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HCPCS J0801 · Level II · Part B drug

HCPCS J0801: Injection, corticotropin (acthar gel), up to 40 units

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 J0801

Billing unit
40 UNITS
Inj. acthar gel to 40 units
ASP payment limit
$3,884.267
October 2026; -6.0% vs July 2026
Practitioner MUE
3
MAI 3
OPPS status
SI K
APC 9268
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J0801 is the Level II code for Injection, corticotropin (acthar gel), up to 40 units, billed per 40 UNITS. The Medicare Part B ASP payment limit for October 2026 is $3,884.267 per billing unit, down 6.0% from July 2026. The practitioner MUE allows up to 3 units per date of service (MAI 3). Under OPPS it carries status indicator K in APC 9268. J0801 is billed in units of 40 UNITS; 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 3 NDCs to it, sold as H.P. Acthar, Acthar Gel by Mallinckrodt ARD LLC. No current Billing and Coding Article lists J0801, 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 J0801 at $3,884.267 per 40 UNITS for October 2026, derived from manufacturer average sales price plus 6%, compared with $4,133.449 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J0801
QuarterPayment limitPerCoinsurance
October 2026$3,884.26740 UNITS20%
July 2026$4,133.44940 UNITS—
CMS note: "lesser of" methodology applied

NDC to HCPCS billing-unit conversion

The October 2026 ASP crosswalk maps 3 NDCs from 1 labeler to J0801. Report the NDC in the claim's drug segment and bill the number of J0801 units that equals the quantity administered divided by 40 UNITS; the last column gives units per full package.

NDCs that crosswalk to J0801
NDCDrug nameLabelerPackage sizeBilling units / package
63004-8710-01H.P. ActharMallinckrodt ARD LLC5 × 110
63004-8711-04Acthar GelMallinckrodt ARD LLC1 × 48
63004-8712-04Acthar GelMallinckrodt ARD LLC1 × 44

Medically Unlikely Edits (MUE)

CMS publishes 2 MUE values for J0801. For practitioners the limit is 3 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 J0801 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services33 Date of Service Edit: ClinicalPrescribing Information
Facility outpatient hospital33 Date of Service Edit: ClinicalPrescribing Information

NCCI edits and add-on relationships

No active practitioner PTP pair lists J0801 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.

J0801 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 J0801 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, J0801 carries status indicator K and is assigned to APC 9268, with a published national unadjusted payment of $4,133.45. Status K means the drug is paid separately under OPPS at the ASP-based rate rather than packaged into the procedure.

Common denials for J0801 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 J0801 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.

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Frequently asked questions — HCPCS J0801

What does HCPCS code J0801 describe?

J0801 is defined by CMS as "Injection, corticotropin (acthar gel), up to 40 units". Each billing unit represents 40 UNITS, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J0801 in October 2026?

The ASP-based payment limit is $3,884.267 per 40 UNITS, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $4,133.449.

How many units of J0801 can be billed per day?

The practitioner Medically Unlikely Edit is 3 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 "Prescribing Information" as the rationale.

Which NDCs map to J0801?

The October 2026 ASP crosswalk lists 3 NDCs from 1 labeler: H.P. Acthar (Mallinckrodt ARD LLC); Acthar Gel (Mallinckrodt ARD LLC). For example NDC 63004-8710-01 is a 5 package equal to 10 billing units. The crosswalk's billing-units-per-package figure converts each package into J0801 units.

Does J0801 have NCCI bundling edits?

No active practitioner PTP pairs list J0801 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.