HCPCS (current)
J3590
NOC unclassified biologics; C9399 alt for HOPPS
| Phase | Timing | Setting | Key codes |
|---|---|---|---|
| 1. Apheresis HSC collection | ~6 mo pre-infusion | QTC outpatient (POS 22) | CPT 38206 or 0540T + plerixafor J2562 (SCD) |
| 2. Ex vivo lentiviral transduction (BB305) | 3–6 mo at bluebird facility | bluebird (no provider billing) | n/a (manufacturer internal) |
| 3. Busulfan myeloablative conditioning | 4 days pre-infusion | QTC inpatient (POS 21) | J0594 (busulfan, per mg) + 96413 chemo admin |
| 4. Autologous HSC infusion | Day 0 | QTC inpatient (POS 21) | J3590 + CPT 38241 (HSCT autologous) |
| 5. Engraftment + LTFU surveillance | 30–45 d inpatient, then outpatient mo 1–24+ through year 15 | QTC inpatient then outpatient | Bundled into HSCT DRG; outpatient E/M + labs + hematologic-malignancy CBC surveillance per BOXED warning |
| Therapy | Mechanism | Indication | Billing pathway | Product list |
|---|---|---|---|---|
| Lyfgenia (J3590) | Lentiviral BB305 + bA-T87Q (ex vivo HSC) | SCD ≥12 yr (no TDT) | Multi-stage HSCT | ~$3.1M (BOXED warning) |
| Casgevy (J3590) | CRISPR/Cas9 BCL11A edit (ex vivo HSC) | SCD / TDT ≥12 yr | Multi-stage HSCT | ~$2.2M |
| Zolgensma (J3399) | AAV9 + SMN1 (in vivo) | Pediatric SMA <2 yr | Single IV infusion | ~$2.125M |
| Hemgenix (J1411) | AAV5 + FIX-Padua (in vivo) | Adult hemophilia B | Single IV infusion | ~$3.5M |
| Roctavian (J1412) | AAV5 + FVIII-SQ (in vivo) | Adult hemophilia A | Single IV infusion | ~$2.9M |
| HbSS with crisis (VOC) | D57.00 / D57.01 |
| HbSC with crisis | D57.20x / D57.21x |
| HbS-β-thal with crisis | D57.40x / D57.41x |
| Sickle-cell trait (NOT eligible) | D57.3 |
| β-thal major (Cooley's) TDT | D56.1 → Casgevy |
| HbE-β-thal TDT | D56.5 → Casgevy |
| Long-term chelator use | Z79.899 |
| Hx stem cell transplant (post) | Z94.81 |
| # | Reason | Fix |
|---|---|---|
| 1 | SCD genetic confirmation missing | Submit hemoglobinopathy genotyping + electrophoresis |
| 2 | Non-QTC facility | Re-route to credentialed QTC (lyfgenia.com/hcp) |
| 3 | VOC documentation gap | Submit detailed VOC log; document hydroxyurea trial |
| 4 | Patient < 12 yr | Not FDA-approved; maintain supportive care |
| 5 | HSCT eligibility incomplete | Complete standard pre-HSCT workup at QTC |
| 6 | Hematologic-malignancy REMS not enrolled | Enroll in bluebird LTFU program at PA stage (Lyfgenia-specific) |
| 7 | TDT attempted (no Lyfgenia indication) | Refer to Casgevy for β-thalassemia patients |
bluebird Patient Services: 1-833-999-6760 / lyfgenia.com/hcp — QTC referral, apheresis logistics, manufacturing chain-of-custody, fertility-preservation counseling, travel/lodging, outcomes-based contract administration, hematologic-malignancy LTFU REMS enrollment (year-15+ surveillance).
Sickle Cell Disease Association of America (SCDAA), BMT InfoNet, PAN Foundation (rare disease), HealthWell Foundation, Patient Advocate Foundation.
Common with all major commercial payers and CMS CGT Access Model (Medicaid). 3–5 yr milestone tracking (absence of severe VOCs). Provider documents outcomes data at mo 6, 12, 24, 60, plus annual hematologic surveillance through year 15.
Launched January 2025. CMS negotiates OBAs for SCD gene therapies (Casgevy + Lyfgenia) on behalf of >20 participating state Medicaid agencies. Standardized outcomes metrics, pricing, and milestone tracking.