Somatuline Depot (lanreotide) — HCPCS J1930

About Somatuline Depot — lanreotide for SSA-responsive disease FDA label most recent rev

Ipsen's long-acting somatostatin analog (SSA), supplied as a ready-to-use deep SC prefilled syringe administered every 4 weeks.

Somatuline Depot (lanreotide acetate) is a long-acting cyclic octapeptide somatostatin analog manufactured by Ipsen. Lanreotide binds primarily to somatostatin receptor subtypes SSTR2 and SSTR5, suppressing growth hormone (GH) and IGF-1 in acromegaly and exerting antiproliferative and antisecretory effects on neuroendocrine tumor cells. It is supplied as a ready-to-use aqueous gel in single-use prefilled syringes of 60 mg, 90 mg, or 120 mg and is administered by deep subcutaneous injection into the upper outer quadrant of the buttock every 4 weeks (q4w). All three strengths bill under the same HCPCS J1930 at 1 mg per unit; the 90 mg syringe is 90 units, the 120 mg syringe is 120 units.

Somatuline Depot was first FDA-approved in August 2007 for the long-term treatment of acromegaly in patients with inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. In December 2014, FDA expanded the labeled indication on the basis of the CLARINET trial to include treatment of patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. In September 2017, FDA added an indication for treatment of carcinoid syndrome — when used, Somatuline Depot reduces the frequency of short-acting somatostatin analog (octreotide) rescue therapy.

Somatuline Depot is the direct injectable competitor to Sandostatin LAR Depot (octreotide, HCPCS J2353) on the long-acting SSA market. Both bill at 1 mg = 1 unit, both have substantially overlapping indications, and clinical trials (CLARINET for lanreotide, PROMID for octreotide LAR) support a class effect on progression-free survival in well-differentiated NETs. The practical differences are administration (Somatuline is a ready-to-use deep SC prefilled syringe; Sandostatin LAR is an IM injection requiring microsphere reconstitution), payer formulary preference, and patient injection-experience preference. Some payers run step therapy specifying one SSA before the other — verify the plan's preferred SSA before initiating treatment.

Dosing & unit math FDA label most recent rev

Indication-specific dosing matrix. Bill 1 unit per mg administered; all three syringe strengths use HCPCS J1930.

Acromegaly

• Initial dose: 90 mg deep SC q4w × 3 months
• Maintenance (titrate based on GH, IGF-1 response, and clinical symptoms after 3 months):
  • GH ≤1 ng/mL, IGF-1 normal, clinical symptoms controlled → 60 mg q4w
  • GH >1 to ≤2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled → 90 mg q4w
  • GH >2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled → 120 mg q4w
• Dose may be increased or decreased based on patient response; re-titrate every 3 months

GEP-NETs (unresectable, well- or moderately-differentiated, locally advanced or metastatic)

• Standard dose: 120 mg deep SC q4w (single fixed dose; no titration scheme)
• Continue until disease progression or unacceptable toxicity

Carcinoid syndrome

• Standard dose: 120 mg deep SC q4w
• Use of short-acting somatostatin analog (octreotide) for rescue may be reduced or eliminated based on symptom response

Renal / hepatic impairment

• Acromegaly: reduce starting dose to 60 mg q4w in patients with moderate or severe renal or hepatic impairment
• GEP-NETs / carcinoid syndrome: no specific dose adjustment recommended in the labeled population; monitor

Worked example — GEP-NET maintenance, year 1

Worked example — acromegaly maintenance at 90 mg q4w

No premedication routinely required

Lanreotide does not require pre-injection antihistamine or steroid. Baseline workup should include gallbladder ultrasound (cholelithiasis risk on chronic SSA), fasting glucose / HbA1c (hyper- and hypoglycemia risk), TSH (suppression risk), and an ECG if cardiac history (bradycardia / conduction abnormalities risk). For NET indications, baseline chromogranin A (CgA), 24-hour urinary 5-HIAA where relevant, and cross-sectional imaging (CT or MRI) document disease and support subsequent reauthorization.

NDC reference FDA NDC Directory verified May 2026

Use the carton-level 11-digit NDC on the claim form (N4 qualifier). All three strengths bill under HCPCS J1930.

Administration codes — 96372 vs 96401 vs 96402 CPT verified May 2026

The single most consequential coding decision on a Somatuline claim. The indication on the claim drives the CPT, not the drug.

Why the indication matters more than the drug

Lanreotide is the same molecule whether it's treating acromegaly or a GEP-NET. CPT administration code selection is driven by what's being treated on the claim, not by the J-code. For acromegaly (non-cancer), the standard SC therapeutic injection family (96372) applies. For GEP-NETs, payers expect the chemo administration family (96401 or, less commonly, 96402) because the labeled use is antineoplastic. Carcinoid syndrome is a mixed case — some payers treat the symptom-control use as non-cancer (96372), others want the chemo family because the underlying NET drives the syndrome.

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. Somatuline Depot ships as a single-patient-use prefilled syringe at a fixed strength (60, 90, or 120 mg) and the labeled administration is one whole syringe delivered as a single dose — there is no partial-dose use case. JZ applies to essentially every J1930 claim.

JW — reports discarded portion of a single-dose container

JW is rarely appropriate for Somatuline because the FDA label does not contemplate partial-syringe administration. If a syringe is partially expelled by accident and the remainder must be discarded, document the residual dose (mg) on a separate JW line on the claim. Most J1930 claims will only carry JZ; one of JZ or JW must be present on every single-dose container claim per CMS policy.

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 (for example, dose-titration assessment with IGF-1 review for an acromegaly patient). Routine pre-injection clinical assessment is bundled.

340B modifiers (JG, TB)

For 340B-acquired Somatuline Depot, follow your MAC's current 340B modifier policy. Endocrinology and oncology practices participating in 340B should attach JG (Medicare standard) or TB (informational, certain Medicare Advantage and commercial) per local guidance.

Modifier 59 / X{EPSU}

Generally not required for a routine J1930 + admin CPT pair. Use only if the payer's NCCI edit pairs trip on the specific admin CPT and another service rendered on the same day — document a distinct and separately identifiable service.

ICD-10-CM by indication group FY2026 verified May 2026

FDA-labeled indications: acromegaly, GEP-NETs, carcinoid syndrome.

Site of care & place of service Verified May 2026

Somatuline Depot is administered by deep subcutaneous injection into the upper outer quadrant of the buttock by a trained health care professional. The injection technique — depth, angle, gel viscosity, and full-syringe delivery — requires training; true patient self-administration is uncommon. Most claims run buy-and-bill at an endocrinology or oncology physician office (POS 11) or an ambulatory infusion center (POS 49). Hospital outpatient department administration (POS 22/19) is acceptable but is increasingly steered to office by commercial site-of-care UM after disease stabilization.

Claim form field mapping — CMS-1500 / 837P Ipsen HCP coding 2025

Payer policy snapshot Reviewed May 2026

All major payers require PA, indication documentation, and specialist consult for J1930. Step therapy between Somatuline and Sandostatin LAR varies by plan.

Required pre-PA labs & workup

• Acromegaly: serum IGF-1, OGTT-suppressed GH, pituitary MRI, endocrinology consult note documenting inadequate response to or contraindication for surgery/radiotherapy
• GEP-NET: tissue biopsy with neuroendocrine histology, Ki-67 proliferation index (G1 or G2, typically ≤20%), chromogranin A (CgA), cross-sectional imaging documenting unresectable/metastatic disease, oncology consult note
• Carcinoid syndrome: documentation of frequency of short-acting somatostatin analog (octreotide) rescue therapy use; supporting CgA and 5-HIAA where available; underlying carcinoid tumor documentation
• Baseline safety (all indications): gallbladder ultrasound, fasting glucose / HbA1c, TSH, ECG if cardiac history

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from the CMS Part B Drug Pricing File. Refreshes automatically each quarter; this page is live-bound to the data layer.

Coverage

There is no NCD specific to lanreotide. Coverage falls under MAC LCDs for somatostatin analogs and the generic Part B drug-coverage framework. All MACs cover J1930 for the FDA-labeled acromegaly, GEP-NET, and carcinoid syndrome indications with appropriate ICD-10 documentation. Routine quarterly ASP refresh applies; the next CMS file is effective July 1, 2026 for Q3.

Code history

• J1930 — permanent CMS-assigned HCPCS code; 1 mg = 1 unit; covers all three syringe strengths (60, 90, 120 mg)

Patient assistance — IPSEN CARES Ipsen verified May 2026

Ipsen's patient support program (Coverage, Access, Reimbursement, Education, Support) handles benefits investigation, PA support, copay assistance, and PAP for Somatuline Depot.

• IPSEN CARES (Patient Support Program): 1-866-435-5677 (1-866-IPSEN-CR) — benefits investigation, prior authorization assistance, appeals support, copay program enrollment, free-drug program (PAP), and patient education
• Copay Assistance Program (commercially insured patients only): reduces out-of-pocket cost to as little as $0 per dose for eligible commercial-insurance patients (excludes Medicare, Medicaid, TRICARE, VA/DoD, and other federal programs); annual benefit cap applies per program terms
• Patient Assistance Program (PAP, free drug): for uninsured / underinsured patients meeting income requirements (typically ≤500% FPL; verify current threshold). Provides Somatuline Depot at no cost through participating provider offices.
• Bridge / quickstart supply: available through IPSEN CARES while coverage is being established for newly diagnosed patients
• Federal patients (Medicare, Medicaid, TRICARE, VA/DoD): refer to independent foundations — PAN Foundation, HealthWell Foundation, CancerCare, NORD — verify current open neuroendocrine cancer / carcinoid / acromegaly funds (funds open and close quarterly)
• Web: ipsencares.com · somatulinedepot.com

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Somatuline Depot?

Somatuline Depot (lanreotide acetate) is billed under HCPCS J1930 — "Injection, lanreotide, 1 mg." One billable unit equals 1 mg of drug, so a 60 mg dose bills as 60 units, a 90 mg dose bills as 90 units, and the 120 mg standard NET maintenance dose bills as 120 units. J1930 is a permanent CMS-assigned code and applies to all three prefilled-syringe strengths.

Should I use CPT 96372 or 96401 to administer Somatuline Depot?

It depends on the indication on the claim. For acromegaly (a non-cancer indication), use 96372 (therapeutic SC injection, non-chemo). For unresectable, well- or moderately-differentiated GEP-NETs treated to improve progression-free survival, most payers expect 96401 (chemo SC, non-hormonal anti-neoplastic) because the labeled use is antineoplastic — even though lanreotide is not cytotoxic chemotherapy. For carcinoid syndrome, practice varies — some payers accept 96372 (symptom-focused use), others want 96402 (chemo SC, hormonal anti-neoplastic). Verify per payer LCD before submission.

Can patients self-administer Somatuline Depot?

Per the FDA label, the deep subcutaneous injection into the upper outer quadrant of the buttock should be administered by a trained health care professional. A caregiver or partner may be trained to give the injection under physician supervision, but true patient self-administration is uncommon because of the deep gluteal injection site. Most claims are buy-and-bill at an endocrinology or oncology office (POS 11), an ambulatory infusion center (POS 49), or a hospital outpatient department.

What are the storage requirements for Somatuline Depot?

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original pouch to protect from light. Per the FDA label, the syringe may be left in the unopened original pouch at room temperature (up to 40°C / 104°F) for up to 24 hours immediately before administration; once removed from refrigeration the syringe must be used within that 24-hour window and any unused drug discarded. Do NOT return a syringe to refrigeration after it has been at room temperature. Buy-and-bill practices typically remove the syringe ~30 minutes before injection to allow the gel to reach a comfortable temperature.

What pre-treatment workup do payers require for prior authorization?

For acromegaly, payers require serum IGF-1 (and often GH suppression on OGTT) confirming biochemical disease, pituitary MRI, and endocrinology consultation; most policies require inadequate response to or contraindication for surgery/radiotherapy. For GEP-NETs, payers expect tissue biopsy with neuroendocrine histology, Ki-67 proliferation index documenting G1/G2 disease (typically ≤20%), chromogranin A (CgA) baseline, and cross-sectional imaging (CT or MRI) documenting unresectable, locally advanced or metastatic disease. For carcinoid syndrome, documentation of the frequency of short-acting somatostatin analog rescue therapy supports the labeled indication.

Somatuline Depot vs Sandostatin LAR — which to choose?

Both Somatuline Depot (lanreotide, J1930, Ipsen) and Sandostatin LAR Depot (octreotide, J2353, Novartis) are long-acting somatostatin analogs with substantially overlapping indications for acromegaly, GEP-NETs, and carcinoid symptom control. Clinical efficacy is broadly comparable (CLARINET for lanreotide and PROMID for octreotide LAR support a class effect on PFS in well-differentiated NETs). The major practical differences are administration (Somatuline ships as a ready-to-use deep SC prefilled syringe with no reconstitution; Sandostatin LAR is an IM injection requiring microsphere reconstitution), payer formulary preference (varies plan by plan and shifts with rebate negotiations), and patient injection-experience preference. See the full Sandostatin (J2354 / J2353) reference for the IM-depot side of the comparison.

Does Somatuline Depot require the JW or JZ modifier?

JZ applies to essentially every Somatuline claim. CMS requires the JZ modifier on all single-dose container claims when no drug is discarded; Somatuline ships as a single-patient-use prefilled syringe with a fixed strength (60, 90, or 120 mg) and the whole syringe contents are delivered in a single dose, so there is no waste — JZ is the correct modifier. JW (discarded portion of a single-dose container) is rarely appropriate; if a syringe is partially expelled in error and the remainder is discarded, document the residual mg as a separate JW line.

What is the Medicare reimbursement for J1930 in Q2 2026?

For Q2 2026 (effective April 1 – June 30, 2026), the Medicare Part B payment limit for J1930 is $35.722 per 1 mg unit (ASP + 6%). A 60 mg dose reimburses at approximately $2,143.32; a 90 mg dose at approximately $3,214.98; and the standard 120 mg q4w NET maintenance dose at approximately $4,286.64. Annualized 120 mg q4w (13 doses/year) totals approximately $55,726.32/year before sequestration; after ~2% sequestration actual paid is roughly $54,612/year. ASP refreshes each quarter; the next CMS update is effective July 1, 2026 for Q3.

Source documents

1. DailyMed — SOMATULINE DEPOT (lanreotide) Prescribing Information
   FDA-approved label, setid 6e4a41fd-a753-4362-87ee-8cc56ed3660d; label revision July 2024; Ipsen Biopharmaceuticals; acromegaly (90 mg q4w then titrate), unresectable GEP-NETs (120 mg q4w), carcinoid syndrome (120 mg q4w); no boxed warning
2. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026 (J1930)
3. SEER CanMED — HCPCS J1930 reference
   HCPCS code definition, units, ASP cross-reference
4. NCCN Clinical Practice Guidelines — Neuroendocrine and Adrenal Tumors
   SSA initiation, dose, and continuation criteria for GEP-NETs and carcinoid syndrome
5. Endocrine Society — Acromegaly Clinical Practice Guideline
   SSA dosing, GH/IGF-1 monitoring, and step-up criteria for acromegaly
6. AACE — Acromegaly Clinical Resources
   SSA dosing and monitoring recommendations
7. Ipsen Biopharmaceuticals — corporate site / HCP resources
   Manufacturer prescribing materials, coding & reimbursement guide
8. IPSEN CARES — 1-866-435-5677
   Manufacturer patient support program: benefits investigation, copay, PAP, bridge supply
9. UnitedHealthcare — Medical Benefit Drug Policies (somatostatin analogs)
10. Aetna — Clinical Policy Bulletins (somatostatin analogs / neuroendocrine tumor therapy)
11. FDA National Drug Code Directory

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to the 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 22, 2026 — Initial publication. ASP data: Q2 2026 ($35.722 per mg, ASP+6%). Three prefilled-syringe strengths (60/90/120 mg) all under HCPCS J1930. Admin CPT framework documented: 96372 for acromegaly, 96401 for GEP-NETs, payer-specific for carcinoid syndrome. IPSEN CARES patient support program documented. Pending SME review.
• May 23, 2026 — SME audit (Tier 3 Batch C). Verified HCPCS J1930 + Q2 2026 ASP $35.722/mg against CMS file. Verified DailyMed label (setid 6e4a41fd-a753-4362-87ee-8cc56ed3660d, revised July 2024) confirms 3 indications: acromegaly (90 mg q4w then titrate), unresectable well/moderately differentiated GEP-NETs (120 mg q4w), and carcinoid syndrome (120 mg q4w). No boxed warning. Replaced 2019 PDF source link with direct DailyMed setid URL.

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 revision for Somatuline Depot. We do not paraphrase from billing-software vendor blogs.