ModifiedCentenePolicy CP.PHAR.330

Protein C Concentrate, Human (Ceprotin)

Medical necessity and authorization criteria for human plasma-derived protein C concentrate (Ceprotin) for neonate, pediatric, and adult patients, including initial and continuation approval criteria and dosing/administration; applies to Centene lines of business.

Policy Summary

PayerCentene

PolicyProtein C Concentrate, Human (Ceprotin)

Policy CodePolicy CP.PHAR.330

Change TypeRevised initial approval duration

Effective DateMar 1, 2017

Next Review Date

Key ActionPrior authorization required and providers must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Revised initial approval duration from 6 months to 12 months.

J2724HCPCS code

IndicatedFDA indication

500/1000 IUVial strengths

12 moApproval duration (Medicaid/HIM)

12 mo

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Approval duration (Commercial)

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Congenital Protein C Deficiency: 1) Diagnosis of congenital protein C deficiency; 2) Prescribed by or in consultation with a hematologist or physician with expertise in inherited thrombophilias; 3) One of the following (a or b): a. Prescribed for use in an acute setting; b. Laboratory result confirms low protein C activity (due to low protein C levels or function or both).

Continued Therapy

Covered when ALL of the following are met:

Continuation Therapy - Congenital Protein C Deficiency: 1) Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 2) Member is responding positively to therapy; 3) If not previously determined, laboratory result confirms baseline low protein C activity (due to low protein C levels or function or both).

Other/Off-label Uses

For other uses:

Other Indications: 1) If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255; or CP.CPA.190/CP.CPA.103/CP.PMN.16 as applicable). OR 2) If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

References: applicable no-coverage, non-formulary, and off-label use policies listed in source.

Requests for uses that are non‑FDA approved and not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. Such requests will be evaluated against the referenced off‑label policies for the member's line of business before authorization is considered.

Coverage under this policy is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and to applicable state and federal laws and regulations. Where there is a conflict with state Medicaid requirements, those provisions take precedence. This policy is guidance for medical necessity determinations and does not guarantee payment; providers must follow the Health Plan's administrative policies and claims submission requirements.

Use of protein C concentrate for non‑FDA approved indications not addressed in this policy is considered not authorized unless the request meets the Health Plan's off‑label use criteria and supporting documentation requirements. Providers should refer to the applicable off‑label use policy for required evidence and submit documentation demonstrating efficacy and safety for the requested indication.

Coding

HCPCS CodesHCPCSCovered

J2724

Injection, protein C concentrate, intravenous, human, 10 IU

Covered HCPCS CodesHCPCSCovered

J2724

Injection, protein C concentrate, intravenous, human, 10 IU

Maximum dosing reference — individualized IU/kg guidance

Dosing is individualized by indicationMaximum dose is individualized; follow indication-specific IU/kg regimens for acute and maintenance therapy.

Acute/short-term initial dosingInitial dose 100–120 IU/kg IV.

Acute/short-term subsequent dosingSubsequent 3 doses: 60–80 IU/kg IV every 6 hours.

Maintenance dosing (short-term/long-term)Maintenance dose 45–60 IU/kg IV every 6 or 12 hours (long-term prophylaxis maintenance commonly 45–60 IU/kg IV every 12 hours).

Provider Actions / Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required. Medical necessity criteria for Ceprotin (protein C concentrate) must be met and documented prior to approval.

Prior authorization required for all lines of business.
Initial authorization duration: Medicaid/HIM - 12 months; Commercial - 12 months or to the member's renewal date, whichever is longer.

Billing Rule

Billing / Coding

Submit claims using HCPCS code J2724 (Injection, protein C concentrate, intravenous, human, 10 IU). Ensure prior authorization is obtained before billing; failure to obtain prior authorization may result in claim denial.

HCPCS: J2724 — Injection, protein C concentrate, intravenous, human, 10 IU

Background

Protein C concentrate (human) is a plasma‑derived enzyme replacementHCPCS code J2724 (Injection, protein C concentrate, intravenous, human, 10 IU).

Definitions and Dosing

Protein C concentrate (Ceprotin) — definition / indication summary

Generic name / productProtein C concentrate, human (Ceprotin).

DescriptionAn enzyme manufactured from human plasma.

FDA‑approved indicationIndicated in neonate, pediatric, and adult patients with severe congenital Protein C deficiency for prevention and treatment of venous thrombosis and purpura fulminans.

Administration routeIntravenous enzyme replacement therapy.

Acute episode / short-term prophylaxis dosing

Initial dose (acute episode/short-term prophylaxis)100–120 IU/kg IV.

Subsequent dosing (acute episode)

Policy Summary

PayerCentene

PolicyProtein C Concentrate, Human (Ceprotin)

Policy CodePolicy CP.PHAR.330

Change TypeRevised initial approval duration

Effective DateMar 1, 2017

Next Review Date

SourceLink

On This Page

Verify authorization dates and units on the prior authorization before claim submission.

Step Therapy

No step therapy requirements apply for Ceprotin. Follow dosing and administration guidance in the policy when prescribing.

No step therapy required.
Refer to Dosage and Administration section for acute and long-term prophylaxis dosing (weight‑based IV dosing and individualized maximum dosing).

Documentation Required

Required Documentation

Provider must submit supporting documentation with the prior authorization request. This includes clinical chart notes, diagnostic and laboratory results (including protein C activity), consultation notes if applicable, and any other information supporting the medical necessity of treatment.

Office chart notes documenting diagnosis and clinical indication.
Relevant laboratory results (e.g., protein C activity levels).
Consultation notes from a hematologist or physician with expertise in inherited thrombophilias when applicable.
Treatment plan, dosing regimen, and rationale for acute or long‑term use.

Denial Risk

Non‑FDA Indications / Denial Risk

Requests for non‑FDA (off‑label) indications may be denied unless the request includes sufficient documentation demonstrating efficacy and safety consistent with the Health Plan's off‑label use policies.

Non‑FDA indications not addressed in this policy require adequate supporting evidence per the plan's off‑label policy.
Provide clinical literature, rationale, and supporting documentation when requesting coverage for off‑label use.

Note

Coverage and Administrative Compliance

Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the members benefit documents and applicable state and federal regulations. Providers must follow Health Plan administrative policies and submit claims in accordance with payer requirements.

Coverage is subject to member benefit documents (EOC, certificate of coverage, policy).
Adhere to Health Plan administrative policies and claims submission rules.
Medicaid providers must follow applicable state Medicaid program requirements.

Three subsequent doses of 60–80 IU/kg IV every 6 hours.

Maintenance dose (short-term/long-term prophylaxis)45–60 IU/kg IV every 6 or 12 hours; long-term prophylaxis maintenance commonly 45–60 IU/kg IV every 12 hours.

Maximum dose guidanceMaximum dosing is individualized per indication (document notes maximums are individualized).

J2724 — HCPCS descriptor

HCPCS codeJ2724.

DescriptorInjection, protein C concentrate, intravenous, human, 10 IU.

Use for billingUse J2724 to report protein C concentrate, human, per 10 IU vial unit.