ModifiedmhnPolicy CP.PHAR.221

Clinical Policy: Factor XIII, Human (Corifact)

Coverage policy for plasma-derived Factor XIII concentrate (Corifact) for treatment and prophylaxis of congenital factor XIII deficiency for members under the payer's lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Factor XIII, Human (Corifact)

Policy CodePolicy CP.PHAR.221

Change TypeClarified and revised coverage/approval durations

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation (office notes, labs, or other clinical information) showing diagnosis, hematologist involvement, intended use, and for new prophylaxis starts include factor XIII activity level or bleed history.

SourceLink

POLICY UPDATE CHANGES

Clarified requirement for coverage of factor XIII for routine prophylaxis: the requirement for factor XIII activity level or documentation of bleed history only applies to requests for new starts to routine prophylactic therapy.

For Medicaid and HIM lines of business, continued approval duration revised from 6 months to 12 months for prophylaxis; for Commercial line of business, all prophylaxis approval durations revised to '6 months or to the member's renewal date, whichever is longer'.

Removed 'life-threatening' from 'life-threatening or serious bleed' criterion to avoid misinterpretation.

Updated sites of serious bleeds per World Federation of Hemophilia (WFH) guideline in Appendix D.

40 IU/kg/28droutine prophylaxis dosing

J7180HCPCS code referenced

3 months

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Coverage Criteria for Factor XIII (Corifact)

Congenital Factor XIII Deficiency (Initial)

Covered when ALL of the following are met for congenital factor XIII deficiency:

Congenital Factor XIII Deficiency initial criteria: 1. Diagnosis of congenital factor XIII deficiency.

From policy A.1; initial approval requirement.

Prescribing requirement: 2. Prescribed by or in consultation with a hematologist.

From policy A.2; specialist involvement required.

Indication requirement (one of)

ONE of: a. Control of acute bleeding (acute bleed control).
From policy A.3.a.
ONE of: b. Perioperative management.
From policy A.3.b.
ONE of: c. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
From policy A.3.c.

Prophylaxis-specific requirement (if routine prophylaxis selected)

ONE of: a. Member has previously used factor XIII for routine prophylaxis.
From policy A.4.a.
ONE of: b. Member has severe hemophilia (defined as factor level < 1%).
From policy A.4.b.
ONE of: c. Member has experienced at least one serious spontaneous bleed (see Appendix D for sites).
From policy A.4.c and Appendix D (definition of serious bleed).

Congenital Factor XIII Deficiency (Continuation)

Continuation/renewal coverage requirements (must meet ALL):

Continuation eligibility (one of): 1. Member meets ONE of the following: - a. Currently receiving medication via the Centene benefit or previously met initial approval criteria; - b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums).

From continuation language in policy section A.

Clinical response: 2. Member is responding positively to therapy.

From continuation language in policy section A.

Documentation requirement: 3. Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met continuation criteria and is responding to therapy.

From policy administrative requirement; lack of documentation may trigger denial.

Covered Indications and Authorization Criteria

Covered indications and authorization criteria (consolidated):

Covered indications: Coverage applies for control of acute bleeds, perioperative management, and routine prophylaxis for congenital factor XIII deficiency.

Consolidated language per policy update (see coding implications).

Documentation for new prophylaxis: For NEW starts of routine prophylactic therapy, documentation must include either factor XIII activity level or documentation of bleed history.

Clarified in coding implications; applies only to new starts of prophylaxis.

Approval duration for prophylaxis: Continued approval duration for routine prophylaxis varies by line of business: Medicaid and HIM = 12 months; Commercial = 6 months or to the member's renewal date, whichever is longer.

Revised effective per 1Q 2025 annual review.

Coverage for plasma‑derived factor XIII concentrate (Corifact) is authorized only when the member meets the specific criteria set forth in this policy. Prior authorization is required and approval is limited to the indications and conditions described, including a documented diagnosis of congenital factor XIII deficiency, involvement of a hematologist (prescribing or in consultation), and an approved intended use (control of an acute bleed, perioperative management, or routine prophylaxis). Requests that do not meet the policy criteria must be supported by sufficient clinical documentation per the payer’s off‑label use procedures to be considered for authorization.

No additional explicit exclusions are listed in the excerpted policy text beyond the general non‑FDA indications language; coverage decisions should follow the policy’s stated exclusions and related references for off‑label or non‑covered uses.

Non‑FDA approved indications are not addressed by this policy and are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the payer’s off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or applicable evidence‑of‑coverage documents.

If documentation or criteria details are not specified in a request, the provider should supply office notes, laboratory results, or other clinical information demonstrating the member meets the applicable approval criteria; lack of supporting documentation may result in denial.

Coding and Dosing Details

HCPCS CodesHCPCS

J7180

Injection, factor XIII (antihemophilic factor, human), 1 IU

HCPCS Codes referencedHCPCS

J7180

Injection, factor XIII (antihemophilic factor, human), 1 IU

inv-10: Factor XIII trough activity target

Target trough FXIII activity5% to 20%

Routine prophylaxis dosing referenceAdjust dose ±5 IU/kg to maintain 5% to 20% trough level

Dosing interval for routine prophylaxis40 IU/kg IV every 28 days (adjust to maintain trough target)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Corifact (factor XIII) prior to initiation. Submit clinical documentation to support that the member meets all approval criteria.

Prior authorization required for all indications
Include HCPCS J7180 on claims as applicable

Documentation Required

Documentation Required — risk of denial if not provided

Provide supporting clinical documentation (office notes, laboratory results, imaging, operative reports, bleed history) with the prior authorization request. Failure to submit documentation that supports the requested indication and clinical criteria may result in denial.

Examples: office chart notes, laboratory factor assays, imaging or operative reports, documentation of bleed events or transfusions

Background on Factor XIII Deficiency and Product

Factor XIII deficiency is a rare congenital bleeding disorder treated with plasma‑derived factor XIII concentrate. Corifact is indicated and used for control of acute bleeding, perioperative management of surgical bleeding, and for routine prophylaxis to prevent recurrent bleeding in patients with congenital factor XIII deficiency. Policy clarifications note that documentation of factor XIII activity level or bleed history is required only for new starts of routine prophylactic therapy, and the definition of a serious bleed was revised to remove the term 'life‑threatening' to avoid misinterpretation.

Definitions and Appendix Terms

inv-20: Serious bleeding (Appendix D)

Intracranial bleedingIncludes intracranial site bleeds (per Appendix D / WFH alignment)

Neck / throat bleedingBleeding in neck or throat potentially compromising airway or surrounding structures

Gastrointestinal bleedingBleeds involving the gastrointestinal tract

Joints (hemarthrosis)Bleeding into joints (hemarthrosis)

Deep muscle compartment bleedingMuscle bleeds, especially deep compartments such as iliopsoas, calf, forearm

Mucous membrane bleedingBleeding from mucous membranes of the mouth, nose, and genitourinary tract