OLINVYK (oliceridine)
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Medical policy governing coverage and medical necessity criteria for Olinvyk (oliceridine) for adults with acute severe pain when alternative treatments are inadequate; applies to applicable Capital BlueCross products and is subject to benefit variations.
No material clinical or coverage changes in this revision.
Coverage / Medical Necessity Criteria
Initial therapy — Olinvyk (oliceridine)
Olinvyk (oliceridine) may be considered medically necessary when ALL of the following criteria are met:
All uses of Olinvyk (oliceridine) that do not meet the medical necessity criteria listed above are considered not medically necessary and are not covered. The policy’s required criteria include age ≥18 years, use for acute severe pain when alternative treatments are inadequate, planned treatment duration ≤48 hours, and administration only in supervised non‑residential inpatient or acute care outpatient settings; failure to meet these conditions may result in denial of coverage.
Use of Olinvyk beyond 48 hours or for indications other than acute severe pain when alternative treatments are adequate is considered not medically necessary. The policy explicitly limits treatment duration to ≤ 48 hours and requires that the medication be reserved for patients for whom alternatives are inadequate; requests exceeding the duration limit or for non‑specified indications do not meet medical necessity criteria.
Initial Therapy
Initial therapy — detailed initial use criteria for Olinvyk
Covered when ALL of the following initial use requirements are satisfied:
Use beyond 48 hours has not been studied in controlled trials; monitor QTc with cumulative doses up to 27 mg due to observed mild prolongation.
Coding, Quantity & Duration Limits
| G89.11 | Acute pain due to trauma |
| G89.12 | Acute post-thoracotomy pain |
| G89.18 | Other acute pain |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| R52 | Pain, unspecified |
Provider Responsibilities & Authorization
Obtain prior authorization and bill with listed codes
Prior authorization is required when coverage is sought for Olinvyk; coverage is allowed only when the medical necessity criteria in this policy are met and the member's health benefit plan permits the service. Use procedure codes C9101 and J3490 as listed for billing when applicable.
Confirm alternatives tried and inadequate
Document that alternative treatment options have been tried and were inadequate or are unsuitable before initiating Olinvyk; the policy requires alternatives be inadequate as a condition of medical necessity.
- Provide clinical rationale and prior therapy details showing alternatives were tried and inadequate or inappropriate.
Submit required clinical documentation with request
Include documentation that supports patient age (≥18 years), the indication of acute severe pain, prior inadequate alternative treatments, planned treatment duration (≤48 hours), and that administration will occur in a non‑residential inpatient or acute care outpatient facility under clinical supervision.
- Record patient age (≥18 years).
- Document diagnosis and clinical justification for IV opioid therapy for acute severe pain.
- Detail prior alternatives attempted or why alternatives are unsuitable.
- Specify planned treatment duration not to exceed 48 hours and that the setting will be supervised non‑residential inpatient or acute care outpatient.
- If applicable, note cumulative daily dose will not exceed 27 mg.
Denial triggers for nonconforming uses
Requests that do not meet the policy criteria will be considered not medically necessary and may be denied, including use in patients under 18 years, use beyond 48 hours, administration outside the specified supervised non‑residential inpatient or acute care outpatient settings, or when alternative treatments are adequate.
- Underage patients (<18 years) — not meeting age criterion.
- Treatment duration >48 hours — use beyond 48 hours is not supported and may be denied.
- Administration in settings other than supervised non‑residential inpatient or acute care outpatient facilities.
- When alternative treatments are adequate — use for indications other than acute severe pain with inadequate alternatives is not medically necessary.
Site of Care Requirements
Limit administration to supervised non-residential inpatient or acute care outpatient settings
Olinvyk must be administered only in non-residential inpatient or acute care outpatient facilities under clinical supervision; inpatient residential or unsupervised settings do not meet the policy’s site-of-care requirement.
Step Therapy / Prior Alternatives
| Step | Requirement |
|---|---|
| 1 | Require documentation that alternative treatment options are inadequate (i.e., alternatives tried and found ineffective, intolerable, or otherwise unsuitable) prior to prior authorization approval. |
Definitions
Background
Oliceridine (Olinvyk) is an intravenous opioid analgesic indicated in this policy for adults with acute severe pain who require an IV opioid and for whom alternative treatment options are inadequate. The policy frames oliceridine as a treatment reserved for short‑term inpatient or acute outpatient use under clinical supervision and restricts use to scenarios meeting the stated medical necessity criteria.
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