CurrentAetnaPolicy 0741

Peripheral Ultrafiltration for Acute Decompensated Heart Failure

This policy governs Aetna's coverage stance for peripheral ultrafiltration as a treatment for hospitalized patients with acute decompensated congestive heart failure (ADHF), including indications considered medically necessary and uses considered experimental/investigational.

Policy Summary

PayerAetna

PolicyPeripheral Ultrafiltration for Acute Decompensated Heart Failure

Policy CodePolicy 0741

Change TypeNo material change

Effective DateNov 20, 2007

Next Review DateAug 8, 2024

Key ActionObtain prior authorization and document inpatient ADHF with confirmed diuretic resistance before requesting peripheral ultrafiltration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

inpatientsetting for medical necessity

diuretic resistancerequired condition

200key trial size

188trial showing harm

510(k)device status

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Experimental and investigational uses

Not covered / considered experimental

Experimental/investigational scenarios: Intermittent peripheral ultrafiltration in persons who are not acutely decompensated; scheduled repetitive peripheral ultrafiltration; peripheral ultrafiltration for all other indications due to insufficient evidence of effectiveness; and peritoneal ultrafiltration as an adjunctive therapy in end-stage heart failure.

These uses are considered experimental/investigational per policy

Coverage criteria and evidence synthesis

Coverage considerations based on the evidence summarized in the policy:

Primary considerations: Ultrafiltration should be considered only for patients with ADHF and clinically confirmed diuretic resistance or persistent congestion despite optimal pharmacologic therapy; it should not be used as a substitute for appropriately prescribed and administered diuretic therapy.

Supported by guideline statements and expert reviews

Evidence of short-term efficacy: Randomized trials and meta-analyses report greater 48-hour weight loss and fluid removal with ultrafiltration compared with intravenous diuretics (examples: WMD ~1.77 kg weight or ~1.2 L fluid at 48 hours in pooled analyses).48 hours

Multiple systematic reviews/meta-analyses report statistically significant greater fluid/weight removal at 48 hours (De Vecchis 2014; Ebrahim 2015)

Renal function and safety considerations: Some randomized data (Bart et al, 2012) showed worse creatinine changes and higher serious adverse events with ultrafiltration versus stepped pharmacologic therapy; other meta-analyses report no significant difference in creatinine change or mortality — interpret heterogenous results with caution.96 hours and 48 hours endpoints reported

Heterogeneous trial results; UF may increase risk of worsening renal function in selected trials

Peritoneal ultrafiltration context: Peritoneal ultrafiltration has been reported in small, nonrandomized series to improve symptoms, LVEF in HFrEF, NYHA class, reduce hospitalizations and body weight in diuretic-resistant or end-stage HF, but evidence is limited and requires larger controlled studies.

Evidence from small nonrandomized studies; effectiveness not established

Aetna considers the following uses experimental and investigational and not covered due to insufficient evidence: intermittent peripheral ultrafiltration (UF) in persons who are not acutely decompensated, scheduled repetitive peripheral UF, peripheral UF for other indications, and peritoneal ultrafiltration as adjunctive therapy in end-stage heart failure. These exclusions apply unless the specific medical necessity criteria for inpatient ADHF with diuretic resistance are met.

Ultrafiltration should not be used as a substitute for appropriately prescribed and administered diuretic therapy or as a quicker mechanical diuresis for inadequately managed diuretics. Instead, UF should be reserved for selected patients with advanced heart failure and true diuretic resistance and not employed in place of optimizing guideline-directed diuretic therapy.

Randomized trial data indicate that UF may be inferior to a stepped pharmacologic strategy in certain populations. In a randomized trial of 188 hospitalized patients with ADHF, worsened renal function, and persistent congestion (Bart et al, 2012), ultrafiltration was inferior to stepped pharmacologic therapy for the primary bivariate endpoint (change in serum creatinine and body weight at 96 hours), driven largely by an increase in creatinine and a higher rate of serious adverse events in the UF arm. Technology assessments have also raised concerns about study limitations and the need for replication of positive findings before routine adoption.

Clinical guideline and evidence syntheses do not support routine use of ultrafiltration for all patients with acute heart failure. The NICE guideline states: “Do not routinely offer ultrafiltration to people with acute heart failure. Consider ultrafiltration for people with confirmed diuretic resistance.” Systematic reviews and meta-analyses report greater short-term fluid and weight removal with isolated UF versus intravenous diuretics at 48 hours, but heterogeneity in trials and safety signals in some randomized studies mean routine UF for unselected ADHF patients is not supported by the evidence.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Expected

Prior authorization is expected when peripheral ultrafiltration (UF) is billed for acute decompensated heart failure (ADHF) with confirmed diuretic resistance. Providers should obtain prior authorization before performing UF in these situations.

Prior authorization expected for UF in diuretic-resistant ADHF

Note

NICE Recommendation

Do not routinely offer ultrafiltration for acute heart failure. Consider UF only for people with confirmed diuretic resistance (defined as dose escalation beyond a person's previously recognized dose ceiling or a dose approaching the maximum recommended daily dose without incremental improvement in diuresis).

NICE: do not routinely offer ultrafiltration; consider only for confirmed diuretic resistance

Documentation Required

Documentation to Support Medical Necessity

Document inpatient hospitalization for acutely decompensated congestive heart failure with dyspnea at rest or with minimal activity, and provide objective documentation of diuretic resistance (trial and failure of escalating diuretic therapy as defined above). Include prior diuretic dosing, evidence of dose escalation to near-maximum or beyond previously effective dose without increased diuresis, and clinical indicators supporting need for UF.

Inpatient hospitalization with dyspnea at rest or minimal activity
Documentation of diuretic resistance (dose escalation to near-max or beyond prior ceiling without improved diuresis)
Clinical notes, diuretic dosing history, weight/fluid status, and renal function trends

Step Therapy

Requirement to Attempt Diuretics First

Before considering UF, attempt and document appropriate diuretic therapy and demonstrate diuretic resistance. A trial and failure of diuretic therapy is required — UF is reserved for patients with confirmed diuretic resistance.

Requirement to attempt diuretics first; document dosing and response
Diuretic resistance definition must be met prior to UF

Note

Evidence and Expert Opinion

Evidence and expert opinion recommend reserving UF for selected patients with advanced heart failure and true diuretic resistance, not for routine use. UF should be part of a comprehensive strategy for control of fluid retention rather than a substitute for inadequately prescribed diuretics.

Reserve UF for selected advanced HF patients with true diuretic resistance
UF is not a routine substitute for appropriately managed diuretic therapy

Note

Peritoneal Ultrafiltration Study Outcomes

Studies of peritoneal ultrafiltration (pUF) report outcomes including survival, NYHA class, LVEF, C-reactive protein, body weight, and hospitalization frequency/duration. Although many case series and observational studies report symptomatic and hospitalization benefits, randomized data are limited and peritoneal ultrafiltration is considered experimental as an adjunctive therapy in end-stage heart failure.

Reported outcomes: survival, NYHA class, LVEF, CRP, body weight, hospitalization frequency/duration
Evidence limited: many nonrandomized studies; insufficient data to establish effectiveness as adjunctive therapy

Definitions

ADHF (acute decompensated heart failure) — definition and key features

DefinitionAcute decompensated heart failure (ADHF) is an acute change in baseline NYHA status to severe symptoms (often to NYHA Class IV) with signs of volume overload such as pitting edema, pulmonary rales, elevated filling pressures, and weight gain.

Key clinical featuresDyspnea at rest or with minimal activity (required for medical necessity), pitting edema, pulmonary rales, elevated filling pressures, and recent weight gain.

Diagnostic supportBNP > 80 pg/ml supports the diagnosis of decompensation.

SettingPolicy applies to inpatient hospitalized patients with acutely decompensated CHF.

Diuretic resistance — policy definition

DefinitionFailure to achieve incremental diuresis despite escalation of diuretic dose beyond a person's previously recognized dose ceiling or approaching the maximum recommended daily dose without incremental improvement in diuresis.

Clinical implicationTrial and failure of diuretic therapy is required before considering ultrafiltration as medically necessary.

DocumentationMedical records should document dose escalation beyond prior ceiling or near-maximum dosing without increased diuresis to support diuretic resistance.

Aquadex FlexFlow / Aquapheresis — regulatory status and intended use

DeviceAquadex FlexFlow system (Aquapheresis)

Regulatory statusReceived initial FDA 510(k) clearance in June 2002; updated/amended 510(k) clearance in February 2006 (classified as a high permeability dialysis system).

Intended use/indicationIndicated for temporary (up to 8 hours) ultrafiltration for patients with fluid overload who have failed diuretic therapy, and for extended (>8 hours) ultrafiltration in hospitalized patients with fluid overload who have failed diuretic therapy.

Diuretic resistance (NICE definition)

NICE definition (diuretic resistance)Dose escalation beyond a person's previously recognized dose ceiling or a dose approaching the maximum recommended daily dose without incremental improvement in diuresis.

Policy alignmentNICE recommends considering ultrafiltration only for people with confirmed diuretic resistance and not routinely offering UF for acute heart failure.

Implication for practiceDose escalation to prior ceiling or near-maximum should be documented before UF is considered; this definition underpins coverage restrictions in the policy.

I50.20 - I50.9	Congestive heart failure
I50.84	End stage heart failure (listed as ICD-10 not covered for indications in the CPB)

OpenPayer

Peripheral Ultrafiltration for Acute Decompensated Heart Failure

Coverage Criteria for Peripheral Ultrafiltration

Coding and Condition Thresholds

Provider Actions, Prior Authorization, and Documentation

Background and Evidence Context

Definitions