Extracorporeal Membrane Oxygenation* Current Clinical Practice, Coding, and Reimbursement

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1 CHEST Topics in Practice Management Extracorporeal Membrane Oxygenation* Current Clinical Practice, Coding, and Reimbursement Douglas J. E. Schuerer, MD; Nikoleta S. Kolovos, MD; Kayla V. Boyd, BA; and Craig M. Coopersmith, MD Extracorporeal membrane oxygenation (ECMO) is a technique for providing life support for patients experiencing both pulmonary and cardiac failure by maintaining oxygenation and perfusion until native organ function is restored. ECMO is used routinely at many specialized hospitals for infants and less commonly for children with respiratory or cardiac failure from a variety of causes. Its usage is more controversial in adults, but select medical centers have reported favorable findings in patients with ARDS and other causes of severe pulmonary failure. ECMO is also rarely used as a rescue therapy in a small subset of adult patients with cardiac failure. This article will review the current uses and techniques of ECMO in the critical care setting as well as the evidence supporting its usage. In addition, current practice management related to coding and reimbursement for this intensive therapy will be discussed. (CHEST 2008; 134: ) Key words: ARDS; cardiac failure; extracorporeal life support; extracorporeal membrane oxygenation; practice management; respiratory failure Abbreviations: CPT current procedural terminology; ECMO extracorporeal membrane oxygenation; Fio 2 fraction of inspired oxygen; VA venoarterial; VV venovenous Critical illness with severe pulmonary or cardiac failure is associated with high mortality. Advances in lung-protective strategies and cardiac assist devices 1,2 have helped to improve survival for patients with lung or heart failure. However, even if evidenced-based best practices are followed, mortality rates can still be as high as 30 to 40% for patients with ARDS and 50% for patients with cardiac failure. In patients who do not respond to traditional treatment *From the Departments of Surgery (Drs. Schuerer and Coopersmith, and Ms. Boyd) and Pediatrics (Dr. Kolovos), Washington University School of Medicine, St. Louis, MO. The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article. Manuscript received October 10, 2007; revision accepted March 26, Reproduction of this article is prohibited without written permission from the American College of Chest Physicians ( org/misc/reprints.shtml). Correspondence to: Craig M. Coopersmith, MD, Washington University School of Medicine, 660 South Euclid Ave, Campus Box 8109, St. Louis, MO 63110; coopersmithc@wustl.edu DOI: /chest algorithms, few options exist for rescue therapy. Extracorporeal membrane oxygenation (ECMO) is an intensive treatment that is currently used in many specialized centers to support patients with respiratory or cardiac failure who are unresponsive to conventional therapeutic interventions. By removing blood from the patient and circulating it through an artificial lung with a pump, ECMO (also known as extracorporeal life support) can provide pulmonary and cardiac support, depending on the cannula arrangement. Despite its highly specialized nature, data from 145 centers in the world have been collected regarding its usage. To date, 24,000 neonates, 7,000 children, and 2,000 adults have been treated with ECMO. 3 This coincides with strong randomized data supporting ECMO usage in some areas such as neonatal respiratory failure, but more equivocal data support its usage in adults with diseases such as ARDS. This review will outline the potential indications for ECMO usage in patients of all age groups, focusing on the medical evidence to evaluate its efficacy. Additionally, practice manage- CHEST / 134 / 1/ JULY,

2 ment information regarding coding and reimbursement for this intensive therapy is discussed. ECMO in Children Neonatal Respiratory Failure Bartlett and colleagues 4 reported the first case series of 28 patients (14 children, 14 adults) who were treated with ECMO in Although only 5 of 28 patients were long-term survivors, the early successes in near-moribund patients led to the first randomized trials of ECMO therapy for respiratory failure in neonates. The first of these trials used a nontraditional play-the-winner randomization technique, where the chance of assigning an infant to a treatment was influenced by the outcome of previous patients in the study. 5 All 11 high-risk patients who were treated with ECMO survived (although 1 patient had a cerebral hemorrhage), while the single patient who received conventional therapy died. In a different trial, 9 of 9 babies with pulmonary hypertension and severe respiratory failure who were randomized to undergo ECMO survived, while 4 of 10 babies who were randomized to receive conventional therapy died. 6 Following this, the next 20 babies were all treated with ECMO, of whom 19 survived. Given the concerns over the randomization process in these two trials, another randomized, controlled trial 7 was completed in 1996 involving 185 neonates with respiratory failure. The mortality rate decreased from 59 to 32% with the usage of ECMO. Subsequently, ECMO has been commonly used in neonatal ICUs for the treatment of respiratory failure due to primary pulmonary hypertension of the newborn, meconium aspiration syndrome, persistent fetal circulation, congenital diaphragmatic hernia, and other reversible lung diseases, yielding survival rates of 80% for all neonates, except those with congenital diaphragmatic hernia, with proven costeffectiveness Therapies such as the jet ventilator, 11 surfactant, 12 and nitric oxide 13 have begun to limit the need for ECMO, decreasing its usage from a high of 1,516 cases in 1992 to 751 cases in Nonetheless, refractory patients still exist, and ECMO continues to be a viable therapy for refractory neonatal pulmonary failure. Pediatric Respiratory Failure The diagnoses for which pediatric ECMO therapy has been commonly employed include pneumonia, ARDS, and pulmonary hemorrhage. 14,15 The best data supporting its use in children have come from a multicenter, retrospective cohort of 331 patients from 32 hospitals from the Pediatric Critical Care Study Group. 16 The study showed that ECMO, but not high-frequency ventilation, reduced mortality as a result of this disease from 47 to 26%. More recently, Swaniker et al 17 reported a survival rate of 60 to 73% in 128 children, depending on the cause of the respiratory failure. Of note, pediatric ECMO cases increased steadily until leveling off in 1994, which was likely due to improvements in open-lung strategies for the treatment of severe hypoxemic respiratory failure. 14 Cardiac Failure Congenital heart disease remains a significant issue for both neonatal and pediatric intensivists. Surgical correction/palliation has markedly improved outcomes, but some children are too sick to undergo surgical intervention, develop worsening cardiac failure in the postoperative period, or have outgrown the ability of their reconstructed heart to function. Additionally, cardiac failure can result from noncongenital medical conditions such as viral cardiomyopathy. For this diverse group of patients, ECMO is often the only option for short-term cardiac support while waiting for either native heart recovery or as a bridge to transplantation. The survival rate for all diseases requiring cardiac support is 38% for neonatal patients and 43% for pediatric patients. 14 In pediatric patients who have undergone cardiac surgery, survival rates as high as 50% have been achieved by implementing ECMO prior to the occurrence of multiple organ failure. 18,19 As ventricular assist devices are designed for smaller children, there may be less need for ECMO in this population in the future. Adult ECMO Respiratory Failure Today, most current controversy surrounds the use of ECMO in adult patients with respiratory failure. The first randomized trial 20 comparing patients in nine medical centers treated with ECMO or conventional ventilation was published in The survival rate in both groups was 10%, and no significant difference in mortality was observed between patients receiving ECMO or conventional ventilation. ECMO proponents today point out that this study was performed in the early days of the field, using techniques that are not standard today. For instance, venoarterial (VA) access was used in this study, whereas venovenous (VV) access is now the favored cannulation method for treating patients with pure respiratory failure. As well, the level of anticoagulation used was much higher than the current standards. In addition, the mean duration of 180 Topics in Practice Management

3 mechanical ventilation prior to ECMO was 9 days (after ventilator-associated lung injury had already been induced), while the current ECMO criteria typically exclude patients who have received mechanical ventilation for 7 days. A second randomized trial 21 of 40 patients in 1994 looked at extracorporeal carbon dioxide removal instead of true ECMO. It too showed no significant difference in survival rate between groups (with conventional ventilation, 42%; with ECMO, 33%; p 0.8), although the low blood flow associated with this method (1 to 2 L/min) is inadequate to provide meaningful blood oxygenation. Since these negative trial results, there has been a growing body of nonrandomized reports supporting the use of ECMO in adults with severe hypoxic respiratory failure. An example is a review 22 of ECMO usage in 255 adult patients from the University of Michigan from 1989 to These patients nearly all had severe ARDS with a Pao 2 /fraction of inspired oxygen (Fio 2 ) ratio of 100 despite receiving optimal conventional treatment and were thus more ill than those patients reported in other ARDS trials. Despite an expected survival rate of 20%, the actual survival rate of patients treated with ECMO was 52%. 22 Multiple nonrandomized studies 23,24 have also shown that ECMO may rescue patients with massive pulmonary emboli, pressor refractory septic shock, and severe pulmonary contusions that are resistant to conventional ventilation. Since both opponents and proponents of the usage of ECMO in cases of adult respiratory failure can point to studies in the literature to support their viewpoint, there is little consensus on the utility of the therapy in this patient population. To address this, a prospective, randomized trial of 180 patients comparing ECMO to conventional ventilation (the Conventional Ventilation or ECMO for Severe Adult Respiratory Failure [or CESAR] trial) has recently been completed in the United Kingdom. Patients randomized to the ECMO arm of the trial were transferred to a single ECMO center to receive treatment, while patients randomized to conventional ventilation remained in regional treatment hospitals with extensive experience managing severe respiratory failure (although no set protocol was used to manage patients in the control arm). Death or disability in the group randomized to receive ECMO was only 37% at 6 months (regardless of whether they actually received ECMO or not) compared to 53% in patients who were randomized to the control arm (p 0.03). Of note, this was an intention-totreat analysis, and only 68 of 90 patients who were randomized to receive ECMO actually received this Table 1 Criteria for Respiratory ECMO* Pao 2 /Fio 2 ratio, 100 on Fio 2 of 1.0, or P(A-a)O 2 of 600 mm Hg, or Murray lung score of 3.0, 35 or uncompensated hypercapnea with a ph of 7.20 Age 65 yr Receipt of mechanical ventilation for 7d No known contraindication to limited anticoagulation Patients who are not moribund and do not have contraindication to full intensive therapy *P(A-a)O 2 alveolar-arterial gradient. therapy, predominantly due to the improvement of a subset of patients prior to arriving at the ECMO center. 25 For centers performing respiratory ECMO, typical entry criteria are listed in Table 1. 22,26 Although the specifics may vary slightly between centers, eligible patients typically have severe respiratory failure from potentially reversible causes, have not spent too much time receiving mechanical ventilation, and thus ventilator-associated lung injury has not developed. Patients with significant comorbidities and elderly patients are typically excluded due to their decreased chances for meaningful recovery after being weaned from ECMO. Cardiac Failure ECMO has been used for the treatment of adult cardiac failure in patients who are unable to wean from cardiac bypass or who have intractable heart failure that is unable to be treated with a ventricular assist device. 27 To date, 500 adults have undergone ECMO therapy for cardiac failure, with hospital survival rates ranging from 33 to 38%, depending on the disease process responsible 14 ; but, functional outcomes are not known. Given the poor prognosis of the small subset of patients who have undergone ECMO for the treatment of cardiac failure, ECMO may represent a beneficial salvage therapy in these instances. Of note, a potential area where ECMO may be useful is following cardiac arrest when a patient requires cooling postresuscitation. 28 With advances in ventricular support devices, there is likely to be a decline in the already small number of patients who undergo cardiac ECMO. Emergent ECMO (Extracorporeal Cardiopulmonary Resuscitation) ECMO has recently been used 29 as a last means of resuscitation for patients undergoing CPR. Extracorporeal cardiopulmonary resuscitation has recently been demonstrated 30 to be associated with survival rates to hospital discharge of 34 to 38% in pediatric patients. Similar results have been seen in adult CHEST / 134 / 1/ JULY,

4 patients among whom survival rates of 38% have been reported. 14 Although survival rates in patients undergoing extracorporeal cardiopulmonary resuscitation are not as high as for other ECMO uses, they compare favorably to overall survival rates among cardiac arrest patients. Bedside Management ECMO is an intensive therapy with a learning curve in its application, 22 and its practice is best suited to centers where the expertise exists in daily management. For this reason, regionalization is appropriate to ensure that adequate volumes are present at each ECMO center. Given the acuity of care and the risk of sudden decompensation if the circuit fails, special training is mandatory for physicians, nurses, respiratory therapists, and patient care technicians providing care to ECMO patients. Additionally, many centers choose to train perfusion specialists who stay in the hospital when a patient is undergoing ECMO. Once a patient is identified as needing ECMO, the route of cannulation must be determined. VA cannulation (usually via the carotid artery and jugular vein) is used in patients who require cardiac support in addition to respiratory support. In patients with pure respiratory failure, VV cannulation (usually via the femoral vein and internal jugular vein) is preferred. Since there is no arterial cannulation in VV ECMO, this eliminates complications secondary to arterial embolic events. This is significant since strokes represent a leading cause of mortality in adult ECMO patients, occurring in up to 10% of patients receiving VA cannulation. 22 After a patient is placed on ECMO, protective ventilation strategies are used to minimize further ventilator-induced lung injury while the lungs recover. Practice Management Coding and Documentation Current procedural terminology (CPT) codes 31 and relative value units 32 for ECMO cannulation and management are listed in Table 2. Charge and reimbursement for ECMO services will vary based on provider and payer, respectively. CPT code covers ECMO cannulation. This code is the same regardless of whether cannulation occurs via the VA or VV approach and regardless of whether the vasculature is cannulated through the chest, neck, or groin. The code also makes no distinction between open and percutaneous cannulation. There is no specific CPT code for ECMO decannulation. In 1997, CPT Assistant 33 instructed providers to use code (unlisted procedure, vascular surgery) with a copy of the procedure note along with the claim to explain the service performed. However, some payers apply a global period to the cannulation code and consider decannulation to be included in the cannulation payment. It is important to check with each payer regarding their payment policy for decannulation and, if covered, obtain instruction as to how to report the service (ie, code or another CPT code). The first day of ECMO management is covered by code 33960, while subsequent days are covered by code Note that both cannulation and management may be billed independently. While the CPT manual does not explicitly list ECMO management codes as being bundled into other physician services, certain states have ruled that critical care services are bundled into ECMO management services and may not be billed separately. 34 Before billing using critical care codes for a patient undergoing ECMO, it is important to check with the payer regarding their individual policy. If allowable, any service or procedure reported in addition to ECMO should be separate and distinct from ECMO treatment and should be fully documented in the medical record. Payer Coverage Individual payers determine when and whether services are payable and may have specific coverage policies related to ECMO treatment. A payer may (1) limit coverage only to conditions for which there is clinical evidence that ECMO improves outcomes, (2) cover only patients who meet specific treatment criteria, (3) exclude ECMO treatment deemed to be Table 2 CPT Codes and RVUs for ECMO Cannulation and Management Service CPT Code CPT Description Relative Value Units Cannulation Insertion of cannula(s) for prolonged extracorporeal circulation for cardiopulmonary insufficiency (ECMO) 1st day of management Prolonged extracorporeal circulation for cardiopulmonary insufficiency; initial 24 h Each subsequent day management Prolonged extracorporeal circulation for cardiopulmonary insufficiency; each additional 24 h Topics in Practice Management

5 experimental, and (4) establish specific documentation and/or coding instruction for reporting ECMO services. It is therefore important to obtain and adhere to each payer s ECMO coverage policies. If a payer has no written policy, conversations with the payer should be explicitly documented, including the date, the name of the payer s representative, the questions asked, and the representative s responses, and this document should be retained on file. Documentation It is critical for the treating physician to document the initial discussion with the patient s surrogate decision maker of the risks and benefits of starting a patient undergoing ECMO. These discussions must include the nature of the disease process and the fact that ECMO carries significant risks such as bleeding and stroke with (depending on the clinical scenario) uncertain benefits. The physician assessment and management plan should be clearly documented in the patient s medical record daily while a patient is being treated with ECMO. Conclusion ECMO is currently being used in ICUs worldwide for neonatal, pediatric, and adult respiratory and cardiac failure. Evidence to support its use is strongest in the neonatal population, but treatment in the pediatric population is also generally accepted. The usage of ECMO in cases of adult respiratory failure is currently controversial, although the promising results of the Conventional Ventilation or ECMO for Severe Adult Respiratory Failure (or CESAR) trial (which await publication in the peer-reviewed literature), a multicenter, prospective randomized trial comparing ECMO to conventional ventilation in regional hospitals, may lead to wider acceptance. Cardiac ECMO support in patients of all age groups will likely not have randomized trials to support it as a therapy in light of the fact that it is typically used as a salvage therapy. ECMO cannulation and daily management may be billed independently. Documentation and knowledge of payer coverage policies are crucial to receiving appropriate reimbursement for ECMO treatment. ACKNOWLEDGMENT: We thank the Office of Physician Billing Compliance for helpful suggestions and for critical review of this manuscript. References 1 Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000; 342: Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001; 345: Extracorporeal Life Support Organization. ELSO registry page. Available at: htm. 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