A: Reclast® (zoledronic acid) is an infused medication used to treat osteoporosis and Paget’s disease of bone. The appropriate HCPCS Level II supply code for Reclast® is J3489 Injection, zoledronic acid, 1 mg.
CPT ® Codes continued Therapeutic, Prophylactic and Diagnostic Injections and IV Infusions (non-chemo) Intravenous Infusions • 96365-Intravenous infusion, for therapy, prophylaxis, or diagnosis;initial up to one hour 23, up to one hour • 96366-Intravenous infusion, for therapy, prophylaxis, or diagnosis; each additional hour
For patients with creatinine clearance ≥35 mL/min the recommended dose of Reclast is 5 mg infused intravenously once a year over no less than 15 minutes given over a constant infusion rate with a 10 mL normal saline flush of the IV line following the infusion.
FDA approval Letter dated 04/16/2007 for coverage of Reclast® (zoledronic acid) for Paget’s disease of the bone. FDA approval Letter dated 08/17/2007 for coverage of Reclast® (zoledronic acid) for post-menopausal osteoporosis.
HCPCS code J3489 (Injection, zoledronic acid 1 mg) should be used to report Reclast®. The number of units billed on a claim should be 5, since Relcast® is given as single 5 mg injection. Reclast is only administered once per 12 months, therefore, only one Reclast® claim should be submitted per year.
Reclast and Zometa are two different brands of zoledronic acid. Reclast is used to treat or prevent osteoporosis caused by menopause, or steroid use. This medicine also increases bone mass in men with osteoporosis.
Reclast is usually not covered for Medicare-eligible patients under Medicare Part D and Medicare Advantage prescription drug plans. However, it may be covered under Medicare Part B as a medical benefit.
CPT® Code 96365 in section: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug)
The code 96365 is used to code for the 20-minute Reclast infusion. For the infusions to be considered as an initial hour, the infusion has to be at least 16 minutes long.
Zoledronic acid (Reclast) is a bisphosphonate. Bisphosphonates work to slow down bone breakdown so the body can make new, healthy, and strong bone. Zoledronic acid (Reclast) helps raise bone mineral density (BMD), which is a measure of how dense your bones are.
The appropriate HCPCS Level II supply code for Reclast® is J3489 Injection, zoledronic acid, 1 mg. For an initial infusion of Reclast® lasting 16 minutes or longer, report 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour.
Reclast is a brand name for the generic drug zoledronic acid. It belongs to a class of osteoporosis treatments known as bisphosphonates, which help decrease bone turnover.
Reclast is a bisphosphonate and Prolia is a monoclonal antibody.
Report 96413 for a single or the initial substance given for up to one hour of service. Report 96415 for each additional hour of service beyond the initial hour. If the medication is not chemotherapy you should code 96365 with start and stop times.
Assign CPT 96360- IV hydration, initial 31-90 minutes, and CPT 96361 (add on code), used once infusion lasts 91 minutes in length. An intravenous infusion of hydration of 30 minutes or less is not billable. Hydration infusion must be at least 31 minutes in length to bill the service.
Injection and Infusion Coding Scenarios How is this reported? Answer: Coders should use 96365 for the first hour of infusion, 96366 for the second hour of infusion, and for the IV push of the same drug.
LCD revised and published on 01/21/2021 to remove the erroneous statement “treatment failure of oral or self-administered drugs for osteoporosis as applicable to the patient that supports IV therapy in lieu of standard oral treatment protocol” listed under Prolia® for Men and Postmenopausal Women with Osteoporosis is allowed under the following circunstances:
Oral glucocorticosteroid therapy for longer than 3 months
All postmenopausal women who have had an osteoporotic vertebral or hip fracture
You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.
The following IV bisphosphonate injections are considered medically reasonable and necessary when administered as outlined in this LCD:
Reclast (zoledronic acid injection) is a drug administered via injection that promotes healing in bones that have been damaged due to cancer, cancer therapies or other causes of osteoporosis.
In most cases, it is administered only once per year, but for some patients, longer intervals may pass between treatments. Reclast can sometimes lead to difficult side effects, so it’s important to discuss any changes in your physical or mental well-being while taking Reclast and ask any questions you have regarding concurrent medications or underlying medical conditions prior to taking Reclast.
Because Reclast is provided as an injection and not a medication that can be purchased at a traditional pharmacy, Medicare Part D insurance generally does not cover Reclast. Under Medicare Part B, benefit recipients may be able to have the cost of Reclast covered when certain criteria are met.
Evidence in the medical record should clearly support the need for the intravenous administration of bisphosphonates for the treatment of osteoporosis.
You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.
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96367: Intravenous infusion, for therapy, prophylaxis or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (List separately in addition to code for primary procedure)
Strength Vial Size Number of Q5119 Billing Units (10 mg rituximab-pvvr) Equivalent to the Milligrams of RUXIENCE in Each Vial
Item 24D:Specify appropriate HCPCS and CPT codes and modifiers; for example: • Drug: Q5119 for RUXIENCE • Administration: 96xxxx for administration
The RUXIENCE HCPCS code Q5119 is described as “Injection, rituximab-pvvr, biosimilar, (ruxience), 10 mg.” Each dose increment of 10 milligrams equals 1 billing unit. For example, a 100 mg vial of RUXIENCE represents 10 billing units of Q5119. See the chart below correlating a vial of RUXIENCE administered with the number of billing units based on the description of Q5119.
This sample form is intended as a reference for the coding and billing of RUXIENCE. This form is not intended to be directive, and the use of the recommended codes does not guarantee reimbursement. HCPs may deem other codes or policies more appropriate and should select the coding options that most accurately reflect their internal guidelines, payer requirements, practice patients, and services rendered.
C91.12Chronic lymphocytic leukemia of B-cell type in relapse
96365: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour