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Ultrafiltration is a technique 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 is a relatively common condition that frequently results in hospitalizations and readmissions. Various treatment approaches are being explored, especially when the condition is refractory (unresponsive) to conventional therapy. Ultrafiltration (sometimes called 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. In recent studies, this technique is also referred to as aquapheresis. Newer devices that allow continuous ultrafiltration in ambulatory patients are under investigation to reduce volume overload.
In June 2002, the Aquadex FlexFlow™ System (Baxter, Deerfield, IL) 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 September 2007 following modifications. FDA determined that this device was substantially equivalent to existing devices for use in temporary (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.
POLICYThe use of ultrafiltration is considered investigational in patients with heart failure.
POLICY EXCEPTIONSFederal 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.
POLICY HISTORY12/13/2006: 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 added.
06/23/2016: Policy description updated. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.02.22
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.