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HCPCS J9395 · Level II · Part B drug

HCPCS J9395: Injection, fulvestrant, 25 mg

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 J9395

Billing unit
25 MG
Injection, fulvestrant
ASP payment limit
$5.021
October 2026; -4.9% vs July 2026
Practitioner MUE
20
MAI 3
OPPS status
SI N
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J9395 is the Level II code for Injection, fulvestrant, 25 mg, billed per 25 MG. The Medicare Part B ASP payment limit for October 2026 is $5.021 per billing unit, down 4.9% from July 2026. The practitioner MUE allows up to 20 units per date of service (MAI 3). Under OPPS it carries status indicator N. J9395 is billed in units of 25 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 22 NDCs to it, sold as Fulvestrant, Faslodex by Hikma Pharmaceuticals USA Inc., AstraZeneca Pharmaceuticals LP, Sandoz Inc.. No current Billing and Coding Article lists J9395, 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 J9395 at $5.021 per 25 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $5.277 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J9395
QuarterPayment limitPerCoinsurance
October 2026$5.02125 MG20%
July 2026$5.27725 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 22 NDCs from 17 labelers to J9395. Report the NDC in the claim's drug segment and bill the number of J9395 units that equals the quantity administered divided by 25 MG; the last column gives units per full package.

NDCs that crosswalk to J9395
NDCDrug nameLabelerPackage sizeBilling units / package
00143-9022-02FulvestrantHikma Pharmaceuticals USA Inc.5 × 220
00310-0720-10FaslodexAstraZeneca Pharmaceuticals LP5 × 220
00781-3532-12FulvestrantSandoz Inc.5 × 220
00781-9055-12FulvestrantSandoz Inc.5 × 220
16714-0070-02FulvestrantNorthstar RxLLC5 × 220
16729-0436-30FulvestrantAccord Healthcare Inc5 × 220
25021-0462-74FulvestrantSagent Pharmaceuticals5 × 220
25021-0471-74FulvestrantSagent Pharmaceuticals5 × 220
43598-0262-02FulvestrantDr. Reddy's Laboratories Inc.5 × 220
43598-0262-23FulvestrantDr. Reddy's Laboratories Inc.5 × 220
55150-0394-02FulvestrantEugia US LLC5 × 220
62332-0650-10FulvestrantAlembic Pharmaceuticals Inc.5 × 220
63323-0715-05FulvestrantFreseniUS Kabi USA, LLC5 × 220
68001-0484-85FulvestrantBluePoint Laboratories5 × 220
68001-0522-85FulvestrantBluePoint Laboratories5 × 220
68001-0626-85FulvestrantBluePoint Laboratories5 × 220
70121-1463-02FulvestrantAmneal Pharmaceuticals, LLC5 × 220
70700-0284-98FulvestrantXiromed, LLC5 × 220
70710-1688-08FulvestrantZydus Pharmaceuticals (USA) Inc.5 × 220
70860-0211-74FulvestrantAthenex Pharmaceutical Division, LLC5 × 220
71288-0555-86FulvestrantMeitheal Pharmaceuticals Inc.5 × 220
83634-0203-74FulvestrantAvenacy Inc.5 × 220

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J9395. For practitioners the limit is 20 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 J9395 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services203 Date of Service Edit: ClinicalPrescribing Information
Facility outpatient hospital203 Date of Service Edit: ClinicalPrescribing Information
DME supplier203 Date of Service Edit: ClinicalPrescribing Information

NCCI edits and add-on relationships

No active practitioner PTP pair lists J9395 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.

J9395 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 J9395 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, J9395 carries status indicator N. Status N means payment is packaged into the associated procedure and no separate OPPS payment is made.

Common denials for J9395 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 J9395 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 J9395

What does HCPCS code J9395 describe?

J9395 is defined by CMS as "Injection, fulvestrant, 25 mg". Each billing unit represents 25 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J9395 in October 2026?

The ASP-based payment limit is $5.021 per 25 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $5.277.

How many units of J9395 can be billed per day?

The practitioner Medically Unlikely Edit is 20 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 J9395?

The October 2026 ASP crosswalk lists 22 NDCs from 17 labelers: Fulvestrant (Hikma Pharmaceuticals USA Inc.); Faslodex (AstraZeneca Pharmaceuticals LP); Fulvestrant (Sandoz Inc.); Fulvestrant (Northstar RxLLC). For example NDC 00143-9022-02 is a 5 package equal to 20 billing units. The crosswalk's billing-units-per-package figure converts each package into J9395 units.

Does J9395 have NCCI bundling edits?

No active practitioner PTP pairs list J9395 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.