Last Modified: 4/10/2024
Location: FL, PR, USVI
Business: Part B
The Recovery Audit Contractor (RAC) is conducting a complex audit of billed claims for the drug Octagam (injection, immune globulin, intravenous, no lyophilized (e.g., liquid), 500 mg). Medical review data shows the top reason for claim denials for this drug is due to lack of documentation. Although the information provided by the RAC does not specify what information is missing, at the end of this article we provide you with the documentation requirements listed in our
Local Coverage Article (LCA) A57778 
. Also, please review this entire educational article to avoid unnecessary denials.
Drugs and biologicals are billed in multiples of the dosage specified in the HCPCS code long descriptor. The number of units billed should be assigned based on the dosage increment specified in that CPT or HCPCS long descriptor and correspond to the actual amount of the drug administered to the patient, including any appropriate discarded drug waste. If the drug dose used in the care of a patient is not a multiple of the HCPCS code dosage descriptor, the provider rounds to the next highest unit based on the HCPCS long descriptor for the code in order to report the dose provided.
When a physician, hospital or other provider or supplier must discard the remainder of a single use vial or other single use package after administering a dose or quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label.
Effective January 1, 2017, providers and suppliers are required to report the JW modifier on all claims that bill for drugs and biologicals (hereafter, drug) separately payable under Medicare Part B with unused and discarded amounts (hereafter, discarded amounts) from single-dose containers or single- use packages (hereafter, single-dose containers). Also, providers and suppliers must document the number of discarded drugs in Medicare beneficiaries’ medical records.
The JW modifier is only applied to the amount of drug or biological that is discarded. A situation in which the JW modifier is not permitted is when the actual dose of the drug or biological administered is less than the billing unit. The JW modifier must not be used to report discarded amounts of overfill. Since January 1, 2011, CMS regulations have expressly prohibited billing for overfill, which is any amount of drug greater than the amount identified on the package or label.
Effective July 1, 2023, providers and suppliers are required to report the JZ modifier on all claims that bill for drugs from single-dose containers that are separately payable under Medicare Part B when there are no discarded amounts. Claims billed with excessive or insufficient units will be reviewed to determine the actual amount administered and the correct number of billable and payable units.
Remember the difference between the JW modifier and the JZ modifier is that the JW is to report when there has been a discarded amount of the drug, which should be documented in the beneficiary’s medical record, and the JZ is to report in the claim that no amount of the drug was discarded.
The complete LCA:
Billing and Coding Article: Immune Globulin, A57778 is included in the LCD which provides documentation requirements, utilization parameters and coding information as applicable. The specific documentation requirements are the following:
• All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
• The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
• The medical record documentation must support the medical necessity of the services as stated in the LCD.
• The information contained in the medical record should include all relevant diagnostic laboratory studies, prior history of bleeding, infection, disease progression, prior medical/surgical therapies, vaccination response, and any other information essential in establishing that the patient meets the coverage indications as set forth in the NCD and LCD.
• An accurate weight in kilograms should be documented prior to the infusion since the dosage is based on mg/kg/dosage.
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