- Change to Roster Claims Information Entry in the Fiscal Intermediary Standard System Direct Data Entry
- Drugs and Biologicals - Coverage and Billing
- Medicare Part B Drug Coverage
- Covered Medicare Part B Drugs/Biologicals
- Self-Administered Drug Exclusion
- Medicare Part B General Billing
- Discarded Drugs/Wastage and JW, JZ Modifier
- Chemotherapy General Infusion Information
- Unlisted Codes for Drugs and Biologicals (J3490, J3590 and J9999)
- Compound Drugs
- Patient-Supplied or Free-of-Charge Drugs
- Prolonged Drug and Biological Infusions Using an External Pump
- Coding for Sinuva™ Claims
- Radiopharmaceutical Reimbursement
- Dermal Injections for Treatment of Facial Lipodystrophy Syndrome
- Factor VIII Billing
- Intravitreal Beovu (Brolucizumab-dbl) Billing
- Proper Billing for LEQVIO® HCPCS Code J1306
- Erythropoiesis Stimulating Agents: Clinical Indications and Coverage Criteria Overview
- Proper Billing for TEZSPIRE™ HCPCS Code J2356
- Proper Billing Units for HCPCS Code J7320
- Providers Performing Facet Joint Injections (CPT Code 64476)
- Skin Substitutes
- Vaccines
- Related Content
Proper Billing for LEQVIO® HCPCS Code J1306
Table of Contents
- Proper Billing for LEQVIO® HCPCS Code J1306
- Claim Completion Requirements
- Drug Wastage
- Related Content
Proper Billing for LEQVIO® HCPCS Code J1306
National Government Services has noticed improper billing of units and diagnosis used for HCPCS code J1306; LEQVIO® injection, inclisiran, 1 mg.
LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical ASCVD or HeFH who require additional lowering of LDL-C.
Limitations of Use: The effect of LEQVIO® on cardiovascular morbidity and mortality has not been determined.
For Medicare patients, LEQVIO® may be covered under Medicare Part B when used for an FDA-approved indication and when medically reasonable and necessary.
Effective for dates of service on or after 7/1/2022 the permanent J-code, J1306 must be used.
LEQVIO® is packaged as 284 mg/1.5ml single dose prefilled syringe.
Claim Completion Requirements
- The number of units administered referenced as 284 units; if the full syringe was used
- Note: Each mg is equal to one unit
- Both a primary and secondary diagnosis are required
- Payable primary diagnosis: E78.00, E78.01, E78.2, E78.4, E78.49, E78.5 and E78.9
- Payable secondary diagnosis are located in the LEQVIO® Billing and Coding Guide
Drug Wastage
Effective 1/1/2017, providers and suppliers are required to report the JW modifier as a way to identify, and be paid for, unused drugs and biologicals.
- The JW modifier is applied to the amount of drug or biological that is discarded, and it’s billed on a separate line item; and
- The discarded drug/biological must be documented in the patient’s medical record.
When billing for wastage, ensure the following is present on the claim:
- A line with the amount administered of the HCPCS code
- A separate line for the wasted amount of the HCPCS code with the JW modifier appended
- For example: If 142 mg was administered and 142 mg was wasted it would be billed as the following:
- HCPCS Line 1: J1306, 142 units
- HCPCS Line 2: J1306/JW, 142 units
- For example: If 142 mg was administered and 142 mg was wasted it would be billed as the following:
Related Content
- CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40 - Discarded Drugs and Biologicals
- Medicare Program: JW Modifier: Drug/Biological Amount Discarded/Not Administered To Any Patient Frequently Asked Questions
Reviewed 3/26/2024