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HCPCS J3385 · Level II · Part B drug

HCPCS J3385: Injection, velaglucerase alfa, 100 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 J3385

Billing unit
100 UNITS
Velaglucerase alfa
ASP payment limit
$393.929
October 2026; +0.3% vs July 2026
Practitioner MUE
80
MAI 3
OPPS status
SI K
APC 9271
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J3385 is the Level II code for Injection, velaglucerase alfa, 100 units, billed per 100 UNITS. The Medicare Part B ASP payment limit for October 2026 is $393.929 per billing unit, up 0.3% from July 2026. The practitioner MUE allows up to 80 units per date of service (MAI 3). Under OPPS it carries status indicator K in APC 9271. J3385 is billed in units of 100 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 1 NDC to it, sold as Vpriv by Takeda Pharmaceuticals America, Inc.. No current Billing and Coding Article lists J3385, 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 J3385 at $393.929 per 100 UNITS for October 2026, derived from manufacturer average sales price plus 6%, compared with $392.843 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J3385
QuarterPayment limitPerCoinsurance
October 2026$393.929100 UNITS20%
July 2026$392.843100 UNITS—
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 1 NDC from 1 labeler to J3385. Report the NDC in the claim's drug segment and bill the number of J3385 units that equals the quantity administered divided by 100 UNITS; the last column gives units per full package.

NDCs that crosswalk to J3385
NDCDrug nameLabelerPackage sizeBilling units / package
54092-0701-04VprivTakeda Pharmaceuticals America, Inc.1 × 14

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J3385. For practitioners the limit is 80 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 J3385 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services803 Date of Service Edit: ClinicalClinical: Data
Facility outpatient hospital803 Date of Service Edit: ClinicalClinical: Data
DME supplier03 Date of Service Edit: ClinicalCMS Policy

NCCI edits and add-on relationships

No active practitioner PTP pair lists J3385 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.

J3385 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 J3385 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, J3385 carries status indicator K and is assigned to APC 9271, with a published national unadjusted payment of $392.84. Status K means the drug is paid separately under OPPS at the ASP-based rate rather than packaged into the procedure.

Common denials for J3385 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 J3385 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 J3385

What does HCPCS code J3385 describe?

J3385 is defined by CMS as "Injection, velaglucerase alfa, 100 units". Each billing unit represents 100 UNITS, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J3385 in October 2026?

The ASP-based payment limit is $393.929 per 100 UNITS, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $392.843.

How many units of J3385 can be billed per day?

The practitioner Medically Unlikely Edit is 80 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 J3385?

The October 2026 ASP crosswalk lists 1 NDC from 1 labeler: Vpriv (Takeda Pharmaceuticals America, Inc.). For example NDC 54092-0701-04 is a 1 package equal to 4 billing units. The crosswalk's billing-units-per-package figure converts each package into J3385 units.

Does J3385 have NCCI bundling edits?

No active practitioner PTP pairs list J3385 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.