ModifiedCentenePolicy CP.PHAR.221

Factor XIII, Human (Corifact) — coverage criteria and authorization

Coverage criteria and authorization requirements for Corifact (plasma-derived factor XIII) for members with congenital factor XIII deficiency and related indications across Centene lines of business.

Policy Summary

PayerCentene

PolicyFactor XIII, Human (Corifact) — coverage criteria

Policy CodePolicy CP.PHAR.221

Change TypeClarified indications and approval durations

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation of factor XIII activity level or bleed history for new routine prophylaxis starts; approvals vary by line of business.

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.

Consolidated language re: covered indications to include control of acute bleeds, perioperative management, and routine prophylaxis.

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

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

Initial approval duration for prophylaxis revised from 6 months to 12 months.

J7180HCPCS code

12 moMedicaid/HIM prophylaxis

6 mo/renewal

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Commercial prophylaxis

40 IU/kg q28dRoutine dosing

Coverage Criteria for Factor XIII (Corifact)

Congenital Factor XIII Deficiency (initial therapy and indications)

Covered when ALL of the following are met:

Congenital Factor XIII Deficiency criteria: 1) Diagnosis of congenital factor XIII deficiency; 2) Prescribed by or in consultation with a hematologist; 3) Request is for one of the following uses: (a) control of acute bleeding; (b) perioperative management; (c) routine prophylaxis to prevent or reduce the frequency of bleeding episodes; 4) For routine prophylaxis requests, member meets one of the following: (a) member has previously used factor XIII for routine prophylaxis; (b) member has severe hemophilia (factor level < 1%); (c) member has experienced at least one serious spontaneous bleed (see Appendix D).

Continuation of therapy

Covered when ALL of the following are met for continuation:

Continuation criteria: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy.

Approval duration

Approval durations: Surgical/acute bleeding: 3 months. Prophylaxis: Medicaid/HIM - 12 months; Commercial - 6 months or to the member's renewal date, whichever is longer.

Covered Indications

Covered indications include the following clinical scenarios when documentation requirements are met:

Covered Indications: Control of acute bleeds OR perioperative management OR routine prophylaxis

Routine prophylaxis for new starts requires documentation of factor XIII activity level or documentation of bleed history; this requirement does not apply to ongoing prophylaxis.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy or the member’s evidence of coverage. See the off‑label use policies referenced for each line of business for acceptable supporting documentation.

This section does not list any additional explicit exclusions beyond those non‑FDA approved indications referenced elsewhere in the policy.

Use of Corifact (factor XIII, human) for off‑label indications without sufficient documentation as required by the relevant off‑label use policy is considered not authorized and may be denied.

The policy wording was revised to remove the term 'life‑threatening' from the phrase 'life‑threatening or serious bleed' to avoid potential misinterpretation; assessments should therefore reference the policy’s definition of serious bleeding episodes rather than a separate 'life‑threatening' classification.

Coding and Dosing Details

HCPCS CodesHCPCS

J7180

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

Referenced HCPCS CodesHCPCS

J7180

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

Factor XIII trough level target

Target trough FXIII activity5% to 20%

Dosing goal contextAdjust dose ±5 IU/kg to maintain 5% to 20% trough level

Routine prophylaxis regimen40 IU/kg IV every 28 days (adjust to maintain trough target)

Approval duration for prophylaxis (Medicaid/HIM)

Medicaid/HIM prophylaxis continued approval12 months

Policy noteContinued approval duration for prophylaxis revised from 6 months to 12 months for Medicaid and HIM lines of business

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests should be submitted by or in consultation with a hematologist when applicable.

Affected product code: J7180 (Injection, factor XIII, human)

Prior Authorization

Prior Authorization and Documentation for Factor XIII

Prior authorization is required for factor XIII (J7180). For routine prophylaxis requests, prior authorization must include documentation that the member meets the specific clinical criteria (see criteria for congenital factor XIII deficiency and other covered indications). The requirement for factor XIII activity level or documentation of bleed history applies to requests for new starts to routine prophylactic therapy only.

Code: J7180
New prophylaxis starts require: factor XIII activity level OR documented bleed history

Background

Factor XIII deficiency is a congenital bleeding disorder treated with plasma‑derived factor XIII concentrate (Corifact). Corifact is FDA‑approved for adults and pediatric patients with congenital factor XIII deficiency for routine prophylaxis and perioperative management, and it is used for control of acute bleeds. Prior authorization is required and requests must include clinical documentation demonstrating that the member meets the coverage criteria; new starts for routine prophylaxis require documentation of factor XIII activity level or a documented bleed history.

Definitions

Serious bleeding episodes — examples

Intracranial bleedIncluded as an example of a serious bleeding episode

Neck or throat bleedIncluded as an example of a serious bleeding episode

Gastrointestinal bleedIncluded as an example of a serious bleeding episode

Hemarthrosis (joint bleed)Included as an example of a serious bleeding episode

Deep muscle compartment bleed (e.g., iliopsoas, calf, forearm)Included as an example of a serious bleeding episode

Mucous membrane bleeding (mouth, nose, genitourinary tract)Included as an example of a serious bleeding episode

Revision History and Policy Changes

2016-05-01policy_effective_date

Policy effective date set for this clinical coverage criteria document.

2021-11-23annual_review

1Q 2022 annual review: references reviewed and updated; clarified that requirement for factor XIII activity level or bleed history applies only to new starts of routine prophylaxis and consolidated covered indications to include control of acute bleeds, perioperative management, and routine prophylaxis.

2022-11-08policy_revision

Policy Summary

PayerCentene

PolicyFactor XIII, Human (Corifact) — coverage criteria

Policy CodePolicy CP.PHAR.221

Change TypeClarified indications and approval durations

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation of factor XIII activity level or bleed history for new routine prophylaxis starts; approvals vary by line of business.

SourceLink

On This Page

Documentation requirement

Requirement for factor XIII activity level or documentation of bleed history applies only to new starts of routine prophylaxis

Commercial prophylaxis approval duration

Commercial prophylaxis approval duration6 months or to the member's renewal date, whichever is longer

Initial approval durationInitial approval duration for prophylaxis revised to 12 months (applies across lines of business)

Documentation Required

Documentation Required for New Prophylaxis Starts

For new starts of routine prophylaxis, provide one of the following as part of the prior authorization: documented factor XIII activity level, or documentation of bleed history (e.g., office notes describing at least one serious spontaneous bleed as defined in Appendix D). Missing this documentation for new prophylaxis starts may result in denial.

Acceptable documentation: office chart notes, lab results (factor XIII activity), operative notes, hospital records

Documentation Required

Authorization Duration Documentation

Approval durations must follow line-of-business rules: Surgical/acute bleeding approvals are for 3 months. Prophylaxis approval duration: Medicaid/HIM — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer. Initial approval durations for prophylaxis may be revised per annual review updates (refer to policy history).

Surgical/acute bleeding: 3 months
Prophylaxis — Medicaid/HIM: 12 months
Prophylaxis — Commercial: 6 months or to member renewal date, whichever is longer

Note

Label Change Handling / Reference Policies

If the drug labeling has changed recently (new indication, age expansion, dosing) and the change is not yet reflected in this policy, follow the appropriate formulary, non-formulary, or off-label use policies for the relevant line of business. See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, and CP.PMN.53 as applicable.

Refer to formulary/no-coverage or non-formulary policies when labeling changes precede policy updates
Refer to off-label use policy when requested use is not listed in this policy

Spontaneous bleed — definition

DefinitionA bleeding episode that occurs without apparent cause and is not the result of trauma.

ContextUsed to define spontaneous bleeds when determining eligibility for routine prophylaxis (e.g., at least one serious spontaneous bleed qualifies)

SourceAppendix D: General Information (policy)

Routine prophylaxis — definition

DefinitionRoutine prophylaxis — regular preventive dosing to reduce risk of bleeding (e.g., 40 IU/kg IV every 28 days)

Documentation for new startsNew routine prophylaxis starts require factor XIII activity level or documentation of bleed history; this requirement does not apply to ongoing prophylaxis

Dosing goalAdjust dose ±5 IU/kg to maintain trough FXIII activity of 5% to 20%

Covered indications

Included indicationsControl of acute bleeds

Included indicationsPerioperative management

Included indicationsRoutine prophylaxis

Policy consolidationCovered indications consolidated to include control of acute bleeds, perioperative management, and routine prophylaxis

1Q 2023 annual review: removed the term 'life-threatening' from 'life‑threatening or serious bleed' criterion to avoid potential misinterpretation; references reviewed and updated.

2023-10-28annual_review

1Q 2024 annual review: updated sites of serious bleeds per WFH guideline in Appendix D and reviewed references; no significant clinical changes.

2025-10-17approval_duration_revisionLatest

1Q 2026 annual review: initial approval duration for prophylaxis revised from 6 months to 12 months; references reviewed and updated.