Looking for LEQVIO® access and
reimbursement resources?

  • Patient coverage types

  • Distributors

  • Alternate injection/infusion centers

  • Billing and coding

  • Annotated claim forms

Patient coverage types

Explore your patient's insurance type to determine the right acquisition method

My patient has Medicare coverage

OVERVIEW

LEQVIO is a subcutaneous injection administered by a health care professional.

LEQVIO is available to all of your Medicare Part B Fee-for-Service patients today. Medicare covers 80% of office-administered products under Part B.

If patients have supplemental insurance (Medigap), their supplemental coverage may pick up the additional 20%.

For additional information on
specialty drug coverage and
acquisition methods, click here.

HELPFUL RESOURCES

Buy-and-Bill Checklist

Download PDF

Distribution & Acquisition Flashcard

Download PDF

Annotated Claim Forms

View Forms

PROCESS STEPS

PROCESS STEPS

Medicare coverage Medicare coverage View Distributors Visit Annotated claim forms Visit Annotated claim forms View Distributors Visit Annotated claim forms Visit Annotated claim forms

My patient has commercial coverage

OVERVIEW

LEQVIO is a subcutaneous injection administered by a health care professional.

New patients with commercial insurance may be eligible to receive the first dose free if coverage is delayed or denied. Limitations apply.*

Your dedicated Specialist is with you every step of the way to help navigate this initial phase of coverage.

For additional information on
specialty drug coverage and
acquisition methods, click here.

HELPFUL RESOURCES

Buy-and-Bill Checklist

Download PDF

Distribution & Acquisition Flashcard

Download PDF

Annotated Claim Forms

View Forms

PROCESS STEPS

PROCESS STEPS

Commercial coverage Commercial coverage View Distributors Visit Annotated claim forms Visit Annotated claim forms View Distributors Visit Annotated claim forms Visit Annotated claim forms

*Eligible patients must have commercial insurance, a valid prescription for LEQVIO, and a prior authorization that has been denied or pending for greater than 14 calendar days. Program provides up to one (1) dose of free medication. Program is not available to patients who are uninsured or whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program, or where prohibited by law. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Other limitations may apply. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

My patient is government-insured
or uninsured

MEDICAID

Coverage under Medicaid varies by state. Contact your patient's plan to understand specific guidance.

UNINSURED OR UNDERINSURED

If uninsured or underinsured patients express financial hardship, the Service Center can help connect them with the Novartis Patient Assistance Foundation to determine eligibility.

LEQVIO Distributors

If you intend to buy-and-bill, LEQVIO can be ordered through our authorized distributors

Distributor

Contact Information

Website

Anda

Phone: 1-855-297-0081
Fax: 1-855-546-8521
https://www.andanet.com

ASD Healthcare

Phone: 1-800-746-6273
Fax: 1-800-547-9413
https://www.asdhealthcare.com

Besse Medical

Phone: 1-800-543-2111
Fax: 1-800-543-8695
https://www.besse.com

Cardinal Health Specialty Pharmaceuticals

CuraScriptSD

Phone: 1-877-599-7748
Fax: 1-800-862-6208
https://curascriptsd.com

Henry Schein

Phone: 1-800-772-4346
Fax: 1-800-329-9109
https://www.henryschein.com

McKesson Medical-Surgical

Phone: 1-866-625-2679
https://mms.mckesson.com

McKesson MPB

Phone: 1-877-625-2566
Fax: 1-888-752-7626
https://connect.mckesson.com

McKesson Specialty
Care Distribution

Phone: 1-855-477-9800
Fax: 1-800-800-5673
https://mscs.mckesson.com

Metro Medical
(A Cardinal Health Company)

Phone: 1-800-768-2002
Fax: 1-615-256-4194
https://metromedicalorder.com

Novartis does not recommend the use of any particular distributor.

Group Purchasing Organizations

If you intend to work with a group purchasing organization (GPO), you can order through the following companies

Novartis does not recommend the use of any particular GPO.

Specialty Pharmacy

Novartis has a large network of participating specialty pharmacies, but payers may dictate a specific specialty pharmacy. The LEQVIO Service Center can conduct a benefits verification to determine the specialty pharmacies available for your patient(s).

LEQVIO Returns

If you have questions about LEQVIO returns, please contact Novartis Pharmaceuticals Corporation by phone at 1-800-526-0175, or email Novartis.phuseh@novartis.com. For returns of product damaged in shipment, please contact your distributor.

If you intend to refer to an alternate injection/infusion center to administer LEQVIO,
you can find a site that is convenient for your patient with our locator tool

The LEQVIO locator tool allows you to enter
your patient's ZIP Code and find centers
in their local area*

Visit alternate injection/
infusion center locator

*The list of injection/infusion centers provided in the locator is not comprehensive, and other injection/infusion centers may be available to you and your patients. These lists are maintained by a third party, and inclusion in the locator is not an endorsement of any of the centers.

Injection Center Locator

Looking to learn more about the alternate injection/infusion center process?

Alternate Injection/Infusion
Center Guide

You can register your practice as an
alternate injection/infusion center
for LEQVIO on the National Infusion
Center Association
website.

Novartis does not recommend the use of any particular alternate injection/infusion center.

Miscellaneous codes for LEQVIO:
J3490 (physician's office) /
C9399
(hospital outpatient department)

Proper coding may help you avoid denied claims and unnecessary administrative burden

Below you will find codes that may be relevant for LEQVIO.

Thumbnail of Billing & Coding Guide

To find a full list of codes that may be related to LEQVIO, download our Billing & Coding Guide. Codes based on site of care are also provided below.

Download the Billing & Coding Guide

The information herein is provided for educational purposes only. Novartis cannot guarantee insurance coverage or reimbursement. Coverage and reimbursement may vary significantly by payer, plan, patient, and setting of care. It is the sole responsibility of the health care provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient.

Coding for physician's office administration

The codes detailed in this section may be used when LEQVIO is administered at a physician's office.

The table below provides common miscellaneous procedure and drug codes related to administration of LEQVIO. A permanent code is anticipated to be available 6 months after product approval.

Healthcare Common Procedure Coding System (HCPCS) level II code(s)1

HCPCS is a collection of standardized codes that represent medical procedures, supplies, products, and services. The codes are used to facilitate the processing of health insurance claims by insurers.

HCPCS code

Descriptor

Site of care

HCPCS code

J3490

Descriptor

Unclassified drugs

Site of care

Physician's office

Current Procedural Terminology (CPT) code2

CPT codes, also known as service codes, are a universal system that identifies medical procedures. Each procedure is given its own unique 5-digit code that identifies to health insurance companies what type of care was provided.

CPT code*

Descriptor

96372

Therapeutic, Prophylactic, and Diagnostic Injection (specific substance or drug; subcutaneous or intramuscular)

National Drug Code (NDC)3

The National Drug Code is a unique 10-digit, 3-segment number. It is a universal product identifier for drugs in the United States present on all over-the-counter and prescription medication packages and inserts.

Many NDC numbers listed on drug packaging are in a 10-digit format. The NDC number is essential for proper claim processing when submitting claims for drugs used; however, to be recognized by payers, it must be formatted into an 11-digit 5-4-2 sequence. This requires a zero (0) to be placed in a specific position to meet the 5-4-2 format requirement. As not all NDC numbers are set up the same, the table below demonstrates how to achieve the 11-digit NDC code for LEQVIO.

Please note, because many practice management systems automatically remove the hyphens, be sure they are excluded from submission on the claim.

Tradename

Package strength

10-digit format

NDC number

New format

NDC number for payer

Tradename

LEQVIO

Package strength

284 mg/1.5 mL single-dose prefilled syringe

10-digit format

4-4-2

NDC number

0078-1000-60

New format

5-4-2

NDC number for payer

00078-1000-60

00078-1000-60

International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)

ICD-10-CM is a comprehensive list of codes used for identifying and capturing a specific diagnosis.

To find a full list of ICD-10 codes that may be relevant for LEQVIO, download our Billing & Coding Guide.

Download the Billing & Coding Guide

*CPT © 2021 American Medical Association. All rights reserved.

References: 1. 2020 HCPCS Codes Level II. HCPCS Code J3490. Accessed August 31, 2021. https://hcpcs.codes/j-codes/j3490 2. Codify by AAPC. CPT® 96372. Accessed August 31, 2021. https://www.aapc.com/codes/cpt-codes/96372 3. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

Coding for hospital outpatient department administration

The codes detailed in this section may be used when LEQVIO is administered at a hospital outpatient department.

The table below provides common miscellaneous procedure and drug codes related to the administration of LEQVIO. A permanent code is anticipated to be available 6 months after product approval.

Healthcare Common Procedure Coding System (HCPCS) level II code(s)1

HCPCS is a collection of standardized codes that represent medical procedures, supplies, products, and services. The codes are used to facilitate the processing of health insurance claims by insurers.

HCPCS code

Descriptor

Site of care

Additional information

HCPCS code

C9399

Descriptor

Drugs and biologicals that have been approved by the Food and Drug Administration (FDA), but that do not yet have a product-specific drug/biological HCPCS code assigned

Site of care

Hospital outpatient department

Additional information

Valid for all Medicare and some commercial claims for hospital outpatient department services and procedures

Current Procedural Terminology (CPT) code2

CPT codes, also known as service codes, are a universal system that identifies medical procedures. Each procedure is given its own unique 5-digit code that identifies to health insurance companies what type of care was provided.

CPT code*

Descriptor

96372

Therapeutic, Prophylactic, and Diagnostic Injection (specific substance or drug; subcutaneous or intramuscular)

Revenue codes3

Revenue code

Descriptor

0636

Drugs requiring detailed coding

0250

General pharmacy

0500

General outpatient services

0510

General clinic services

National Drug Code (NDC)4

The National Drug Code is a unique 10-digit, 3-segment number. It is a universal product identifier for drugs in the United States present on all over-the-counter and prescription medication packages and inserts.

Many NDC numbers listed on drug packaging are in a 10-digit format. The NDC number is essential for proper claim processing when submitting claims for drugs used; however, to be recognized by payers, it must be formatted into an 11-digit 5-4-2 sequence. This requires a zero (0) to be placed in a specific position to meet the 5-4-2 format requirement. As not all NDC numbers are set up the same, the table below demonstrates how to achieve the 11-digit NDC code for LEQVIO.

Please note, because many practice management systems automatically remove the hyphens, be sure they are excluded from submission on the claim.

Tradename

Package strength

10-digit format

NDC number

New format

NDC number for payer

Tradename

LEQVIO

Package strength

284 mg/1.5 mL single-dose prefilled syringe

10-digit format

4-4-2

NDC number

0078-1000-60

New format

5-4-2

NDC number for payer

00078-1000-60

00078-1000-60

International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)

ICD-10-CM is a comprehensive list of codes used for identifying and capturing a specific diagnosis.

To find a full list of ICD-10 codes that may be relevant for LEQVIO, download our Billing & Coding Guide.

Download the Billing & Coding Guide

*CPT © 2021 American Medical Association. All rights reserved.

References: 1. 2020 HCPCS Codes Level II. HCPCS Code C9399. Accessed August 31, 2021. https://hcpcs.codes/c-codes/c9399 2. Codify by AAPC. CPT® 96372. Accessed August 31, 2021. https://www.aapc.com/codes/cpt-codes/96372 3. Noridian Healthcare Solutions. Revenue Codes. Accessed August 31, 2021. https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes 4. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

The information herein is provided for educational purposes only. Novartis cannot guarantee insurance coverage or reimbursement. Coverage and reimbursement may vary significantly by payer, plan, patient, and setting of care. It is the sole responsibility of the health care provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient.

Completing forms accurately may help with timely reimbursement

Two forms are commonly used to submit claims for payment.

As you prepare your claims, you can use our Claim Filing Checklist as a reference to help to ensure your claims are being submitted with the necessary information.

Download Claim Filing Checklist

Coding for a physician's office |
CMS-1500 form

Coding for a physician's office | CMS-1500 form

The sample claim form provided below is only an example.1 The sample claim form provided below is only an example.1 It is always the provider's responsibility to determine the appropriate health care setting and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, payment policies, and fee schedules.

  • This Centers for Medicare & Medicaid Services (CMS) CMS-1500 Form is used for billing for prescribed medications administered in HCP offices

  • It should be completed (generally electronically) and submitted to the insurance provider in accordance with your organization's policies

CMS-1500 (UB-92) FORM Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms CMS-1500 (UB-92) FORM
Close Button

Field

Information Required

Field

Information required

Box 19*

LEQVIO (inclisiran) 284 mg/1.5 mL, subcutaneous injection NDC 00078-1000-602

Box 21A

Primary diagnosis code (ICD-10-CM)

Box 21B

Secondary diagnosis code (ICD-10-CM)

Box 23

Prior authorization number, if available

Box 24A

In the non-shaded area, list the date of service. In the shaded area, give a detailed drug description. List the N4 indicator first, then the 11-digit NDC number. Third is the unit of measurement qualifier; the unit quantity is listed at the end.

Example N400078100060ML1.5

Box 24D

Enter the appropriate HCPCS code for LEQVIO use as required by the payer. J3490, Unclassified drug,3 may be appropriate. Include the appropriate CPT code to report the administration procedure, 96372.4

Box 24E

Enter the diagnosis code reference letter (A or B) as shown in Box 21 to relate the date of service and the procedures performed to the primary diagnosis. If there is more than one diagnosis required for a procedure code, only reference one letter from Box 21.

Box 24G

The appropriate number of units for an unclassified drug may vary by payer. For Medicaid, the units may also vary by state. For many payers, the appropriate number of units to enter for LEQVIO is 1 unit.

* Mandatory for newly approved drugs using miscellaneous J-codes. See specific payer guidance for Box 19 instructions.

Download Annotated CMS-1500

References: 1. Centers for Medicare & Medicaid Services. CMS-1500 Sample Form. Accessed August 31, 2021. https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf 2. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 3. 2020 HCPCS Codes Level II. HCPCS Code J3490. Accessed August 31, 2021. https://hcpcs.codes/j-codes/j3490 4. Codify by AAPC. CPT® 96372. Accessed August 31, 2021. https://www.aapc.com/codes/cpt-codes/96372

Coding for a hospital outpatient
department | CMS-1450 (UB-04) form

Coding for a hospital outpatient department | CMS-1450 (UB-04) form

The sample claim form provided below is only an example.1 It is always the provider's responsibility to determine the appropriate health care setting and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, payment policies, and fee schedules.

The sample claim form provided below is only an example.1 It is always the provider's responsibility to determine the appropriate health care setting and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, payment policies, and fee schedules.

  • The CMS-1450 (UB-04) form is used for billing for prescribed medications administered in hospital outpatient settings

  • It should be completed and submitted (generally electronically) to the insurance provider in accordance with your organization's policies

CMS-1450 (UB-04) FORM Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms Visit Annotated claim forms CMS-1450 (UB-04) FORM
Close Button

Field

Information Required

Field

Information Required

Box 42

Enter the appropriate revenue code corresponding with the HCPCS code in Box 44, which is required for billing the unclassified HCPCS code (eg, 0636 revenue code for drugs requiring detailed coding, and/or 0250 for general pharmacy). Then enter the appropriate revenue code corresponding with the CPT code in Box 44 (eg, 0500 for general outpatient services or 0510 for general clinic services).2

Box 43*

Enter a detailed drug description for the payer. The N4 indicator is listed first, the 11-digit National Drug Code number is listed second, a code describing the unit of measurement qualifier is listed third (eg, ML for milliliters), and the unit quantity is listed at the end.

Example N400078100060ML1.5

Box 44

Enter the appropriate HCPCS code for LEQVIO use as required by the payer. J3490, Unclassified drug may be appropriate.3 C9399 may be appropriate for patients with Medicare Part B as the primary payer.4 To report the administration procedure, enter an appropriate CPT code, 96372.5

Box 46

Enter the total number of units of service. For LEQVIO, payers may request that the miscellaneous code be billed at 1 unit. Please note that the appropriate number of units for an unclassified drug may vary by payer. For Medicaid, the units may also vary by state. Some payers may refer to the actual quantity administered via Box 43 and Box 80.

Box 63

Treatment authorization codes

Box 66

Primary diagnosis code (ICD-10-CM)

Secondary diagnosis code (ICD-10-CM)

Box 80

LEQVIO (inclisiran) 284 mg/1.5 mL, subcutaneous injection6

* Mandatory for newly approved drugs using miscellaneous J-codes.

Download Annotated CMS-1450 (UB-04) Form

References: 1. Centers for Medicare & Medicaid Services. CMS-1450 Form. Accessed August 31, 2021. https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1450 2. Noridian Healthcare Solutions. Revenue Codes. Accessed August 31, 2021. https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes 3. 2020 HCPCS Codes Level II. HCPCS Code J3490. Accessed August 31, 2021. https://hcpcs.codes/j-codes/j3490 4. 2020 HCPCS Codes Level II. HCPCS Code C9399. Accessed August 31, 2021. https://hcpcs.codes/c-codes/c9399 5. Codify by AAPC. CPT® 96372. Accessed August 31, 2021. https://www.aapc.com/codes/cpt-codes/96372 6. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

The information herein is provided for educational purposes only. Novartis cannot guarantee insurance coverage or reimbursement. Coverage and reimbursement may vary significantly by payer, plan, patient, and setting of care. It is the sole responsibility of the health care provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient.

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IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO® and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- and placebo-treated patients, respectively.

Please click here for LEQVIO full Prescribing Information.

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

Please click here for LEQVIO full Prescribing Information.