CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

BAL in Oil (dimercaprol) and Calcium EDTA (edetate calcium disodium)

Policy governs coverage and prior authorization requirements for BAL in Oil (dimercaprol) and Calcium EDTA (edetate calcium disodium) for treatment of lead poisoning for Neighborhood Health Plan of Rhode Island members (Medicaid, Commercial, Medicare‑Medicaid Plan).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBAL in Oil (dimercaprol) and Calcium EDTA (edetate calcium disodium)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation of lead poisoning and blood lead level >44 mcg/dL for coverage consideration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

44blood lead threshold

70concomitant threshold

1 mocoverage duration

J0470,J0600HCPCS codes

Coverage Criteria for Chelation Therapy

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Coverage Criteria

Covered when ALL of the following are met

Primary diagnosis and lab threshold: Patient has documented diagnosis of lead poisoning with blood lead levels greater than 44 mcg/dL> 44 mcg/dL

If request is for BAL in Oil

BAL in Oil — indication and restrictions: Medication is being used for acute lead poisoning ONLY
BAL in Oil — concomitant therapy: Medication is prescribed concomitantly with Calcium EDTA
BAL in Oil — contraindication: Medication is not used in patients with hepatic insufficiency

If request is for Calcium EDTA

Calcium EDTA — indications: Medication is being used for acute or chronic lead poisoning
Dosage guidance: Calcium EDTA 1000 mg/m2/day for 5 days (alone) or 1500 mg/m2/day for 5 days when given with BAL in Oil
Calcium EDTA — concomitant use at high lead level: Medication is prescribed concomitantly with BAL in Oil when blood lead levels exceed 70 mcg/dL> 70 mcg/dL
Calcium EDTA — laboratory monitoring: Member's laboratory values (renal and hepatic function, urinalysis and urine sediment and serum electrolyte levels) are routinely monitored before each course of therapy and daily during therapy in severe cases
Calcium EDTA — contraindication: Medication is not used in patients with active renal disease or hepatitis

Prescriber and dosing requirements: Medication is prescribed by or in consultation with a provider who specializes in chelation therapy (e.g., a medical toxicologist or poison control specialist); AND medications are dosed according to the US Food and Drug Administration labeled dosing for lead poisoningFDA labeled dosing

Dosage examples: BAL in Oil 4 mg/kg every 4 hours for 2-7 days; Calcium EDTA dosing per labeled guidance

Contraindications: BAL in Oil (dimercaprol) must not be used in patients with hepatic insufficiency. Calcium EDTA (edetate calcium disodium) must not be used in patients with active renal disease or hepatitis. These restrictions align with the coverage criteria requiring avoidance of BAL in hepatic insufficiency and avoidance of Calcium EDTA in active renal disease or hepatitis (see dosing and monitoring requirements).

Investigational use: Therapies administered at doses or for indications that are not recognized as medically accepted in the standard reference compendia (AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or supported by peer‑reviewed literature are considered investigational and are not covered by Neighborhood Health Plan of Rhode Island.

Use of BAL in Oil or Calcium EDTA at doses or for clinical indications that are not recognized as medically accepted by standard compendia is considered investigational and not covered. The policy follows standard compendia (AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs) and peer‑reviewed literature to determine accepted indications; requests for off‑label uses outside those sources should be considered non‑covered.

Applicable Codes and Clinical Thresholds

Applicable HCPCS/CPT CodesHCPCSCovered

J0470	Injection, dimercaprol, per 100 mg
J0600	Injection, edetate calcium disodium, up to 1,000 mg

Blood lead level thresholds

Coverage blood lead level threshold> 44 mcg/dL (patient must have documented lead poisoning with blood lead levels greater than 44 mcg/dL)

Threshold triggering concomitant therapy> 70 mcg/dL (when blood lead levels exceed 70 mcg/dL, Calcium EDTA must be prescribed concomitantly with BAL in Oil)

Applicable requirementMedications must be prescribed by or in consultation with a provider who specializes in chelation therapy (e.g., medical toxicologist or poison control specialist)

Monitoring requirementMember's laboratory values (renal and hepatic function, urinalysis and urine sediment and serum electrolytes) must be routinely monitored before each course and daily during therapy in severe cases

Provider Actions and Authorization

Prior Authorization

Prior authorization required

Coverage is reviewed prospectively via the prior authorization process and requests must meet the plan's clinical criteria to be approved. Applicable HCPCS codes: J0470, J0600.

Submit prior authorization before treatment initiation.
Include clinical criteria evidence (see Coverage Criteria).

Note

Clinical review by P&T

These coverage criteria were adopted by the Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics (P&T) Committee to align use with FDA labeling and relevant clinical literature; the plan will give individual consideration to each request based on submitted information.

Criteria ensure use for medically accepted indications and promote safety and cost-effectiveness.
Individual consideration provided for each prior authorization request.

Documentation Required

Required documentation

Documentation submitted with prior authorization must demonstrate the diagnosis and relevant laboratory monitoring and specialist involvement.

Documented diagnosis of lead poisoning and blood lead level (> 44 mcg/dL).
Evidence that medication is prescribed by or in consultation with a chelation specialist (e.g., medical toxicologist or poison control specialist).
Relevant laboratory monitoring: renal and hepatic function, urinalysis and urine sediment, and serum electrolyte levels as applicable (routine before each course and daily during severe cases).

Denial Risk

Noncompliant use may be denied

Requests that do not meet the plan's stated coverage guidelines may be denied or result in nonpayment unless approved through an exception process.

Use outside the stated guidelines may result in nonpayment.
Exceptions require plan approval.

Background on Chelation Agents

BAL in Oil (dimercaprol) and Calcium EDTA (edetate calcium disodium) are chelating agents used to treat lead poisoning by binding heavy metals and facilitating excretion. BAL in Oil is indicated for acute lead poisoning and is dosed per the policy at 4 mg/kg every 4 hours for 2–7 days. Calcium EDTA is indicated for acute and chronic lead poisoning with dosing guidance of 1000 mg/m2/day for 5 days when used alone or 1500 mg/m2/day for 5 days when given with BAL in Oil. Clinical use requires monitoring of renal and hepatic function and specialist involvement as specified in the coverage criteria.

Definitions and Dosing Guidance

Acute lead poisoning — BAL in Oil (dimercaprol)

Condition treatedAcute lead poisoning (indication for BAL in Oil)

Recommended BAL agent and routeBAL in Oil (dimercaprol), administered per labeled dosing

Dosing guidance4 mg/kg every 4 hours for 2–7 days

Prescriber requirementMedication must be prescribed by or in consultation with a provider who specializes in chelation therapy

Chronic (and acute) lead poisoning — Calcium EDTA (edetate calcium disodium)

Conditions treatedAcute or chronic lead poisoning (indication for Calcium EDTA)

Calcium EDTA dosing — alone1000 mg/m2/day for 5 days (when given alone)

Calcium EDTA dosing — with BAL1500 mg/m2/day for 5 days when given with the second BAL in Oil dose

Monitoring and safetyDo not use in patients with active renal disease or hepatitis; monitor renal and hepatic function, urinalysis, urine sediment, and serum electrolytes before each course and daily in severe cases