HCPCS
J0202
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm third-line eligibility, REMS enrollment, and the unique two-course induction schedule.
Lemtrada vs. other MS DMTs FDA verified May 2026
Lemtrada is the only MS DMT with a finite induction schedule and a third-line label restriction.
Lemtrada is a humanized anti-CD52 monoclonal antibody that depletes both T and B lymphocytes — broader than the anti-CD20 agents (Ocrevus, Briumvi, Kesimpta) which spare T cells. The deeper, longer immune depletion drives both the unique efficacy profile (induction-only dosing with multi-year disease control) and the unique safety profile (autoimmunity, malignancy risk). FDA's third-line restriction reflects that risk-benefit calculus.
| Drug | HCPCS | Mechanism | Line of therapy | Schedule |
|---|---|---|---|---|
| Lemtrada (alemtuzumab) | J0202 |
Anti-CD52 (T+B cells) | 3rd-line (post-2 DMT failures) | Induction only: 5d + 3d, 12 mo apart |
| Ocrevus (ocrelizumab) | J2350 |
Anti-CD20 (B cells) | 1st-line OK | 600 mg q6 months |
| Briumvi (ublituximab) | J2329 |
Anti-CD20 (B cells) | 1st-line OK | 450 mg q6 months |
| Tysabri (natalizumab) | J2323 |
Anti-α4β1 integrin | 2nd-line (JC virus risk) | 300 mg q4 weeks |
| Tyruko (natalizumab-sztn) | Q5134 |
Tysabri biosimilar | 2nd-line | 300 mg q4 weeks |
Key billing tell: if you see
J0202 with 96413 + 96415 × 3 for
5 consecutive days, that's a Course 1 induction — flag for REMS verification and 4 years of monitoring
labs. A Course 2 (3 consecutive days) should appear ~12 months later. No q4-week or q6-month maintenance
encounters should appear for J0202; if they do, the coding is wrong.
Total drug exposure: standard 2-course induction = 96 mg total over 2 years (60 mg in Year 1,
36 mg in Year 2). Compare to Ocrevus at 1,200 mg/year indefinitely or Tysabri at ~3,900 mg/year indefinitely.
Lemtrada's per-mg cost is high but cumulative drug exposure is finite — the comparison shifts when total
cost-of-care is modeled across 5+ year horizons.
Two-course induction dosing FDA label current
From FDA prescribing information (BLA 103948).
FDA-labeled dose schedule (verbatim):
"The recommended dosage of LEMTRADA is 12 mg/day administered by intravenous (IV) infusion for 2 treatment courses: First course: 12 mg/day on 5 consecutive days (60 mg total dose). Second course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course."
Standard induction schedule
- Course 1 (Month 0): 12 mg/day IV × 5 consecutive days (60 mg total)
- Course 2 (Month 12): 12 mg/day IV × 3 consecutive days (36 mg total)
- Optional Course 3 (≥ Month 24): 12 mg/day × 3 days, if disease activity returns
- Optional Course 4 (≥ Month 36): 12 mg/day × 3 days, if disease activity returns
- Standard 2-course total: 96 mg over 2 years
- Per dose: 1 vial (12 mg / 1.2 mL) diluted in 100 mL 0.9% NaCl or D5W
- Infusion rate: ~4 hours per dose
- Post-infusion observation: 2 hours mandatory after each infusion (per boxed warning #2)
- 1 mg = 1 unit: bill 12 units of J0202 per infusion day
Mandatory premedication & prophylaxis
- Methylprednisolone 1,000 mg IV (or equivalent corticosteroid) immediately prior to infusion
on the first 3 days of each course. Bill
J1100× 1,000 units per day on those days. - Antihistamine (commonly diphenhydramine 50 mg IV) before each infusion. Bill
J1200. - Antipyretic (commonly acetaminophen 650 mg PO) before each infusion. Generally not separately billable.
- Herpes antiviral prophylaxis (acyclovir 200 mg PO BID or equivalent) starting Day 1 and continuing at least 2 months post-treatment OR until CD4+ count ≥ 200 cells/µL (whichever later).
- PJP prophylaxis commonly added per institutional protocol.
Worked example — Course 1 billing (5 days)
# Each of 5 consecutive infusion days — 12 mg over 4 hours
Drug units billed: 12 per day (HCPCS J0202)
Modifier: JZ (whole-vial use, 12 mg SDV = exact dose) · Vials: 1 × 12 mg
Admin (each day):
96413 × 1 (chemo/complex IV, initial 1 hr)
96415 × 3 (each additional hour, hours 2-4)
96417 × 1-2 (sequential push for premed, if separate)
Premedication (Days 1-3 of course):
J1100 × 1000 units (methylprednisolone 1,000 mg)
J1200 (diphenhydramine, when applicable)
# Course 1 totals:
Drug units billed: 60 (5 × 12 mg)
Methylprednisolone units: 3,000 (3 days × 1,000 mg)
Total chair time: ~8 hours/day × 5 days = ~40 hours
Drug units billed: 12 per day (HCPCS J0202)
Modifier: JZ (whole-vial use, 12 mg SDV = exact dose) · Vials: 1 × 12 mg
Admin (each day):
96413 × 1 (chemo/complex IV, initial 1 hr)
96415 × 3 (each additional hour, hours 2-4)
96417 × 1-2 (sequential push for premed, if separate)
Premedication (Days 1-3 of course):
J1100 × 1000 units (methylprednisolone 1,000 mg)
J1200 (diphenhydramine, when applicable)
# Course 1 totals:
Drug units billed: 60 (5 × 12 mg)
Methylprednisolone units: 3,000 (3 days × 1,000 mg)
Total chair time: ~8 hours/day × 5 days = ~40 hours
Worked example — Course 2 billing (3 days, 12 months later)
# Each of 3 consecutive infusion days — 12 mg over 4 hours
Drug units billed: 12 per day (HCPCS J0202)
Same admin pattern as Course 1
Methylprednisolone Days 1-3 of course (all 3 days)
# Course 2 totals:
Drug units billed: 36 (3 × 12 mg)
# Cumulative 2-year drug exposure: 96 mg (60 + 36)
Drug units billed: 12 per day (HCPCS J0202)
Same admin pattern as Course 1
Methylprednisolone Days 1-3 of course (all 3 days)
# Course 2 totals:
Drug units billed: 36 (3 × 12 mg)
# Cumulative 2-year drug exposure: 96 mg (60 + 36)
Required pre-infusion checks (per Lemtrada REMS)
- Verify patient + prescriber + site Lemtrada REMS enrollment is current
- Baseline labs on file: CBC with diff, serum creatinine, urinalysis with cell counts, TSH
- No active untreated infection (TB, HIV, hepatitis B/C, herpes simplex/zoster reactivation)
- HPV / cervical screening current (women)
- Skin exam current (melanoma surveillance)
- Pregnancy test negative if applicable; effective contraception during and 4 months post-treatment
- Herpes antiviral prophylaxis prescription active
NDC reference FDA NDC Directory verified May 2026
| NDC (10-digit) | NDC (11-digit, claim form) | Package | Manufacturer |
|---|---|---|---|
58468-0200-1 |
58468-0200-01 |
12 mg alemtuzumab in 1.2 mL (10 mg/mL), single-dose vial — 1 vial per carton, must dilute | Genzyme Corporation (Sanofi) |
11-digit NDC required on most claim forms. Pad the package segment with a leading zero:
58468-0200-01. Use the
N4 qualifier in CMS-1500 Box 24A and UB-04 Box 43.
Lemtrada vials must be refrigerated (2-8°C); after dilution, infuse immediately or within 8 hours
(refrigerated, protected from light).
Same molecule, different brand: alemtuzumab was historically marketed as Campath for
chronic lymphocytic leukemia (CLL). Genzyme withdrew Campath from the commercial market in 2012 to facilitate
the MS development program; Lemtrada is the relabeled MS formulation. Campath remains available through a
limited-distribution program for CLL but is not billed under J0202 in MS contexts. Older billing systems may
cross-reference the historical Campath NDC
62856-0596-01 — do not use for Lemtrada.
Administration codes CPT verified May 2026
Lemtrada bills under chemotherapy/complex biologic codes — NOT 96365/96366.
Although alemtuzumab is not a cytotoxic chemotherapy agent, CPT guidance and AMA editorial direction support billing the chemotherapy and complex biologic agent administration codes (96413/96415/96417) for monoclonal antibodies that require complex preparation, anaphylaxis monitoring, and significant clinical oversight. Lemtrada's 4-hour infusion duration, mandatory premedication regimen, anaphylaxis risk, and 2-hour post-infusion monitoring all support the use of the chemo/complex biologic codes.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code, 1 unit/day. Covers hour 1 of the alemtuzumab infusion. |
96415 |
Chemotherapy administration, IV infusion technique; each additional hour | 3 units/day for the standard 4-hour Lemtrada infusion (hours 2, 3, 4). |
96417 |
Chemotherapy administration, IV infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour | For sequential premedication push or additional sequential drug infusion. |
96360 / 96361 |
IV hydration; initial 31 min - 1 hr / each additional hour | Often added — bill when separately documented and clinically indicated. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo); initial / each additional hour | Generally NOT used for Lemtrada. The complex biologic admin codes (96413 series) are appropriate per CPT guidance for high-complexity mAbs requiring anaphylaxis monitoring. |
J1100 |
Injection, dexamethasone sodium phosphate, 1 mg (or use the methylprednisolone code your MAC accepts) | Methylprednisolone 1,000 mg IV premedication on first 3 days of each course. Verify your MAC's preferred steroid HCPCS for IV methylprednisolone. |
J1200 |
Injection, diphenhydramine HCl, up to 50 mg | Antihistamine premedication. |
Why chemo codes apply: per the AMA CPT Editorial Panel and CPT Assistant guidance, the
96413-series chemotherapy/complex biologic codes apply to monoclonal antibody therapies that require complex
preparation, prolonged infusion, and significant patient monitoring — not solely cytotoxic agents.
Lemtrada's 4-hour infusion, mandatory premedication, anaphylaxis risk profile, and 2-hour post-infusion
observation all qualify it as a "complex biologic agent" for billing purposes. Major payers and MACs accept
96413 + 96415 × 3 for J0202; some require documentation of the complex preparation/monitoring rationale
in the encounter note.
A typical Lemtrada infusion day will bill substantial admin revenue: 96413 + 96415 × 3 +
96417 (premedication push) + 96360 (hydration) + the steroid/antihistamine drug HCPCS codes. Document each
component start/stop time and the indication. With premedication infusion + 4-hour alemtuzumab infusion +
2-hour post-infusion monitoring, total chair time per day approaches 8 hours.
Modifiers CMS verified May 2026
JZ — whole-vial use, default expectation
Effective July 1, 2023, CMS requires JZ on all claims for single-dose container drugs when no drug is discarded. Lemtrada's 12 mg single-dose vial equals exactly one daily dose — no drug is wasted in routine administration. JZ is the default modifier for J0202 in standard induction billing.
JW — rarely applies
Because the vial size and the daily dose match exactly, JW is rarely applicable. Use JW only if the dose is adjusted downward (e.g., dose interruption mid-infusion, documented partial-vial use) and a discrete portion of the vial contents is documented as discarded. In standard 12 mg/day induction, do not bill JW.
JG / TB — 340B
For 340B-acquired Lemtrada, follow your MAC's current 340B modifier policy. JG is the historical Medicare 340B modifier; TB has been used for informational purposes in some MAC jurisdictions. Verify current rules at billing time.
Modifier 25 — situational
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 infusion. Routine pre-infusion REMS checks and consent verification are bundled and do not support a separate E/M.
Modifier 59 / X{EPSU} — situational
Use to indicate distinct procedural services when premedication push (96417), hydration (96360), and primary Lemtrada infusion (96413) are billed on the same encounter. Most MACs prefer the X-modifier subset (XE, XP, XS, XU) over the legacy 59 where applicable.
Lemtrada REMS Program Sanofi verified May 2026
Lemtrada is available only through the Lemtrada REMS Program — distinct from anti-CD20 REMS programs.
Per FDA, Lemtrada is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the Lemtrada REMS Program. The program exists because of the four boxed warnings — particularly the autoimmunity, infusion reaction, and stroke risks. Site of care must verify enrollment before drug ships. Enrollment is product-specific: Ocrevus REMS / Tysabri TOUCH / TYRUKO REMS certifications do not authorize Lemtrada administration.
Who must enroll
- Prescribers — must complete REMS training and certify before prescribing
- Healthcare facilities / infusion centers — must enroll the site, with anaphylaxis management capability documented
- Specialty pharmacies dispensing Lemtrada must be REMS-certified
- Patients — enrolled by prescriber, must acknowledge risks via Patient Enrollment Form, receive Medication Guide
Mandatory monitoring schedule — 48 months after last dose
| Test | Frequency | Why |
|---|---|---|
| CBC with differential | Monthly | Detect ITP, autoimmune cytopenias, infection |
| Serum creatinine | Monthly | Detect anti-GBM disease (renal autoimmunity) |
| Urinalysis with cell counts | Monthly | Detect anti-GBM disease (hematuria, proteinuria) |
| TSH (thyroid function) | Every 3 months | Detect autoimmune thyroid disease (most common autoimmune AE) |
| HPV / cervical cancer screening | Annually (women) | HPV + reactivation surveillance |
| Annual skin exam | Annually | Melanoma surveillance (boxed warning #4) |
Monitoring continues for 48 months after the last Lemtrada dose — not 48 months after
the start of treatment. For a standard 2-course induction with the last dose in Month 12, surveillance extends
through Month 60 (Year 5). Monitoring labs are not separately billable to Lemtrada; they bill under standard
outpatient lab CPT codes (CBC 85025, BMP/creatinine, UA, TSH 84443) under the
patient's medical benefit.
Billing implications
There is no separate REMS HCPCS code — REMS enrollment itself is not billable. However, documentation of Lemtrada REMS enrollment is a frequent payer audit target. Notes should reference REMS enrollment identifiers on each infusion encounter and confirm baseline labs on file. Most payers' Lemtrada PA criteria require attestation that prescriber, site, and patient are enrolled in REMS and current on monitoring.
Contact: Lemtrada REMS Program. Web: lemtradarems.com · prescriber resources at lemtradahcp.com/rems.
Common error: Site administers Lemtrada based on existing Ocrevus REMS, TOUCH (Tysabri), or
TYRUKO REMS certification. Each REMS is independent and product-specific. Using the wrong certification is a
hard REMS violation that triggers audit, payer recoupment, and potential FDA action. Confirm
Lemtrada-specific REMS enrollment for the prescriber, site, dispensing pharmacy, and patient before drug
order is placed.
Phase 2
Code the claim
Build the line items: ICD-10, site of care, claim form fields.
ICD-10-CM diagnosis codes FY2026 verified May 2026
Lemtrada is FDA-approved for relapsing forms of MS only — PPMS will deny.
| ICD-10 | Description | Lemtrada-eligible? |
|---|---|---|
G35 | Multiple sclerosis (parent) | Many payers reject parent — use specific G35.x |
G35.A | Relapsing-remitting MS | Yes (preferred primary) |
G35.C0 | Secondary progressive MS, unspecified | Use only if active relapses present |
G35.C1 | Active SPMS | Yes (covered indication) |
G35.D | MS, unspecified | Acceptable but specific code preferred |
G35.B0 | Primary progressive MS, unspecified | NO — PPMS not approved; PA will deny |
G35.B1 | Active PPMS | NO — PA will deny |
G35.B2 | Non-active PPMS | NO — PA will deny |
G37.9 | CNS demyelinating disease, NOS | Generally not accepted — Lemtrada not approved for CIS |
PPMS will deny. Lemtrada's FDA approval is restricted to relapsing forms of MS.
For PPMS (G35.B family), the only FDA-approved DMT is Ocrevus (J2350). Submitting
J0202 with G35.B0/B1/B2 is an automatic medical-necessity denial and audit flag.
Preferred primary diagnosis: use
G35.A (RRMS) or G35.C1 (active
SPMS) as the primary diagnosis on Lemtrada claims. These map cleanly to the FDA-approved relapsing MS
indication and to the third-line PA criteria. Always document specific MS subtype in the encounter note;
non-specific G35 / G35.D will increase audit risk.
Site of care & place of service Verified May 2026
Lemtrada's combination of anaphylaxis risk, 4-hour infusion + 2-hour observation, multi-day consecutive scheduling, and stroke/arterial dissection risk in the 3-day post-infusion window drives most administration to hospital outpatient infusion settings. Some commercial plans steer toward office or ambulatory infusion centers (AIC) for cost; others mandate hospital outpatient because of the boxed warning profile and required emergency response capability.
| Setting | POS | Claim form | Electronic | Lemtrada use |
|---|---|---|---|---|
| Hospital outpatient | 19 or 22 | UB-04 / CMS-1450 | 837I | Most common — anaphylaxis & stroke management capability |
| Ambulatory infusion suite | 49 | CMS-1500 | 837P | Allowed by some plans if AIC has full anaphylaxis & code response capability |
| Physician office | 11 | CMS-1500 | 837P | Rare — office infusion uncommon for Lemtrada due to safety profile |
| Patient home | 12 | CMS-1500 | 837P | Not recommended — FDA label requires anaphylaxis-equipped setting |
REMS site requirement: regardless of POS, the site must be enrolled in the Lemtrada REMS
Program with documented anaphylaxis-management capability. The site must also be equipped to monitor for
stroke and arterial dissection symptoms during the 3-day post-infusion window.
Site-of-care UM: UnitedHealthcare and Aetna both run site-of-care utilization management
programs for high-cost infusions, typically steering away from hospital outpatient toward AIC for
cost-of-administration savings. For Lemtrada specifically, payers tend to allow hospital outpatient as
clinically appropriate given the boxed warning profile, but document the safety rationale in the medical
necessity letter to support hospital site selection.
Claim form field mapping Verified May 2026
CMS-1500 / 837P (physician office, AIC; POS 11/49) and UB-04 / 837I (hospital outpatient; POS 19/22).
| Information | CMS-1500 box | UB-04 box | Notes |
|---|---|---|---|
| NPI | 17b / 24J / 33a | 56 / 76 | Rendering / billing provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | 43 | Format: N4584680200001ML1.2 |
| HCPCS J0202 (drug line) | 24D | 44 | One drug line per infusion day; 12 units |
| Admin CPT 96413 + 96415 (admin lines) | 24D | 44 | 96413 × 1; 96415 × 3 for the 4-hour infusion |
| Drug units | 24G | 46 | 12 (mg) per infusion day |
| ICD-10 | 21 | 67 | G35.A or G35.C1 preferred (relapsing MS only) |
| PA / authorization number | 23 | 63 | Required by all major commercial payers |
| REMS reference (encouraged) | Box 19 / NTE segment | 80 (remarks) | Lemtrada REMS enrollment number for audit-readiness |
| Revenue code (hospital outpatient) | n/a | 42 | 0636 (drugs requiring detailed coding) or facility-specific |
Form references: NUCC (CMS-1500) · NUBC (UB-04).
Phase 3
Get paid
Universal PA + step-therapy gate; documented failure of 2+ prior MS DMTs is non-negotiable.
Payer policy snapshot Reviewed May 2026
Universal PA. Universal step therapy. Documented inadequate response to ≥2 prior MS DMTs is required across all major plans.
| Payer | PA? | Step therapy | Site-of-care UM | Re-auth |
|---|---|---|---|---|
| UnitedHealthcare Alemtuzumab medical policy |
Yes | Failure of ≥2 prior MS DMTs documented | Yes — AIC preferred where safety supports | For Course 2; new PA for optional Courses 3/4 |
| Aetna Clinical Policy Bulletin (alemtuzumab) |
Yes | Inadequate response/intolerance/contraindication to ≥2 DMTs | Yes — precertification required for site | w/ documented response, REMS still current |
| Cigna Coverage Policy IP0213 (alemtuzumab) |
Yes | Failure of ≥2 prior MS DMTs — some plans require Tysabri AND Ocrevus failure | Yes | For Course 2 and any optional re-treatment |
| Anthem / Carelon Alemtuzumab medical policy |
Yes | Documented inadequate response to ≥2 DMTs | Yes | w/ disease stability + REMS current |
| BCBS FEP Alemtuzumab pharmacy policy |
Yes | Documented failure of preferred DMTs | Yes | For Course 2 and optional re-treatment |
Universal third-line gate: No major commercial payer approves Lemtrada as first or second-line
therapy. Every PA submission must include documented inadequate response, intolerance, or contraindication to
at least two prior MS DMTs. Some plans (notably Cigna and several BCBS plans) explicitly
require failure of both Tysabri AND Ocrevus before approving alemtuzumab.
What to document for approval
- Confirmed diagnosis of relapsing MS (G35.A or G35.C1 preferred — not PPMS)
- Documented inadequate response, intolerance, or contraindication to ≥2 prior MS DMTs (drug names, dates, duration, response/AE rationale for each)
- Lemtrada REMS enrollment verification (prescriber + site + dispensing pharmacy + patient)
- Baseline labs on file: CBC with diff, serum creatinine, urinalysis with cell counts, TSH
- HPV/cervical screening current (women); skin exam current
- No active malignancy (especially thyroid, melanoma, lymphoproliferative)
- No active untreated HIV, TB, hepatitis B/C, herpes simplex/zoster reactivation
- Negative pregnancy test if applicable; effective contraception during and 4 mo post-treatment
- Anaphylaxis-equipped site of care; emergency response plan documented
- Acknowledgment of 48-month monitoring plan post-last-dose
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J0202
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$2,440.415
per mg / per unit
12 mg daily dose
$29,285.00
12 units × ASP+6%
After sequestration
~$28,699
~2% reduction (actual paid)
Course-level cost (drug only, ASP+6%):
- Course 1 (5 days × 12 mg = 60 mg): ~$146,425
- Course 2 (3 days × 12 mg = 36 mg): ~$87,855
- 2-year drug total (96 mg): ~$234,280
One of the highest per-mg ASPs in Medicare Part B. J0202 at $2,440/mg places Lemtrada among
the top per-mg ASPs in the entire Part B catalog. The total drug cost is contained by the finite induction
schedule (96 mg over 2 years vs. indefinite maintenance dosing of competitors), but per-encounter and
per-course cost are substantial. Patient OOP modeling should account for two-course Year-1/Year-2 cost
distribution and the impact of MOOP/coinsurance reset at year boundary.
Coverage
No NCD or LCD specific to alemtuzumab/Lemtrada in MS. Coverage falls under the generic drug-coverage LCD framework. All MACs cover J0202 for FDA-approved on-label indications when third-line criteria are documented. Bill with G35.A or G35.C1 for the MS indication.
Code history
- 2014 — Lemtrada FDA approved Nov 14, 2014 (BLA 103948)
- 2015 — J0202 effective Jan 1, 2015 (replacing prior temporary code), "Injection, alemtuzumab, 1 mg" (1 mg = 1 unit)
- 2018 — FDA label updated to add stroke and arterial dissection boxed warning
Patient assistance — Sanofi Patient Connection Sanofi verified May 2026
- Sanofi Patient Connection (PAP): uninsured / underinsured Patient Assistance Program for Lemtrada. Phone: 1-888-847-4877. Web: sanofipatientconnection.com.
- MS One to One Co-Pay Program: commercial copay assistance for eligible privately-insured patients (Medicare, Medicaid, and other federal program patients ineligible). Phone: 1-855-676-6326.
- MS One to One Patient Support: nurse support, infusion coordination, REMS navigation, insurance navigation. Same number: 1-855-676-6326.
- Independent foundations for federally-insured patients (Medicare, Medicaid, TRICARE): HealthWell Foundation, PAN Foundation, The Assistance Fund. MS funds open and close periodically; check fund status at the time of each course.
- Manufacturer free drug via PAP for income-qualified patients without insurance coverage.
- Web: lemtrada.com · lemtradahcp.com.
Need to model what a specific patient will actually pay across both courses after copay assistance, deductible,
coinsurance, and OOP max — with the Year-1/Year-2 dose distribution? Run a
CareCost Estimate — J0202 pre-loaded.
Federal payer copay limitation: the MS One to One Co-Pay Program excludes Medicare, Medicaid,
TRICARE, and other federal program beneficiaries (per anti-kickback statute). For these patients, route
copay support through independent charitable foundations (HealthWell, PAN, TAF) and verify fund availability
before each course; MS-specific funds at these foundations open and close based on funding cycles.
Phase 4
Fix problems
Step-therapy denials, REMS confusion, ICD-10 PPMS misuse, and admin code disputes are the top four.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Step therapy — not 3rd-line | PA submitted without documented failure of ≥2 prior MS DMTs | Submit drug names, dates, duration, and response/AE rationale for each prior DMT. Some plans require Tysabri AND Ocrevus failure specifically. Cite FDA label restriction language verbatim in appeal. |
| REMS not on file | Site administered Lemtrada based on Ocrevus REMS, TOUCH, or TYRUKO REMS certification (or no REMS) | Enroll in Lemtrada REMS independently (lemtradarems.com). Re-submit with Lemtrada REMS enrollment number documented. Be prepared for REMS audit + recoupment risk. |
| Wrong ICD-10 (PPMS) | G35.B0 / G35.B1 / G35.B2 used — alemtuzumab not approved for PPMS | If patient has PPMS, switch to Ocrevus (J2350). Use G35.A (RRMS) or G35.C1 (active SPMS) for Lemtrada billing. |
| Wrong admin code (96365) | Therapeutic IV admin billed instead of complex biologic admin | Resubmit with 96413 (initial hour) + 96415 × 3 (additional hours). Document anaphylaxis monitoring + premedication preparation rationale. |
| Hours of admin denied | 96415 units denied as exceeding necessity | Submit start/stop times for each hour of the 4-hour infusion. Reference FDA label specifying ~4-hour infusion duration. |
| JZ/JW modifier dispute | Modifier missing or contested by MAC | Default to JZ (12 mg vial = exact dose, no waste). Include start/stop on documentation. |
| NDC format | 10-digit NDC submitted; payer requires 11-digit | Use 11-digit form: 58468-0200-01 with N4 qualifier. |
| Site of care denial | Hospital outpatient denied as not medically necessary; payer prefers AIC | Appeal with safety rationale: anaphylaxis risk (boxed warning), stroke risk window (3 days post-infusion), required emergency response capability. Cite patient-specific risk factors. |
| Course 2 PA expired | 12-month gap between Course 1 and Course 2 lapsed authorization | Submit fresh PA for Course 2 with updated baseline labs, REMS still current, and disease activity status. Most plans require new PA for Course 2 even with Course 1 approval on file. |
| Optional Course 3/4 denied | Re-treatment beyond standard 2 courses requires new clinical justification | Document return of disease activity (relapse, new MRI lesions, EDSS progression). Standard 2-course induction is the FDA-approved schedule; Courses 3/4 are at-risk for additional PA scrutiny. |
| Premedication unbundled denial | Methylprednisolone or antihistamine billed but considered bundled | Document medical necessity per FDA label requirement; some MACs accept J1100/J1200 separately, others bundle into 96417. Verify MAC policy. |
Frequently asked questions
What is the HCPCS code for Lemtrada?
Lemtrada (alemtuzumab) is billed under HCPCS J0202 — "Injection, alemtuzumab, 1 mg." Each
milligram equals one billable unit, so each 12 mg daily dose is billed as 12 units. Course 1 (5 consecutive
days) totals 60 units; Course 2 (3 consecutive days, 12 months later) totals 36 units.
How is Lemtrada dosed?
Lemtrada uses a unique two-course induction schedule with no maintenance dosing. Course 1 (Month 0): 12 mg/day IV over 4 hours for 5 consecutive days (60 mg total). Course 2 (Month 12): 12 mg/day IV over 4 hours for 3 consecutive days (36 mg total). Optional Courses 3 or 4 may be administered at least 12 months apart if disease activity returns (12 mg/day × 3 days each). Each 12 mg dose uses one full single-dose vial (12 mg/1.2 mL).
Why is Lemtrada restricted to third-line MS use?
Per FDA label: "Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS." Lemtrada carries four boxed warnings — autoimmunity, infusion reactions, stroke and arterial dissection (within 3 days of administration), and malignancies. This third-line restriction is unique among major MS DMTs; Ocrevus, Briumvi, Tysabri, and Tyruko are all approvable as first- or second-line therapy.
What administration codes apply to Lemtrada?
Lemtrada uses the chemotherapy and complex biologic IV infusion administration codes, NOT the standard
therapeutic codes (96365/96366). Bill CPT 96413 (chemo/complex IV infusion, up to 1 hour) once
per day as the primary admin code, plus 96415 (each additional hour) × 3 for the 4-hour
alemtuzumab infusion. Premedication and antihistamine pushes bill under 96417 (each additional
sequential infusion). Hydration is billable separately under 96360/96361. A typical Lemtrada
infusion day will bill 96413 + 96415 × 3 plus premedication push codes.
Does Lemtrada require REMS enrollment?
Yes. The Lemtrada REMS Program is mandatory and is distinct from the anti-CD20 REMS programs. Prescribers, healthcare facilities/infusion centers, specialty pharmacies, and patients must all enroll. Patients require monthly CBC with differential, monthly serum creatinine, monthly urinalysis, quarterly TSH, annual HPV/cervical screening, and annual skin exams for 48 months after the last dose. The REMS portal is lemtradarems.com. Site of care must verify enrollment before drug ships.
What are the boxed warnings for Lemtrada?
Lemtrada carries four boxed warnings: (1) Autoimmunity — serious and sometimes fatal autoimmune conditions including immune thrombocytopenia (ITP), anti-glomerular basement membrane disease, autoimmune hepatitis, and thyroid disorders. (2) Infusion reactions — serious and life-threatening; must be administered where anaphylaxis can be managed; monitor 2 hours post-infusion. (3) Stroke and arterial dissection — within 3 days of administration (added to label in 2018). (4) Malignancies — increased risk of thyroid cancer, melanoma, and lymphoproliferative disorders.
What premedication is required for Lemtrada?
All premedication is mandatory: methylprednisolone 1,000 mg IV (or equivalent corticosteroid) immediately prior to infusion on the first 3 days of each course; antihistamine and/or antipyretic (commonly diphenhydramine plus acetaminophen) before each infusion; herpes antiviral prophylaxis (acyclovir or equivalent) starting Day 1 and continuing at least 2 months post-treatment OR until CD4+ count is at least 200 cells/µL (whichever is later). Pneumocystis jirovecii pneumonia (PJP) prophylaxis is commonly added per institutional protocol.
What is the Medicare reimbursement for J0202?
For Q2 2026, the Medicare Part B payment limit for J0202 is $2,440.415 per mg (ASP + 6%). Each 12 mg daily dose reimburses at approximately $29,285.00 before sequestration. Course 1 (5 days × 12 mg) drug cost is approximately $146,425; Course 2 (3 days × 12 mg) drug cost is approximately $87,855. Total two-year drug cost for the standard induction is approximately $234,280 — among the highest in the entire Medicare Part B catalog on a per-mg basis. ASP is updated quarterly by CMS.
Does the JZ or JW modifier apply to Lemtrada?
JZ is the default modifier for Lemtrada because each 12 mg single-dose vial equals exactly one daily dose with no drug discarded. CMS has required JZ on all single-dose container claims since July 1, 2023 when no drug is wasted. JW (discarded amount) rarely applies to alemtuzumab because the dose and vial size match exactly; only use JW if dose is adjusted downward and a documented portion is wasted. JG/TB modifiers apply if the drug is acquired through 340B.
How does Lemtrada compare to other MS DMTs?
Lemtrada is the only major MS DMT with an induction-only schedule (5 days + 3 days, 12 months apart) and the only one restricted to third-line use after 2+ DMT failures. Anti-CD20 agents (Ocrevus J2350, Briumvi J2329, Kesimpta) deplete only B cells and are approvable as first-line; Lemtrada depletes both T and B lymphocytes (anti-CD52). Tysabri (J2323) and the Tyruko biosimilar (Q5134) target alpha4-beta1 integrin and are typically second-line due to JC virus / PML risk. Lemtrada's per-mg ASP ($2,440.415) dwarfs all other MS DMTs, but total cumulative drug exposure is finite (96 mg over 2 years) versus indefinite maintenance dosing of competitors.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- FDA — LEMTRADA (alemtuzumab) Prescribing Information (2024)
- Sanofi — LEMTRADA Prescribing Information PDF
- DailyMed — LEMTRADA (alemtuzumab) Prescribing Information
- Lemtrada REMS Program (Sanofi)
- Lemtrada HCP — REMS detail
- HCPCSdata — J0202 (Injection, alemtuzumab, 1 mg)
- SEER CanMED — J0202 (alemtuzumab)
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file (canonical J-code source)
- Cigna — Coverage Policy IP0213 (alemtuzumab)
- Sanofi Patient Connection
- Lemtrada Financial Support — MS One to One
- FDA National Drug Code Directory
- AAPC — HCPCS J0202
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
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, Cigna IP0213, Carelon, BCBS FEP) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Quarterly | JZ/JW applicability + 340B modifier rules verified each quarter. |
| NDC, dosing, FDA label | Event-driven | Tied to manufacturer document version + FDA label revision date. |
| Lemtrada REMS Program requirements | Annual | Reviewed against lemtradarems.com program documentation. |
| Step-therapy criteria | Semi-annual | Track plans requiring Tysabri AND Ocrevus failure specifically. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, manufacturer,
payer documents — all linked above). Final review by our SME, Catherine Rose (CPC), is in progress.
Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes
claims.
Change log
- — Initial publication. ASP data: Q2 2026 (J0202 = $2,440.415/mg). Payer policies: UHC, Aetna, Cigna IP0213, Carelon, BCBS FEP. Reciprocal cross-links to Ocrevus, Briumvi, Tysabri, Tyruko MS DMT pages.
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. We do not paraphrase from billing-software vendor blogs. Boxed warning language and the third-line restriction quote are taken verbatim from the FDA-approved label (BLA 103948, 2024 revision).