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Ultrafiltration is a technique being evaluated for removal of excess fluid from patients with volume overload and heart failure. Ultrafiltration removes fluid from the blood by using pressure differentials with dialysis equipment or similar filtration devices.
Heart failure is a relatively common problem and frequently results in hospitalizations and readmissions. Various approaches are being explored in treating this condition, especially when it is refractory (unresponsive) to conventional therapy. Ultrafiltration is one technique receiving increasing notice for a possible role in hospitalized patients with marked volume overload from heart failure. Ultrafiltration is a process utilized to remove fluid from the blood by using pressure differentials during treatment with a dialysis machine or similar filtration device.
Proponents of this technique suggest that it may offer the potential for greater and more expeditious volume and sodium removal compared with conventional therapies. Ultrafiltration is generally used for those with decompensated heart failure whose fluid overload is unresponsive to medical management. In recent studies, this technique is also referred to as aquapheresis. Work is also beginning on newer devices that allow for continuous ultrafiltration in ambulatory patients.
In June 2002, the Aquadex™ FlexFlow™ System (CHF Solutions, Brooklyn Park, MN) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. An updated/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.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
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.