Nplate (romiplostim) — Medicare Part B coverage and prior authorization criteria
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Medicare Part B coverage, prior authorization, and renewal criteria for Nplate (romiplostim) for Aloha Care Medicare members; includes clinical indications, dosing references, and transition/step therapy rules.
Added Continuity of Care requirement.
Coverage Criteria for Nplate (romiplostim)
Nplate Coverage Criteria
Covered when ALL of the following are met:
ALL of the following
ALL of the following
- Prescribed by or in consultation with a hematologist/oncologist
ANY of the following
- Hematopoietic subsyndrome of acute radiation syndrome (HS-ARS): member acutely exposed to myelosuppressive radiation >2 gray (Gy)
ALL of the following
- Baseline platelet count <30,000/mcL
- Inadequate response or intolerance to prior therapy with one of: corticosteroids (e.g., dexamethasone, prednisone), immune globulins (e.g., Gammaplex, Gammagard S/D), or splenectomy
ALL of the following
- Platelet count <100 x 10^9/L for at least 3–4 weeks after last chemotherapy administration OR platelets <100 x 10^9/L with delays in chemotherapy related to thrombocytopenia
- Member was receiving a cytotoxic chemotherapy agent known to cause thrombocytopenia
- Goal of therapy is to maintain chemotherapy dosing schedule and/or intensity when benefit outweighs risks
ALL of the following
- Diagnosis of lower‑risk MDS (per IPSS‑R/IPSS/WPSS definitions)
- Severe or refractory thrombocytopenia following progression or no response to hypomethylating agents or immunosuppressive therapy
ALL of the following
- Documentation of response to therapy as confirmed by increased platelet counts
ANY of the following
- For ITP: continuation to maintain platelet count 50–100 x 10^9/L
- For CIT: continuation to maintain platelet count 100–150 x 10^9/L to allow resumption of chemotherapy
- For MDS: documentation of clinical benefit or response per treating clinician
ALL of the following
- Not approved to normalize platelet counts or to treat thrombocytopenia caused by conditions other than the listed indications
Covered Regimens and Dosing
| Indication | Regimen | Coverage |
|---|---|---|
| Hematopoietic subsyndrome of acute radiation syndrome (HS-ARS) | ||
| Single 10 mcg/kg subcutaneous (subQ) injection administered as soon as possible after suspected or confirmed exposure to radiation >2 Gy; administer regardless of whether a CBC can be obtained; estimate whole-body absorbed dose using public health/biodosimetry/clinical findings. | ||
| Covered for a single administration per episode |
| Indication | Regimen | Coverage |
|---|---|---|
| Immune thrombocytopenia (ITP) — relapsed/refractory or insufficient response to corticosteroids, IVIG, or splenectomy | ||
| Initial dose 1 mcg/kg subQ once weekly (actual body weight); increase weekly in 1 mcg/kg increments to achieve platelet counts ≥50 x10^9/L; maximum weekly dose 10 mcg/kg; discontinue if platelet count is not adequate to control bleeding after 4 weeks at the maximum dose. | ||
| Covered with criteria to document prior therapies and response; max weekly dose 10 mcg/kg |
Billing Codes and Limits
| J2796 | Injection, romiplostim, 10 mcg [Nplate] |
Provider Actions, Prior Authorization, and Transition Rules
Prior authorization required; Approval durations
Prior authorization is required for Nplate (romiplostim) under the medical benefit (HCPCS J2796). Initial approvals are 6 months for all indications except HS-ARS; renewals are 12 months. For HS-ARS, approval is limited to a single administration per episode.
- HCPCS J2796 — Injection, romiplostim, 10 mcg [Nplate] — Medical Benefit: Authorization Required
- Initial approval duration: 6 months for all indications except HS-ARS
- Renewal approval duration: 12 months
- HS-ARS: single administration per episode
90‑day transition period for new Medicare members
For new Medicare members there is a 90‑day transition period during which Coverage and Step Therapy do not apply if the member is on an active course of the requested treatment (including when furnished by an out‑of‑network provider). After 90 days of enrollment, Coverage and Step Therapy criteria must be met for continued coverage.
- Transition period length: 90 days
- Applies when member is on an active regimen at enrollment, including out‑of‑network treatments
- After 90 days, standard Coverage and Step Therapy requirements apply
Step therapy requirement for new starts (despite 'No step therapy' note)
The document states both that 'No step therapy' and that 'For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.' Providers must follow Medicare Part B Step Therapy Criteria for new treatment starts where applicable despite the 'No step therapy' line.
- For new starts: Step Therapy Criteria must be met in addition to Coverage Criteria before approval
- The policy also contains a 'No step therapy' statement; providers should rely on the requirement that Step Therapy Criteria apply for new starts where applicable
As-Needed / Line of Therapy Notes
as_needed
Used as needed to maintain chemotherapy dosing/intensity when thrombocytopenia threatens planned chemotherapy delivery.
ALL of the following
- Indication: Chemotherapy-induced thrombocytopenia (CIT) when platelet counts and clinical circumstance threaten chemotherapy schedule/intensity
- Requirements: platelet count <100 x 10^9/L for at least 3–4 weeks after last chemotherapy administration OR platelets <100 x 10^9/L with chemotherapy delays due to thrombocytopenia; member was receiving a cytotoxic agent known to cause thrombocytopenia; goal is to maintain chemotherapy dosing/intensity when benefits outweigh risks
Key Definitions
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