Cerezyme (imiglucerase) — HCPCS J1786

CareCost Estimate · Billing Cheat Sheet

Sanofi Genzyme 400 IU lyophilized single-dose vial IV infusion 1–2 hours Type 1 (and select Type 3) Gaucher disease Reviewed: May 2, 2026 ASP: Q2 2026

⚠️

1 BILLING UNIT = 10 IU. A 4,200 IU dose is billed as 420 units, NOT 4,200. Submitting IU as units overstates by 10× and triggers payer recoupment.

HCPCS

J1786

1 unit = 10 IU

Typical dose

420 units

60 IU/kg q2w · 70 kg pt

Modifiers

JZ + JW

Fixed 400 IU vial → waste

Admin CPT

96365

+ 96366 (1–2 hr therapeutic IV)

Medicare ASP+6%

$42.825

/billing unit · $17,986.50/dose

Codes & NDC

HCPCS	`J1786` — "Imiglucerase injection, 10 units" (permanent)
NDC	`58468-1916-01` (10) / `58468-1916-1` (11)
Vial	400 IU lyophilized SDV; reconstitute w/ 10.2 mL SWFI → ~40 IU/mL
Dilution	100–200 mL 0.9% NaCl, 0.2 micron filter
Benefit	Medical (provider buy-and-bill or specialty pharmacy → provider)

Dosing & unit math

60 IU/kg q2w (most common; 26 doses/yr) OR 2.5 IU/kg 3×/wk
Titrate to Hgb, platelets, organ size, biomarkers (chitotriosidase, lyso-Gb1)
1 mg/kg dose math: units = total IU ÷ 10
70 kg × 60 IU/kg = 4,200 IU = 420 billing units
Vials: 4,200 ÷ 400 = 10.5 → round UP to 11 vials (4,400 IU drawn)
Waste: 200 IU = 20 units (bill on JW line)
Year-1 (admin only): 10,920 units (26 × 420)

Brand interchangeability — Gaucher ERTs

Brand	HCPCS	Mfr
Cerezyme (imiglucerase) — reference, FDA 1994	`J1786`	Sanofi Genzyme
VPRIV (velaglucerase alfa) — FDA 2010	`J3385`	Takeda
Elelyso (taliglucerase alfa) — FDA 2012	`J3060`	Pfizer
Oral SRT (pharmacy benefit, NOT medical): Cerdelga (eliglustat, Sanofi) · Zavesca (miglustat, Janssen)

Each ERT has its own permanent HCPCS. Mismatched code/product pairs trigger immediate denial. Switch brands → new PA + new HCPCS.

Administration & modifiers

Code	When
`96365`	Therapeutic IV initial, 1 hr (primary)
`96366`	Each additional hour (1–2 hr Cerezyme infusions)
`96413`	NOT appropriate — ERT is non-chemo

Always bill BOTH lines: J1786/JZ for administered units + J1786/JW for waste units. Single-dose vial waste IS reimbursable but must be reported.

ICD-10 — Gaucher disease

Code	For
`E75.22`	Primary — Gaucher disease (required)
`D69.6`	Thrombocytopenia (secondary)
`D64.9`	Anemia, unspecified (secondary)
`K76.89`	Other liver disease (hepatosplenomegaly)
`R16.0/.1/.2`	Hepato-/spleno-/hepatosplenomegaly
`M89.9`	Bone disorder, unsp (skeletal disease)
`M85.80`	Other bone density/structure disorder (Erlenmeyer flask, AVN)

Confirmation required: acid β-glucosidase enzyme assay AND GBA gene mutation analysis. Geneticist or hematologist consult typically required.

Payer requirements (May 2026)

Payer	PA	Step / Preference
UnitedHealthcare	Yes	LSD ERT policy; class-level (Cerezyme/VPRIV/Elelyso); preferred brand by contract
Aetna	Yes	Gaucher disease CPB; class parity, ASH-aligned
BCBS plans	Yes	Plan-specific; some mandate VPRIV-first
Medicare (MAC LCDs)	Documentation	Covered with E75.22 + diagnostic confirmation

Annual reauth: submit current Hgb, platelets, hepatic/splenic volume, bone status, biomarker trend (chitotriosidase or lyso-Gb1).

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6%	$42.825 / billing unit (10 IU)
4,200 IU dose (420 units)	$17,986.50
Waste 200 IU (20 units)	$856.50 (JW line)
Annual q2w (admin only)	~$467,649
Annual q2w (admin + waste)	~$489,917

Site of care

Setting	POS	Notes
Physician office (genetics/heme)	11	Preferred by UM
Ambulatory infusion suite	49	Preferred by UM
Hospital outpatient	19/22	Disfavored after stabilization
Patient home	12	Common for stable patients via specialty pharmacy + ERT-experienced nursing

Patient assistance — Sanofi Patient Connection

Phone: 1-800-745-4447 (Sanofi Patient Connection)
Cerezyme Patient Support: case management, home infusion coordination, BI/PA help
Commercial copay: available for eligible commercially-insured (excludes Medicare/Medicaid)
PAP: free drug for uninsured/underinsured
Foundations (Medicare): National Gaucher Foundation, PAN, HealthWell — verify open LSD funds
Web: sanofipatientconnection.com

NO Boxed Warning. W&P only: hypersensitivity reactions, IgG antibody formation (~15% of patients, may reduce efficacy), rare pulmonary hypertension. Persistent inhibitor antibodies → consider switch to alternative ERT.

Sources: FDA label (BLA 103573, current revision), CMS ASP Q2 2026, ICGG Gaucher Registry, ASH/MGCC consensus, Sanofi Patient Connection, UHC/Aetna LSD ERT policies. Pending SME review. carecostestimate.com/drugs/cerezyme