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DESCRIPTIONCongestive heart failure is a relatively common problem and frequently results in hospitalizations and readmissions. Various approaches are being explored in treating these patients, especially those who are refractory (unresponsive) to conventional therapy. Ultrafiltration is one technique receiving increasing publicity for a possible role in hospitalized patients with marked volume overload from congestive heart failure. Ultrafiltration is a process 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 some recent studies, this technique is also referred to as aquapheresis. Work is also beginning on newer devices which could allow for continuous ultrafiltration in ambulatory patients.
For example, researchers at UCLA have reported on use of a continuous device in animals. They built and tested in vivo a wearable belt that can provide continuous ultrafiltration, 24 hours a day and 7 days a week. The device consists of a hollow-fiber filter, a 9-volt battery-operated pulsatile blood pump, a micro pump for heparin infusion, and another micro pump to control ultrafiltration rate. In their study, nine pigs underwent ureteral ligation and subsequently were allowed fluids ad lib, producing fluid overload. The next day, ultrafiltration was performed for 8 hours. Fluid removal rate averaged 106 ml/h and salt removed was 7.6 g. The authors speculate that this device could have an important economic impact in reducing hospital admissions and length of stay, intensive care unit utilization, and drug consumption in those with heart failure.
One device for ultrafiltration is the Aquadex™ FlexFlow™ system. Aquapheresis™ is the trademarked term for removal of salt and water with the Aquadex system. The Aquadex FlexFlow technology received initial 510(k) marketing clearance from the FDA in June 2002. An updated/amended 510(k) approval (classified as a high permeability dialysis system) was given in February 2006 following some modifications. That Aquadex FlexFlow System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patient 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.
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.