CurrentColorado Rocky Mountain Health PlansPolicy CSOH2026D00117.D

Tzield (Teplizumab‑mzwv) — Medical Benefit Drug Policy (Ohio Only)

Defines coverage and medical necessity determination for Tzield (teplizumab-mzwv) under a UnitedHealthcare Community Plan medical benefit drug policy that applies only to Ohio.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTzield (Teplizumab-mzwv) — Medical Benefit Drug Policy (Ohio Only)

Policy CodePolicy CSOH2026D00117.D

Change TypeRoutine review — no material changes

Effective DateJun 1, 2026

Next Review Date

Key ActionUse the current InterQual guideline to determine medical necessity for Tzield and reference HCPCS code J9381 when submitting prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

Routine review; no content changes

OhioApplicable state

1HCPCS code listed

InterQualUses external clinical criteria

Coverage Criteria

Coverage per InterQual

Covered when InterQual criteria are met

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InterQual-based coverage: Coverage is provided when the patient meets the current InterQual guideline criteria for teplizumab-mzwv (Tzield)see InterQual

Provider must reference InterQual guideline for specific clinical entry and continuation criteria

The listing of a procedure or diagnosis code in this policy is for reference only and does not imply that the service described is covered. Benefit coverage and any reimbursement determinations are governed by applicable federal and state law and the terms of the member’s contract or plan. Inclusion of a code is not a guarantee of payment; other policies, laws, or contractual provisions may affect coverage.

Services that do not meet the criteria in the current InterQual ® guideline for Tzield (teplizumab-mzwv) will not be considered medically necessary under this policy. Providers must reference the InterQual guideline for specific clinical entry and continuation criteria when seeking coverage.

Coding and Billing

Applicable HCPCS CodesHCPCS

J9381

Injection, teplizumab-mzwv, 5 mcg

Coding and policy identifiers

HCPCS codeJ9381 — Injection, teplizumab-mzwv, 5 mcg

Applicable stateOhio

Policy numberCSOH2026D00117.D

Document statusCURRENT

Related (superseded) policyCSOH2025D00117.C (archived)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization requirement — Coverage and medical necessity determinations are made using the current InterQual® guideline for Teplizumab (Tzield). Requests must include clinical information sufficient to demonstrate that InterQual criteria are met. Reference HCPCS J9381 when submitting prior authorization requests and claims.

Prior authorization required: use current InterQual guideline
Include HCPCS J9381 on requests/claims

Step Therapy

Step therapy — No step therapy requirements are specified for Tzield. Medical necessity and coverage are determined using the current InterQual criteria; if InterQual criteria are not met, the request may be denied as not medically necessary.

No step-therapy sequencing required
Denials may occur if InterQual criteria are not met

Documentation Required

Documentation and Compliance

Documentation and compliance — Providers must comply with applicable federal and state requirements and any contractual plan terms when submitting requests. Include complete clinical documentation demonstrating how the patient meets InterQual medical necessity criteria. This policy is provided as interpretation guidance; in the event of a conflict, federal, state (e.g., Ohio Administrative Code where applicable), or contractual requirements govern.

Provide complete clinical records showing InterQual criteria are satisfied
Follow federal, state (OAC), and contractual requirements; those requirements prevail in case of conflict
This policy is guidance and not a substitute for plan contract terms

Denial Risk

Denial Triggers

Denial triggers — Requests that do not meet the current InterQual guideline may be deemed not medically necessary and denied. Absence of required documentation, submission without prior authorization when required, or billing without the appropriate HCPCS code may also lead to claim denials.

Denial if InterQual criteria are not met
Denial for missing or incomplete clinical documentation
Denial for lack of required prior authorization or incorrect/missing HCPCS coding

Background

Tzield (teplizumab-mzwv) is a biologic agent addressed by the InterQual ® specialty therapy guideline. This policy delegates clinical coverage determinations to the current InterQual ® CP: Specialty Rx Non-Oncology, Teplizumab-Mzwv (Tzield) guideline; coverage is provided when the patient meets those InterQual criteria. Providers should consult the InterQual guideline for the specific medical necessity entry and continuation requirements.

Definitions

InterQual CP: Specialty Rx Non-Oncology, Teplizumab-Mzwv (Tzield)

External guideline referencedInterQual ® CP: Specialty Rx Non-Oncology, Teplizumab-Mzwv (Tzield)

Coverage determinationCoverage and medical necessity are determined using the current InterQual guideline for Tzield.

Action for providersRefer to the current InterQual criteria for specific entry and continuation requirements when requesting authorization.

Clinical scopePolicy delegates clinical coverage criteria to the InterQual specialty Rx guideline for teplizumab-mzwv.

Initial Therapy Criteria

Initial Therapy

Initial coverage is determined by InterQual entry criteria.

InterQual initial: Initial authorization for Tzield requires meeting InterQual initial eligibility criteriasee InterQual

Policy defers to InterQual for specific entry criteria

Continuation (Renewal) Criteria

Continuation Therapy

Continuation (renewal) coverage is subject to meeting InterQual continuation criteria.

InterQual continuation: Continuation of Tzield requires meeting InterQual continuation criteriasee InterQual

No internal continuation criteria listed in this policy

Step Therapy

Step	Requirement
No step therapy specified	Coverage and medical necessity determinations rely on the current InterQual® guideline for teplizumab‑mzwv (Tzield); providers must refer to InterQual criteria for entry and continuation requirements.

Site of Care

Note

Site‑of‑care informational — follow contractual/federal/state rules

Site‑of‑care determinations (for example, infusion center placement) are informational in this policy; actual site‑of‑care requirements must follow federal, state, or contractual plan terms.

Follow contractual, federal, and state requirements when selecting infusion center or other site of care.
This policy does not establish site‑of‑care mandates and is provided for informational use.