically appropriate provider.

Prior Authorization

Cimzia prior authorization

Submit Cimzia prior authorization with specialist involvement, use within FDA-approved labeling or accepted standards of practice, and documentation that combination-therapy and step-therapy requirements are met.

Two qualifying therapies must be tried and failed.
Do not use Cimzia with another biologic, Otezla, or a JAK inhibitor.

Prior Authorization

Cinqair prior authorization

Submit Cinqair prior authorization on the Medicare Part B Non-Oncology drug request form or Web Form with supporting records, prior treatment history and responses, current weight, and applicable eosinophil results.

Prior Authorization

Cinryze prior authorization

Submit Cinryze prior authorization on the Medicare Part B Non-Oncology drug request form or Web Form with supporting records and prior treatment history and responses.

Documentation Required

Cinqair specialist prescriber requirement

For Cinqair, the prescriber must be a specialist or must have consulted with a specialist for the condition being treated.

Prior Authorization

Conexxence prior authorization

Complete the Medicare Part B Non-Oncology drug request form or Web Form for Conexxence and submit records documenting the medically accepted indication, prior therapies, and responses.

Coverage may be authorized for up to 2 years.

Prior Authorization

Cosentyx IV prior authorization

Complete the Medicare Part B Non-Oncology drug request form or Web Form for Cosentyx IV and submit records documenting prior therapies and responses. The prescriber must be a specialist or have consulted with one.

Coverage duration: 2 years.
Do not use with another biologic, Otezla, or a JAK inhibitor.

Prior Authorization

Docivyx prior authorization

Complete the Medicare Part B Non-Oncology drug request form or Web Form for Docivyx and submit supporting medical records. Coverage may be authorized for 1 year when criteria are met.

Prior Authorization

Durysta prior authorization

Complete the Medicare Part B Non-Oncology drug request form or Web Form for Durysta and submit supporting medical records documenting prior therapies and treatment response.

Coverage duration and dosing follow FDA-approved labeling or accepted standards of practice.

Documentation Required

Durysta submission requirements

Durysta requires submission of the Medicare Part B Non-Oncology drug request form or Web Form and supporting medical records.

Include documentation of prior therapies and response to treatment.

Prior Authorization

Elevidys prior authorization

Submit Elevidys through the Medicare Part B Non-Oncology drug request form or Web Form with documentation meeting the genetic and antibody eligibility requirements. The drug must be prescribed by or in consultation with a neurologist or other specialist experienced in treating DMD.

Anti-AAVrh74 titer must be less than 1:400.
The DMD mutation must not be a deletion in exon 8 or exon 9.

Prior Authorization

Emblaveo prior authorization

Submit Emblaveo through the Medicare Part B Non-Oncology drug request form or Web Form with microbiology information, infectious disease specialist involvement, and documentation that all other susceptible generic antibiotics were tried.

Provide culture and sensitivity results or identify the suspected organism when results are unavailable.
Approval is limited to 6 months.

Prior Authorization

Encelto prior authorization

Submit Encelto through the Medicare Part B Non-Oncology drug request form or Web Form with documentation of all initial coverage criteria. The drug must be prescribed by or in consultation with an ophthalmologist.

Patient must be at least 18 years old.
Coverage is limited to 1 implant per affected eye per lifetime.

Prior Authorization

Encelto authorization requirements

Encelto requires prior authorization. The patient must be at least 18 years old, and the drug must be prescribed by or in consultation with an ophthalmologist.

Prior Authorization

Enjaymo prior authorization

Enjaymo requires prior authorization. The patient must be at least 18 years old, and the drug must be prescribed by or in consultation with a hematologist.

Submit current weight, baseline hemoglobin, and supporting medical records.
Document a qualifying transfusion, CAD symptoms, and rituximab-containing regimen failure.

Prior Authorization

Entyvio prior authorization

Entyvio requires prior authorization with documentation of prior therapies and treatment responses. The prescriber must be a specialist or must have consulted with a specialist for the condition being treated.

Dose must follow FDA-approved labeling or accepted standards of practice.
Do not use with another biologic, Otezla, or a JAK inhibitor.

Step Therapy

Try Tyenne and Avtozma first

Before Actemra IV, the member must first try both Tyenne and Avtozma. Part B step therapy applies to MAPD members who are not currently receiving the Part B drug.

Step Therapy

Hydroxyurea first-line trial

Before Adakveo coverage, the patient must try hydroxyurea for 6 months unless hydroxyurea is contraindicated or not tolerated.

Step Therapy

Alhemo Hemlibra trial

For hemophilia A, the patient must have tried and failed Hemlibra before initial Alhemo approval.

Step Therapy

Alyglo preferred IVIG trials

For requests determined to be a Part B benefit, the patient must first try two preferred IVIG products, such as Gammagard Liquid, Gamunex-C, or Privigen.

Step Therapy

Alymsys Mvasi and Zirabev trials

The patient must first try both Mvasi and Zirabev before Alymsys coverage.

Step Therapy

Tafamidis trial for ATTR-CM

For Amvuttra treatment of ATTR-CM, the patient must try and fail tafamidis, specifically Vyndamax or Vyndaqel.

Step Therapy

Armlupeg Neulasta and Fulphila trials

The member must first try both Neulasta and Fulphila before Armlupeg coverage.

Step Therapy

Asceniv preferred IVIG trials

For requests determined to be a Part B benefit, the member must first try two preferred IVIG products, such as Gammagard Liquid, Gamunex-C, or Privigen.

Step Therapy

Aukelso biosimilar trials

The member must first try Wyost, Xtrenbo, and Bilprevda before Aukelso coverage.

Step Therapy

Avastin biosimilar trials

The member must first try both Mvasi and Zirabev before Avastin intravenous chemotherapy coverage.

Step Therapy

Avastin biosimilar step therapy

Before Avastin, the patient must first try both Mvasi and Zirabev.

Step Therapy

Aveed testosterone step therapy

For Aveed for hypogonadism or gender dysphoria, the patient must have tried and failed generic testosterone cypionate or enanthate and a generic topical testosterone therapy. Failure means inability to improve symptoms or testosterone levels.

Step Therapy

Avgemsi gemcitabine step

Before Avgemsi, the patient must first try generic gemcitabine injection (Gemzar).

Step Therapy

Avtozma prerequisite

For all medically accepted Avtozma indications except cytokine release syndrome, giant cell arteritis, and COVID-19 treatment, the patient must first try Avsola or Renflexis.

Step Therapy

Axtle pemetrexed prerequisite

The patient must first try generic pemetrexed before Axtle.

Step Therapy

Azmiro testosterone prerequisite

The patient must first try and fail generic testosterone cypionate before Azmiro for hypogonadism or gender dysphoria.

Step Therapy

Beizray docetaxel step

Before Beizray or Beizray kit is covered, the patient must first try generic docetaxel (Taxotere, J9171).

Step Therapy

Bivigam preferred IVIG trials

When Bivigam is determined to be a Part B benefit, the patient must first try two preferred IVIG products, such as Gammagard Liquid, Gamunex-C, or Privigen.

Step Therapy

Bkemv preferred-product sequencing

Before Bkemv, the patient must try and fail Epysqli; failure means an inadequate response or intolerance. For generalized AChR-antibody-positive myasthenia gravis, the patient must also try Vyvgart or Vyvgart Hytrulo with intolerance or inadequate response.

Step Therapy

Benlysta standard therapy

For initial Benlysta coverage in SLE, the patient must receive standard of care consisting of two of the following together for at least 12 weeks each: a steroid, an immunosuppressant, or hydroxychloroquine.

Step Therapy

Bomyntra prerequisite therapy

Before Bomyntra, the patient must first try Wyost, Xtrenbo, and Bilprevda.

Step Therapy

Boruzu prerequisite therapy

Before Boruzu, the patient must first try one generic bortezomib injectable product, such as a product billed with HCPCS code J9049 or J9041.

Step Therapy

Bosaya prerequisite therapy

Before Bosaya, the patient must first try Jubbonti, Enoby, and Bildyos.

Step Therapy

Casgevy sickle cell treatment history

For sickle cell disease, the patient must have tried and failed hydroxyurea or, if hydroxyurea was not tolerated, at least one other sickle cell disease treatment such as Endari (L-glutamine).

Step Therapy

Cimzia two-drug prerequisite

For all medically accepted indications, the patient must first try and fail two drugs with a supported use for the requested condition from the listed alternatives.

Failure means intolerance or inability to improve symptoms.
Options include a preferred adalimumab product, Rinvoq, Skyrizi, Tyenne, Cosentyx, Otezla, Xeljanz, Xeljanz XR, Yesintek/Selarsdi, or Enbrel.

Step Therapy

Cinqair asthma step therapy

For severe eosinophilic asthma, Cinqair requires a trial and failure of one ICS/LABA inhaler in combination with one other asthma controller medication during the previous 6 months.

Failure means intolerance or inability to improve the condition on required therapy for at least 4 weeks.

Step Therapy

Cinryze Haegarda prerequisite

Cinryze requires the patient to first try Haegarda.

Step Therapy

Conexxence step therapy

The member must first try Jubbonti, Enoby, and Bildyos before Conexxence is covered.

Step Therapy

Cosentyx IV step therapy

The member must first try Avsola, Renflexis, or Simponi Aria before Cosentyx IV is covered.

Step Therapy

Docivyx step therapy

The member must first try generic docetaxel, identified as Taxotere and HCPCS code J9171, before Docivyx is covered.

Step Therapy

Durysta prostaglandin therapy

Before Durysta is covered, the patient must try two of the following: latanoprost, bimatoprost, or travoprost.

Step Therapy

Emblaveo susceptible antibiotics

Before Emblaveo is covered, the patient must try all other generic, susceptible antibiotics identified by culture and sensitivity or appropriate for empiric therapy.

Step Therapy

Rituximab-containing regimen

Before Enjaymo, the patient must have a documented trial and failure of a rituximab-containing regimen.

Denial Risk

Actemra exclusions and unapproved IV use

Actemra IV may be denied when used with another biological drug, Otezla, or a Janus kinase inhibitor. Intravenous Actemra is not approved for systemic sclerosis-associated interstitial lung disease.

Denial Risk

Actemra biosimilar step therapy

Actemra IV requires prior trials of both Tyenne and Avtozma before approval.

Denial Risk

Unsupported indication, dose, or route

Requests for non-FDA-approved indications, doses, or routes require supporting evidence, including medical records or published peer-reviewed literature demonstrating medical necessity and appropriateness.

Denial Risk

Adakveo step requirement not met

Adakveo may be denied when the patient has not first tried hydroxyurea for 6 months and lacks documented hydroxyurea intolerance or contraindication.

Denial Risk

Adzynma diagnostic criteria not met

Initial Adzynma requests may be denied without genetic confirmation of congenital TTP, ADAMTS13 activity below 10%, supporting medical records, and dosing documentation.

Denial Risk

Adzynma response not demonstrated

Adzynma reauthorization may be denied without documentation of beneficial response, such as fewer acute or subacute TTP events, improved platelet count from baseline, or fewer microangiopathic hemolytic anemia episodes.

Denial Risk

Alhemo criteria or documentation not met

Alhemo may be denied when the patient is younger than 12 years, specialist involvement is absent, or the required hemophilia-specific criteria and medical records are not supplied.

Denial Risk

Alhemo clinical benefit absent

Alhemo reauthorization may be denied when routine prophylaxis is not continuing or documentation of clinical benefit is absent.

Denial Risk

Alyglo benefit determination or step failure

Alyglo Part B requests may be denied if the Part B versus Part D determination is incomplete or if the member has not first tried two preferred IVIG products.

Denial Risk

Alymsys documentation or step failure

Alymsys may be denied when required medical records are not supplied or when the patient has not first tried both Mvasi and Zirabev.

Denial Risk

Amvuttra prohibited combinations and diagnosis

Amvuttra is not covered when used with a TTR stabilizer such as tafamidis or a TTR-lowering agent such as Onpattro, or when the patient has primary light-chain amyloidosis.

Denial Risk

ATTR-CM criteria not met

Amvuttra for ATTR-CM requires a documented trial and failure of tafamidis. If disease is confirmed by radionuclide imaging, Grade 2 or 3 cardiac uptake must also be documented.

Denial Risk

Aralast NP eligibility not met

Aralast NP requires confirmed severe alpha-1 antitrypsin deficiency and symptomatic emphysema. Augmentation therapy is not indicated without confirmed deficiency or for generally non-qualifying genotypes such as PiMZ, PiSZ, or PiMS.

Denial Risk

Armlupeg step therapy and documentation

Armlupeg may be denied when the member has not first tried both Neulasta and Fulphila or when required records documenting prior therapies and treatment responses are not submitted.

Denial Risk

Asceniv Part B determination and IVIG trials

Asceniv requests require a Part B versus Part D determination. For a Part B benefit, the member must first try two preferred IVIG products and provide supporting records, including applicable LCD L34771 information.

Denial Risk

Aukelso step therapy

Aukelso may be denied when the member has not first tried Wyost, Xtrenbo, and Bilprevda or when records documenting prior therapies and responses are not submitted.

Denial Risk

Avastin step therapy and LCD criteria

Avastin intravenous chemotherapy requests under code J9035 require prior trials of both Mvasi and Zirabev and are subject to LCD L37205 criteria.

Denial Risk

Avastin biosimilar trials

Avastin may be denied if the patient has not first tried both Mvasi and Zirabev.

Denial Risk

Aveed hypogonadism criteria

Aveed for hypogonadism may be denied without failed generic testosterone cypionate or enanthate and generic topical testosterone trials, required low morning testosterone results, compatible signs or symptoms, and the stated sex-assigned-at-birth criterion.

Denial Risk

Aveed gender dysphoria step therapy

Aveed for gender dysphoria may be denied if the patient has not tried and failed generic testosterone cypionate or enanthate and a generic topical testosterone therapy.

Denial Risk

Avgemsi step requirement

Avgemsi may be denied if the patient has not first tried generic gemcitabine injection (Gemzar).

Denial Risk

Avtozma prohibited combinations

Avtozma must not be used in combination with other biologic drugs, Otezla, or Janus kinase inhibitors.

Denial Risk

Avtozma prohibited combination therapy

Avtozma may be excluded when used with another biologic drug, Otezla, or a Janus kinase inhibitor.

Denial Risk

Avtozma step therapy

For Avtozma requests outside cytokine release syndrome, giant cell arteritis, and COVID-19 treatment, the patient must first try Avsola or Renflexis.

Denial Risk

Required pemetrexed trial

Axtle requires a prior trial of generic pemetrexed.

Denial Risk

Testosterone trial and documentation

Azmiro requests require a prior trial and failure of generic testosterone cypionate. Hypogonadism requests also require diagnostic laboratory and clinical evidence.

Denial Risk

Generic docetaxel step

Beizray or Beizray kit may be denied when the member has not first tried generic docetaxel (Taxotere, J9171).

Denial Risk

Benlysta prohibited concomitant therapy

Benlysta IV must not be used with another biologic drug or Lupkynis.

Denial Risk

Benlysta disease-specific criteria

Initial Benlysta coverage may be denied when the applicable SLE or lupus nephritis clinical, laboratory, biopsy, or standard-therapy requirements are not met.

Denial Risk

Bivigam Part B and preferred-product trial

For Bivigam, failure to establish that the request is a Part B benefit or failure to try two preferred IVIG products may result in nonapproval; additional criteria may apply under LCD L34771.

Denial Risk

Bkemv clinical and combination restrictions

Bkemv may be denied when the patient has not failed the required preferred therapy, diagnostic or response criteria are not met, required records are absent, or Bkemv is combined with prohibited therapies.

Denial Risk

Benlysta standard therapy and response

For Benlysta, requests may fail when required standard therapy has not been used for the specified duration or when reauthorization lacks evidence of clinical improvement.

Denial Risk

Bomyntra prior therapies

Bomyntra may be denied or not approved when prior treatment with Wyost, Xtrenbo, and Bilprevda is not documented.

Denial Risk

Boruzu prerequisite

Boruzu requires prior use of one generic bortezomib injectable product. Failure to document this prerequisite may result in denial.

Examples include products billed with HCPCS J9049 or J9041.

Denial Risk

Bosaya prior therapies

Bosaya may be denied or not approved when prior treatment with Jubbonti, Enoby, and Bildyos is not documented.

Documentation Required

Insufficient clinical documentation

Medical records supporting the request, including documentation of prior therapies and responses to treatment, must be submitted.

Denial Risk

Casgevy prior transplant or gene therapy

Casgevy is not covered for patients with prior hematopoietic stem cell transplantation or prior gene therapy.

Denial Risk

Casgevy clinical criteria

Casgevy may be denied when the patient does not meet the required disease, genotype, severity, organ-function, transplant-eligibility, contraindication, treatment-history, donor-availability, or age criteria.

Denial Risk

Cimzia prohibited combination therapy

Cimzia must not be used in combination with another biologic drug, Otezla, or a Janus kinase inhibitor.

Denial Risk

Cimzia step therapy

Cimzia requests require failure of two listed supported-use therapies before coverage for medically accepted indications.

Denial Risk

Cinqair concomitant biologic therapy

Cinqair must not be used in combination with other biologic drugs.

Denial Risk

Cinqair asthma treatment failure

For severe eosinophilic asthma, the patient must have tried and failed the required controller regimen. Failure means intolerance or inability to improve the condition despite at least 4 weeks of required therapy.

Denial Risk

Cinryze Haegarda step

Cinryze requires prior use of Haegarda.

Denial Risk

Cosentyx prohibited combination therapy

Cosentyx IV must not be used in combination with other biologic drugs, Otezla, or Janus kinase inhibitors.

Denial Risk

Conexxence biosimilar trials

Conexxence requires prior trials of Jubbonti, Enoby, and Bildyos.

Denial Risk

Cosentyx first-line biologic

Cosentyx IV requires a prior trial of Avsola, Renflexis, or Simponi Aria.

Denial Risk

Docivyx docetaxel trial

Docivyx requires a prior trial of generic docetaxel.

Denial Risk

Durysta prostaglandin trials

Durysta requests may be denied when the patient has not tried two of the following: latanoprost, bimatoprost, or travoprost.

Denial Risk

Elevidys eligibility

Elevidys may be denied when DMD is not genetically confirmed, the DMD mutation includes a deletion in exon 8 or exon 9, or the anti-AAVrh74 titer is not less than 1:400.

Denial Risk

Emblaveo documentation or step therapy

Emblaveo may be denied when culture and sensitivity information or the suspected organism is not provided, infectious disease specialist involvement is absent, or all other susceptible generic antibiotics have not been tried.

Denial Risk

Encelto eligibility or lifetime limit

Encelto may be denied when the patient has prior Encelto treatment, lacks documented MacTel type 2 or required test findings, has a BCVA score worse than the stated threshold, has neovascular MacTel, is younger than 18, or the lifetime implant limit has been reached.

Denial Risk

Encelto eligibility requirements

Encelto may be denied when the patient has previously received an Encelto implant, lacks test-supported MacTel type 2, does not meet the IS/OS photoreceptor break or BCVA thresholds, has neovascular MacTel, is under age 18, or required medical records are not submitted.

Denial Risk

Enjaymo biologic combination exclusion

Enjaymo is not covered when used in combination with biologic drugs.

Denial Risk

Enjaymo clinical criteria

Enjaymo may be denied without a confirmed diagnosis of cold agglutinin disease, a blood transfusion within 6 months before starting treatment, qualifying CAD symptoms, and documented failure of a rituximab-containing regimen.

Denial Risk

Entyvio combination exclusion

Entyvio is not covered when used in combination with other biologic drugs, Otezla, or Janus kinase inhibitors.

Genetic congenital TTP confirmation; ADAMTS13 below 10%; supporting records and current weight; specialist prescriber or consultation; and prophylactic dosing every 2 weeks unless documented support for weekly dosing.ADAMTS13 <10%; 12 months

Alhemo initial therapy

The applicable indication pathway is required.

ANY of the following

Hemophilia A: Routine prophylaxis; hemophilia A with or without factor VIII inhibitors; and Hemlibra failure.
Hemophilia B: Routine prophylaxis and hemophilia B with or without factor IX inhibitors.

Amvuttra initial hATTR-PN

All hATTR-PN criteria are required.

TTR mutation, baseline PND score IIIb or lower, and clinical signs or symptoms.PND ≤ IIIb

Amvuttra initial ATTR-CM

All ATTR-CM criteria are required.

NYHA I–III heart failure; ECHO or CMR cardiac involvement; diagnostic confirmation; tafamidis failure; and Grade 2 or 3 uptake if radionuclide imaging confirms diagnosis.NYHA I–III; uptake Grade 2–3

Armlupeg initial therapy

Both prior therapies are required.

Neulasta and Fulphila have been tried, with prior therapies and responses documented.

Asceniv initial therapy

For a Part B benefit, the required preferred-product trial applies.

Preferred IVIG products: Try two preferred IVIG products, such as Gammagard Liquid, Gamunex-C, or Privigen.2 products

Aukelso initial therapy

All listed biosimilar trials are required.

Try Wyost, Xtrenbo, and Bilprevda before Aukelso.

Avastin initial therapy

Both biosimilar trials are required.

Try Mvasi and Zirabev before Avastin chemotherapy under J9035.J9035

Avastin initial biosimilar therapy

Both biosimilar trials are required.

Try Mvasi and Zirabev before Avastin.

Aveed initial therapy

Meet the applicable indication pathway.

ANY of the following

Hypogonadism: Failure of generic testosterone cypionate or enanthate and topical testosterone; two low morning testosterone levels; compatible symptoms; assigned male at birth.Two levels <300 ng/dL or low by laboratory range
Gender dysphoria: Failure of generic testosterone cypionate or enanthate and topical testosterone.

Avgemsi initial therapy

The prerequisite is required.

Try generic gemcitabine injection (Gemzar) before Avgemsi.

Avtozma initial therapy

All initial criteria apply.

Medically accepted indication, supporting records, and specialist prescriber or consultation; and Avsola or Renflexis tried unless the indication is cytokine release syndrome, giant cell arteritis, or COVID-19 treatment.

Axtle initial therapy

All initial criteria apply.

Medically accepted indication supported by records and prior generic pemetrexed trial.

Azmiro initial therapy

Meet the applicable indication pathway.

ANY of the following

Hypogonadism: Generic testosterone cypionate failure; two separate low morning testosterone levels; compatible symptoms; assigned male at birth.Two levels <300 ng/dL or low by laboratory range
Gender dysphoria: Generic testosterone cypionate failure.

Beizray initial therapy

All initial criteria apply.

Medically accepted indication; supporting records; generic docetaxel tried first; and appropriate dosing.

Beizray kit initial therapy

All initial criteria apply.

Medically accepted indication; supporting records; generic docetaxel tried first; and appropriate dosing.

Benlysta IV initial therapy

Meet the applicable disease-specific pathway.

ANY of the following

SLE: SELENA-SLEDAI ≥6; anti-dsDNA >30 IU/mL or ANA >1:80; and two standard therapies together for at least 12 weeks each.
Lupus nephritis: Confirmed SLE; biopsy-confirmed class 3, 4, and/or 5 disease; and standard therapy such as mycophenolate or azathioprine plus a steroid.

Benlysta initial therapy

Standard therapy is required before initial coverage.

ANY of the following

SLE: Two of a steroid, immunosuppressant, or hydroxychloroquine together for at least 12 weeks each.
Lupus nephritis: Standard therapy such as mycophenolate or azathioprine plus a steroid.

Bivigam initial therapy

For a Part B benefit, all criteria apply.

Part B benefit determination and two preferred IVIG products tried first.Two products

Bkemv initial therapy

The applicable indication-specific criteria are required.

Meet the NMOSD, PNH, aHUS, or generalized myasthenia gravis pathway, including required diagnosis, Epysqli failure, prohibited-combination restrictions, and supporting records; myasthenia gravis also requires Vyvgart or Vyvgart Hytrulo failure.

Bomyntra initial therapy

All listed step therapy is required.

Try Wyost, Xtrenbo, and Bilprevda before Bomyntra.

Boruzu initial therapy

One prior injectable product is required.

Try one generic injectable bortezomib product before Boruzu.

Examples: HCPCS J9049 or J9041.

Bosaya initial therapy

All listed step therapy is required.

Try Jubbonti, Enoby, and Bildyos before Bosaya.

Casgevy sickle cell initial therapy

All sickle cell disease criteria are required.

Qualifying genotype; at least 2 severe vaso-occlusive events per year for 2 years; adequate organ function; HSCT eligibility; no contraindication; current weight; and hydroxyurea failure or alternative SCD treatment if hydroxyurea was not tolerated.≥2 events/year for 2 years

Casgevy beta thalassemia initial therapy

All beta thalassemia criteria are required.

Transfusion-dependent beta thalassemia; no known available HLA-matched donor; and provider attestation of clinical stability and HSCT eligibility without such a donor.≥100 mL/kg/year or ≥10 units/year pRBC for 2 years

Cimzia initial authorization

All initial criteria are required.

Medically accepted indication; specialist prescriber or consultation; no prohibited combination; and failure of two qualifying therapies.2 failed therapies

Cinqair initial therapy

All initial criteria are required.

Elevated eosinophils; failure of one ICS/LABA plus one other controller during the past 6 months, with at least 4 weeks of therapy; supporting records; and current weight.≥150 at start or ≥300 in prior 12 months; ≥4 weeks

Cinryze initial therapy

All initial criteria are required.

Supporting records including prior therapies and responses, and prior Haegarda trial.

Conexxence initial therapy

All listed prior products are required.

Try Jubbonti, Enoby, and Bildyos before Conexxence.

Cosentyx IV initial therapy

At least one listed prior biologic is required.

Try Avsola, Renflexis, or Simponi Aria before Cosentyx IV.

Docivyx initial therapy

The prior chemotherapy trial is required.

Try generic docetaxel before Docivyx.

Taxotere; HCPCS J9171.

Durysta initial therapy

All initial criteria are required.

Medically accepted indication; supporting records; and two of latanoprost, bimatoprost, or travoprost tried.Two of three agents

Elevidys initial therapy

All initial criteria are required.

Genetically confirmed DMD without exon 8 or 9 deletion; anti-AAVrh74 titer below 1:400; and neurologist or experienced DMD specialist prescriber or consultation.<1:400

Emblaveo initial therapy

All initial criteria are required.

Culture and sensitivity results or suspected organism; infectious disease specialist prescriber or consultation; and all other susceptible generic antibiotics tried.Approval limited to 6 months

Encelto initial therapy

All initial criteria are required.

Age at least 18; no previous Encelto implant; test-supported MacTel type 2; IS/OS PR break 0.16–2.00 mm²; BCVA ≥54 letters; no neovascular MacTel; supporting records; and ophthalmologist prescriber or consultation.1 implant per affected eye per lifetime

Encelto clinical initial therapy

All listed clinical, diagnostic, age, prescriber, and documentation criteria are required.

No previous implant; confirmed MacTel type 2; IS/OS break 0.16–2.00 mm²; BCVA ≥54 ETDRS letters; no neovascular disease; records submitted; age ≥18; and ophthalmologist prescriber or consultation.

Enjaymo initial therapy

All initial criteria are required.

Confirmed CAD; transfusion within 6 months; qualifying CAD symptom; rituximab-containing regimen failure; age ≥18; hematologist prescriber or consultation; and supporting records.

Entyvio initial therapy

All initial criteria are required.

Medically accepted, non-excluded indication; prior therapies and responses documented; specialist prescriber or consultation; no prohibited combination; and dosing within FDA labeling or accepted standards.

Continues Alhemo for routine prophylaxis and demonstrates clinical benefit, such as fewer bleeding episodes or reduced factor or bypassing-agent use.

Amvuttra continuation therapy

A positive response from baseline is required.

ANY of the following

hATTR-PN: Improved neuropathy, motor function, quality of life, or slowed progression.
ATTR-CM: Reduced cardiovascular hospitalizations, improved function, or improved quality of life.

Benlysta IV reauthorization

Clinical improvement is required.

ANY of the following

SLE: Clinical improvement since starting Benlysta.
Lupus nephritis: Clinical improvement including improved or stable eGFR.

Benlysta continuation

The applicable response criterion is required.

For SLE, clinical improvement since starting Benlysta; for lupus nephritis, clinical improvement including improved or stable eGFR.

Bkemv continuation

The applicable indication-specific response is required.

NMOSD: decreased relapse rate; PNH: improved symptoms and hematologic or transfusion response; aHUS: decreased thrombotic microangiopathy signs; myasthenia gravis: improved MG-ADL score, with applicable combination restrictions and records.

Cinqair reauthorization

Documented clinical benefit is required.

Clinical benefit such as decreased exacerbations, improved symptoms, or decreased oral steroid use.

Elevidys continuation

Reauthorization is available for 1 year.

The patient continues to meet applicable eligibility requirements and treatment follows FDA labeling or accepted standards.1 year