Part B Step Therapy Program Prior Authorization Criteria
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Defines step therapy prior authorization requirements for selected Part B drugs (medical benefit) and biosimilars for Quartz members; applies to providers requesting coverage for the listed HCPCS/J-codes and brand/generic products under the insurer's Part B program.
Add new denosumab step (Prolia, Xgeva, Ospomyv, Xbryk, Jubbonti, Wyost, Aukelso, Bosaya, Osenvelt, Stoboclo, Bomyntra, Conexxence, Osvyrti, Jubereq, Boncresa, Oziltus).
Add Armlupeg.
Remove bevacizumab.
Coverage Criteria
Long-acting colony stimulating factors - Non-Preferred
Covered when ALL of the following are met for non-preferred long-acting colony stimulating factors
Required prior trials of two preferred long-acting CSFs
Short-acting colony stimulating factors - Non-Preferred
Covered when ALL of the following are met for non-preferred short-acting colony stimulating factors
Required prior trials of two preferred short-acting CSFs
Denosumab - Non-Preferred
Covered when ALL of the following are met for non-preferred denosumab products
Must demonstrate trial/failure of the specified preferred denosumab biosimilars/alternatives
Epoetin alfa - Non-Preferred
Covered when ALL of the following are met for non-preferred epoetin alfa products
Retacrit is preferred; trial required before Procrit/Epogen
Hyaluronidase products - Non-Preferred
Covered when ALL of the following are met for non-preferred hyaluronidase/viscosupplementation products
Required prior trials of two preferred viscosupplements
Infliximab - Non-Preferred
Covered when ALL of the following are met for non-preferred infliximab products
Required prior trials of two preferred infliximab biosimilars
Inclisiran (Leqvio) - Non-Preferred
Covered when ALL of the following are met for non-preferred inclisiran
Statin requirement applies as stated
Rituximab - Non-Preferred
Covered when ALL of the following are met for non-preferred rituximab products
Required prior trials of two preferred rituximab biosimilars
Trastuzumab - Non-Preferred
Covered when ALL of the following are met for non-preferred trastuzumab products
Required prior trials of two preferred trastuzumab biosimilars
This policy follows applicable Medicare coverage guidance. Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and related manuals apply where relevant; providers should consult the Medicare Coverage Database for the most current Medicare policy. Where Medicare coverage differs from this policy, the applicable NCDs/LCDs take precedence.
Coding and HCPCS/J-code Lists
| J0897 | Denosumab (Prolia, Xgeva, Ospomyv, Xbryk, Jubbonti, Wyost, Aukelso, Bosaya, Osenvelt, Stoboclo, Bomyntra, Conexxence, Osvyrti, Jubereq, Boncresa, Oziltus) |
| Q5136 | Denosumab - see listed brands |
| Q5157 | Denosumab - see listed brands |
| Q5158 | Denosumab - see listed brands |
| Q5159 | Denosumab - see listed brands |
| Q5161 | Denosumab - see listed brands |
| Q5165 | Denosumab - see listed brands |
| Q5166 | Denosumab - see listed brands |
| J7318 | Hyaluronidase/viscosupplementation products |
| J7320 | Hyaluronidase/viscosupplementation products |
| J7321 | Hyaluronidase/viscosupplementation products |
| J7326 | Hyaluronidase/viscosupplementation products |
| J7328 | Hyaluronidase/viscosupplementation products |
| J7322 | Hyaluronidase/viscosupplementation products |
| J7327 | Hyaluronidase/viscosupplementation products |
| J7324 | Hyaluronidase/viscosupplementation products |
| J7331 | Hyaluronidase/viscosupplementation products |
| J7332 | Hyaluronidase/viscosupplementation products |
Provider Actions and Requirements
Prior authorization required; approvals limited to 12 months
Prior authorization is required for the listed Part B J- and Q-codes; approvals are limited to 12 months per listed product unless otherwise noted.
Step therapy: document required trials/failures of preferred agents
Providers must document trials and failures (or contraindication/intolerance) of the specified preferred drugs before coverage of non-preferred products; the required number of failed preferred agents varies by class (typically two agents or the specific pair noted for denosumab and inclisiran).
- Most classes require history of trial and failure, contraindication, or intolerance to TWO preferred agents (e.g., long- and short-acting CSFs, hyaluronidase products, infliximab, rituximab, trastuzumab).
- Denosumab requires trial/failure, contraindication, or intolerance to either (1) Enoby and Bildyos, or (2) Xtrenbo and Bilprevda (the specified pair).
- Inclisiran requires trial/failure or contraindication/intolerance to Repatha AND the member must be on (or intolerant/contraindicated to) high‑intensity or maximally tolerated statin therapy as specified.
Required documentation: trials, failures, contraindications/intolerances, and continuation evidence
Providers must document prior trials, failures, contraindications, or intolerances to the required preferred products and, when requesting continuation, evidence the member received the prior therapy within the past 365 days.
- Document the specific preferred agents tried and the reason for failure, intolerance, or contraindication.
- For continuation requests, provide documentation showing prior therapy within the last 365 days to qualify for continuation without re‑meeting step therapy.
Denial risk if step therapy or Medicare coverage requirements are unmet
Requests that do not meet the step therapy restrictions or applicable Medicare NCDs/LCDs may be denied.
- Confirm applicability of Medicare NCDs/LCDs; where Medicare coverage differs, NCDs/LCDs apply and lack of compliance may result in denial.
Background
This policy implements a Part B step therapy prior authorization program for medical-benefit drugs and biosimilars. Drugs are grouped by class with designated preferred and non-preferred products, and coverage of non-preferred agents requires documented trials of the specified preferred agents or documentation of contraindication or intolerance. Providers must supply evidence of prior trials and failures (or contraindication/intolerance) as described in the class-specific criteria, and continuation rules and Part D–specific notes apply where stated.
Definitions
Initial Therapy Criteria
Initial therapy requirements
Initial coverage requires trials of preferred agents
See class-specific step therapy details
Continuation Therapy Criteria
Continuation of therapy
Continuation criteria
Applies to continuation of therapy
Part D specific requirement
Part D note
Policy includes Part D-specific requirement for inclisiran
Step Therapy Details
| Drug class / non-preferred product(s) | Required documented trial(s) of preferred agent(s) |
|---|---|
| Long-acting colony stimulating factors — Non-preferred: Neulasta; Neulasta Onpro; Armlupeg; Fylnetra; Stimufend; Ziextenzo; Rolvedon; Ryzneuta | History of trial and failure, contraindication, or intolerance to TWO of: Nyvepria, Fulphila, Udenyca, Udenyca Autoinjector, Udenyca On-body |
| Short-acting colony stimulating factors — Non-preferred: Neupogen | History of trial and failure, contraindication, or intolerance to TWO of: Granix, Nivestym, Nypozi, Releuko, Zarxio |
| Denosumab — Non-preferred: Prolia, Xgeva, Ospomyv, Xbryk, Jubbonti, Wyost, Aukelso, Bosaya, Osenvelt, Stoboclo, Bomyntra, Conexxence, Osvyrti, Jubereq, Boncresa, Oziltus | History of trial and failure, contraindication, or intolerance to either (1) Enoby and Bildyos, or (2) Xtrenbo and Bilprevda |
| Epoetin alfa — Non-preferred: Procrit, Epogen | History of trial and failure, contraindication, or intolerance to Retacrit |
| Hyaluronidase / viscosupplementation products — Non-preferred: Durolane; Gel-One; Gelsyn-3; GenVisc 850; Hyalgan; Hymovis; Orthovisc; Monovisc; Supartz FX; Synojoynt; TriVisc; Triluron; Visco-3 | History of trial and failure, contraindication, or intolerance to TWO of: Euflexxa, Synvisc, Synvisc-One |
| Infliximab — Non-preferred: Remicade, Renflexis, infliximab unbranded | History of trial and failure, contraindication, or intolerance to TWO of: Inflectra, Avsola |
| Inclisiran (Leqvio) — Non-preferred: Inclisiran | History of trial and failure, contraindication, or intolerance to Repatha AND member is currently taking a high‑intensity OR maximally tolerated statin, or has statin contraindication/intolerance |
| Rituximab — Non-preferred: Rituxan | History of trial and failure, contraindication, or intolerance to TWO of: Riabni, Ruxience, Truxima |
| Trastuzumab — Non-preferred: Herceptin, Herzuma, Ogivri, Ontruzant, Hercessi | History of trial and failure, contraindication, or intolerance to TWO of: Kanjinti, Trazimera |
Quantity Limits
Biosimilar Guidance
Try preferred rituximab biosimilars before Rituxan
Before Rituxan (Rituximab) will be approved, the patient must have a history of trial and failure, contraindication, or intolerance to TWO of the preferred rituximab biosimilars Riabni, Ruxience, and Truxima.
- Preferred agents to try: Riabni, Ruxience, Truxima
- Required failures: two of the listed preferred biosimilars
Try preferred infliximab biosimilars before Remicade/Infliximab
Before coverage of Remicade, Renflexis, or unbranded infliximab, the patient must have a history of trial and failure, contraindication, or intolerance to TWO of the preferred infliximab biosimilars Inflectra and Avsola.
- Preferred agents to try: Inflectra, Avsola
- Required failures: two of the listed preferred biosimilars
Try preferred trastuzumab biosimilars before Herceptin
Before Herceptin or other non-preferred trastuzumab products are approved, the patient must have a history of trial and failure, contraindication, or intolerance to TWO of the preferred trastuzumab biosimilars Kanjinti and Trazimera.
- Preferred agents to try: Kanjinti, Trazimera
- Required failures: two of the listed preferred biosimilars
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