Patient coverage types
Patient coverage types
Distributors
Alternate injection/infusion centers
Billing and coding
Annotated claim forms
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 PDFDistribution & Acquisition Flashcard
Download PDFAnnotated Claim Forms
View FormsPROCESS STEPS
PROCESS STEPS
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 PDFDistribution & Acquisition Flashcard
Download PDFAnnotated Claim Forms
View FormsPROCESS STEPS
PROCESS STEPS
*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
ASD Healthcare
Phone: 1-800-746-6273
Fax: 1-800-547-9413
https://www.asdhealthcare.com
Cardinal Health Specialty Pharmaceuticals
Phone: 1-866-677-4844
https://specialtyonline.cardinalhealth.com
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 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
GPO
Contact Information
Website
Cornerstone Rheumatology GPO
Phone: 1-800-768-2002
https://www.cardinalhealth.com/cornerstonerheumatology
Intalere
Phone: 1-877-711-5600
https://www.intalere.com/contact-us
MosaicGPO Solutions
Phone: 1-800-768-2002
https://www.cardinalhealth.com/mosaicgpo
Onmark GPO
Phone: 1-800-482-6700
https://www.mckesson.com/Specialty/Group-Purchasing/
Premier
Phone: 1-877-777-1552
https://solutioncenter@premierinc.com/contact-us
The Resource Group
Phone: 1-844-753-4778
https://theresourcegroup.com/Participants
VitalSource GPO
Phone: 1-877-453-3972
https://www.cardinalhealth.com/vitalsourcegpo
Vizient
Phone: 1-800-842-5146
https://vizientsupport@vizientinc.com
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*
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.
Looking to learn more about the alternate injection/infusion center process?
Alternate Injection/InfusionCenter 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.
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 GuideThe 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
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-1500References: 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
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) FormReferences: 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.
