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HCPCS J7631 · Level II · Part B drug

HCPCS J7631: Cromolyn sodium, inhalation solution, fda-approved final product,

Reviewed by QuickIntell RCM Editorial Team · Last reviewed

Data effective
Data currency: ASP payment limits October 2026 (effective October 1, 2026); MUE and NCCI edits 2026 Q4 (effective October 1, 2026); OPPS Addendum B July 2026 (effective July 1, 2026). Next CMS release: January 1, 2027 (ASP, MUE, NCCI and OPPS quarterly updates).

Key facts for J7631

Billing unit
10 MG
Cromolyn sodium noncomp unit
ASP payment limit
$0.385
October 2026; -44.3% vs July 2026
Practitioner MUE
4
MAI 3
OPPS status
SI M
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J7631 is the Level II code for Cromolyn sodium, inhalation solution, fda-approved final product,, billed per 10 MG. The Medicare Part B ASP payment limit for October 2026 is $0.385 per billing unit, down 44.3% from July 2026. The practitioner MUE allows up to 4 units per date of service (MAI 3). Under OPPS it carries status indicator M. J7631 is billed in units of 10 MG; the quantity administered, the NDC package and the units on the claim must reconcile, which is the check that prevents CARC 16 and 151 returns on this line. The ASP crosswalk maps 2 NDCs to it, sold as Cromolyn Sodium by Ivax Pharmaceuticals, Inc., Ritedose Pharmaceuticals, LLC. No current Billing and Coding Article lists J7631, so coverage follows the FDA label, compendia and any applicable NCD.

Medicare Part B payment limit (ASP)

CMS sets the Part B payment limit for J7631 at $0.385 per 10 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $0.691 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J7631
QuarterPayment limitPerCoinsurance
October 2026$0.38510 MG20%
July 2026$0.69110 MG—
Source: CMS Medicare Part B Drug Payment Limit File. Commercial and Medicaid payers set their own rates.

NDC to HCPCS billing-unit conversion

The October 2026 ASP crosswalk maps 2 NDCs from 2 labelers to J7631. Report the NDC in the claim's drug segment and bill the number of J7631 units that equals the quantity administered divided by 10 MG; the last column gives units per full package.

NDCs that crosswalk to J7631
NDCDrug nameLabelerPackage sizeBilling units / package
00172-6406-49Cromolyn SodiumIvax Pharmaceuticals, Inc.2 × 60120
76204-0028-60Cromolyn SodiumRitedose Pharmaceuticals, LLC2 × 60120

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J7631. For practitioners the limit is 4 units per date of service with adjudication indicator 3, a date-of-service clinical edit: units above the limit deny but can be paid on appeal with documentation that the quantity was medically reasonable.

MUE values for J7631 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services43 Date of Service Edit: ClinicalClinical: Data
Facility outpatient hospital03 Date of Service Edit: ClinicalCMS Policy
DME supplier7443 Date of Service Edit: ClinicalPublished Contractor Policy

NCCI edits and add-on relationships

No active practitioner PTP pair lists J7631 as a column-1 or column-2 code in v323r0. Drug supply codes are rarely bundled; the administration codes billed with them are where PTP edits usually apply.

J7631 is neither an add-on code nor a designated primary code in the 2026 Q4 NCCI add-on edit file.

Medicare coverage articles

No current Billing and Coding Article lists J7631 in its HCPCS table. Coverage then follows the drug's FDA label, compendia and any National Coverage Determination; check the Medicare Coverage Database before administering off-label.

Hospital outpatient (OPPS) status

In the July 2026 OPPS Addendum B, J7631 carries status indicator M. Consult the OPPS status indicator table for payment treatment.

Common denials for J7631 and how to prevent them

CARC 16 · M119

NDC missing, invalid or not matched to the HCPCS code

CARC 151 · N362

units billed exceed the MUE for the date of service

CARC 50 · N115

diagnosis not covered by the applicable coverage article or LCD

How QuickIntell checks J7631 before the claim leaves

QuickCode validates the NDC-to-unit conversion against the current ASP crosswalk, checks units against every published MUE setting and flags PTP and add-on conflicts on the same claim. QuickRCM routes CARC 16, 151 and 50 denials on drug lines with the matching coverage article attached so the appeal starts with evidence.

Explore QuickCodeExplore QuickRCMBook a demo

Frequently asked questions — HCPCS J7631

What does HCPCS code J7631 describe?

J7631 is defined by CMS as "Cromolyn sodium, inhalation solution, fda-approved final product,". Each billing unit represents 10 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J7631 in October 2026?

The ASP-based payment limit is $0.385 per 10 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $0.691.

How many units of J7631 can be billed per day?

The practitioner Medically Unlikely Edit is 4 units per date of service with adjudication indicator 3 (3 Date of Service Edit: Clinical). MAI 3 edits can be appealed with documentation that the units were medically reasonable. CMS cites "Clinical: Data" as the rationale.

Which NDCs map to J7631?

The October 2026 ASP crosswalk lists 2 NDCs from 2 labelers: Cromolyn Sodium (Ivax Pharmaceuticals, Inc.); Cromolyn Sodium (Ritedose Pharmaceuticals, LLC). For example NDC 00172-6406-49 is a 2 package equal to 120 billing units. The crosswalk's billing-units-per-package figure converts each package into J7631 units.

Does J7631 have NCCI bundling edits?

No active practitioner PTP pairs list J7631 as a column-1 or column-2 code in the v323r0 release. Unit limits (MUE) and medical-necessity coverage rules still apply.

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-01. Verify against the primary file before billing or contracting decisions.

Disclaimer

This page is an operational reference compiled from CMS publications: the Medicare Part B drug payment limit and NDC crosswalk files, NCCI MUE and add-on edit tables, aggregate PTP statistics, OPPS Addendum B and the Medicare Coverage Database. Payment limits are Medicare national amounts; commercial and Medicaid payers differ. CPT codes are shown as numbers only; CPT descriptors are copyright AMA. Nothing here is legal, clinical or billing advice.