Leqvio (inclisiran) — HCPCS J1306

About Leqvio FDA label verified Jul 2026

Leqvio (inclisiran) is a cholesterol-lowering small interfering RNA (siRNA), licensed by Novartis from Alnylam Pharmaceuticals. Inclisiran is conjugated to a triantennary N-acetylgalactosamine (GalNAc) ligand that targets it to hepatocytes, where it uses the RNA-interference pathway to direct catalytic breakdown of the messenger RNA that codes for PCSK9 (proprotein convertase subtilisin/kexin type 9). Less PCSK9 protein means fewer LDL receptors get tagged for degradation, so the liver recycles more LDL receptors and clears more LDL cholesterol from circulation.

The FDA-approved dose is fixed, not weight-based: 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months. That twice-yearly maintenance cadence (after the first-year loading pair) is Leqvio's defining commercial feature relative to the PCSK9 monoclonal antibodies, which are typically self-injected every 2 to 4 weeks. Leqvio is not self-administered — it is given by a healthcare professional in the office, making it a buy-and-bill or specialty-pharmacy-sourced medical-benefit drug rather than a pharmacy-benefit prescription the patient picks up.

From a billing standpoint, three things make Leqvio distinctive. First, it is billed with a subcutaneous injection CPT (96372), not an infusion code — there is no infusion time and no chair-time admin ladder to bill. Second, because the dose never varies by patient weight, the unit count is essentially always 284 — there is no mg/kg math like the infliximab or trastuzumab families. Third, sourcing can go either buy-and-bill or through specialty pharmacy depending on the payer, so confirming the required channel before the first dose matters as much as getting the code right.

Leqvio vs. PCSK9 monoclonal antibodies FDA labels + payer policy verified Jul 2026

Leqvio, Repatha, and Praluent all lower LDL-C through the PCSK9 pathway, but they are different drug classes with different HCPCS codes, dosing cadences, and administration models. Payer policy frequently treats them as a step-therapy sequence, not interchangeable options.

Dosing schedule — fixed 284 mg, twice yearly FDA label verified Jul 2026

Leqvio is the rare specialty injectable with no weight-based or BSA-based dosing math. The entire billing question is the schedule, not the milligram calculation.

Unit math

Because 1 billed unit = 1 mg and the dose is fixed at 284 mg, the billed unit count is 284 for essentially every administration — there is no per-patient calculation to perform, unlike weight-based infusion biologics. The single-dose prefilled syringe contains exactly 284 mg/1.5 mL, so a full syringe corresponds exactly to the billed dose.

NDC reference DailyMed / FDA NDC Directory verified Jul 2026

Pad to 11 digits with a leading zero in the labeler segment for CMS-1500 Box 24A.

Administration code — 96372, NOT an infusion code CPT verified Jul 2026 · Novartis billing guide

Leqvio is a subcutaneous injection administered by a healthcare professional. It is billed with the standard SC/IM therapeutic injection code, never an infusion admin code.

Source: Novartis LEQVIO Billing and Coding Guide, Relevant Codes: CPT and Setting of Care Codes section.

Modifiers — JZ and TB CMS + Novartis billing guide verified Jul 2026

Because the dose is a fixed single-dose prefilled syringe with no partial draw, JZ (no discard) is the modifier used on nearly every claim. TB is the only current 340B modifier.

JZ — used on essentially every claim

Leqvio ships as a 284 mg single-dose prefilled syringe and the approved dose is the entire syringe, so there is no partial-vial waste scenario the way there is with a weight-based, multi-vial infusion drug. Per the Novartis billing guide's own sample claim forms, the JZ modifier (indicating zero drug wasted) accompanies the J1306 line on both the physician-office CMS-1500 sample and the hospital- outpatient UB-04 sample. If, in the rare case, a full prefilled syringe is compromised before injection (e.g., dropped or damaged) and the entire dose is not administered to the patient, that would be reported as a discard scenario on its own claim line per standard single-dose-container rules — not a split administered/discarded line the way a partially-drawn multi-dose vial would be.

TB — the only current 340B modifier (JG retired Jan 1, 2025)

Effective January 1, 2025, CMS discontinued the JG modifier for all 340B-covered entities. Every 340B-covered entity now reports TB on claim lines for Leqvio acquired through the 340B Drug Pricing Program, per the Novartis billing guide and CMS's Part B inflation-rebate modifier guidance. Do not use JG on any 2026 claim.

ICD-10-CM diagnosis codes Novartis billing guide + FY2026 verified Jul 2026

Primary codes document the lipid disorder; secondary codes document ASCVD or increased cardiovascular risk where relevant to medical necessity. This is a representative subset — see the source guide for the complete list.

Source: Novartis LEQVIO Billing and Coding Guide, ICD-10-CM Codes section (referencing CMS ICD-10-CM, accessed March 2026). The 3-digit codes above (E11, N18) are category codes and are not billable on their own — use the fully specified code per the ICD-10-CM manual.

Site of care, place of service & sourcing model Novartis billing guide verified Jul 2026

Leqvio may be given in the physician office or hospital outpatient department. Sourcing (buy-and-bill vs. specialty pharmacy) is the bigger operational fork — get it wrong and the claim denies regardless of the codes being correct.

Buy-and-bill vs. specialty pharmacy

Most payers cover physician-administered Leqvio under the medical benefit. Medicare typically covers it under Part B — outpatient (Part B) drugs furnished incident to a physician's service are covered when the drug is not usually self-administered, which applies to Leqvio since it is clinician-given. Private payers and Medicaid programs, however, may require the practice to obtain Leqvio through a specialty pharmacy instead of buying and billing it directly; the specialty pharmacy then bills under either the medical or pharmacy benefit depending on that specific payer's requirement (white-bagging). Medicare Advantage plans can follow either model depending on plan benefit design. Confirm the required sourcing channel during benefit verification — before ordering the syringe, not after the visit.

Claim form field mapping Novartis Billing and Coding Guide

CMS-1500 / 837P (physician office; POS 11) example, drawn directly from the manufacturer's sample claim form.

Source: Novartis LEQVIO Billing and Coding Guide, "Physician's office: sample CMS-1500 claim form" and "Hospital outpatient: sample CMS-1450 (UB-04) form" sections.

Payer prior authorization & step therapy Reviewed Jul 2026 · example: UnitedHealthcare policy 2026D0101L

Criteria are payer-specific and change; the UnitedHealthcare commercial policy below (effective 6/1/2026) is presented as a documented, sourced example of the statin-plus-PCSK9-inhibitor step-therapy pattern now common at national payers — not a universal rule.

• Diagnosis of HeFH, ASCVD, or primary hyperlipidemia; and
• Medical-record documentation of one of: prior PCSK9 monoclonal antibody therapy (Praluent/Repatha); OR ≥12 consecutive weeks of high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg); OR a documented statin-intolerance pathway (12+ weeks of low/moderate-intensity statin plus intolerable myalgia/myositis); OR inability to tolerate any statin (contraindication or CK elevation >10× ULN); and
• Separately, medical-record documentation of a history of failure, contraindication, or intolerance to PCSK9 monoclonal antibody therapy specifically; and
• LDL-C ≥ 55 mg/dL; and
• Prescribed by a cardiologist, endocrinologist, or lipid specialist; and
• Not used in combination with a PCSK9 inhibitor; and
• Dosing per the FDA label; initial authorization limited to 12 months, with reauthorization requiring documented positive clinical response.

A separate HoFH pathway in the same policy requires genetic or clinical confirmation of HoFH, concurrent other lipid-lowering therapy (statin, ezetimibe, or LDL apheresis), and the same PCSK9-monoclonal-antibody failure/contraindication/intolerance documentation.

Read plainly, this policy makes Leqvio a third-line therapy at UHC: a statin trial (or prior PCSK9 exposure) must be documented, and a specific history of PCSK9 monoclonal antibody failure or intolerance must also be documented — not either/or. Confirm the exact criteria against the patient's specific plan policy; other payers' Leqvio policies vary in whether PCSK9-antibody history is mandatory versus one acceptable path among several.

Medicare reimbursement CMS Q3 2026 (live)

Quarterly ASP from the CMS Part B Drug Pricing File. Medicare typically covers Leqvio under Part B when administered incident to a physician's service.

Coverage

No NCD specific to inclisiran. Medicare covers Part B drugs furnished incident to a physician's service that are not usually self-administered by the patient, per the Medicare Benefit Policy Manual, Chapter 15, §50. Medicare Advantage step-therapy criteria for Leqvio should be checked under each plan's specific medical policy.

Patient assistance — the LEQVIO Co-pay Program Novartis billing guide + leqvio.com verified Jul 2026

Novartis Patient Support operates two relevant programs for Leqvio. The LEQVIO Co-pay Program can help eligible commercially insured patients pay as little as $0 per treatment, subject to terms and conditions; a per-treatment maximum and an annual benefit cap apply — confirm the current dollar figures directly at start.leqvio.com before quoting a number to a patient, since manufacturer copay-card terms change without notice. The program is not valid for patients using Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program. Separately, the LEQVIO Care Program offers dedicated one-on-one patient education and ongoing adherence support (not a payment program).

Enroll or get access/reimbursement support through the LEQVIO Service Center: phone 833-LEQVIO2 (833-537-8462), fax 877-LEQVIO8 (877-537-8468), or LEQVIOhcp.com / ServiceCenterPortal.com.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Leqvio?

Leqvio (inclisiran) is billed under HCPCS J1306 — "Injection, inclisiran, 1 mg." The FDA-approved dose is fixed at 284 mg, so nearly every claim bills J1306 at exactly 284 units.

Is Leqvio administered by infusion?

No. Leqvio is a subcutaneous injection, billed with CPT 96372, not an infusion code such as 96365 or 96413. There is no infusion time to bill.

How often is Leqvio dosed?

284 mg subcutaneously once, again at 3 months, then every 6 months thereafter — effectively twice a year after the first-year loading pair. Missed doses under 3 months late keep the original schedule; doses missed by more than 3 months restart the initial-then-3-month sequence.

Is Leqvio billed buy-and-bill or through specialty pharmacy?

Both models exist. Most payers, including Medicare Part B, cover physician-administered Leqvio under the medical benefit (buy-and-bill). Some private payers and Medicaid programs require specialty-pharmacy sourcing (white-bagging) instead. Confirm the required channel during benefit verification before the first dose.

Does Leqvio require prior authorization, and what step therapy applies?

Yes. As a sourced example, UnitedHealthcare's 2026 commercial policy requires a qualifying diagnosis, documented statin history or prior PCSK9-inhibitor use, a separate documented history of PCSK9 monoclonal antibody failure/contraindication/intolerance, an LDL-C ≥ 55 mg/dL, prescribing by a cardiologist/endocrinologist/lipid specialist, and no concurrent PCSK9 inhibitor use. Criteria are payer-specific — always verify against the patient's actual plan policy.

What is the Q3 2026 Medicare reimbursement for J1306?

Q3 2026 ASP + 6% for J1306 is approximately $12.905 per 1 mg unit. At the fixed 284 mg dose, that prices to roughly $3,581 per administration before sequestration. ASP refreshes quarterly — see the live snapshot above.

Does Leqvio have a boxed warning?

No. Leqvio's label carries a warnings-and-precautions note on hypersensitivity reactions (including anaphylaxis and angioedema) and a contraindication for patients with a prior serious hypersensitivity reaction to inclisiran or its excipients, but it does not carry an FDA boxed warning.

Source documents

1. DailyMed — LEQVIO (inclisiran) prescribing information
   NDC 0078-1000-60/-98; dosing schedule; indications; warnings; manufacturer
2. FDA — Leqvio original approval letter, NDA 214012 (December 2021)
   Original approval history
3. AAPC — HCPCS J1306 (Leqvio / inclisiran)
   Code descriptor and billing-unit reference
4. Novartis — LEQVIO Billing and Coding Guide (FA-11607044, 3/26)
   HCPCS/CPT/NDC/modifier reference; sample CMS-1500 and UB-04 claim forms; ICD-10-CM code list; LEQVIO Service Center contacts
5. Novartis — LEQVIO Co-pay Program terms
   Patient affordability program; commercial-insurance-only eligibility; enrollment at start.leqvio.com
6. UnitedHealthcare — Commercial Medical Benefit Drug Policy: Leqvio (Inclisiran), Policy 2026D0101L, eff. 6/1/2026
   Prior-authorization and step-therapy criteria (statin + PCSK9-inhibitor history); LDL-C threshold; prescriber-specialty requirement; HoFH pathway
7. CMS — Medicare Part B inflation rebate guidance: use of the 340B modifier
   JG modifier discontinued for all 340B-covered entities effective January 1, 2025; TB is the sole 340B modifier
8. CMS — Medicare Part B Drug ASP Pricing File
   Q3 2026 quarterly file (J1306)

About this page

Medicare ASP pricing for J1306 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 the manufacturer guide, FDA label, or a major payer policy changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• Jul 25, 2026 — Initial publication. Leqvio (J1306) billing reference: fixed 284 mg / 284-unit dosing (no weight-based math), DailyMed-verified NDC (0078-1000-60), subcutaneous admin CPT 96372 (explicitly not an infusion code), JZ/TB modifier guidance sourced from the Novartis billing guide's sample claim forms (JG retired 1/1/2025 per CMS MLN4800856), buy-and-bill vs. specialty-pharmacy sourcing nuance, a sourced UnitedHealthcare step-therapy example (statin history + separate PCSK9-inhibitor-failure documentation), ICD-10 codes, and the LEQVIO Co-pay Program.

Methodology

Every claim on this page is sourced inline. NDC and dosing are taken from the current DailyMed structured product label; the ASP figure is read live from the CMS Part B ASP file; the admin CPT and modifier guidance are taken directly from the Novartis manufacturer billing guide's sample claim forms; and the step-therapy example is quoted from a specific, dated, published payer policy rather than generalized. We do not paraphrase from billing-software vendor blogs, and we flag anything not yet SME-verified rather than assert it.