Printer Friendly Version
Printer Friendly Version
L.2.02.407
Ultrafiltration is used to remove excess fluid from patients with volume overload and heart failure. It removes fluid from the blood by using pressure differentials with dialysis equipment or similar filtration devices.
Heart Failure
Heart failure is a relatively common condition that frequently results in hospitalizations and readmissions.
TreatmentVarious treatment approaches are being explored, especially when the condition is refractory to conventional therapy. Ultrafiltration, also referred to as aquapheresis, is a technique being investigated for a possible role in hospitalized patients with marked volume overload from heart failure. It is used to remove fluid from the blood via pressure differentials during treatment with a dialysis machine or similar filtration device.
It has been suggested that ultrafiltration may offer greater and more expeditious volume and sodium removal than conventional therapies, particularly in patients with decompensated heart failure whose fluid overload is unresponsive to medical management.
Newer devices that allow continuous ultrafiltration in ambulatory patients are under investigation to reduce volume overload.
Outcome MeasuresHeart failure is a condition with a variable natural history and multiple confounders of outcome. Clinical outcomes of interest in the treatment of heart failure include survival, hospitalization, complications, and quality of life; although removal of fluid and sodium, and weight loss, are important, they are surrogate outcomes that do not necessarily translate into clinical outcomes. Because ultrafiltration does not directly affect ventricular function, its effect on clinical outcomes is difficult to evaluate.
In 2002,the Aquadex FlexFlow™ System (Baxter; acquired by CHF Solutions in 2016) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. An amended 510(k) approval (classified as a high permeability dialysis system) was given in 2007 following system modifications. The FDA determined that this device was substantially equivalent to existing devices for use intemporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and for extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
In 2020, the FDA approved the Aquadex FlexFlow® System 2.0 for a slightly modified use: "Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies."
The use of ultrafiltration is considered investigational in patients with heart failure.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
This policy does not apply to patients with renal failure being treated using dialysis.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
12/13/2006: Policy added.
3/22/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC).
5/15/2009: Policy reviewed, no changes.
07/09/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed; no changes.
10/15/2013: Policy reviewed; no changes.
08/04/2014: Policy reviewed; description updated. Policy statement unchanged.
08/27/2015: Code Reference section updated for ICD-10.
10/20/2015: Policy description updated. Policy statement unchanged. Policy guidelines updated to state that this policy does not apply to patients with renal failure being treated using dialysis. Investigative definition updated.
06/06/2016: Policy number A.2.02.22 added.
06/23/2016: Policy description updated. Policy statement unchanged.
06/06/2017: Policy reviewed; no changes.
06/01/2018: Policy description updated regarding outcome measures in the treatment of heart failure. Policy statement unchanged.
06/01/2019: Policy reviewed; no changes.
06/12/2020: Policy description updated regarding devices. Policy statement unchanged.
08/24/2021: Policy description updated regarding devices. Policy statement unchanged.
12/16/2021: Code Reference section updated to add new CPT code 0692T, effective 01/01/2022.
11/16/2022: Policy updated to change the medical policy number from A.2.02.22 to L.2.02.407.
07/26/2023: Policy reviewed; no changes.
06/25/2024: Policy reviewed; no changes.
Blue Cross Blue Shield Association Policy # 2.02.22
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description | ||
CPT-4 | |||
0692T | Therapeutic ultrafiltration | ||
HCPCS | |||
ICD-9 Procedure | ICD-10 Procedure | ||
99.78 | Aquapheresis | 6A550Z3, 6A551Z3 | Pheresis of plasma |
ICD-9 Diagnosis | ICD-10 Diagnosis |
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.