HCPCS (SC)
J2354
25 mcg = 1 unit
Phase 1
Identify what you're billing
Two HCPCS codes for two formulations. Get the unit basis right before anything else.
Sandostatin SC (J2354) vs. Sandostatin LAR Depot (J2353) CMS verified May 2026
Same active ingredient (octreotide acetate), two completely separate billing codes with different unit bases and order-of-magnitude different ASPs.
Novartis manufactures octreotide in two formulations that share an indication footprint but bill under distinct HCPCS codes. The immediate-release subcutaneous Sandostatin is for initiation, tolerance confirmation, and acute symptomatic control. The LAR Depot (Long-Acting Release) is the maintenance formulation, given as a single deep gluteal IM injection every 4 weeks.
| Sandostatin (immediate-release SC) | Sandostatin LAR Depot (IM) | |
|---|---|---|
| HCPCS | J2354 | J2353 |
| HCPCS descriptor | "Octreotide, injection, non-depot form for subcutaneous or intravenous injection, 25 mcg" | "Octreotide, injection, depot form for intramuscular injection, 1 mg" |
| Unit basis | 1 unit = 25 mcg (unusual) | 1 unit = 1 mg |
| Route | Subcutaneous (occasionally IV) | Deep gluteal intramuscular |
| Frequency | 2–4 times daily | Every 4 weeks (q4w) |
| Formulations | 50 mcg/mL, 100 mcg/mL, 500 mcg/mL ampules + 1 mg/mL (5 mL = 5 mg) MDV | 10 mg, 20 mg, 30 mg single-use kits |
| Administration setting | Patient self-admin (most common) OR HCP office | HCP office / infusion center (deep IM technique) |
| Admin CPT | 96372 (when HCP-administered) / none (home self-admin) | 96402 (chemo IM hormonal) or 96372 per payer |
| Q2 2026 ASP+6% | $0.624 per 25 mcg unit | $188.350 per 1 mg unit |
| Typical role | Initiation / acute symptom control / tolerance trial | Chronic maintenance |
| Benefit category | Often specialty pharmacy (when self-administered) | Medical (provider buy-and-bill) |
Why two codes: CMS assigned separate J-codes because the immediate-release ampule and the
LAR microsphere depot are distinct products (different NDCs, different manufacturing, different prices,
different administration). Reporting Sandostatin LAR under J2354 (or vice versa) will produce a unit-basis
mismatch that triggers automatic denial or massive over/under-payment.
Highest-impact billing error: billing a Sandostatin LAR 30 mg dose as 30 units of
J2354 (instead of 30 units of J2353) reports the dose as 750 mcg of immediate-release
SC drug. The reverse error — billing a 100 mcg SC dose as 100 units of J2353 — reports
100 mg of depot drug. Both errors get caught (eventually) but cause refund demands and appeals.
SC-to-LAR transition workflow FDA label + AACE/NANETS guidelines
Standard practice for chronic indications: 2-week SC tolerance trial, then transition to LAR maintenance.
FDA labeling for both Sandostatin and Sandostatin LAR Depot, plus AACE acromegaly and NANETS/ENETS NET guidelines, recommend a brief immediate-release SC trial before initiating LAR. The trial confirms drug tolerance, refines dose, and ensures gastrointestinal/glycemic side effects are manageable. LAR is then substituted for ongoing maintenance because once-monthly IM dosing dramatically improves adherence vs TID SC injections. Both J2354 and J2353 will appear on the patient's claim history during the transition window.
| Phase | Days/weeks | Drug + code | Typical dose |
|---|---|---|---|
| 1. SC tolerance trial | Days 1–14 | Sandostatin SC (J2354) | 50–100 mcg SC TID (acromegaly); 100–600 mcg/day divided 2–4 doses (carcinoid/VIPoma) |
| 2. LAR initiation | Day 14–15 | Sandostatin LAR (J2353) | 20 mg IM × 1; continue SC for ~2 weeks (microspheres take time to peak) |
| 3. Bridging SC overlap | ~2 weeks post-LAR | Sandostatin SC (J2354) tapered + LAR (J2353) | SC at original dose, then taper as LAR effect builds |
| 4. LAR maintenance | Month 2 onward | Sandostatin LAR (J2353) | 20 mg IM q4w; titrate to 30 mg q4w (acromegaly/NET); max 40 mg q4w (VIPoma) |
| 5. Rescue / breakthrough | As needed | Sandostatin SC (J2354) | 50–500 mcg SC PRN for breakthrough symptoms (carcinoid syndrome) |
Billing implication: patients in months 1–2 of therapy will commonly have both
J2354 and J2353 on the same claim history. Plan benefit checks on both codes
before initiating treatment so the bridging weeks are not denied for missing PA on whichever code your
initial PA omitted.
Somatostatin analog (SSA) class comparison FDA label + payer LCDs
Sandostatin is the original SSA. The class now includes lanreotide IM depot, oral octreotide capsules, and an octreotide SC autoinjector.
| Brand | Generic | HCPCS | Route / cadence | Manufacturer | Indications |
|---|---|---|---|---|---|
| Sandostatin | octreotide acetate | J2354 (25 mcg) |
SC, 2–4×/day | Novartis | Acromegaly initiation; carcinoid; VIPoma; bridging |
| Sandostatin LAR Depot | octreotide acetate (microspheres) | J2353 (1 mg) |
IM, q4w | Novartis | Acromegaly maintenance; metastatic carcinoid; VIPoma |
| Somatuline Depot | lanreotide | J1930 (1 mg) |
Deep SC, q4w (prefilled syringe, gluteal) | Ipsen | Acromegaly; GEP-NETs; carcinoid syndrome |
| Mycapssa | octreotide capsules | None (pharmacy benefit) | Oral, BID | Chiasma / Amryt | Acromegaly maintenance (responders to injectable octreotide) |
| Bynfezia Pen | octreotide | None (pharmacy benefit; same molecule as Sandostatin SC) | SC autoinjector pen | Sun Pharma | Acromegaly; carcinoid symptomatic relief |
Class billing note: Sandostatin LAR (J2353) and Somatuline Depot (J1930) are direct
injectable competitors for chronic acromegaly and NETs. Both bill at 1 mg = 1 unit but have different
ASPs and different injection devices (LAR requires reconstitution; Somatuline ships in a prefilled syringe).
Mycapssa and Bynfezia are pharmacy-benefit products and do not generate medical claims with J-codes.
Step therapy reality check: several major payers prefer Somatuline Depot (J1930) over
Sandostatin LAR (J2353) on formulary, or vice versa, depending on plan-level rebate negotiations. Always
verify the payer's preferred SSA before initiating LAR — mid-therapy switch from Sandostatin LAR to
Somatuline (or back) is common and creates cross-coverage workflow.
Dosing & unit math FDA label most recent rev
Indication-specific dosing matrix. Watch the J2354 25 mcg unit basis carefully.
Acromegaly
- SC initiation (J2354): 50–100 mcg SC TID × 2 weeks for tolerance check
- LAR maintenance (J2353): 20 mg IM q4w; titrate to 30 mg q4w based on GH/IGF-1 response; max 40 mg q4w
Carcinoid tumors (severe diarrhea/flushing)
- SC initiation (J2354): 100–600 mcg/day SC divided in 2–4 doses × 2 weeks; titrate to clinical response
- LAR maintenance (J2353): 20 mg IM q4w × 2 months, then titrate to 30 mg q4w if needed
VIPomas (profuse watery diarrhea)
- SC initiation (J2354): 200–300 mcg/day SC divided in 2–4 doses
- LAR maintenance (J2353): 20 mg q4w; can titrate to 30 mg q4w; max 40 mg q4w
Symptomatic neuroendocrine tumors (NETs)
- Same as carcinoid — 20 mg LAR q4w start, titrate to 30 mg q4w if symptomatic control inadequate
- Per NANETS/ENETS guidelines, transition from SC to LAR after ~2 weeks of SC tolerance
Worked example — acromegaly initiation + maintenance, year 1
# Phase 1: SC tolerance trial (J2354), days 1–14
Dose: 100 mcg SC TID = 300 mcg/day total
Per administration: 100 mcg / 25 mcg per unit = 4 units J2354
Daily total: 4 units × 3 doses = 12 units J2354 / day
14-day total: 168 units J2354
# Phase 2: LAR maintenance (J2353), months 2–12
Dose: 20 mg IM q4w = 20 units J2353 per dose
Doses year 1 (post-initiation): ~12 doses × 20 units = 240 units J2353
# Year-1 totals (Q2 2026 ASP+6%)
J2354 SC: 168 units × $0.624 = ~$104.83
J2353 LAR: 240 units × $188.350 = ~$45,204.00
# Most patient cost is in the LAR depot, not the SC initiation.
Dose: 100 mcg SC TID = 300 mcg/day total
Per administration: 100 mcg / 25 mcg per unit = 4 units J2354
Daily total: 4 units × 3 doses = 12 units J2354 / day
14-day total: 168 units J2354
# Phase 2: LAR maintenance (J2353), months 2–12
Dose: 20 mg IM q4w = 20 units J2353 per dose
Doses year 1 (post-initiation): ~12 doses × 20 units = 240 units J2353
# Year-1 totals (Q2 2026 ASP+6%)
J2354 SC: 168 units × $0.624 = ~$104.83
J2353 LAR: 240 units × $188.350 = ~$45,204.00
# Most patient cost is in the LAR depot, not the SC initiation.
No premedication routinely required
Sandostatin and Sandostatin LAR do not require pre-injection antihistamine or steroid. Recommended baseline workup includes gallbladder ultrasound (cholelithiasis risk), fasting glucose / HbA1c (hyper/hypoglycemia risk), TSH (suppression risk), and ECG if cardiac history (bradycardia / conduction abnormalities risk).
NDC reference FDA NDC Directory verified May 2026
Use the carton-level 11-digit NDC on the claim form (N4 qualifier). Verify against current Novartis package inserts.
| Formulation | NDC reference | Bills under | Units / dose typical |
|---|---|---|---|
| Sandostatin 50 mcg/mL ampule | Novartis NDC family 0078-1xxx | J2354 | 2 units (50 mcg / 25) |
| Sandostatin 100 mcg/mL ampule | Novartis NDC family 0078-1xxx | J2354 | 4 units (100 mcg / 25) |
| Sandostatin 500 mcg/mL ampule | Novartis NDC family 0078-1xxx | J2354 | 20 units (500 mcg / 25) |
| Sandostatin 1 mg/mL multi-dose vial (5 mL = 5 mg) | Novartis NDC family 0078-1xxx | J2354 | per dose drawn |
| Sandostatin LAR 10 mg single-use kit | Novartis NDC family 0078-0xxx | J2353 | 10 units |
| Sandostatin LAR 20 mg single-use kit | Novartis NDC family 0078-0xxx | J2353 | 20 units |
| Sandostatin LAR 30 mg single-use kit | Novartis NDC family 0078-0xxx | J2353 | 30 units |
Verify exact NDCs at billing time. Novartis has periodically refreshed Sandostatin NDCs;
always pull the current 11-digit NDC from the actual carton or Novartis HCP coding & reimbursement page.
Use carton NDC, not vial-only NDC.
Multi-dose vial waste: the 1 mg/mL Sandostatin MDV is the only Sandostatin presentation
that is NOT single-dose. JZ/JW modifier policy on single-dose containers does not apply; track and bill
only the units actually administered.
Phase 2
Code the claim
Different admin CPT for SC vs LAR; different unit basis for J2354 vs J2353.
Administration codes CPT verified May 2026
SC self-administration is the norm; LAR IM is always HCP-administered.
| Code | Description | When to use |
|---|---|---|
96372 |
Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular | Primary admin code for HCP-administered Sandostatin SC (J2354). Also accepted by some payers for Sandostatin LAR IM (J2353) when used for non-cancer indications (e.g., acromegaly). |
96402 |
Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic | Primary admin code for Sandostatin LAR (J2353) for cancer / NET / carcinoid indications. Octreotide is classified as hormonal anti-neoplastic for SSA-treated NETs. |
96401 |
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic | Some payers accept this for Sandostatin LAR cancer indications instead of 96402; verify per payer LCD. |
| (none) | Patient self-administration at home | When SC Sandostatin (J2354) is dispensed via specialty pharmacy and self-injected, no admin CPT applies. The drug shifts to specialty pharmacy benefit. |
Why 96402 for LAR cancer indications: per CPT, hormonal anti-neoplastic includes
somatostatin analogs used to treat hormone-secreting NETs (octreotide for carcinoid syndrome, VIPomas).
96402 pays materially more than 96372 because the depot reconstitution and deep gluteal IM technique are
more complex than a routine SC injection.
Mixed-indication patients: a patient with both acromegaly (non-cancer) and a NET (cancer)
may need different admin CPTs depending on which indication is being treated at the time. Some payers
always apply the higher-paying 96402 if any oncology indication is on the chart; others insist on 96372
for any non-cancer use. Get this in writing from the payer.
Modifiers CMS verified May 2026
JZ — required on single-dose container claims with no waste
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Sandostatin LAR Depot ships as 10/20/30 mg single-use kits — one whole kit per dose, no waste — so JZ applies to virtually every J2353 claim. The 50, 100, and 500 mcg Sandostatin SC ampules are also single-dose; JZ applies to J2354 ampule claims.
JW — reports discarded portion of single-dose container
JW is rare for Sandostatin because the SC ampules and LAR kits are typically used in whole-vial multiples. JW would apply if a clinic opens a 500 mcg/mL ampule and only administers 250 mcg — bill JW for the 250 mcg (10 units) of waste on a separate claim line, plus the JZ-style line for the 250 mcg administered. One of JZ or JW must be on every single-dose container claim.
JZ/JW NOT applicable to the 1 mg/mL multi-dose vial
The 5 mL multi-dose vial is not a single-dose container; CMS's JZ/JW policy explicitly excludes MDVs. Bill only the units actually administered.
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 is bundled.
340B modifiers (JG, TB)
For 340B-acquired Sandostatin or Sandostatin LAR, follow your MAC's current 340B modifier policy. Endocrinology and oncology practices participating in 340B should attach JG (Medicare) or TB (informational) per local guidance.
ICD-10-CM by indication group FY2026 verified May 2026
FDA-labeled indications: acromegaly, metastatic carcinoid, VIPoma, symptomatic NETs.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Acromegaly | E22.0 | Primary acromegaly Dx; pair with abnormal IGF-1 / GH lab results |
| Malignant carcinoid tumors | C7A.0xx family | Site-specific 5th/6th characters (e.g., C7A.020 carcinoid lung, C7A.090 carcinoid GI NOS) |
| Secondary carcinoid (metastatic) | C7B.xx | Secondary neuroendocrine tumor codes for liver/distal mets |
| Benign carcinoid | D3A.xx | Less commonly approved — payers may require additional clinical justification |
| Pancreatic NET | C25.4 + biomarker | Functional or non-functional pNET |
| Carcinoid lung | C7A.090 / C7A.091 | Typical / atypical bronchopulmonary carcinoid |
| VIPoma | E16.8 | "Other specified disorders of pancreatic internal secretion" — covers VIPoma |
| Carcinoid syndrome (symptoms) | E34.0 | Pair with malignant carcinoid C-code as primary; E34.0 documents symptoms |
Payers want a labeled indication. Off-label uses (GI bleeding from varices, refractory
hypoglycemia, dumping syndrome, etc.) are frequently denied by commercial payers even with literature
support. Document acromegaly, carcinoid, VIPoma, or symptomatic NET diagnosis in the PA and on the claim.
Site of care & place of service Verified May 2026
Sandostatin SC (J2354) is most commonly self-administered at home via specialty pharmacy. Sandostatin LAR Depot (J2353) is always HCP-administered (deep gluteal IM technique requires training; reconstitution of microspheres is time-sensitive). UnitedHealthcare, Aetna, and major BCBS plans all run site-of-care UM for chronic injectables; HOPD administration of LAR is increasingly steered to physician office or AIC.
| Setting | POS | Claim form | Typical use |
|---|---|---|---|
| Patient home (SC self-admin) | 12 | Specialty pharmacy (no medical claim for admin) | Most common for J2354 SC chronic dosing |
| Physician endocrinology office | 11 | CMS-1500 / 837P | Preferred for J2353 LAR acromegaly |
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred for J2353 LAR carcinoid / NET |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable for J2353 LAR |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored by commercial UM after stabilization |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored by commercial UM after stabilization |
Specialty pharmacy benefit shift: when J2354 SC is dispensed via specialty pharmacy for
home self-injection, the drug moves from medical to pharmacy benefit. The patient's pharmacy copay
structure (deductible, coinsurance, OOP max) applies, NOT the medical benefit. This is a major
cost-modeling distinction. Use a tool like CareCost Estimate to model both.
Claim form field mapping Novartis HCP coding 2025
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + carton NDC + ML or UN + total volume / count |
| HCPCS J2354 + JZ (or JW for waste) | 24D (drug line) | SC formulations — 25 mcg = 1 unit |
| HCPCS J2353 + JZ | 24D (drug line) | LAR depot — 1 mg = 1 unit |
| Drug units | 24G | For J2354: total mcg / 25. For J2353: total mg. |
| CPT 96372 (SC admin) / 96402 (LAR IM cancer) | 24D (admin line) | Only when HCP-administered; omit for home self-admin |
| ICD-10 | 21 | Acromegaly E22.0 / carcinoid C7A.x / VIPoma E16.8 / NET site-specific |
| PA number | 23 | Required by all major payers for both J2354 and J2353 |
Phase 3
Get paid
PA + indication-specific labs + specialist consult are the standard SSA gates.
Payer policy snapshot Reviewed May 2026
All major payers require PA, indication documentation, and specialist consult for both J2354 and J2353.
| Payer | PA? | Required documentation | Step / preference |
|---|---|---|---|
| UnitedHealthcare Medical Benefit Drug Policy |
Yes (both J2354 and J2353) | Acromegaly: GH/IGF-1 baseline + endocrinology consult. NET/carcinoid: CgA + 5-HIAA baseline + oncology consult. Imaging confirming tumor. | SSA class managed under common policy; SC-to-LAR transition treated as standard (both codes pre-approved together) |
| Aetna CPB Medical Drug policies |
Yes (both) | Same lab + specialist requirements as UHC; site-of-care UM for HOPD LAR | Sandostatin LAR and Somatuline Depot generally at parity; verify formulary preference per plan |
| BCBS plans Vary by plan |
Yes (both) | Plan-specific; generally aligned with NCCN NET guidelines + AACE acromegaly | Some plans prefer Somatuline Depot (J1930) over Sandostatin LAR (J2353) per rebate negotiations |
| Medicare MACs No NCD specific to octreotide |
Generally no PA | FDA-labeled indication + appropriate ICD-10; 340B modifiers if applicable | Coverage under generic biologic LCD framework; both codes routinely paid for labeled indications |
Required pre-PA labs & workup
- Acromegaly: serum IGF-1, OGTT-suppressed GH, pituitary MRI, endocrinology consult note
- Carcinoid / NET: chromogranin A (CgA), 24-hour urinary 5-HIAA, cross-sectional imaging (CT/MRI), tissue biopsy with neuroendocrine markers, oncology consult note
- VIPoma: serum VIP level, electrolyte/glucose panel documenting refractory diarrhea, imaging
- Baseline safety: gallbladder ultrasound, fasting glucose / HbA1c, TSH (chronic SSA use only)
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J2354 (SC non-depot)
Effective April 1 – June 30, 2026 · 1 unit = 25 mcg
ASP + 6%
$0.624
per 25 mcg unit
100 mcg SC dose
$2.50
4 units × ASP+6%
600 mcg/day TID
$14.98
24 units/day × ASP+6%
Q2 2026 payment snapshot — J2353 (LAR depot IM)
Effective April 1 – June 30, 2026 · 1 unit = 1 mg
ASP + 6%
$188.350
per 1 mg unit
20 mg LAR q4w
$3,767.00
20 units × ASP+6%
30 mg LAR q4w
$5,650.50
30 units × ASP+6%
Annualized maintenance cost: 20 mg LAR q4w × 13 doses = ~$48,971/year
(Medicare ASP+6%). 30 mg LAR q4w × 13 doses = ~$73,457/year.
After ~2% sequestration: roughly $47,963 to $71,925/year actual paid for the LAR depot alone. SC bridging
costs add <$200/year.
Coverage
No NCD specific to octreotide. Coverage falls under MAC LCDs for SSAs and the generic Part B drug-coverage framework. All MACs cover J2353 and J2354 for FDA-labeled acromegaly, carcinoid, VIPoma, and symptomatic NET indications with appropriate ICD-10 documentation.
Code history
- J2354 — permanent code for non-depot SC octreotide; 25 mcg unit basis
- J2353 — permanent code for depot IM octreotide; 1 mg unit basis
Patient assistance — Novartis Patient Assistance Foundation Novartis verified May 2026
- Novartis Patient Assistance Foundation: 1-800-282-7630 — free product for uninsured / underinsured patients meeting income requirements
- Sandostatin Patient Support / Universal Co-Pay Program (Novartis Oncology): commercial copay assistance for eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients)
- Foundations (Medicare patients): refer to PAN Foundation, HealthWell Foundation, CancerCare — verify open neuroendocrine tumor / carcinoid / acromegaly funds quarterly
- Reimbursement support: Novartis Patient Support also offers benefits investigation, PA assistance, and appeals support for both J2354 and J2353
- Web: novartispharma.com — Patient Support landing
Need to model what a specific patient will actually pay for SC bridging plus LAR maintenance after copay
assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate
— J2353 and J2354 both pre-loaded.
Phase 4
Fix problems
Wrong code, wrong unit basis, missing labs, and wrong admin CPT are the top four.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong HCPCS (LAR billed under J2354) | Coder billed Sandostatin LAR 30 mg as 30 units of J2354 — reports 750 mcg of immediate-release SC drug | Resubmit corrected: 30 units of J2353 for the LAR depot dose. Verify NDC matches LAR kit. |
| Wrong unit math on J2354 | Coder billed 100 mcg dose as 100 units of J2354 instead of 4 units (100 mcg / 25 mcg per unit) | Resubmit corrected with the divided unit count. Update internal coding macro to remind staff: 25 mcg per unit on J2354. |
| Wrong admin CPT (96365) | Therapeutic IV billed for SC or IM administration | 96365 is IV only. Use 96372 for SC or non-cancer IM; 96402 for cancer/NET IM LAR. |
| JZ missing on single-dose container claim | LAR kit or SC ampule billed without JZ | Resubmit with JZ. Required since 7/1/2023 on every single-dose container claim with no waste. |
| PA missing on bridging code | PA was obtained for J2353 LAR but not J2354 SC bridging during the 2-week tolerance trial | Submit separate PA for J2354 SC concurrent with the LAR PA. Always pre-auth both codes for transition workflows. |
| Indication not documented | Off-label use (GI bleeding from varices, dumping syndrome, etc.) without payer-specific evidence | Submit literature + medical necessity letter. Many off-label SSA uses remain difficult to authorize for commercial plans. |
| Missing baseline labs (acromegaly) | PA submitted without IGF-1 / GH | Order labs, obtain endocrinology consult note, resubmit PA. Most payers require these in initial submission. |
| Missing baseline labs (NET / carcinoid) | PA submitted without CgA / 5-HIAA / imaging | Order labs, obtain oncology consult note + tissue biopsy report with neuroendocrine markers, resubmit. |
| Site of care (HOPD denied) | HOPD administration of LAR after stabilization on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD truly required. |
Frequently asked questions
What is the HCPCS code for Sandostatin?
Sandostatin has two HCPCS codes for two distinct formulations. J2354 ("Octreotide injection,
non-depot") is for immediate-release subcutaneous Sandostatin and is billed at 1 unit per 25 mcg.
J2353 ("Octreotide injection, depot form for intramuscular injection") is for Sandostatin LAR
Depot and is billed at 1 unit per 1 mg. Confusing the two unit bases is the most common
Sandostatin coding error.
How many units do I bill for a 100 mcg Sandostatin SC dose?
Bill 4 units of J2354 for a 100 mcg subcutaneous dose (100 mcg ÷ 25 mcg per
unit = 4 units). For 50 mcg bill 2 units; for 500 mcg bill 20 units; for 600 mcg total daily dose split TID
bill 8 units per administration. The 25 mcg unit basis is unusual — do not confuse with the 1 mg basis
used for J2353 LAR.
How many units do I bill for a 30 mg Sandostatin LAR depot dose?
Bill 30 units of J2353 for a 30 mg LAR IM dose (1 mg = 1 unit). 20 mg = 20 units;
10 mg = 10 units; 40 mg max = 40 units. LAR comes in 10/20/30 mg single-use kits, so the standard q4w dose
uses one whole kit with no waste — JZ modifier applies.
What administration CPT do I use for Sandostatin?
For Sandostatin SC (J2354): 96372 (therapeutic SC/IM injection) when administered by HCP staff;
no admin CPT applies when patient self-administers at home through specialty pharmacy. For Sandostatin LAR
(J2353): 96402 (chemo IM, hormonal anti-neoplastic) for cancer / NET / carcinoid indications.
Some payers accept 96401 or 96372 — verify per payer LCD.
What is the Medicare reimbursement for J2354 and J2353?
For Q2 2026, the Medicare Part B payment limit for J2354 is $0.624
per 25 mcg unit (ASP + 6%). A 100 mcg SC dose reimburses at approximately $2.50;
a 600 mcg/day TID regimen totals approximately $14.98/day.
The Q2 2026 payment limit for J2353 is $188.350 per 1 mg unit.
A 20 mg LAR q4w dose reimburses at approximately $3,767.00; a 30 mg LAR
q4w dose at approximately $5,650.50; annualized at 13 doses/year,
roughly $48,971 to $73,457 depending on dose. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Why do patients start on Sandostatin SC and switch to LAR?
FDA labeling and major guidelines (AACE acromegaly, NANETS/ENETS for NETs) recommend a 2-week trial of immediate-release SC Sandostatin (J2354) before initiating LAR depot (J2353). The SC trial confirms tolerance and titrates dose; LAR is then initiated for maintenance because q4w IM injections dramatically improve adherence vs multiple-times-daily SC injections. Both codes will appear on the patient's claim history during the 2–4 week transition window.
How does Sandostatin compare to Somatuline Depot, Mycapssa, and Bynfezia Pen?
Sandostatin (octreotide) and Somatuline Depot (lanreotide, J1930,
Ipsen) are the two long-acting SSA IM depot competitors for acromegaly and NETs — similar efficacy,
different injection volumes and devices. Mycapssa is oral octreotide capsules
(Chiasma/Amryt, pharmacy benefit only — no J-code) approved for acromegaly maintenance.
Bynfezia Pen is an octreotide SC autoinjector (same molecule as Sandostatin SC, different
device) for symptomatic relief and acromegaly bridging. Mycapssa and Bynfezia are both pharmacy-benefit
products and do not bill under medical with J-codes.
Does Sandostatin have a boxed warning?
No. Sandostatin and Sandostatin LAR Depot do not carry an FDA boxed warning. Notable warnings and precautions in the prescribing information include cholelithiasis (gallstones with chronic use), hyper- and hypoglycemia, cardiac conduction abnormalities (bradycardia), and TSH suppression / thyroid function changes. Periodic monitoring of gallbladder ultrasound, fasting glucose / HbA1c, and TSH is recommended for chronic use.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Novartis — Sandostatin (octreotide acetate) Prescribing Information
- Novartis — Sandostatin LAR Depot Prescribing Information
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J2353 reference (LAR depot)
- SEER CanMED — HCPCS J2354 reference (SC non-depot)
- AACE — Acromegaly Clinical Practice Guidelines
- NANETS — Neuroendocrine Tumor Consensus Guidelines
- ENETS — Neuroendocrine Tumor Consensus Guidelines
- UnitedHealthcare — Medical Benefit Drug Policies (somatostatin analogs)
- Aetna — Clinical Policy Bulletins (somatostatin analogs / NET therapy)
- FDA National Drug Code Directory
- Novartis Patient Assistance Foundation — 1-800-282-7630
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 (J2353, J2354) | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to Novartis package insert version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, payer documents — all linked above). Editorial review in progress. Until that review is complete, treat this as a draft reference and verify each cited
source for high-stakes claims — in particular, confirm the J2354 25 mcg unit basis math on every
claim before submission.
Change log
- — Initial publication. ASP data: Q2 2026 (J2354 $0.624 per 25 mcg; J2353 $188.350 per mg). Two-formulation framing emphasizes the J2354 vs J2353 unit-basis distinction. SC-to-LAR transition workflow per FDA label + AACE/NANETS guidelines. SSA class comparison: Sandostatin / Somatuline Depot / Mycapssa / Bynfezia Pen.
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 and dosing matrix are verified against the current FDA label revisions for both Sandostatin and Sandostatin LAR Depot. We do not paraphrase from billing-software vendor blogs.