ModifiedmhnPolicy CP.PHAR.608

Furosemide (Furoscix)

Defines medical necessity and prior authorization criteria for outpatient use of Furoscix (subcutaneous furosemide delivered via a single-use on-body infusor) for adults with edema due to chronic heart failure or chronic kidney disease, and related coverage guidance for other uses.

Policy Summary

Payermhn

PolicyFurosemide (Furoscix)

Policy CodePolicy CP.PHAR.608

Change TypeMaterial clinical and dosing updatesclarified examples

Effective DateMar 1, 2023

Next Review Date

Key ActionProviders must submit documentation showing the member is refractory to at least one oral loop diuretic at maximally indicated doses and meets all listed clinical stability and volume-expansion criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Updated FDA indication and criteria to include CKD including nephrotic syndrome and added nephrologist as an option for the prescriber specialty requirement.

Revised dosage strength description from 80 mg/mL to 80 mg/10 mL and removed specification of NYHA Class II/III from criteria.

Added examples of extracellular volume expansion due to CHF to approval criteria.

80 mg/daymaximum single-day dose allowed

8 kitsmaximum kits allowed over 30 days

≥18patient age requirement

4 wks

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initial approval length

Coverage / Medical Necessity Criteria

Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Operational note: Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including prior refractory response to oral loop diuretics; prior authorization is required and re-authorization is not permitted; each request must meet initial criteria.

Non-FDA approved indications that are not explicitly addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage determinations under this clinical policy are guides to medical necessity and do not constitute a contract or guarantee of payment. All coverage decisions and benefit administration are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, or policy), applicable Health Plan administrative policies and procedures, and state or federal requirements. Where state Medicaid provisions conflict with this policy, state Medicaid provisions take precedence.

Re-authorization for Furoscix is not permitted. Each prior authorization request must demonstrate that the member meets the initial approval criteria; approval cannot be extended by a re-authorization process.

Billing and Coding

HCPCS CodesHCPCS

J1941

Injection, furosemide (Furoscix), 20 mg

Maximum dose — single-day dose allowed

Maximum single-day dose80 mg per day (1 cartridge) — 80 mg SC once over 5 hours

Per‑cartridge strengthOne cartridge delivers 80 mg furosemide

Dosing frequency limitDo not exceed 80 mg in any single day

Maximum kits per 30 days — quantity limit

Maximum kits per 30 daysUp to 8 kits per 30 days (total of 8 kits over 30 days)

Approval duration related limitApproval duration: 4 weeks (up to 8 kits total)

Daily dose cap tied to kits

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Furoscix. Initial approval must meet all criteria in the policy; re-authorization is not permitted. Requests must document that the member meets the initial approval criteria for each request.

Prior authorization required — initial criteria must be met
Re-authorization not permitted; each request must meet initial criteria

Note

Prior Authorization Governed by Plan Documents

Providers must follow the member's specific coverage documents (e.g., Evidence of Coverage, certificate of coverage, benefit booklet) when submitting clinical information and when determining coverage applicability. Coverage decisions are governed by the member’s plan terms, exclusions, and limitations.

Use the member-specific Evidence of Coverage or plan documents to verify benefits and submission requirements
Plan-level administrative policies and exclusions may affect coverage determination

Clinical Background

Furoscix is a subcutaneous formulation of furosemide delivered via a single‑use, wearable on‑body infusor to provide outpatient parenteral diuresis. It is FDA‑approved for the treatment of edema in adults with chronic heart failure (CHF) or chronic kidney disease (including nephrotic syndrome). The product is intended for short‑term outpatient use with transition to oral diuretics as soon as practical. Dosing guidance in the policy specifies a maximum of 80 mg per day (one cartridge) and limits use to a total of 8 kits per 30 days.

Definitions and Plan Terms

Refractory to loop diuretics — failure to respond to full dose

DefinitionFailure to relieve volume overload, edema, or congestion despite a full dose of loop diuretic.

Full dose definitionFull dose of loop diuretic is defined as oral furosemide 80 mg daily or equivalent.

Equivalent dosing ratioApproximate conversion ratio (bumetanide : torsemide : furosemide) = 1 : 20 : 40.

Health Plan — definition and applicability

Health Plan definitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or affiliates.

Policy applicationThis clinical policy provides guidance to support coverage decisions and benefit administration by the Health Plan.

Policy Summary

Payermhn

PolicyFurosemide (Furoscix)

Policy CodePolicy CP.PHAR.608

Change TypeMaterial clinical and dosing updatesclarified examples

Effective DateMar 1, 2023

Next Review Date

SourceLink

On This Page

Each kit contains one cartridge (80 mg); cumulative kits must not exceed 8 in 30 days

Step Therapy

Step Therapy / Refractory to Oral Loop Diuretic Required

Providers must attest and submit documentation that the member is refractory to at least one oral loop diuretic (oral furosemide, torsemide, or bumetanide) at maximally indicated doses as defined by the policy (see Appendix D). Incomplete demonstration of refractory status may result in denial.

Member must be refractory to at least one oral loop diuretic at up to maximally indicated doses (see Appendix D for definition and dose equivalents)
Examples of acceptable agents: oral furosemide, torsemide, bumetanide

Documentation Required

Documentation Submission Requirement

Providers must submit supporting clinical documentation with the PA request, such as office chart notes, recent lab results, imaging, and specialist consultation notes that demonstrate the member meets all required criteria (diagnosis, specialist involvement, age, signs of extracellular volume expansion, candidate for outpatient parenteral diuresis, refractory to oral loop diuretics, and dosing limits).

Include office notes showing signs of volume expansion (e.g., JVD, ≥1+ pitting edema, pulmonary rales)
Include cardiology or nephrology consultation or attestation
Include documentation of attempts and doses of oral loop diuretics and rationale for parenteral outpatient diuresis

Denial Risk

Requests Lacking Required Documentation May Be Denied

Requests that lack required documentation (diagnosis, specialist involvement, age, evidence of extracellular volume expansion, documentation of outpatient candidacy, or evidence the member is refractory to an adequate trial of oral loop diuretics) may be denied. Failure to follow the member’s coverage terms or plan exclusions may also result in denial.

Missing evidence of refractory status to oral loop diuretics may lead to denial
Missing specialist attestation (cardiologist or nephrologist) may lead to denial
Failure to adhere to member plan terms or exclusions may result in denial

Coverage decisions subject to plan documentsCoverage decisions and benefit administration are subject to all terms, conditions, exclusions, and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance).