RetiredUnitedHealthcarePolicy CSLA2025D0070G

Ryplazim (Plasminogen, Human-Tvmh) (for Louisiana Only) Retired April 1, 2026

Policy governs medical benefit coverage of Ryplazim for treatment of plasminogen deficiency type 1 for UnitedHealthcare Community Plan in Louisiana members; describes criteria for initial and continuation therapy and notes retirement of the policy.

Policy Summary

PayerUnitedHealthcare

PolicyRyplazim (Plasminogen, Human-Tvmh) (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CSLA2025D0070G

Change TypeRetired (membership disenrolled)routine review

Effective DateMarch 1, 2025 - March 31, 2026

Next Review Date

Key ActionSubmit prior authorization with diagnosis E88.02, plasminogen activity ≤45%, hematologist involvement, and FDA-consistent dosing.

SourceLink

POLICY UPDATE CHANGES

Policy retired and Louisiana plan membership disenrolled on Apr. 1, 2026.

Routine review on 03/01/2025 with no content changes.

J2998HCPCS

E88.02ICD-10

n = 15Trial size

78%Lesion resolution

Coverage Criteria for Ryplazim (plasminogen, human-tvmh)

Policy Summary

PayerUnitedHealthcare

PolicyRyplazim (Plasminogen, Human-Tvmh) (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CSLA2025D0070G

Change TypeRetired (membership disenrolled)routine review

Effective DateMarch 1, 2025 - March 31, 2026

Next Review Date

Key ActionSubmit prior authorization with diagnosis E88.02, plasminogen activity ≤45%, hematologist involvement, and FDA-consistent dosing.

SourceLink

On This Page

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 Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met for initial therapy:

Initial therapy criteria: Diagnosis of hypoplasminogenemia as measured by plasminogen activity level ≤ 45% of laboratory standard; presence of clinical signs and symptoms of the disease (e.g., ligneous conjunctivitis, gingivitis, tonsillitis, abnormal wound healing); prescribed by or in consultation with a hematologist; dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling; initial authorization will be for no more than 12 months.plasminogen activity ≤ 45%

Support with laboratory and clinical documentation

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met for continuation of therapy:

Continuation therapy criteria: Patient has previously received treatment with Ryplazim; patient has experienced a positive clinical response to Ryplazim (e.g., reduction in lesion number/size, improved wound healing, plasminogen activity trough level increased by at least 10 percentage points from baseline); prescribed by or in consultation with a hematologist; dosing is in accordance with the U.S. Food and Drug Administration (FDA) approved labeling; reauthorization will be for no more than 12 months.trough increase ≥ 10 percentage points

Document prior response and ongoing benefit

Not Medically Necessary Indication

Not covered indication: Treatment of idiopathic pulmonary fibrosis is unproven and not medically necessary.

Explicit exclusion in policy

Ryplazim (plasminogen, human-tvmh) is unproven and not medically necessary for the treatment of idiopathic pulmonary fibrosis.

Use of Ryplazim for idiopathic pulmonary fibrosis is considered not medically necessary.

Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J2998

Injection, plasminogen, human-tvmh, 1 mg.

Applicable Diagnosis CodesICD-10

E88.02

Plasminogen deficiency

inv-08: Plasminogen activity level — diagnostic threshold and trial enrollment ranges

Diagnostic thresholdPlasminogen activity level ≤ 45% of laboratory standard

Pivotal trial baseline rangeRYPLAZIM trial enrolled patients with baseline plasminogen activity between <5% and 45% of normal

Trial primary endpoint related thresholdPrimary endpoint: individual trough plasminogen activity increase by an absolute ≥10 percentage points from baseline

Use for coverage decisionsDiagnosis for coverage requires plasminogen activity ≤45% plus clinical signs/symptoms

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ryplazim (plasminogen, human-tvmh). Submit documentation demonstrating the diagnosis of plasminogen deficiency (ICD-10: E88.02), a plasminogen activity level ≤ 45% of laboratory standard, evidence of clinical signs/symptoms, hematologist involvement, and that dosing follows FDA‑approved labeling. Initial and reauthorization approvals are limited to a maximum of 12 months.

Prior authorization required before dispensing Ryplazim (HCPCS: J2998).
Initial authorization limited to ≤ 12 months; reauthorization limited to ≤ 12 months.

Note

Provider Action

Prescriber must document that Ryplazim was prescribed by or in consultation with a hematologist. When submitting claims or PA requests, include the hematology consult note or attestation and ensure billing uses the appropriate HCPCS code for plasminogen (J2998).

Include hematologist name and NPI on request.
Use HCPCS code J2998 for billing.

Documentation Required

Required Documentation

Include the following documentation with the prior authorization request: diagnosis (ICD-10 E88.02); laboratory result showing plasminogen activity ≤ 45% of laboratory standard; description of clinical signs or symptoms (e.g., ligneous conjunctivitis, gingivitis, tonsillitis, abnormal wound healing); prior treatment history and response (for continuation requests); hematologist involvement (prescribing or consultation note); and planned dosing consistent with FDA labeling.

Diagnosis code: E88.02 (plasminogen deficiency).
Plasminogen activity result ≤ 45% of laboratory standard (attach lab report).
Clinical signs/symptoms and clinical course (attach relevant notes).
For continuation: documentation of prior Ryplazim use and positive clinical response (e.g., reduced lesion number/size, improved wound healing, or plasminogen trough increase ≥ 10 percentage points from baseline).
Hematologist prescription or consultation note.
Proposed dosing schedule consistent with FDA‑approved labeling.

Denial Risk

Denial Triggers for Medical Necessity

Requests will be denied if required criteria are not met or not documented. Denial triggers include absence of a confirmed diagnosis (E88.02), plasminogen activity > 45%, no clinical signs/symptoms consistent with hypoplasminogenemia, lack of hematologist involvement, dosing inconsistent with FDA labeling, or missing/insufficient supporting records for prior response when requesting continuation.

Denial if plasminogen activity > 45%.
Denial if clinical signs/symptoms are not documented.
Denial if hematologist is not the prescriber or not consulted.
Denial if documentation does not show prior clinical response for continuation requests.

Background on Plasminogen Deficiency and Ryplazim

Plasminogen is a circulating protein synthesized by the liver and is converted to plasmin, an enzyme that degrades fibrin. In type 1 plasminogen deficiency (hypoplasminogenemia), low plasminogen levels lead to impaired fibrinolysis and accumulation of fibrin-rich, ligneous pseudomembranous lesions on mucous membranes (most commonly the conjunctiva), which can cause functional impairment such as visual loss. Replacement with plasminogen can restore plasmin activity and reduce these fibrin-rich lesions when used according to labeled dosing and with clinical monitoring.

OpenPayer

Ryplazim (Plasminogen, Human-Tvmh) (for Louisiana Only) Retired April 1, 2026

Coverage Criteria for Ryplazim (plasminogen, human-tvmh)

Billing and Diagnosis Codes

Provider Actions, Prior Authorization, and Documentation

Background on Plasminogen Deficiency and Ryplazim

Key Definitions

Policy Revision History