Looking for LEQVIO® access and
reimbursement resources?

  • Patient coverage types

  • Acquisition

  • 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 two free doses of LEQVIO 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 3 calendar days. Program provides up to two (2) doses 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

AmerisourceBergen Besse Medical (physician distribution)

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

AmerisourceBergen Oncology Supply (practice distribution)

Phone: 1-800-633-7555
Fax: 1-800-248-8205
https://www.oncologysupply.com

AmerisourceBergen Specialty Distribution (health systems and specialty pharmacy)

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

Anda

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

Specialty Pharmacies

Novartis has made LEQVIO widely available through specialty pharmacies (SP), in the event white-bagging is required or preferred.

The following SPs have self-identified as supporting HCP-administered medical benefit products like LEQVIO. This means they currently support white-bagging for physicians and have familiarity and comfort with processing under both the medical and pharmacy benefits. This may be an option for private payers that offer Medicare Advantage and commercial health plans. Medicare Part B does not apply, as it is mandatory buy-and-bill.

This list of SPs is not comprehensive and other SPs may be available to you and your patients. Inclusion in this list is not an endorsement and Novartis cannot guarantee accuracy of this list or coverage of product. Novartis does not recommend or require the use of any particular pharmacy. Any SP in the LEQVIO distribution network that fits these criteria may be added to this list by contacting leqvio.spteam@novartis.com. This list is periodically updated.

Specialty Pharmacy

Contact Information

Website

Albertsons

Phone: 1-877-466-8028
Fax: 1-877-466-8040
Albertsons.com/specialtycare

AllianceRx Walgreens Pharmacy

Phone: 1-855-244-2555
Fax: 1-800-332-9581
alliancerxwp.com

ASP Cares

Phone: 1-903-354-0231
Fax: 1-903-630-7262
aspcares.com

Blue Sky

Phone: 1-866-822-0103
Fax: 1-833-898-3992
blueskyspecialtypharmacy.com

Hill Country Pharmacy

Phone: 1-844-295-5516
Fax: 1-844-295-5518
hillcountrypharmacy.com

Kroger

Phone: 1-866-580-8100
Fax: 1-866-794-4844
krogerspecialtypharmacy.com

Meijer

Phone: 1-855-263-4537
Fax: 1-877-222-5036
meijerspecialtypharmacy.com

Noble Health Services

Phone: 1-888-843-2040
Fax: 1-888-842-3977
noblehealthservices.com

Orsini Specialty Pharmacy

Phone: 1-800-372-6153
Fax: 1-877-515-9670
https://www.orsinispecialtypharmacy.com

ReCept

Phone: 1-866-326-1425
Fax: 1-866-326-9731
https://www.recept-pharmacy.com

Soleo Health Inc.

Phone: 1-844-575-1515
Fax: 1-877-393-1618
https://www.soleohealth.com/orlando.html

Absolute Pharmacy
(Puerto Rico)

Phone: 1-787-892-8700
Fax: 1-787-496-1010

Alivia Specialty Pharmacy
(Puerto Rico)

Phone: 1-787-925-1989
Fax: 1-787-925-1015
http://aliviahealth.com/specialty

Axium Healthcare
(Puerto Rico)

Phone: 1-787-780-7200
Fax: 1-787-779-1430
https://www.axiumpr.com

Special Care Pharmacy Services
(Puerto Rico)

Phone: 1-787-781-4585
Fax: 1-787-783-2951
https://specialcarepr.com

SPS Specialty Pharmacy Services (Puerto Rico)

Phone: 1-787-704-2025
Fax: 1-787-704-2027
https://www.spscaguas.com

Novartis does not recommend the use of any particular SP.

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.

Now available: Permanent J-code J1306 effective July 1, 2022 for all sites of care

Thumbnail of Billing & Coding Guide

Understanding the permanent
J-code, J1306

Learn how and where to apply the permanent
J-code, J1306, when submitting a claim for LEQVIO

Download the J-code flashcard

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.

Billing and coding information

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.

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

Billing units

HCPCS code

J1306

Descriptor

Injection, inclisiran, 1 mg

Billing units

284

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 © 2022 American Medical Association. All rights reserved.

References: 1. Centers for Medicare & Medicaid Services. CMS HCPCS Application Summaries and Coding Recommendations: First Quarter, 2022 HCPCS Coding Cycle. Accessed May 2, 2022. https://www.cms.gov/files/document/2022-hcpcs-application-summary-quarter-1-2022-drugs-and-biologicals.pdf 2. Codify by AAPC. CPT® 96372. Accessed May 3, 2022. 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.

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

Billing units

HCPCS code

J1306

Descriptor

Injection, inclisiran, 1mg

Billing units

284

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 © 2022 American Medical Association. All rights reserved.

References: 1. Centers for Medicare & Medicaid Services. CMS HCPCS Application Summaries and Coding Recommendations: First Quarter, 2022 HCPCS Coding Cycle. Accessed May 2, 2022. https://www.cms.gov/files/document/2022-hcpcs-application-summary-quarter-1-2022-drugs-and-biologicals.pdf 2. Codify by AAPC. CPT® 96372. Accessed May 3, 2022. https://www.aapc.com/codes/cpt-codes/96372 3. Noridian Healthcare Solutions. Revenue Codes. Accessed May 3, 2022. https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes 4. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

*CPT © 2022 American Medical Association. All rights reserved.

References: 1. Centers for Medicare & Medicaid Services. CMS HCPCS Application Summaries and Coding Recommendations: First Quarter, 2022 HCPCS Coding Cycle. Accessed May 2, 2022. https://www.cms.gov/files/document/2022-hcpcs-application-summary-quarter-1-2022-drugs-and-biologicals.pdf 2. Codify by AAPC. CPT® 96372. Accessed May 3, 2022. https://www.aapc.com/codes/cpt-codes/96372 3. Noridian Healthcare Solutions. Revenue Codes. Accessed May 3, 2022. 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 CMS-1500 (UB-92) FORM
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Field

Information Required

Field

Information required

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 J1306 for LEQVIO use as required by the payer.2 Include the appropriate CPT code to report the administration procedure, 96372.3

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

Include the appropriate number of billing units for LEQVIO: 284 mg=284 billing units

References: 1. Centers for Medicare & Medicaid Services. CMS-1500 Sample Form. Accessed May 3, 2022. https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf 2. Centers for Medicare & Medicaid Services. CMS HCPCS Application Summaries and Coding Recommendations: First Quarter, 2022 HCPCS Coding Cycle. Accessed May 2, 2022. https://www.cms.gov/files/document/2022-hcpcs-application-summary-quarter-1-2022-drugs-and-biologicals.pdf 3. Codify by AAPC. CPT® 96372. Accessed May 3, 2022. 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 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 (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 J1306 for LEQVIO use as required by the payer.3 To report the administration procedure, enter an appropriate CPT code, 96372.4

Box 46

Include the appropriate number of billing units for LEQVIO: 284 mg=284 billing units. Some payers may refer to the actual quantity administered via Box 43.

Box 63

Treatment authorization codes

Box 66

Primary diagnosis code (ICD-10-CM)

Secondary diagnosis code (ICD-10-CM)

References: 1. Centers for Medicare & Medicaid Services. CMS-1450 Form. Accessed May 3, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1450 2. Noridian Healthcare Solutions. Revenue Codes. Accessed May 3, 2022. https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes 3. Centers for Medicare & Medicaid Services. CMS HCPCS Application Summaries and Coding Recommendations: First Quarter, 2022 HCPCS Coding Cycle. Accessed May 2, 2022. https://www.cms.gov/files/document/2022-hcpcs-application-summary-quarter-1-2022-drugs-and-biologicals.pdf 4. Codify by AAPC. CPT® 96372. Accessed May 3, 2022. https://www.aapc.com/codes/cpt-codes/96372

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.