Some Medicare requirements have been in place for years. Take the Medicare Part B requirement to bill for waste when the entire vial of a single-dose or single-use container of a drug is not utilized in its entirety. While the Centers for Medicare & Medicaid Services (CMS) rolled out this regulation in 2017, it was uncommon for a provider to take the time to bill for the waste. Why? The answer’s simple. The provider is reimbursed for the full vial whether they billed for a full vial or billed the drug on two separate lines (one for the portion used and the other line for the portion wasted). Additionally, some pharmacies are set up to bill exact quantity. In those instances, the pharmacy may not have even realized they could bill for the portion not used from a single-use vial. The reality is that there simply was no incentive nor penalty for the provider to take the extra steps and time to capture and bill for the waste.
It was obvious to CMS that providers weren’t billing for waste when it occurred because the amount of waste reported for single-dose vials was miniscule compared to the volume of claims submitted with the single-use drugs. This created a loss for CMS because the Infrastructure Investment and Jobs Act amended section 1847A requires manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drugs. Whenever the waste was not reported, CMS missed out on the rebate.
A more stringent billing for waste regulation mandate for single-use drugs was scheduled to go into effect on July 1, 2023; however, last-minute changes have simplified the process and made it optional to use waste-related modifiers. These changes came after the National Home Infusion Association (NHIA) advocated on behalf of members, outlining to CMS the significant administrative burden this would create for providers. So now the mandate to report to Medicare Part B for any single-use drug, whether there is waste or not, is voluntary.
Here’s what you need to know:
*Each line above may have other applicable modifiers outside of the waste-related modifiers such as KX (to confirm you have a signed order on file) or JB (if the drug is given subcutaneously), etc.
Notification on June 15th from CMS states that the use of the JW or JZ modifiers are now optional versus mandatory. While you may put using the JZ (for no waste) modifier on hold, I strongly suggest you evaluate how you are capturing waste in your billing process and that you are billing for waste from a single-use vial that must be discarded if not used. If not, it could mean throwing out hundreds of dollars with the discarded drugs.
Some important points of reference and reminders:
If you have any additional questions on this process or challenges related to home infusion billing and collections, Brightree has a team of experts that provide home infusion reimbursement services to take the complexity and burden off your shoulders. Get more information at https://www.brightree.com/brightree-revenue-cycle-management-rcm/
Jeanne has more than 39 years of experience in home infusion revenue cycle management, including building a successful home infusion reimbursement and consulting business, and was awarded an inaugural NHIA Fellow position (FNHIA). She’s an expert in the areas of intake, billing and collections, operations, and reimbursement management and is widely known throughout the home and specialty infusion industry for her expertise, thoroughness, and integrity. As a result, Jeanne is a fixture at NHIA conference podiums and the Payer Advocacy and Relations Committee and has authored several articles in INFUSION magazine.
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