CurrentHealthPartnersPolicy N/A

Medicare Part B Drugs Requiring Step Therapy

Defines step therapy requirements for selected Medicare Part B drugs for HealthPartners Medicare Advantage plans and describes when non-preferred products may be authorized. Affects providers prescribing these Part B medications for HealthPartners Medicare members.

Policy Summary

PayerHealthPartners

PolicyMedicare Part B Drugs Requiring Step Therapy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionUse the preferred step agent for patients new-to-therapy unless an exception is met; document medical necessity and prior treatment history to support exceptions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiple agentslisted preferred step agents for biologics and specialty drugs

3 exceptionsconditions allowing coverage of non-preferred product

Medicare Advantage plansapplies to

Coverage and Step Therapy Criteria

Initial coverage with step therapy and exceptions

Covered when ALL of the following are met

Policy Summary

PayerHealthPartners

PolicyMedicare Part B Drugs Requiring Step Therapy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionUse the preferred step agent for patients new-to-therapy unless an exception is met; document medical necessity and prior treatment history to support exceptions.

SourceLink

On This Page

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Step agent required for new-to-therapy: Patient is new-to-therapy and trial of the preferred (step) agent is required before coverage of the non-preferred medication.

Refer to specific step agents listed in policy chunks 3-4 and 6-7.

Exceptions allowing non-preferred coverage: Coverage of a non-preferred product is authorized when ANY of the following are met: (1) medical necessity has been demonstrated based on applicable medical necessity criteria; (2) the patient has been taking the non-preferred medication and is stable on the non-preferred product; (3) the patient has tried and failed or has medical contraindications to preferred products.

See chunk 7 for exact exception language.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization and Reference Materials

Applies to Medicare Advantage plans only. Step therapy requirements apply and prior authorization may be required; reference the external step-therapy list and any applicable Medicare NCDs/LCDs for full medical necessity coverage criteria. If there is no applicable NCD or LCD, the Medicare Benefit Policy Manual will be used to determine coverage.

HealthPartners Medicare products in scope include Journey (H4882), Robin (H4882), Freedom (H2462), MSHO (H2422)

Step Therapy

General Step Therapy Requirement

Use of the preferred medication (step agent) is required for patients new-to-therapy. Patients new-to-therapy are defined as those who have not yet taken the medication being requested for coverage. Patients who are stable on a non-preferred medication may continue that medication if medical necessity requirements are met.

Failure to use the preferred step agent for patients new-to-therapy may result in lack of coverage unless an exception is met

Documentation Required

Documentation and Exception Criteria

Coverage for a non-preferred product may be authorized when all of the following are met: (1) medical necessity is demonstrated based on applicable Medicare coverage criteria; and (2) the patient is stable on the non-preferred medication, or (3) the patient has tried and failed or has medical contraindications to preferred products. Providers should reference applicable Medicare NCDs/LCDs or the Medicare Benefit Policy Manual for complete medical necessity documentation requirements.

Document prior therapy, treatment response, and any contraindications when requesting an exception
The step therapy list may change at any time — verify current preferred agents prior to prescribing

Denial Risk

Denial Risk for Not Using Preferred Agent

Failure to use the preferred step agent for patients new-to-therapy without meeting exception criteria may result in claim denial or lack of coverage.

Denial risk applies to new-to-therapy requests where preferred agent was not tried and no exception documented

Policy Background

Step therapy is a utilization management tool that requires a trial of a preferred medication (the step agent) before coverage will be provided for a non-preferred agent for members who are new-to-therapy. This policy requires use of the preferred step agent for patients who have not previously taken the requested medication unless an exception is documented and meets the policy’s exception criteria.

Exceptions that may allow coverage of a non-preferred product include situations where medical necessity is demonstrated per applicable Medicare medical necessity criteria, the patient is already stable on the non-preferred medication, or the patient has tried and failed or has a contraindication to preferred agents. Providers should be prepared to document prior treatment history and medical necessity when requesting coverage of a non-preferred product.

Key Definitions

Patient New-to-therapy definition

DefinitionA 'Patient New-to-therapy' is a patient who has not yet taken the medication being requested for coverage.

Implication for step therapyPatients new-to-therapy are required to trial the preferred (step) agent before coverage of a non-preferred medication is considered.

Exceptions relevanceExceptions (medical necessity, stability on a non-preferred product, or contraindication/failure of preferred agents) may allow coverage without a step-agent trial.

Documentation noteProviders should be prepared to document prior treatment history and medical necessity to support exceptions for patients not following step therapy.

Initial Therapy — Preferred Step Agents

Initial therapy step agent mappings

Preferred step agents for specific products

Specific step agent mappings: Inflectra or Renflexis are the preferred (step) agents for Remicade and other infliximab products; Kanjinti, Ogivri, or Trazimera are the preferred agents for Herceptin and single-agent trastuzumab products; Ruxience or Truxima are the preferred agents for Rituxan and rituximab products (including Enjaymo where listed); Mvasi or Zirabev are the preferred agents for Avastin and bevacizumab products; Neulasta, Neulasta Onpro, Fulphila, or Ziextenzo are the preferred agents for listed long-acting G-CSF products; Feraheme, Ferrlecit, Infed, or Venofer are the preferred agents for listed IV iron products; Ocular Avastin is the preferred agent for listed ocular anti-VEGF products; Generic pemetrexed or Alimta are preferred for pemetrexed products; Generic docetaxel is preferred for docetaxel products; Erbitux is preferred for Vectibix; Repatha is the preferred agent for Leqvio and Evkeeza (Part D only); Ajovy is the preferred agent for Vyepti (Part D only); IV steroids (e.g., methylprednisolone) are the preferred agents for Tepezza; and additional mappings are listed in chunks 3-4 and 6-7.

Use the full step-agent table in chunks 3-4 and 6-7 for complete product-to-step mappings.

Continuation Therapy

Continuation therapy

Continuation for patients stable on non-preferred products

Continuation allowed: Patients who are stable on a non-preferred medication will have continued coverage of the non-preferred medication if other requirements of medical necessity are met.

Document stability and ongoing medical necessity per applicable NCDs/LCDs or the Medicare Benefit Policy Manual.

Step Therapy Table and Specific Drug Mappings

Non-preferred medication or group	Step agent / Preferred medication	Coverage
Remicade and infliximab products not listed at right	Inflectra or Renflexis	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Herceptin, Herceptin Hylecta, and single-agent trastuzumab products not listed at right	Kanjinti, Ogivri, or Trazimera	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Rituxan and rituximab products not listed at right	Ruxience or Truxima	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Avastin and bevacizumab products not listed at right	Mvasi or Zirabev	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Udenyca, Udenyca Onbody, Nyvepria, Ryzneuta, Fylnetra, Rolvedon, and other long-acting G-CSF products not listed at right	Neulasta, Neulasta Onpro, Fulphila, or Ziextenzo	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Injectafer, Monoferric, Triferic and IV iron products not listed at right	Feraheme, Ferrlecit, Infed, or Venofer	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Eylea, Eylea HD, Beovu, Lucentis, Susvimo, Byooviz, Cimerli, Vabysmo, and other ocular anti-VEGF products not listed at right	Ocular Avastin	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Saphnelo	Benlysta	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Durolane, Genvisc, Hyalgan, Supartz, Visco-3, Hymovis, OrthoVisc, Gel-One, Monovisc, Gel-Syn, Trivisc, Synojoynt, Triluron, and other intra-articular hyaluronan products not listed at right	Euflexxa, Synvisc, or Synvisc One	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Lanreotide (Somatuline Depot, Cipla)	Sandostatin or Sandostatin LAR	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Cimzia IV	Inflectra or Renflexis	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Pemetrexed products (Pemfexy, Pemrydi RTU, Axtle and others) not listed at right	Generic pemetrexed or Alimta	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Docivyx and docetaxel products not listed at right	Generic docetaxel	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Vectibix	Erbitux	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Entyvio IV	Inflectra or Renflexis	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Enjaymo	Ruxience or Truxima	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Leqvio, Evkeeza	Repatha (Part D only)	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Vyepti	Ajovy (Part D only)	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Tepezza	IV steroids (e.g. methylprednisolone)	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Orencia	Generic methotrexate	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage
Multiple other products listed (e.g., Fasenra, Nucala, Cinqair, Xolair, Tezspire, Ilumya, etc.)	Referenced alternative preferred agents as listed (see policy)	Use preferred step agent for patients new-to-therapy; exceptions may allow coverage

Preferred Biosimilar Step Agents

Billing Rule

Inflectra or Renflexis are the preferred step agents for infliximab products

For infliximab products (including Remicade and listed infliximab items), the preferred step agents are the infliximab biosimilars Inflectra or Renflexis; providers should use these step agents for patients new-to-therapy unless an exception is met.

Billing Rule

Kanjinti, Ogivri, or Trazimera are the preferred trastuzumab step agents

For Herceptin and single-agent trastuzumab products not otherwise listed, the preferred step agents are the trastuzumab biosimilars Kanjinti, Ogivri, or Trazimera; these are the step agents to be used for patients new-to-therapy unless an exception applies.

Billing Rule

Ruxience or Truxima are the preferred rituximab step agents

For Rituxan and other rituximab products (and Enjaymo), the preferred step agents are the rituximab biosimilars Ruxience or Truxima; providers should use these biosimilars as the step agents for patients new-to-therapy unless an exception is met.

Billing Rule

Mvasi or Zirabev are the preferred bevacizumab step agents

For Avastin and other bevacizumab products not listed separately, the preferred step agents are the bevacizumab biosimilars Mvasi or Zirabev; use these step agents for patients new-to-therapy unless an exception applies.