Faslodex (fulvestrant) — HCPCS J9395

J9395 (NOS) vs. J9394 (Fresenius Kabi) CMS HCPCS verified May 2026

Two HCPCS codes exist for fulvestrant. Pick correctly based on which product your facility purchased.

Fulvestrant has two active HCPCS codes: J9395 is the not-otherwise-specified (NOS) code used for branded Faslodex (AstraZeneca) and most generic fulvestrant products, while J9394 is a manufacturer-specific code created for the Fresenius Kabi generic. CMS publishes ASP separately for each code each quarter, so the right code matters for accurate reimbursement and audit defensibility.

Dosing & unit math FDA label verified May 2026

From FDA prescribing information for Faslodex (fulvestrant), most recent label revision 2024.

Adult dosing — HR+/HER2- advanced or metastatic breast cancer

• 500 mg IM on Days 1, 15, and 29 (loading: three doses in the first month)
• 500 mg IM monthly thereafter (maintenance, every 28–30 days)
• Each dose = TWO 250 mg / 5 mL prefilled syringes (one IM in each buttock)
• 1 unit = 25 mg — 500 mg dose = 20 units

Bilateral IM administration technique

• Each 5 mL prefilled syringe is administered slowly (1–2 minutes) into the gluteal muscle
• One injection in the right buttock + one in the left buttock
• Maximum recommended IM volume per site = 5 mL, so the 10 mL total dose mandates two sites
• Document both injection sites in the encounter note (right and left gluteal)
• Use the included SafetyGlide needles per OSHA needlestick safety

Hepatic dose adjustment

• Moderate hepatic impairment (Child-Pugh B): reduce to 250 mg per dose (= 10 units, ONE syringe IM)
• Severe hepatic impairment (Child-Pugh C): not studied; avoid use
• No dose adjustment needed for renal impairment

Worked example — first-year billing for a 1L HR+/HER2- mBC patient (mono or + CDK4/6)

No premedication required

Faslodex does NOT require pre-injection corticosteroid, antihistamine, or antiemetic. Manage injection-site reactions (very common with bilateral IM) with local care. Consider INR check before injection in patients on warfarin or other anticoagulants — gluteal IM injection carries hematoma risk in coagulopathic patients.

NDC reference FDA NDC Directory verified May 2026

Endocrine therapy class comparison NCCN Breast Cancer 2026

Faslodex is the only IV/IM SERD — all other endocrine therapies for HR+/HER2- breast cancer are oral (pharmacy benefit, not J-code).

Administration codes CPT verified May 2026

Faslodex is a hormonal antineoplastic — CPT 96402 is the correct admin code, not 96401 or 96372.

Modifiers CMS verified May 2026

JZ — required on virtually every claim

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Faslodex prefilled syringes (250 mg / 5 mL) are single-dose containers; the 500 mg dose uses two syringes with zero waste. JZ applies to virtually every Faslodex claim.

JW — rare with Faslodex

JW reports the discarded portion of a single-dose container. Because Faslodex is dosed in 250 mg whole-syringe increments and the standard 500 mg dose is exactly two whole syringes, JW rarely applies. The hepatic-impairment 250 mg dose uses one whole syringe (no waste, JZ). Partial-syringe waste only occurs in unusual scenarios (e.g., contamination requiring discard mid-administration) — document and bill JW for the discarded units only if it occurs. One of JZ or JW must be on every J9395 claim.

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the injection. Routine pre-injection clinical assessment (vital signs, brief check-in) is bundled into 96402.

340B modifiers (JG, TB)

For 340B-acquired fulvestrant, follow your MAC's current 340B modifier policy. Post-genericization the 340B price advantage is smaller than it was for branded Faslodex.

RT / LT — not applicable

Despite bilateral IM injection technique, RT and LT modifiers are NOT used for J9395 or 96402. RT/LT modifiers apply to anatomically paired procedures (e.g., joint injections), not to standard hormonal antineoplastic administration. Document both sites in the note; do not append RT/LT to the claim.

ICD-10-CM by indication FY2026 verified May 2026

Faslodex is approved for HR+/HER2- advanced or metastatic breast cancer. Use the most specific C50.x code with Z17.0 supplementary.

CDK4/6 inhibitor combo regimens NCCN Breast Cancer 2026

Faslodex + CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is current standard of care for 1L+ HR+/HER2- mBC.

For more on the immunotherapy adjacent in HR+/HER2- mBC (rare PD-L1+ cohorts that may use combos with checkpoint inhibitors), see our Keytruda (J9271) reference.

Site of care & place of service Verified May 2026

Faslodex's IM administration is a 5–10 minute clinical encounter (one or two slow IM injections). Office and ambulatory infusion suite settings are strongly preferred — HOPD administration of a simple IM injection draws aggressive site-of-care UM from commercial payers. Most major commercial plans (UHC, Aetna, BCBS) steer hormonal antineoplastic IM out of HOPD entirely.

Claim form field mapping AZ Access 360 + payer guides 2026

From AstraZeneca Access 360 HCP coding & coverage page and major payer billing guides.

Payer policy snapshot Reviewed May 2026

Most commercial payers require PA confirming HR+/HER2- status, postmenopausal status (or concurrent ovarian suppression), and intended regimen.

Generic vs branded PA stance

Generic fulvestrant under J9395 or J9394 is often less PA-restricted than branded Faslodex was pre-genericization. Some payers no longer require PA for generic fulvestrant in clear HR+/HER2- mBC cases, but most still require PA when the drug is part of a CDK4/6 combo regimen (because the combo PA is the gating step).

Step therapy

Generally NOT required for FDA-labeled 1L Faslodex monotherapy or 1L Faslodex + CDK4/6 combo regimens. Some payers require prior aromatase inhibitor failure for 2L+ Faslodex use unless the patient has a contraindication to AI therapy. Verify per-payer.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter. 1 unit = 25 mg for both J9395 and J9394.

Coverage

No NCD specific to fulvestrant. Coverage falls under MAC LCDs for biologic/anti-neoplastic agents and the generic Part B drug coverage framework. All MACs cover J9395 (and J9394) for FDA-approved on-label indications with appropriate ICD-10 (C50.x + Z17.0) and pathology documentation (HR+/HER2- status).

Code history

• J9395 — permanent code, "Injection, fulvestrant, 25 mg" (the not-otherwise-specified code)
• J9394 — permanent code, "Injection, fulvestrant (Fresenius Kabi), 25 mg" (manufacturer-specific generic code)
• Both codes published with separate quarterly ASP files

Patient assistance — AstraZeneca Access 360 + generic manufacturer programs AZ verified May 2026

• AstraZeneca Access 360: 1-844-275-2360 / myaccess360.com — benefits investigation, prior authorization assistance, appeal support for branded Faslodex
• Faslodex Co-pay Program: commercial copay support for branded Faslodex; eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients)
• AstraZeneca Patient Assistance Program (AZ&MeRx): free product for uninsured / underinsured patients meeting income requirements
• Generic manufacturer support: Fresenius Kabi, Sandoz/Eugia, Zydus, and other generic manufacturers offer their own access support programs — typically lower cost, less robust copay support than the branded program
• Foundations: for Medicare patients, refer to PAN, HealthWell, CancerCare — verify open metastatic breast cancer funds quarterly
• CDK4/6 combo support (separate): Pfizer (Ibrance Direct), Novartis (Kisqali Patient Support), Lilly (Verzenio Cares) — coordinate combo support across both manufacturers

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Faslodex?

Faslodex (fulvestrant IM) is billed under HCPCS J9395 — "Injection, fulvestrant, 25 mg." Each 25 milligrams equals one billable unit, so the standard 500 mg dose is billed as 20 units. A separate code, J9394, exists specifically for the Fresenius Kabi generic fulvestrant product. Most payers accept J9395 for branded Faslodex and most generic equivalents.

How many units do I bill for a 500 mg Faslodex dose?

Bill 20 units of J9395 per 500 mg dose. The 500 mg dose is administered as TWO 250 mg / 5 mL prefilled syringes — one IM injection in each buttock. Both syringes count toward the same 20-unit drug line; do not double-bill. The 25 mg unit basis is a common biller error trap — using "500" instead of "20" will be denied or overpaid and recouped.

What administration CPT do I use for Faslodex?

CPT 96402 — "Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic." Faslodex is a hormonal antineoplastic (SERD), so 96402 is correct, NOT 96401 (non-hormonal SC/IM chemo) or 96372 (therapeutic IM injection). Bill 96402 once per encounter even though two injections are administered (bilateral IM technique on the same date).

Is the Faslodex dose given as one injection or two?

Two injections per 500 mg dose — one 250 mg / 5 mL prefilled syringe administered IM into each buttock (right and left gluteal sites), each over 1–2 minutes. Bilateral IM technique is required because 5 mL is the maximum recommended IM volume per site and the total dose is 10 mL. Document both injection sites in the encounter note. Bill the drug as 20 units of J9395 (one combined drug line) and 96402 once for the administration.

What is the Faslodex loading and maintenance schedule?

500 mg IM on Days 1, 15, and 29 (loading: three doses in the first month), then 500 mg IM monthly thereafter as maintenance. Year-1 typical: 14 doses (3 loading + 11 monthly = 14 total injections billed). Year-2+ steady state: 12–13 doses per year. Each dose = 20 units of J9395 + 96402 + bilateral IM technique.

What is the Medicare reimbursement for J9395?

For Q2 2026, the Medicare Part B payment limit for J9395 is $4.938 per 25 mg unit (ASP + 6%). The standard 500 mg dose reimburses at approximately $98.76 (20 units × ASP+6%). Year-1 (14 doses) ~$1,382.64; steady-state monthly maintenance ~$1,185/year. Pricing has dropped substantially post-genericization (multiple generic fulvestrant products available since 2019). Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.

What is the difference between J9395 and J9394?

J9395 is the not-otherwise-specified (NOS) code for branded Faslodex and most generic fulvestrant products. J9394 is a manufacturer-specific code for the Fresenius Kabi generic. ASP is published separately for each code each quarter. If your facility purchases the Fresenius generic, verify whether your payer requires J9394; otherwise J9395 is more universally accepted.

Does Faslodex require prior authorization?

Yes for most commercial payers. UnitedHealthcare, Aetna, and most BCBS plans require PA confirming HR-positive (ER+ and/or PR+) and HER2-negative status (with IHC ER/PR and IHC/ISH HER2 results), and post-menopausal status (or premenopausal with concurrent ovarian function suppression). When billed in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, abemaciclib) or alpelisib, both PAs are typically processed concurrently. Generic fulvestrant under J9395 or J9394 is often less PA-restricted than the branded Faslodex was pre-genericization.

Source documents

1. DailyMed — FASLODEX (fulvestrant) Prescribing Information
   FDA-approved label (NDA 21-344), most recent revision 2024
2. FDA Faslodex label PDF
   Original NDA 21-344, April 2002; 500 mg loading dose adopted 2010
3. AstraZeneca Access 360 — Faslodex HCP coding & coverage
   1-844-275-2360 — benefits investigation, PA support, copay program
4. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026 (separate ASP for J9395 and J9394)
5. SEER CanMED — HCPCS J9395 reference
6. SEER CanMED — HCPCS J9394 reference (Fresenius Kabi)
7. NCCN Clinical Practice Guidelines in Oncology — Breast Cancer (current version)
   HR+/HER2- mBC endocrine therapy + CDK4/6 combo recommendations
8. UnitedHealthcare — Oncology Medication Clinical Coverage Policy
9. Aetna CPB 0173 — Hormonal Therapy for Breast Cancer (covers Faslodex)
10. FDA National Drug Code Directory
11. AMA CPT — chemotherapy administration codes 96401–96425 (96402 hormonal SC/IM)

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 2, 2026 — Initial publication. ASP data: Q2 2026 (J9395 NOS code). Manufacturer source: AstraZeneca Access 360 2026. FDA label: most recent 2024 revision (NDA 21-344). Generic landscape: multiple generics since 2019. CDK4/6 combo regimens (palbociclib, ribociclib, abemaciclib), alpelisib, capivasertib referenced per current NCCN Breast Cancer guidelines.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list is verified against the current FDA label revision and NCCN Breast Cancer guidelines. We do not paraphrase from billing-software vendor blogs.