CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

BAL in Oil (dimercaprol) and Calcium EDTA (edetate calcium disodium) therapy for lead poisoning

Medical benefit coverage policy for use of BAL in Oil (dimercaprol) and Calcium EDTA for treatment of lead poisoning for Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBAL in Oil (dimercaprol) and Calcium EDTA therapy for lead poisoning

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, blood lead levels, renal/hepatic function and monitoring, and prescriber specialty or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>44blood lead level threshold

70threshold prompting concomitant use

1 motypical coverage duration

J0470, J0585applicable HCPCS codes

Coverage Criteria

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Coverage Criteria

Covered when ALL of the following are met:

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

Coverage Criteria

Indication for use: Medication is used for acute lead poisoning only (except Calcium EDTA may be used for acute or chronic lead poisoning)

Administration and Coverage Criteria

Concomitant use rules: If request is for BAL in Oil, BAL must be prescribed concomitantly with Calcium EDTA; if request is for Calcium EDTA and blood lead level > 70 mcg/dL, it must be prescribed concomitantly with BAL in Oil>70 mcg/dL triggers concomitant BAL

Coverage Criteria and Administration

Contraindications: Medication is not used in patients with hepatic insufficiency, active renal disease, or hepatitis

Coverage Criteria

Monitoring requirements: Member's renal and hepatic function, urinalysis and urine sediment, and serum electrolyte levels are routinely monitored before each course and daily during therapy in severe cases

Coverage Criteria

Prescriber qualifications: Medication is prescribed by or in consultation with a provider who specializes in chelation therapy (for example, a medical toxicologist)

Coverage Criteria

Dosing: Medications are dosed according to the FDA‑labeled dosing for lead poisoning (BAL in Oil: 4 mg/kg every 4 hours for 2–7 days; Calcium EDTA: per label)

Administration and Coverage Criteria

Investigational use: therapies used at a dose or for a condition other than recognized medically accepted indications are considered investigational and are not covered. The policy follows standard reference compendia (e.g., AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs) and peer‑reviewed literature to determine whether sufficient evidence supports a given use; uses that do not meet those recognized indications will be denied as investigational.

Use outside the specified guidelines — including dosing, indication, required monitoring, or prescriber qualifications — may be considered not medically necessary and is subject to nonpayment unless an exception is approved. Requests for coverage must meet the policy’s coverage criteria (for example, documented lead poisoning with blood lead > 44 mcg/dL, appropriate concomitant use rules, monitoring of renal/hepatic function, and specialist prescribing or consultation).

Prior authorization is required and requests are reviewed prospectively; failure to provide required documentation or to meet the stated criteria may result in denial or nonpayment. Providers seeking an exception should follow the payer’s exception process and supply clinical justification and supporting evidence from recognized compendia or peer‑reviewed literature.

Coding

Applicable HCPCS/CPT CodesHCPCSCovered

J0470	Injection, dimercaprol, per 100 mg.
J0585	Injection, edetate calcium disodium, Up to 1,000 mg

Blood lead level thresholds (inv-05)

Coverage consideration threshold> 44 mcg/dL (member has documented diagnosis of lead poisoning with blood lead levels greater than 44 mcg/dL)

Concomitant therapy trigger> 70 mcg/dL — when blood lead levels exceed 70 mcg/dL, Calcium EDTA must be prescribed concomitantly with BAL in Oil

Use limitation for BAL in OilBAL in Oil is indicated for acute lead poisoning only; when requested it must be prescribed concomitantly with Calcium EDTA

Calcium EDTA indicationsMay be used for acute or chronic lead poisoning; when blood lead >70 mcg/dL it must be given with BAL in Oil

Monitoring requirementMember’s renal and hepatic function, urinalysis/urine sediment, and serum electrolytes are monitored before each course and daily during severe therapy

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Therapy is subject to prospective review and approval. Prior authorization is required and requests will be reviewed against the clinical coverage criteria. Use outside these guidelines may result in nonpayment unless approved under an exception process.

Authorization required prior to initiation
Use outside guidelines may be denied/nonpaid

Step Therapy

Step/Therapeutic Consideration

Follow FDA labeling for dosing and indications. Consider other drug options first where applicable and ensure chelation is indicated for acute or chronic lead poisoning per the coverage criteria.

Adhere to FDA‑approved dosing and indications
Consider alternative therapies when appropriate

Documentation Required

Required Documentation for Prior Authorization

Submit documentation that supports medical necessity, including diagnosis of lead poisoning, blood lead level values, intent (acute vs chronic), and relevant clinical information such as renal and hepatic function, urinalysis, urine sediment, and serum electrolytes. Include specialist consultation notes when applicable.

Required: diagnosis and blood lead levels
Required: labs — renal/hepatic function, urinalysis, urine sediment, serum electrolytes
Include: specialist (e.g., medical toxicologist) consultation when available

Denial Risk

Nonpayment Risk for Out‑of‑Guideline Use

Use outside the stated coverage criteria (for example dosing, indication, or patient populations with active renal disease, hepatic insufficiency, or other contraindications) may result in nonpayment. Requests not meeting criteria require exception approval and will be individually considered.

Non‑covered: use in patients with active renal disease or hepatic insufficiency as specified
Non‑covered: doses or indications outside FDA‑approved labeling without supporting compendia or peer‑reviewed evidence

Background

Dimercaprol (BAL in Oil) and edetate calcium disodium (Calcium EDTA) are chelating agents used to treat heavy metal (lead) poisoning by binding lead and facilitating its excretion. The policy specifies that BAL in Oil is indicated for acute lead poisoning and must be dosed per label (BAL: 4 mg/kg every 4 hours for 2–7 days) and prescribed concomitantly with Calcium EDTA. Calcium EDTA may be used for acute or chronic lead poisoning and is dosed per label (examples in the documentation include regimens around 1,000–1,500 mg/day for 5 days, with higher dosing when given with BAL).

The policy requires routine monitoring of renal and hepatic function, urinalysis, urine sediment and serum electrolytes before each course and daily during severe therapy, and excludes use in patients with hepatic insufficiency, active renal disease, or hepatitis. Concomitant use rules apply: if blood lead levels exceed 70 mcg/dL, Calcium EDTA must be prescribed with BAL; conversely, BAL requests must be accompanied by Calcium EDTA.

Definitions

Acute lead poisoning definition and thresholds (inv-11)

DefinitionAcute lead poisoning: lead exposure with elevated blood lead levels warranting urgent chelation therapy as indicated by policy blood lead thresholds and clinical judgment

Policy-specified acute indication for BAL in OilBAL in Oil indication = acute lead poisoning (dose: 4 mg/kg every 4 hours for 2–7 days)

Calcium EDTA role in acute poisoningCalcium EDTA indicated for acute lead poisoning (dose guidance per administration section); may be used alone for chronic poisoning

Therapeutic intentAgents (dimercaprol/BAL in Oil and edetate calcium disodium/Calcium EDTA) are chelators used to reduce blood lead levels and facilitate excretion