Lasix ONYU was designed for patients at imminent risk for hospitalization. The patient may be in the clinic or emergency department and needs treatment TODAY.
Effective October 1, 2026, Lasix ONYU will also be available under Medicare Part B medical benefit and similarly under medical benefit coverage from other payors.
Medical benefit coverage works differently than the pharmacy benefit. It is also known as “buy and bill”. In this case Lasix ONYU is not provided by an outpatient pharmacy, but provided as part of the medical service and billed to Medicare or other insurer along side other elements of the service.
Why Medical Benefit in Addition to Pharmacy Coverage?
Pharmaceutical products used at home are typically dispensed through outpatient pharmacies and covered under the pharmacy benefit. But the pharmacy benefit’s verification and dispensing process is not designed for important treatments that need to start the same day, where any delay carries real risk.
The clinical community has been clear: for patients at imminent risk of a heart failure hospital admission, delays and denials tied to pharmacy benefit dispensing are not acceptable. Timely treatment can be jeopardized by several pharmacy benefit factors, including:
- Benefit verification
- Prior authorization requirements
- Pharmacy hours of operation
- Inventory availability
- Wait times
- Risks to the patient in managing the process themselves
For at-home decongestion of a patient who would otherwise have been admitted, it is a medical necessity that the product be in place and ready for the patient to start treatment immediately upon arrival home. This is what the Medical Benefit enables and the Pharmacy Benefit cannot guarantee.
Guide to Coverage
For the Clinician
Where: The patient is in the medical facility because of worsening heart failure. This can be in:
- The emergency department (ED) or urgent care
- The outpatient clinic
- The infusion clinic for IV diuretic
- The observation unit
Imminent Risk of Admission: The patient is at imminent risk of admission and parenteral diuretics are indicated.
Lasix ONYU Preparation and Placement: The first unit of Lasix ONYU is prepared and placed. The patient is instructed how to activate the unit upon arriving home.
Lasix ONYU for the Treatment Course: The number of treatments a patient needs varies. Up to 12 units (including the one placed on the stomach) are provided under the medical benefit. There is no Prior Authorization requirement under Medicare Part B*.
Home Decongestion Instructions and Support: Home decongestion requires clear instructions, arrangements for monitoring and follow-up including arrangements for laboratory testing.
For the Pharmacy/Institution
The Right Pharmacy: Lasix ONYU needs to be purchased by the pharmacy that can provide this for use under the medical benefit (“buy and bill”). Sometimes it is called the “inpatient pharmacy”. It is the same pharmacy that provides furosemide injection for use in the clinic or infusion center.
Ordering: The pharmacy can order from Cardinal or Cencora – see the ordering page on this website for details. Make sure both the Lasix ONYU Treatment Kits (furosemide injection 80mg/2.67mL) and the Reusable Unit and Charger are ordered. Conservatively order one Reusable Unit and Charger for 6 Treatment Kits. All products need to be preordered and in inventory onsite.
Billing: Lasix ONYU is billed at HCPCS Level II code J1946, “Injection, furosemide (lasix onyu), 1 mg“. A single Treatment Kits is 80 units and up to 960 units can be billed which corresponds to 12 Treatment Kits. Lasix ONYU is indicated for use in patients with heart failure only – ICD-10-CM 150.X.
Other Payors
Medical benefit coverage for Lasix ONYU is new and highly unusual. It has been reviewed with CMS and all CMS contractors have been informed to expect claims under Part B starting October 1. Medicaid and Medicare Advantage providers have been informed and to date no insurer has informed the company of prior authorization requirements or other restrictions. Some insurers have confirmed that they follow Medicare coverage decisions. Benefit verification should be performed when possible. Contact SQ Innovation at coverage@sqinnovation.com if restrictions are imposed or claims are denied.
The Patient and Medical Benefit Coverage
Medicare Part B has a 20% coinsurance. Most Part B beneficiaries, about 87% in 2023*, also have supplemental insurance that covers some or all of this cost.
For patients without supplemental insurance, the 20% coinsurance for a full treatment (12 units of Lasix ONYU) may be around $1,200. By comparison, for a patient without supplemental coverage, the 2026 Medicare Part A deductible for a hospital stay is $1,736.
Charges and the patient’s share are billed like any other medical service.
For patients with Medicare Advantage or commercial insurance, Lasix ONYU is subject to the plan’s usual deductible, copay, and coinsurance for medical services.
For Questions or Assistance
Coverage under the medical benefit is new and unusual. This page will be updated when we learn more. If you have any questions or would like to report coverage issues you have encountered, please email us at payor@sqinnovation.com
Product Information
CASE SIZE: Both the Lasix ONYU kit and the Reusable Unit and Charger box come in a case of 24 units. For questions related to ordering, please contact distribution@sqinnovation.com
Please note that Lasix ONYU requires the use of one Reusable Unit, so the first prescription requires one Reusable Unit (UPC 8113790131) and as many Lasix ONYU Kits (NDC 81137-001-15) as the patient is expected to need.
| Product | Package Contents | |
|---|---|---|
| NDC: 81137-001-15 | Lasix ONYU Kit | Carton containing one 80 mg/2.67 mL single- dose prefilled cartridge co-packaged with one Disposable Unit (DU) and two alcohol pads |
| UPC: 8113790131 | Lasix ONYU Reusable Unit and Charger Box | Carton containing one Reusable Unit (RU), charger, and Instructions for Use |
Please read the Important Safety Information, full Prescribing Information and Instructions for Use.
*KFF: A Snapshot of Sources of Coverage Among Medicare Beneficiaries (Dec 2025) https://www.kff.org/medicare/a-snapshot-of-sources-of-coverage-among-medicare-beneficiaries/