CurrentUnitedHealthcarePolicy N/A

Review at Launch for New to Market Medications (Ohio)

Defines UnitedHealthcare Community Plan's process for medical-benefit review of new-to-market, provider-administered, FDA-approved medications reimbursable under the medical benefit in Ohio and how providers should request pre-determinations.

Policy Summary

PayerUnitedHealthcare

PolicyReview at Launch for New to Market Medications (Ohio)

Policy CodePolicy N/A

Change TypeAuthorization limits addedmedication list updated

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionProviders should seek pre-determination prior to providing new-to-market, provider-administered medications on the Review at Launch list.

SourceLink

POLICY UPDATE CHANGES

Added language that authorization will be up to the maximum FDA-approved dose, frequency, and duration for no more than 6 months.

Updated the Review at Launch Medication List with multiple specific additions and removals of drugs (examples: added Avtozma, Starjemza; removed Tremfya intravenous).

6 monthsmaximum default authorization duration

Ohioapplicability (state)

3example procedure code references

Review at Launch Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Review at Launch Coverage Criteria

Covered when ALL of the following are met

Eligibility and product characteristics: Medication is new-to-market, healthcare provider–administered, FDA‑approved, and reimbursable under the member's medical benefit (placed on the Review at Launch Medication List).

Medical necessity assessment: Medical necessity is established using a UHC Pharmacy & Therapeutics approved medical benefit drug policy or applicable Medicaid state criteria, FDA labeling, compendia (if available), and current standard‑of‑care evidence.

Authorization limits: Authorization will be up to the maximum FDA‑approved dose and frequency, and duration not to exceed 6 months.<= 6 months

Subsequent extensions or placement on the Prior Authorization List possible after evaluation.

Services determined to be experimental, investigational, unproven or not medically necessary based on published clinical evidence and UnitedHealthcare Medical Benefit Drug Policies may not be covered. When clinical evidence does not support effectiveness or medical necessity, the service may be excluded from coverage and, when appropriate, providers may be redirected to State Medicaid Fee‑For‑Service programs.

Items or services that are determined not medically appropriate or not covered after review — including instances where a pre‑determination was not requested — are not covered. Providers are strongly encouraged to request a pre‑determination for new‑to‑market medications on the Review at Launch list to confirm coverage prior to providing the service; failure to do so may result in a later denial of the claim.

Applicable Codes and Authorization Limits

Applicable Codes (reference)HCPCS

C9399	Unclassified or biologicals drugs.
J3490	Unclassified drugs.
J3590	Unclassified biologics.

Authorization duration

Authorization durationAuthorization will be up to the maximum FDA‑approved dose and frequency, and duration for no more than 6 months.

ScopeApplies to new-to-market, provider-administered, FDA‑approved medications reimbursable on the member's medical benefit.

Initial authorization limitDuration limited to a maximum of 6 months; subsequent extensions or utilization management may follow after UHC P&T evaluation.

Provider Requirements and Risk Notices

Prior Authorization

Pre-service review required

Pre-service review is required for medications on the Review at Launch Medication List. These are new-to-market, provider‑administered, FDA‑approved medications reimbursable on the medical benefit and will be reviewed upon FDA approval to determine coverage and medical necessity.

Applies to provider‑administered, FDA‑approved, medical‑benefit reimbursable medications
Providers are encouraged to request pre‑service review (pre‑determination) prior to administering new‑to‑market medications

Note

Potential placement on Prior Authorization List

Medications reviewed under this policy may later be placed on UnitedHealthcare’s Prior Authorization List or be subject to other utilization management requirements. Providers should monitor plan communications and formulary updates for changes in authorization or billing requirements.

Potential future placement on the Prior Authorization List or other utilization management lists
Coverage and billing requirements may change after initial review

Documentation Required

Required clinical references and recommended pre‑determination

Medical necessity determinations will follow UnitedHealthcare Pharmacy & Therapeutics (UHC P&T) approved medical benefit drug policies and applicable state or FDA criteria. Providers should reference the applicable UHC medical benefit drug policy, Medicaid state criteria when required, FDA‑approved labeling, and available compendia when requesting a pre‑determination.

Reference UHC P&T‑approved medical benefit drug policies
When applicable, include Medicaid state criteria, FDA labeling (indication, age, dosing, contraindications), and compendia evidence in pre‑determination requests

Denial Risk

Risk of post‑service denial without pre‑determination

If a provider does not obtain a pre‑determination before providing or referring for a service or item that is subject to Review at Launch, UnitedHealthcare may later determine the service or item is not medically necessary or not covered and deny the claim. Providers who know or have reason to believe a service may not be covered must request a pre‑service organization determination prior to providing the service.

Claims may be denied post‑service if no pre‑determination was obtained
Request pre‑service organization determination before providing or referring services when coverage is uncertain

Key Definitions

Review at Launch Medication List

DefinitionReview at Launch Medication List: a list of new-to-market, provider-administered, FDA‑approved medications reimbursable under the medical benefit that are subject to pre‑service review and medical necessity evaluation.

Pre-service review requirementMedications on the list require review and are subject to medical necessity evaluation prior to service; providers should seek pre‑determination.

Potential outcomesMedications may be added to the Prior Authorization List or other utilization management strategies following UHC Pharmacy & Therapeutics evaluation.

Site of careApplies to provider‑administered settings (site of care determined by benefit and medical necessity).

Step	Policy statement
{"text":"1","status":""},{"text":"Medications reviewed at launch will be evaluated for medical necessity against health plan benefits using a UHC P&T–approved medical benefit drug policy (and may reference Medicaid state criteria, FDA labeling, and compendia); after evaluation they may be placed on the Prior Authorization List or other utilization management programs determined by UHC P&T.","status":""}

Policy Summary

PayerUnitedHealthcare

PolicyReview at Launch for New to Market Medications (Ohio)

Policy CodePolicy N/A

Change TypeAuthorization limits addedmedication list updated

Effective DateFeb 1, 2025

Next Review DateN/A

Key ActionProviders should seek pre-determination prior to providing new-to-market, provider-administered medications on the Review at Launch list.

SourceLink

On This Page

OpenPayer

Review at Launch for New to Market Medications (Ohio)

Review at Launch Coverage Criteria

Applicable Codes and Authorization Limits

Provider Requirements and Risk Notices

Program Background

Key Definitions

Initial Authorization and Limits

Potential Utilization Management After Review

Site of Care Applicability