J7631 HCPCS code: Cromolyn sodium, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per 10 milligrams
J7631 is the HCPCS Level II code for cromolyn sodium, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per 10 milligrams. In 2024 Medicare paid an average of $0.50 per service for J7631 across 113 services. Its Medicare coverage code is D (Special coverage instructions apply): Medicare covers it when its national or local coverage criteria are met. The NCCI unit limit is 744 per day on DME suppliers. In 2024, 308 suppliers billed Medicare for J7631 (purchases), serving 289 beneficiaries; New York, Wisconsin, California accounted for 40% of services.
Code details
| Field | Value |
|---|---|
| Section | J codes — Drugs administered other than oral method |
| Coverage code | D — Special coverage instructions apply |
| Pricing indicator | 51 — Drug or biological (priced per ASP/average sales price rules) |
| BETOS category | D1G — Drugs administered through DME |
| Added | 2000-01-01 |
| Last action effective | 2008-01-01 |
Who bills J7631 (2024)
| Measure | Value |
|---|---|
| Suppliers billing rentals | — |
| Suppliers billing purchases | 308 |
| Referring clinicians | 273 |
| Medicare beneficiaries | 289 |
| States with claims | 21 |
| Share of services in top 3 states (New York, Wisconsin, California) | 40% |
| Year | Suppliers | Beneficiaries |
|---|---|---|
| 2022 | 357 | 357 |
| 2023 | 352 | 345 |
| 2024 | 308 | 289 |
Counts only. Supplier and clinician names, contact lists and state-by-state detail are in Caduvo.
Medicare utilization for J7631, 2024–2024
| Year | Services | Beneficiaries | Avg. allowed | Avg. paid |
|---|---|---|---|---|
| 2024 | 113 | 27 | $0.63 | $0.50 |
States with the most J7631 services (2024)
| State | Services | Avg. paid |
|---|---|---|
| California | 112 | $0.50 |
NCCI unit limits (MUE)
| Claim type | Max units per day | Rationale |
|---|---|---|
| DME suppliers | 744 | Published Contractor Policy |
| practitioner claims | 4 | Clinical: Data |
Medicare policy articles for this code
- A52466: Nebulizers - Policy Article (CGS Administrators, LLC (DME MAC) Noridian Healthcare Solutions, LLC (DME MAC)) — mentions this code in its coding guidance
Covered diagnoses (215 ICD-10-CM codes)
The diagnoses most often listed as covered in the policy articles above:
| ICD-10-CM | Diagnosis | Articles listing it |
|---|---|---|
| A15.0 | Tuberculosis of lung | 1 |
| A22.1 | Pulmonary anthrax | 1 |
| A37.01 | Whooping cough due to Bordetella pertussis with pneumonia | 1 |
| A37.11 | Whooping cough due to Bordetella parapertussis with pneumonia | 1 |
| A37.81 | Whooping cough due to other Bordetella species with pneumonia | 1 |
| A37.91 | Whooping cough, unspecified species with pneumonia | 1 |
| A48.1 | Legionnaires' disease | 1 |
| B20 | Human immunodeficiency virus [HIV] disease | 1 |
| B25.0 | Cytomegaloviral pneumonitis | 1 |
| B44.0 | Invasive pulmonary aspergillosis | 1 |
Showing 10 of 215. The full list, non-covered diagnoses and CSV export are in Caduvo.
What changed for J7631
- 2000-01-01: J7631 added to HCPCS Level II
- Next scheduled CMS quarterly update (HCPCS and DMEPOS fee schedule): 2027-01-01
Frequently asked questions
What is HCPCS code J7631?
J7631 is the HCPCS Level II code for cromolyn sodium, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per 10 milligrams. Short descriptor: "Cromolyn sodium noncomp unit".
How much does Medicare pay for J7631?
In 2024, the average Medicare payment was $0.50 per service (average allowed $0.63).
Does Medicare cover J7631?
Coverage code D — Special coverage instructions apply. Medicare covers it when its national or local coverage criteria are met.
Which diagnoses support coverage for J7631?
Medicare policy articles that cite J7631 list 215 covered ICD-10-CM diagnosis codes across 1 article. The most cited include A15.0 (Tuberculosis of lung), A22.1 (Pulmonary anthrax), A37.01 (Whooping cough due to Bordetella pertussis with pneumonia). A listed diagnosis is necessary but not sufficient; the policy's other criteria still apply.
How many units of J7631 can be billed per day?
744 on DME suppliers; 4 on practitioner claims (NCCI medically unlikely edits).
Related J76 codes
- J7601 — Ensifentrine, inhalation suspension, fda approved final product, non-compounded, administered through dme, unit dose form, 3 mg
- J7604 — Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, per gram
- J7605 — Arformoterol, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 15 micrograms
- J7606 — Formoterol fumarate, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 20 micrograms
- J7607 — Levalbuterol, inhalation solution, compounded product, administered through dme, concentrated form, 0.5 mg
- J7608 — Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram
- J7609 — Albuterol, inhalation solution, compounded product, administered through dme, unit dose, 1 mg
- J7610 — Albuterol, inhalation solution, compounded product, administered through dme, concentrated form, 1 mg
- J7611 — Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, 1 mg
- J7612 — Levalbuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, concentrated form, 0.5 mg
- J7613 — Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 1 mg
- J7614 — Levalbuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 0.5 mg
Building a device that would bill under a code like this? Caduvo matches a device description to HCPCS/CPT codes, Medicare coverage and payment, and the FDA pathway in one report.
Next steps
- Run a reimbursement report for a device billed under J7631
- Watch J7631 for fee, coverage and descriptor changes
- Build a full Medicare revenue model for J7631
Sources: CMS HCPCS Level II release October 2025; CMS DMEPOS fee schedule; CMS NCCI MUE tables; CMS Medicare utilization (physician and DME supplier files); CMS Medicare Coverage Database articles. Fees are Medicare allowables, not commercial rates. Not billing or legal advice.