Summary & Overview
HCPCS J7631: Cromolyn Sodium Inhalation Solution, Unit Dose
HCPCS Level II code J7631 identifies cromolyn sodium inhalation solution, an FDA-approved, non‑compounded unit-dose product supplied for administration through durable medical equipment. The code matters nationally as it standardizes billing for a specific inhaled therapy used to prevent bronchospasm and allergic respiratory symptoms, enabling consistent reimbursement and utilization tracking for outpatient and home-based respiratory care.
Key payers in the analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical context for cromolyn sodium, typical sites of service tied to DME-supported inhalation therapy, and the scope of coverage considerations across major national payers. The publication also outlines benchmarks related to billing frequency and unit reporting, common billing modifiers used in practice, and policy updates relevant to HCPCS drug coding and DME administration.
This summary is intended for clinicians, billing professionals, and policy analysts seeking concise guidance on coding and service context for J7631. Data not available in the input is identified where applicable in detailed sections.
Billing Code Overview
HCPCS Level II code J7631 represents cromolyn sodium inhalation solution, FDA-approved final product, non-compounded, unit dose form, per 10 milligrams, supplied for administration through durable medical equipment (DME). This medication is an inhaled mast cell stabilizer used for prevention of bronchospasm and allergic respiratory symptoms in appropriate clinical contexts.
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Service type: Drug administration via inhalation solution supplied in unit-dose form through DME
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Typical site of service: Outpatient settings where DME is used, including home administration with DME support and outpatient infusion or respiratory therapy areas
Clinical & Coding Specifications
Clinical Context
A pediatric or adult patient with mild persistent asthma presents for scheduled administration of inhaled cromolyn sodium solution via a nebulizer. The patient has been prescribed the FDA-approved, non-compounded, unit-dose inhalation solution J7631 (per 10 mg) to be administered through durable medical equipment (DME) in the outpatient clinic, hospital outpatient department, or home health setting when nebulizer therapy is required. The common workflow: clinician documents indication and confirms medication order, pharmacy dispenses unit-dose vials, nursing or respiratory therapy prepares the dose, assembles the nebulizer (DME) and delivers the inhalation treatment while monitoring for tolerance. Clinical documentation includes medication administration record, dose, lot number, route (inhalation/nebulizer), site of service, and diagnosis supporting medical necessity.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | When no additional modifier applies to the service or supply |
11 | Normal, usual, or reference (facility) |