Radicava (edaravone) — Intravenous
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This policy governs prior authorization, dosing limits, clinical criteria, and billing for intravenous edaravone (Radicava) for treatment of amyotrophic lateral sclerosis (ALS) for Viva Health members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Radicava (edaravone)
Initial Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Continuation Therapy / Renewal — Renewal allowed when ALL of the following are met:
Renewal is allowed when ALL of the following are met:
Use of Radicava (intravenous edaravone) in combination with other formulations of edaravone (for example, oral edaravone) is excluded and will not be authorized.
Appendix — Medicare Part B covered diagnosis codes: N/A. There are no specific Medicare Part B covered diagnosis codes listed for this therapy in the appendix.
Treatment is not supported when the member fails to meet required clinical criteria, including a diagnosis of clinically definite or probable ALS by El Escorial/Gold Coast/Awaji criteria, disease duration > 2 years, or percent-predicted forced vital capacity below the required threshold. Baseline functional requirements must also be met (ALSFRS-R item scores of 2 or better on each item); lack of these baseline measures or evidence of unacceptable toxicity or absence of response (no stability or slowed decline on ALSFRS-R) will preclude authorization or continuation.
Billing and Coding
| J1301 | Injection, edaravone, 1 mg; 1 billable unit = 1 mg |
| G12.21 | Amyotrophic lateral sclerosis |
| 70510-2171-xx | Radicava 30 mg/100 mL single-dose bag (NDC) |
| G12.21 | Amyotrophic lateral sclerosis |
| No codes listed |
Provider Actions, Documentation, and Denial Risks
Obtain prior authorization — note validity periods
Prior authorization is required for Radicava (edaravone). Initial authorizations are valid for 6 months (180 days); renewals may be issued for up to 12 months (365 days).
- Initial: 6 months (180 days)
- Renewal: up to 12 months (365 days)
Follow Medicare Benefit Policy Manual and applicable NCDs/LCDs/LCAs
When making preauthorization or coverage determinations for outpatient drug claims under Part B, follow the Medicare Benefit Policy Manual, Chapter 15 §50 and any applicable NCDs, LCDs, and LCAs; compliance with those Medicare policies is required where applicable.
Do not combine with other edaravone formulations
Do not prescribe or administer Radicava in combination with other formulations of edaravone (for example, oral edaravone). Use with other edaravone formulations is excluded.
Provide required clinical documentation at initial request
Include documentation that the member meets diagnostic and baseline clinical thresholds: a diagnosis of clinically definite or probable ALS (El Escorial/Gold Coast/Awaji criteria), disease duration ≤ 2 years, baseline percent-predicted FVC (%FVC) ≥ 80%, and baseline ALSFRS-R item scores of 2 or better (documenting retained functionality).
- Diagnosis per El Escorial, Gold Coast, or Awaji criteria
- Disease duration ≤ 2 years
- Baseline %FVC ≥ 80%
- Baseline ALSFRS‑R item score ≥ 2 on each item
Include ICD-10 diagnosis code G12.21 on claims
Include the appropriate diagnosis code on claims: use ICD-10 code G12.21 (Amyotrophic lateral sclerosis) as listed in Appendix 1 for Radicava (edaravone).
- ICD-10: G12.21 = Amyotrophic lateral sclerosis
Risk of denial for unacceptable toxicity or lack of clinical benefit
Be aware that renewal or continuation may be denied if the member experiences unacceptable toxicity from the drug (examples: hypersensitivity reactions, anaphylaxis, sulfite allergic reactions) or if there is lack of clinical benefit at renewal (no stability or slowed decline on ALSFRS‑R).
- Examples of unacceptable toxicity: hypersensitivity reactions, anaphylaxis, sulfite allergic reactions
- Lack of response (no stability or slowed decline on ALSFRS‑R) may prompt denial
Risk of denial for failure to meet clinical criteria
Requests may be denied if the member does not meet initial or renewal clinical criteria — including documented diagnosis, disease duration ≤ 2 years, required %FVC threshold, or baseline functional ALSFRS‑R requirements.
- Failure to document diagnosis per required criteria
- Disease duration > 2 years
- %FVC below required threshold
- Baseline ALSFRS‑R item scores not meeting minimums
Comply with applicable Medicare NCDs/LCDs/LCAs to avoid denial
Ensure claims and authorization decisions for Part B drugs comply with applicable Medicare NCDs, LCDs, and LCAs; noncompliance with those Medicare policies where they apply may result in claim denial.
Background
Edaravone (Radicava) is an intravenous free radical scavenger approved by the FDA for the treatment of amyotrophic lateral sclerosis (ALS). This policy applies to use of IV edaravone in members with clinically definite or probable ALS who are early in their disease course, have preserved respiratory function (percent-predicted FVC threshold required by the policy), and demonstrate retained baseline activities of daily living as documented by the ALSFRS-R.
Definitions and Scales
Revision History
Policy last reviewed and document updated with current coverage criteria and administrative details; effective and last review date recorded as 2026-07-01.
Medicare Part B coverage and determinations must follow Medicare Benefit Policy Manual, Chapter 15 §50 and any applicable NCDs/LCDs/LCAs; plan information is intended for non‑Medicare determinations and CMS guidance must be followed where applicable.
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