HCPCS
J1306
1 billing unit = 1 mg
Leqvio (inclisiran)
One HCPCS code, one presentation, no biosimilar and no shared-code alternative to confuse the claim. Pricing lives in Current Leqvio pricing.
| Brand | HCPCS | Manufacturer | Generic | Form |
|---|---|---|---|---|
| Leqvio (reference) | J1306 | Novartis | inclisiran | 284 mg/1.5 mL single-dose prefilled syringe |
Leqvio (NDA 214012) has no biosimilar and no other product sharing J1306. Every claim under this code is the same 284 mg/1.5 mL prefilled syringe, so there is no cross-product unit-count or HCPCS mismatch to check for, unlike some other J-coded specialty drugs on this site. Two NDCs are listed for the syringe, 0078-1000-60 and 0078-1000-98; confirm the one on the package against the billing reference before submitting the claim.
Leqvio dosing and missed doses
One fixed regimen applies to every labeled indication and age, so the variable that matters to a biller is what happens when a scheduled date slips.
| Indication | Regimen | Notes |
|---|---|---|
| All labeled indications | 284 mg subcutaneously at day 0, again at 3 months, then every 6 months | Same dose for adults with hypercholesterolemia, adults and children 12 and older with heterozygous familial hypercholesterolemia, and children 12 and older with homozygous familial hypercholesterolemia. Administered by a healthcare professional into the abdomen, upper arm or thigh. |
Missed or delayed doses
A late injection can move every later claim date. If a planned dose is missed by less than 3 months, give it and keep the patient's original schedule. If it is missed by more than 3 months, restart the schedule from the beginning: an initial dose, a dose at 3 months, then every 6 months.
Administration
Leqvio is given by a healthcare professional as a subcutaneous injection into the abdomen, upper arm, or thigh — never into a site with active skin disease or injury, such as a sunburn, rash, or infection. It is not self-administered and not infused, so the visit always carries an office administration code, not an infusion-suite code.
Assessing response
LDL-C can be measured as early as 30 days after any dose and at any time after that, without regard to when the next dose is due. Several reauthorization rules in the coverage corpus ask for this comparison; BCBS Kansas, for one, requires that the "Member has had a reduction in LDL-C when compared to the baseline labs (prior to initiating inclisiran)."
The dose itself does not change with the answer. Leqvio is not weight-based: every adult, and every child 12 or older who qualifies under a labeled indication, gets the same 284 mg.
Need the billing units for a patient? Convert dose to J1306 billing units →
Leqvio billing reference
HCPCS
J1306 — 1 mg per billing unit. A 284 mg dose is 284 units.
NDC
Two package identifiers are listed for the 284 mg/1.5 mL single-dose prefilled syringe (Novartis, labeler 0078). Pad the labeler segment to 5 digits for CMS-1500 Box 24A.
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
0078-1000-60 | 00078-1000-60 | 284 mg/1.5 mL single-dose prefilled syringe |
0078-1000-98 | 00078-1000-98 | 284 mg/1.5 mL single-dose prefilled syringe |
Administration
Leqvio is a subcutaneous injection, not an infusion. Each dose is one 1.5 mL injection of the whole 284 mg syringe, so the visit carries one 96372 line and no add-on administration code.
| CPT | Description | Use for |
|---|---|---|
96372 | Therapeutic, prophylactic or diagnostic injection; subcutaneous or intramuscular | The only administration code Leqvio uses ($15.36, Medicare PFS national non-facility, 2026). |
96413 / 96415 | Chemotherapy/complex-biologic IV infusion administration | Not appropriate. These are the IV infusion codes used by infused drugs elsewhere in this reference (Remicade, Keytruda) — Leqvio is not infused and does not use them. |
96401 | Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic | Not appropriate. Leqvio is not a chemotherapeutic agent. |
Modifiers
JZ — required when no drug is discarded; the norm on essentially every Leqvio claim. JW — required for documented waste; very rare here.
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Because Leqvio's one fixed dose (284 mg) exactly matches the one fixed syringe size (284 mg), there is normally nothing left over to waste — append JZ to the J1306 line on essentially every claim. The Medicare MUE for J1306 is 284 units per day (practitioner table, effective July 1, 2026): one syringe.
A JW line belongs on a Leqvio claim only when part of the 284 mg was not injected. Then the claim drops JZ: the injected milligrams go on one J1306 line and the unused milligrams on a second J1306 line with JW, with the discarded amount documented in the chart.
Modifier 25 — same-day E/M. Append modifier 25 to the same-day E/M code only if a significant, separately identifiable evaluation occurred beyond the routine pre-injection check-in, which is bundled into the administration code.
TB — 340B drug pricing. Hospitals that acquire inclisiran through 340B and bill Medicare report the TB modifier, the sole 340B identifier since CMS discontinued JG on January 1, 2025.
Claim form
CMS-1500 / 837P (physician office; POS 11) field map for a J1306 claim.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N4 qualifier + 11-digit NDC + UN + quantity drawn (1 syringe) |
| HCPCS J1306 + JZ (JW only if waste) | 24D (drug line) | 284 units for Leqvio — the whole syringe, no waste line |
| CPT 96372 | 24D (admin line) | One line — no second admin code |
| ICD-10 | 21 | Indication-specific — see Coverage |
| NPI | 17b / 24J / 33a | Rendering and billing provider NPI |
| PA number (when required) | 23 | Required by 22 of 28 commercial payer policies |
| TB modifier (340B sites only) | 24D | Hospital outpatient 340B claims only |
Leqvio coverage
- 23 of 28 commercial payer policy sets require prior authorization; 5 do not say clearly, so confirm those on the call
- 332 individual coverage rules span the 28 payers in this corpus. Clinical prerequisites are the largest category (152 rules), ahead of covered-indication rules (72) and prior authorization (22); 36 of the 152 quote a statin requirement
- 9 of the 28 payers carry a distinct site-of-care rule for Leqvio; one, BCBS Massachusetts, restricts it to the pharmacy benefit entirely, not the medical benefit this page assumes
- 15 of the 28 payers ask for a documented trial, failure, intolerance or contraindication to a PCSK9 inhibitor before Leqvio; at Cigna the rule is limited to Individual and Family Plans, and at Centene it applies "if applicable"
- 19 of the 28 payers include a reauthorization rule; most that specify a duration set it at 12 months
Statin and PCSK9 prerequisites
25 of the 28 payers ask for statin history, PCSK9-inhibitor history, or both before Leqvio. Aetna's statin rule is a common form: "Member has received at least three months of treatment with a high-intensity statin. If the member is unable to tolerate a high-intensity statin dose, a moderate-intensity statin dose may be used."
15 of those payers ask about a PCSK9 inhibitor, and for 5 of them the rule is tagged step_external: Anthem, Arkansas BCBS, Florida Blue, BCBS Nebraska and Regence. Regence's reads, "For Leqvio (inclisiran) only: Praluent (alirocumab) or Repatha (evolocumab)." The remaining step_external rules are Anthem's step table (Praluent and Repatha preferred, Leqvio non-preferred), BCBS Nebraska's 8-week statin rule, BCBS Michigan's pointer to its preferred-drug list and BCBS South Carolina's 12-week statin and ezetimibe trials.
ICD-10 codes by indication
This reference bills three indications, each with its own code. A policy that still prints the five-character E78.01 is naming a family, not a billable value.
| Indication | ICD-10 | Notes |
|---|---|---|
| Primary hypercholesterolemia (adults) | E78.00 | Pure hypercholesterolemia, unspecified |
| Heterozygous familial hypercholesterolemia (adults and children 12+) | E78.011 | Bill the six-character code; E78.01 became a non-billable header when E78.010, E78.011 and E78.019 were added |
| Homozygous familial hypercholesterolemia (children 12+ only) | E78.010 | Pediatric only — the label does not cover adults with HoFH |
23 of the 28 payers whose Leqvio policies are in this corpus still cite
E78.01 for heterozygous familial hypercholesterolemia. That code became a non-billable header when E78.010, E78.011 and E78.019 were added — bill the six-character code, E78.011, even when the payer's own policy text prints the header.
E78.5 (hyperlipidemia, unspecified) appears in the covered-code lists of 23 of the 28 payers (26 rules); the corpus does not resolve whether it independently supports a Leqvio claim, so verify with the specific payer before relying on it alone.
The payer-by-payer diagnosis lists are on the Leqvio coverage page.
Check the patient's actual policy: See Leqvio coverage by payer →
Current Leqvio pricing
Medicare ASP+6%: $12.897 / 1 mg · $3,662.75 / 284 mg. Add the $15.36 administration allowance for 96372 and the claim totals $3,678.11 before the sequester.
Sequestration reduces Medicare's 80% share by 2%. Commercial plans pay a contracted rate that differs by payer and state.
2 maintenance doses a year; 3 in the first year at day 0, month 3 and month 9 (284 mg SC initially, at 3 months, then every 6 months) at $3,678.11 per dose — drug plus 96372 administration — total $7,356.22 before the sequester. That is a maintenance year. The first year has three doses, so it totals $11,034.33 (3 × $3,678.11) before benefits or assistance.
The ASP+6% rate has moved from $12.28 per mg in Q1 2025 to $12.90 in Q4 2026, roughly a 5% rise across eight quarters, with most of that increase landing between Q4 2025 and Q1 2026.
Every one of the 36 commercial payer price files in this corpus carries a J1306 rate; Aetna's median across all states is $12.91 per unit, close to the $12.897 Medicare ASP+6% rate above.
Look up commercial reimbursement →
Patient cost
What someone actually owes depends on: payer allowed rate · remaining Part B deductible ($283 in 2026) · benefits · − assistance · = out-of-pocket total. At Medicare's standard 20% coinsurance on the full claim above ($3,678.11, drug plus administration), the coinsurance alone is $735.62 per dose, before the deductible or any assistance.
Calculate a Leqvio patient estimate →
Copay & financial assistance
Manufacturer and foundation programs exist for Leqvio. The manufacturer copay card covers the drug cost only, not the administration or office-visit fee, so confirm what a program actually pays before quoting a patient's total. Check current open or closed status before assuming availability; status changes without notice.
Common Leqvio denials & fixes
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong administration code | Biller defaulted to an infusion code (96413/96415) or the chemo injection code (96401) out of habit from other drugs | Resubmit with 96372 — the only administration code Leqvio bills. |
| JZ missing | Single-dose-syringe claim without JZ when no drug was discarded | Resubmit with JZ on the drug line — the norm on nearly every Leqvio claim. |
| Statin trial not documented | Claim or PA request submitted without documented statin trial, intolerance, or contraindication | Submit statin history — 36 of the corpus's 152 clinical-prerequisite rules, from 20 payers, quote a statin requirement. |
| PCSK9-inhibitor step not met | Leqvio billed where the payer requires a PCSK9-inhibitor trial, failure, intolerance or contraindication first | Submit the PCSK9-inhibitor history the policy asks for (15 of 28 payers ask for one). |
| E78.01 billed instead of the six-character code | Claim carries E78.01, which became a non-billable header when E78.010, E78.011 and E78.019 were added | Resubmit with the six-character code: E78.00 for primary hypercholesterolemia, E78.011 for HeFH, E78.010 for HoFH. |
| Wrong benefit routed | Claim billed under the medical benefit (J1306 + 96372) for a payer that routes Leqvio through the pharmacy benefit | Confirm benefit routing before billing; at least one payer in this corpus (BCBS Massachusetts) covers Leqvio only under the pharmacy benefit. |
| PA missing | Claim submitted without prior authorization | Submit PA before the next scheduled dose; 22 of 28 commercial payer policies require it. |
| Reauthorization lapsed | Continuing therapy billed past the payer's reauthorization window without a renewal | Confirm LDL-C reduction from baseline and resubmit before the window closes — most of the 19 payers with a reauthorization rule that state a duration set it at 12 months. |
Frequently asked questions
What HCPCS code and unit count does Leqvio bill?
J1306, at 1 mg per billing unit. The 284 mg/1.5 mL prefilled syringe is billed as 284 units, with modifier JZ on almost every claim since the full syringe is given. Administration bills separately as 96372, the subcutaneous injection code.
What is the dosing for inclisiran by indication?
One fixed regimen covers every labeled indication and age — 284 mg at day 0, again at 3 months, then every 6 months:
- Every labeled indication = 284 mg at day 0, again at 3 months, then every 6 months
What ICD-10 code should be billed for Leqvio?
E78.00 for primary hypercholesterolemia in adults, E78.011 for heterozygous familial hypercholesterolemia in adults and children 12 and older, and E78.010 for homozygous familial hypercholesterolemia in children 12 and older only. E78.01 became a non-billable header code when E78.010, E78.011 and E78.019 were added, though 23 of the 28 payer policies in this corpus still print it — bill the six-character code regardless of what the policy text shows.
Is Leqvio billed under the medical benefit or the pharmacy benefit?
The payer policies in this corpus are J1306 policies, so the default path is a medical claim: J1306 plus 96372 for the in-office injection. One payer states a different rule: BCBS Massachusetts's policy says, "This medication is covered ONLY under the pharmacy benefit." Confirm the benefit with the specific payer before billing the medical claim.
Does the Leqvio Co-Pay Card cover the office visit or administration fee?
No. The manufacturer's LEQVIO Co-Pay Program pays the patient's cost to $0 per injection, up to per-treatment and yearly maximums that Novartis does not publish, but it covers the drug cost only — not the 96372 administration or the office visit. It is limited to commercial insurance; Medicare, Medicaid and other government coverage are excluded.
Sources
- AAPC — HCPCS J1306 (Leqvio / inclisiran)
- DailyMed — Leqvio (inclisiran) prescribing information
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file
- CMS — JW / JZ modifier guidance
Dataset dates: pricing Q4 2026 · payer policies Aug 2026 · assistance Oct 2026.
Reviewed September 22, 2026 by Erin Rose, CareCost Estimate founder. Methodology →