CurrentHealth NetPolicy CP PHAR.564

Antithrombin III (ATryn; Thrombate III) coverage

Defines medical necessity, authorization, and coverage criteria for antithrombin products (recombinant ATryn and human Thrombate III) for members of Health Net/Centene lines of business (Commercial, HIM, Medicaid). Applies to providers requesting coverage for these products.

Policy Summary

PayerHealth Net

PolicyAntithrombin III (ATryn; Thrombate III) coverage

Policy CodePolicy CP PHAR.564

Change TypeNo material change

Effective DateMar 1, 2022

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation (chart notes, lab results) demonstrating that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2antithrombin products requiring authorization

80-120%target antithrombin activity

J7196, J7197HCPCS codes listed

NCDocument origin

Coverage Criteria for Antithrombin Products

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.

Initial Approval: Diagnosis of hereditary antithrombin deficiency.

Initial Approval: Prescribed by or in consultation with a hematologist.

Initial Approval: Member is age ≥ 18 years.

Initial Approval: Request is for one of the following: (a) Thrombate III for treatment or prevention of thromboembolism; OR (b) Prevention of peri-operative or peri-partum thromboembolism with ATryn or Thrombate III.

Approval durations differ by indication and line of business: acute thrombosis or peri-operative/peri-partum prevention: 3 months; prevention: Medicaid/HIM 6 months; Commercial 6 months or to member renewal date, whichever is longer.

Continued Therapy Criteria

Covered when ONE of the following is met:

Continued Therapy: Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria AND member is responding positively to therapy.

Approval durations for prevention: Medicaid/HIM 6 months; Commercial 6 months or to member renewal date, whichever is longer.

Continued Therapy: Member is currently receiving medication and is enrolled in a state/product continuity of care program (per state-specific continuity of care regulations).

Refer to state-specific addendums for continuity of care (CCPHARM.03A and CCPHARM.03B).

Requests for non‑FDA approved (off‑label) indications are not addressed by this policy unless the provider submits sufficient clinical documentation of efficacy and safety consistent with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

ATryn (recombinant antithrombin) is indicated for the prevention of peri‑operative and peri‑partum thromboembolic events in hereditary antithrombin deficiency but is not indicated for treatment of thromboembolic events; use of ATryn for treatment is therefore not an FDA‑approved indication. Non‑FDA uses (including treatment of thromboembolic events) require documentation per off‑label policies and may not be covered under this policy.

Coding and Target Levels

HCPCS Codes referencedHCPCS

J7196	Injection,antithrombin recombinant 50 IU
J7197	Injection,antithrombin (human) [description truncated in source]

HCPCS Codes referencedHCPCS

J7196	Injection,antithrombin recombinant 50 IU
J7197	Injection,antithrombin recombinant (other description present but truncated in source)

Target antithrombin activity

Target antithrombin activity (therapeutic goal)Restore and maintain functional antithrombin activity levels between 80% and 120% of normal human plasma.

Thrombate III dosing targetIndividualize dose to achieve antithrombin level of 80% to 120% of normal human plasma; loading and maintenance dosing adjusted per baseline and target levels.

ATryn dosing targetTreatment with recombinant ATryn is to restore and maintain functional antithrombin activity levels between 80% and 120% of normal human plasma; continue until adequate follow-on anticoagulation established.

HCPCS codes for antithrombin (billing guidance)

J7196Injection, antithrombin recombinant 50 IU — HCPCS code referenced for recombinant antithrombin injections.

J7197Injection, antithrombin (human) — HCPCS code referenced for human antithrombin injection (Thrombate III).

Billing noteCodes are provided for informational purposes; inclusion does not guarantee coverage — providers should reference current professional coding guidance when submitting claims.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for antithrombin products including ATryn (antithrombin, recombinant) and Thrombate III (antithrombin III, human). Providers must obtain authorization prior to dispensing or administering these products to ensure coverage.

Affected products: ATryn (antithrombin, recombinant) and Thrombate III (antithrombin III, human)

Documentation Required

Required Clinical Documentation

Providers must submit clinical documentation (e.g., chart notes, laboratory results, dosing records, and other relevant medical information) demonstrating that the member meets all approval criteria. Failure to supply required documentation may result in denial of the prior authorization request or claim.

Examples: chart notes, lab results, dosing rationale, prior treatment history

Billing Rule

Claims Coding and Documentation

Claims should be billed using the appropriate HCPCS codes for antithrombin products. Providers are responsible for accurate coding and for referencing current professional coding guidance when submitting claims for reimbursement.

HCPCS: J7196 — Injection, antithrombin recombinant 50 IU
HCPCS: J7197 — (additional antithrombin product code)
Note: Inclusion of codes in this policy is informational only and does not guarantee coverage

Note

Formulary and Off-Label Handling

If the requested use is for a diagnosis, age group, or dosing regimen not specifically addressed in this policy, or if the product is not on the member’s formulary/PDL, providers should follow the applicable formulary, non-formulary, and off-label use policies for the member's line of business prior to requesting coverage.

Follow formulary/non-formulary and off-label use policies for the member's line of business
If drug recently had a label change within 6 months, refer to applicable change guidance

Note

Coverage Subject to Plan Terms

Coverage decisions are subject to the member’s plan terms, conditions, exclusions, and limitations. Prior authorization approval does not guarantee payment — final adjudication is subject to verification of benefits and plan rules.

Confirm member eligibility and benefit limitations prior to service delivery
Authorization approval does not supersede plan exclusions or limitations

Background on Antithrombin Products

Antithrombin products replace or augment physiologic antithrombin activity in patients with hereditary antithrombin deficiency. They are used most commonly to prevent peri‑operative and peri‑partum thromboembolic events; ATryn (recombinant) is approved for prevention only, while Thrombate III (human antithrombin) is approved for both treatment and prevention of thromboembolism in this population. Hereditary antithrombin deficiency is a congenital condition characterized by insufficient antithrombin activity and an increased risk of thromboembolism, which is the clinical context for considering antithrombin replacement therapy.

Definitions and Key Terms

Hereditary antithrombin deficiency — definition & relevance

DefinitionHereditary antithrombin deficiency is a congenital condition in which patients have insufficient antithrombin activity, increasing the risk of thromboembolism.

Clinical relevancePatients with hereditary antithrombin deficiency may require antithrombin replacement to prevent peri-operative and peri-partum thromboembolic events; Thrombate III is indicated for treatment and prevention of thromboembolism in these patients.

ATryn limitationATryn (recombinant) is indicated for prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients but is not indicated for treatment of thromboembolic events.

HCPCS code explanations

J7196 — descriptionInjection, antithrombin recombinant 50 IU (HCPCS).

J7197 — descriptionInjection, antithrombin (human) (HCPCS) — code referenced for human antithrombin injections (Thrombate III).

Usage guidanceHCPCS J7196 and J7197 are referenced in this clinical policy for claim submission and prior authorization requests; verify current code descriptors with professional coding sources.