Hearing that an Impella® Case didn’t get Reimbursed

August 1, 2016

Q :The CFO at my hospital says that the costs associated with one of the Protected PCI™ cases that I performed were not reimbursed because the patient was discharged as an outpatient.  How can this be?  The patient only stayed one night in the hospital and didn’t meet criteria to be an inpatient.  Why wouldn’t this procedure be reimbursed because they went home sooner?  This is supposed to be a benefit of Protected PCI with the Impella 2.5™ heart pump.

A: Reduction in length of stay is one of the many benefits to Protected PCI with Impella 2.5 procedures.  Impella is listed on the Medicare “Inpatient Only Procedure” list.  All “inpatient only” procedures are excluded from the Medicare Two Midnight Stay Rule, regardless of the time spent in the hospital.  However, a formal “Admit to inpatient” status order is still required, prior to the patient being discharged from the hospital.  Without this order, the patient status remains outpatient.  There is no reimbursement for Impella as an outpatient procedure.   Unfortunately, if this happens, you are not able to update the patient status once the patient is discharged from the hospital and the situation cannot be appealed on the backend of a claim.  A simple solution for this is to write an “admit to inpatient” status order as soon as possible after inserting the Impella device.  Other physicians participating in the care of the patient should not change this inpatient status order prior to discharge.

Many hospitals are now adopting quality efforts to prevent "never events "such as decubitus ulcer's, wrong side surgery and DVT. A medical documentation "never event" for Impella is never keep a patient status as “outpatient or observation”. Always update patient status to “Admit to inpatient” prior to patient discharge.

Should you have additional questions, please email us at reimbursement@abiomed.com.  

Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

Protected PCI

The Impella 2.5® and Impella CP® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Cardiogenic Shock

The Impella 2.5®, Impella CP®, Impella 5.0®, and Impella LD® Catheters, in conjunction with the Automated Impella Controller (collectively, “Impella® System Therapy”), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

Important Risk Information for Impella devices

CONTRAINDICATIONS

The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*

* This condition is a contraindication for the cardiogenic shock indication only.

POTENTIAL ADVERSE EVENTS

Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.

Right-Side Support – Indication & Safety Info.

INDICATIONS FOR USE

The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Important Risk Information for Impella RP

CONTRAINDICATIONS

The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter.

POTENTIAL ADVERSE EVENTS

The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.

General Indication and Safety Information

To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/

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