Currentsierra health and lifePolicy 2025D0112D

Provider Administered Drugs - Preferred Products

Defines UnitedHealthcare preferred and non-preferred medical-drug products for treprostinil and the criteria under which non-preferred products may be covered; applies to provider-administered drug claims under the medical benefit.

Policy Summary

Payersierra health and life

PolicyProvider Administered Drugs - Preferred Products

Policy CodePolicy 2025D0112D

Change TypeRevised non-preferred product listclarified Benefit Considerations

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization for provider‑administered treprostinil (J3285) when coverage depends on diagnosis-specific criteria and preferred/non-preferred status.

SourceLink

POLICY UPDATE CHANGES

Revised list of non-preferred medical drug products and removed several inactive Par Sterile Products NDCs.

Updated Benefit Considerations section to reflect the most current information.

1HCPCS code listed (J3285)

multiplePreferred presentations

multipleNon-preferred presentations

NoneRelated policies

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Coverage criteria

Coverage available for UnitedHealthcare preferred products and for non-preferred products only when the Preferred Product Criteria and any Diagnosis-Specific Criteria are met.

General coverage for preferred products: Coverage provided for UnitedHealthcare preferred product contingent on meeting the coverage criteria in the Diagnosis-Specific Criteria section.

Members new to therapy must use preferred product unless exceptions apply.

Non-preferred product medical necessity: Treatment with a specified non-preferred product is medically necessary when BOTH: (1) history of intolerance or contraindication to one of UnitedHealthcare's preferred products; AND (2) physician attests that the same intolerance, contraindication, or adverse event would not be expected to occur with the respective non-preferred product.

Applies to the non-preferred products listed in the Non-Preferred Drug Products tables.

This policy distinguishes between UnitedHealthcare preferred treprostinil formulations and non-preferred alternatives. Coverage will be provided for a UnitedHealthcare preferred product contingent on meeting the coverage criteria in the Diagnosis-Specific Criteria. Members who are new to therapy are required to start with the UnitedHealthcare preferred product unless they meet the Preferred Product Criteria (see Definitions and Initial Therapy sections).

Non-preferred treprostinil products (for example, various Remodulin and alternate manufacturer presentations listed in the Non‑Preferred Drug Products tables) may be covered only when the Preferred Product Criteria and any applicable Diagnosis‑Specific Criteria are satisfied. Providers should therefore verify whether the member’s clinical situation meets those criteria before requesting coverage for a non-preferred formulation.

The policy does not list standalone not‑medically‑necessary conditions; instead, lack of coverage authorization arises when the required criteria are not met. Specifically, treatment will not be authorized if the member fails to meet the applicable Diagnosis‑Specific Criteria or the Preferred Product Criteria required for a non‑preferred product.

When requesting coverage, the provider must reference the member specific benefit plan document and any applicable federal or state mandates because the member’s plan governs final coverage determinations. This policy is informational and does not replace the member specific benefit plan terms.

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization for treprostinil (J3285) — provider-administered treprostinil products are subject to coverage criteria. Prior authorization is required when coverage is contingent on meeting the Diagnosis-Specific Criteria or Preferred Product Criteria. Providers should include clinical documentation that demonstrates the member meets the applicable coverage criteria when submitting a prior authorization request.

Affected HCPCS: J3285
Prior authorization required when coverage is contingent on Diagnosis-Specific Criteria or Preferred Product Criteria
Include clinical documentation supporting criteria (e.g., intolerance, contraindication, physician attestation)

Step Therapy

Step / Product Selection Requirement

Step / product selection requirement — members new to therapy are required to utilize the UnitedHealthcare preferred product unless they meet the Preferred Product Criteria. If a non-preferred product is requested, documentation must demonstrate both: (1) history of intolerance or contraindication to a preferred product, and (2) physician attestation that the same intolerance/contraindication or adverse event would not be expected with the requested non-preferred product.

New-to-therapy members must start with UnitedHealthcare preferred product
Non-preferred product requests require documented intolerance/contraindication and physician attestation

Documentation Required

Plan Document Requirement

Plan document requirement — before requesting coverage or prior authorization, providers must reference the member specific benefit plan document and any applicable federal or state mandates. The member specific benefit plan governs in the event of a conflict with this policy. This policy is informational and may be modified; providers should confirm applicability to Medicare Advantage when relevant (in absence of NCD/LCD guidance).

Reference the member specific benefit plan document
Check applicable federal or state mandates
Member specific plan governs if conflict exists
For Medicare Advantage, confirm NCD/LCD guidance or MAO-specific determinations

Denial Risk

Coverage Contingent on Criteria

Coverage for preferred products is contingent on meeting the coverage criteria in the Diagnosis-Specific Criteria section. Failure to meet those criteria may result in denial of coverage or requirement for additional documentation.

Coverage contingent on Diagnosis-Specific Criteria
Failure to meet criteria may lead to denial or additional documentation requests

Definitions

Preferred Product Criteria

Condition 1: Intolerance or contraindicationHistory of intolerance or contraindication to one of UnitedHealthcare's preferred products.

Condition 2: Physician attestationPhysician attests that the same intolerance, contraindication, or adverse event would not be expected to occur with the non-preferred product.

ScopeApplies only to the non-preferred products specified in the Non-Preferred Drug Products table.

ApplicabilityFor proven indications where both conditions are met; members new to therapy must use preferred products unless criteria met.

DocumentationPhysician clinical opinion/attestation required to support medical necessity of the non-preferred product.

Step	Requirement	Exceptions / Notes
1
Members new to therapy must use the UnitedHealthcare preferred product as the initial step before a non-preferred treprostinil product will be covered.
Use of a non-preferred product at initiation is allowed only when the Preferred Product Criteria are met: (1) history of intolerance or contraindication to a UnitedHealthcare preferred product; and (2) physician attestation that the same intolerance/contraindication or adverse event would not be expected with the non-preferred product.

Background

This Medical Benefit Drug Policy governs use of treprostinil formulations administered under the medical benefit and identifies UnitedHealthcare preferred formulations and non‑preferred alternatives. The Preferred Drug Products tables list preferred presentations and the corresponding non‑preferred products (for example, Sandoz treprostinil presentations as preferred and Remodulin or other manufacturers as non‑preferred).

Coverage for preferred products is provided when the Diagnosis‑Specific Criteria are met; coverage for non‑preferred products requires meeting the Preferred Product Criteria (history of intolerance or contraindication to a preferred product plus physician attestation that the same issue would not be expected with the non‑preferred product) as well as any Diagnosis‑Specific Criteria. Providers should confirm member plan terms because the member specific benefit plan governs final coverage decisions.

OpenPayer

Provider Administered Drugs - Preferred Products

Coverage Criteria

Coding

Provider Actions

Definitions

Initial Therapy Criteria

Step Therapy

Background

Site of Care