Clinical and Billing Review of Extracorporeal Membrane

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Topics in Practice Management
]
Clinical and Billing Review of Extracorporeal
Membrane Oxygenation
James M. Blum, MD; William R. Lynch, MD; and Craig M. Coopersmith, MD
Extracorporeal membrane oxygenation (ECMO) is a temporary technique for providing life
support for cardiac dysfunction, pulmonary dysfunction, or both. The two forms of ECMO,
veno-arterial (VA) and veno-venous (VV), are used to support cardiopulmonary and pulmonary dysfunction, respectively. Historically, ECMO was predominantly used in the neonatal
and pediatric populations, as early adult studies failed to improve outcomes. ECMO has
become far more common in the adult population because of positive results in published
case series and clinical trials during the 2009 influenza A(H1N1) pandemic in 2009 to 2010.
Advances in technology that make the technique much easier to implement likely fueled the
renewed interest. Although exact criteria for ECMO are not available, patients who are good
candidates are generally considered to be relatively young and suffering from acute illness
that is believed to be reversible or organ dysfunction that is otherwise treatable. With the
increase in the use in the adult population, a number of different codes have been generated to better identify the method of support with distinctly different relative value units
assigned to each code from a very simple prior coding scheme. To effectively be reimbursed
for use of the technique, it is imperative that the clinician understands the new coding scheme
and works with payers to determine what is incorporated into each specific code.
CHEST 2015; 147(6):1697-1703
A(H1N1) 5 2009 influenza A(H1N1); CESAR 5 Conventional Ventilation or ECMO
for Severe Adult Respiratory Failure; CPT 5 current procedural terminology; ECMO 5 extracorporeal
membrane oxygenation; ELSO 5 Extracorporeal Life Support Organization; VA 5 veno-arterial;
VV 5 veno-venous
ABBREVIATIONS:
Extracorporeal membrane oxygenation
(ECMO) is a temporary technique for providing life support for cardiac dysfunction, pulmonary dysfunction, or both until the native
organ(s) recover or other definitive therapy is
implemented. Although the technique has
existed since the 1970s, early failures in randomized clinical trials in adults resulted in
a limited number of centers supporting
the technology in patients over the age of
Manuscript received November 25, 2014; revision accepted February 7,
2015; originally published Online First March 19, 2015.
AFFILIATIONS: From the Department of Anesthesiology (Dr Blum)
and the Department of Surgery (Dr Coopersmith), Emory Critical Care
Center, Emory University, Atlanta, GA; and the Section of Thoracic
Surgery (Dr Lynch), Department of Surgery, University of Michigan,
Ann Arbor, MI.
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18 years.1 Over the past 5 years, there has been
a dramatic increase in the number of ECMO
cases in the adult population motivated by
improved technologies and demonstration of
improved outcomes in select populations.2-4
This article reviews the current indications
for ECMO therapy in the adult population
and the evidence supporting its use. Furthermore, 2015 updates to the coding and reimbursement for the therapy are discussed.
James M. Blum, MD, Emory University
Hospital, 1364 Clifton Rd NE, Atlanta, GA 30322; e-mail: jmblum@
emory.edu
© 2015 AMERICAN COLLEGE OF CHEST PHYSICIANS. Reproduction of
this article is prohibited without written permission from the American
College of Chest Physicians. See online for more details.
DOI: 10.1378/chest.14-2954
CORRESPONDENCE TO:
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For decades, severe respiratory and cardiac failure have
been associated with heroic efforts, high costs, and frequent mortality. For the most severe cases of ARDS and
acute heart failure, mortality can approach or exceed
50%, respectively.5-8 Although mortality rarely occurs
because of the primary insult, patients will frequently
develop shock and multisystem organ dysfunction and
ultimately die of withdrawal of support in what is perceived to be a futile state. The thought of providing temporary extracorporeal support to allow stabilization of
other end organs and allow definitive treatment of the
primary organ has been available at a few specialized
centers for decades.9-12 However, with the development
of many new technologies, the use of extracorporeal
support has continued to increase.2 What was once
believed to be a rare salvage therapy is now rapidly
becoming a commonly considered, potentially effective
option in high-mortality situations.13,14
ECMO is, in essence, cardiopulmonary bypass that has
been optimized for weeks rather than hours of operation. A typical circuit (Fig 1) has a venous inflow that
draws blood from the patient’s venous circulation into
a pump, pushes that blood through an artificial lung
(oxygenator), and returns the oxygenated blood to the
patient’s venous circulation (veno-venous [VV] ECMO)
for circulation to the lungs or the patient’s arterial circulation (veno-arterial [VA] ECMO) for cardiopulmonary
support. In the adult patient, VV ECMO support is
achieved through cannulae in either the internal jugular
and femoral vein or using newer dual-lumen internal
jugular cannulae (Fig 2). For VA support, there are a
multitude of cannulation options. Typically, percutaneous adult support is achieved via the femoral artery
and vein. Central cannulation is used after failure to
wean from cardiopulmonary bypass or when sufficient
flow cannot be obtained from peripheral cannulation.
Over the past decade, multiple technological innovations, including centrifugal pumps and polymethylpentene oxygenators, have made it easier and safer to
implement the technology. There are also a variety of
pump-based technologies designed to temporarily support left-sided heart failure exclusively that are useful,
but their discussion is beyond the scope of this article.15
Adult ECMO
The use of adult ECMO has continued to expand for
both cardiac and respiratory failure. There has been
explosive growth in the use of adult ECMO for respiratory failure likely due to the results of studies and experience from the 2009 influenza A(H1N1) (A[H1N1])
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pandemic. According to the Extracorporeal Life Support
Organization (ELSO) registry reports from 2004 and 2012,
the number of adult ECMO cases has dramatically
expanded from around 150 reported runs in 2003 to
just under 1,000 reported runs in 2011.2,9 From recent
reports, it appears there has been continued acceleration
of ECMO use in the adult population.
Respiratory Support
The original randomized trial of ECMO for respiratory
support was published in 1979 by Zapol et al.1 The trial,
conducted at nine centers, involved patients with
extremely severe ARDS randomized to either contemporary ventilator management or VA ECMO. Mortality
in both groups exceeded 90%. Supporters of ECMO
therapy are quick to identify fundamental flaws of the
design, including implementation at inexperienced
centers, the use of VA instead of VV ECMO for respiratory failure, the time until initiation of therapy (. 9 days)
allowing continued lung injury, and a very high level of
anticoagulation and subsequent bleeding.
In the neonatal population, ECMO therapy has been
considered a standard of care because of the results of
several randomized controlled trials.16-19 However, adult
data remained lacking. Since the Zapol trial, there have
been a variety of case series and nonrandomized trials
published on the adult population but nothing with the
certainty of the neonatal literature. The frequently cited
series by Hemmila et al20 from the University of Michigan
detailed the experienced of treating 255 patients with
Pao2/Fio2 ratios , 100 and expected mortality of . 80%
at the time. The series reported a survival of 52%. There
were also multiple case reports and several series detailing successful treatment of patients with specific conditions, including pulmonary embolism and pulmonary
contusion.21-26
After decades of disagreement on the actual efficacy of
ECMO, the results of the Conventional Ventilation or
ECMO for Severe Adult Respiratory Failure (CESAR)
trial were published in 2009.4 In this randomized trial,
patients were treated using conventional mechanical
ventilation at one of many large hospitals in the United
Kingdom or were transported to Glenfield Hospital in
Leicester, England. Death or disability in the group
transferred was 37% at 6 months vs 53% in the control
group (P 5 .03). There was considerable controversy
surrounding what on the surface appears to be a definitive result. Concerns surrounding the lack of a standardized ventilator and management protocol for
patients in the control group and the fact the analyses
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147#6 CHEST JUNE 2015
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Figure 1 – A, B, Diagrammatic
representation of veno-venous
(A) and veno-arterial (B) extracorporeal membrane oxygenation.
(Image courtesy of MAQUET
Cardiopulmonary AG.)
were intention to treat and one-fourth of patients randomized to ECMO did not receive the therapy because
of improvement are most commonly cited. Many consider the CESAR trial not to be a trial of ECMO but a
trial of transfer of patients to a high-volume ARDS
referral center that has ECMO capability.
Around the same time CESAR was published, the initial ECMO experience from the A(H1N1) pandemic
was released. The first major manuscript was from The
Australia and New Zealand Extracorporeal Membrane
Oxygenation (ANZ ECMO) Influenza Investigators.27
Here, the authors compared 68 patients who received
ECMO for confirmed or suspected A(H1N1) vs 133 who
did not. Survival to discharge in the conventional
therapy group was 87%. The patients who received
ECMO were younger and had fewer comorbidities but
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were remarkably more ill, with 57% requiring vasopressors at ICU admission compared with 34% in the conventional therapy group and an average Pao2/Fio2 ratio
of 56 on 18 cm H2O of partial end-expiratory pressure.
Overall survival for this group was 75%.
Similar experiences for confirmed or suspected A(H1N1)
to the ANZ ECMO group were reported by investigators in Great Britain.3 Using sophisticated matching
techniques, they demonstrated a survival benefit for
80 patients referred for ECMO vs 195 patients not
referred for ECMO. In contrast, the REVA Research
Network in France reported their experience as well
for 123 patients with influenza A (probable H1N1)
receiving ECMO.28 After matching, they demonstrated
no benefit to ECMO vs conventional treatment, but
their matching algorithm left 51 patients unmatched
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Cardiac Support
There are generally three indications for adult
VA ECMO therapy: (1) inability to wean from cardiopulmonary bypass; (2) hypoxic, biventricular, or
right-sided cardiac failure; and (3) extracorporeal
cardiopulmonary resuscitation. Of note, the use of
ECMO for isolated left-sided heart failure is an option,
but other forms of temporary mechanical circulatory
support are potentially better options that require less
anticoagulation and/or supervision.15 Despite the
increasing number of options, the number of adult
VA ECMO cases continues to increase. The reasons for
this are probably multifactorial, including acquisition
of equipment and ease of use at facilities that previously
did not have the technology.
Figure 2 – Image of the AVALON ELITE Bi-Caval Dual Lumen Cannula. (Image courtesy of MAQUET Cardiopulmonary AG.)
who were younger with lower Pao2/Fio2 ratios with a
high rate of survival.
Although the actual benefit of ECMO therapy for respiratory failure continues to be debated in the adult population, one item that is universally agreed upon is the desire
to have meaningful recovery. Criteria tend to vary slightly
from center to center, but in general many now use the
criteria for enrollment into the CESAR trial to be the
base criteria for initiation of ECMO therapy (Table 1).4
The guiding principle is that patients not have too much
time, typically between 5 and 10 days, on the ventilator
prior to cannulation minimizing additional ventilatorinduced lung injury and that their disease state be potentially reversible. As such, patients of advanced age, with
significant comorbidities and/or other terminal illness
are usually excluded from consideration for therapy.
TABLE 1
] Criteria Used in the CESAR Trial
Criteria for CESAR
Measure
Enrollment criteria
Age
18-65 y old
Murray score or uncompensated
hypercapnia
ⱖ 3 or pH , 7.20
Reversible disease process
Opinion of 1 of 3
ECMO consultants
Exclusion criteria
High pressure (peak . 30 cm H2O) . 7 d
or high FIO2 (. 0.80)
Intracranial bleeding
...
Contraindication to heparinization
...
CESAR 5 Conventional Ventilation or ECMO for Severe Adult Respiratory
Failure; ECMO 5 extracorporeal membrane oxygenation.
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Data supporting the use of ECMO for VA support are
sparse. Although there exist some data to suggest that
certain patients will expire without extracorporeal
support, such as the intraaortic balloon pump score,
predictors of survival after VA ECMO in the adult population are lacking.29 Overall survival for adult VA support from the 2014 ELSO registry is 40% and from
extracorporeal cardiopulmonary resuscitation, 29%.
Although the number of ECMO centers has continued
to expand over the past 5 years, there are data to suggest
that high-volume centers have superior outcomes. Data
presented at the 2014 ELSO conference suggest that
centers performing more than 30 cases/y were consistently associated with better survival. This is likely
because of the sophisticated nature of the technology
requiring numerous team members to execute highly
specialized tasks. Protocolized management of patients
is probably of benefit in addition to having emergency
procedures in place. Some high-volume centers have
transport programs to receive patients who have been
placed on support with the plan for referral. Survival in
this situation is around 60%.12
Practice Management
The existing current procedural terminology (CPT)
codes and relative value units have been heavily revised
for 2015 and reflect the increased use of ECMO in the
adult population. Prior CPT codes 36822 (cannulation
for ECMO), 33960 (first day of management for prolonged
ECMO), and 33961 (subsequent day management) have
been replaced with a complex set of codes that much
better define the care provided. The new codes for adult
management and cannulation are shown in Table 2.30
The most important changes in the codes include
differentiation in the form of support being provided,
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TABLE 2
] HCPCS Codes, Definitions, and RVUs for 2015 Related to Adult ECMO30
HCPCS Code
Long Descriptor
2015
Work RVUs
33946
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; initiation, veno-venous
6
33947
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; initiation, veno-arterial
6.63
33948
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; daily management, each day, veno-venous
4.73
33949
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; daily management, each day, venoarterial
4.6
33952
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; insertion of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 y and
older (includes fluoroscopic guidance, when performed)
8.15
33954
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; insertion of peripheral (arterial and/or venous) cannula(e), open, 6 y and older
9.11
33956
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; insertion of central cannula(e) by sternotomy or thoracotomy, 6 y and older
33958
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, 6 y and
older (includes fluoroscopic guidance, when performed)
3.51
33962
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided
by physician; reposition peripheral (arterial and/or venous) cannula(e), open, 6 y and older
(includes fluoroscopic guidance, when performed)
4.47
33964
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided
by physician; reposition central cannula(e) by sternotomy or thoracotomy, 6 y and older
(includes fluoroscopic guidance, when performed)
9.5
33966
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; removal of peripheral (arterial and/or venous) cannula(e), percutaneous, 6 y and
older
4.5
33984
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; removal of peripheral (arterial and/or venous) cannula(e), open, 6 y and older
5.46
33986
Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by
physician; removal of central cannula(e) by sternotomy or thoracotomy, 6 y and older
33987
Arterial exposure with creation of graft conduit (eg, chimney graft) to facilitate arterial
perfusion for ECMO/ECLS (list separately in addition to code for primary procedure)
33988
Insertion of left heart vent by thoracic incision (eg, sternotomy, thoracotomy) for ECMO/ECLS
33989
Removal of left heart vent by thoracic incision (eg, sternotomy, thoracotomy) for ECMO/ECLS
16
10
4.04
15
9.5
HCPCS 5 Healthcare Common Procedure Coding System; RVU 5 relative value unit.
VV or VA. Initiation and daily management of VV support is recorded with codes 33946 and 33948, respectively. VA support initiation and daily management
are identified with codes 33947 and 33949. Additional
changes in the codes help to better identify cannulation
techniques and the age of the patient. Codes 33951 to
33956 help identify percutaneous cannulation, open,
and central techniques in addition to the age of patients.
For the adult population, codes 33952 (percutaneous
cannulation for ages ⱖ 6 years), 33954 (open cannulation for ages ⱖ 6 years), and 33956 (central cannulation
for ages ⱖ 6 years) will be most commonly used.
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There are also new codes to support repositioning of
cannulae (33958, percutaneous; 33962, open; and 33964,
central; for ages ⱖ 6 years), which are to only be used on
days after initial cannulae placement. New codes for
decannulation have also been provided (33966, percutaneous; 33984, open; and 33986, central; for ages ⱖ 6 years).
Finally, there have been new codes submitted for leftsided heart vent placement (33988) and removal (33989)
when placed through sternotomy or thoracotomy.
Although the new codes better define service, they also
are designed to offer better clarity on what is being covered. Prior codes, depending on the state, may have
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incorporated critical care time as part of the management of ECMO. It is the intention of the new codes that
all additional services will be billed separately. Each
code has been assigned a zero-day global period. Critical
care time or other appropriate evaluation and management services should be billed separately provided there
is no time overlap and should be accompanied by the
-25 modifier. During the first 24 h of support, daily
management and repositioning of the cannulae should
not be charged, as they are considered part of the initiation and cannulation codes.
Payer Coverage
Individual payers may determine when ECMO is an
appropriate therapy. Centers for Medicare & Medicaid
Services provide coverage for ECMO in the adult population; however, certain payers may decide ECMO
therapy is only supported where there is clinical evidence it improves outcomes. Other payers may consider ECMO to be experimental and not eligible for
reimbursement. Hence, one should attempt to clarify
a payer’s ECMO policy and adhere to their coverage
guidelines. With the issuance of the new CPT codes, it
is important for payers to update their policies with the
new codes. Many policies by payers are limited in scope
and/or have not been updated for considerable periods
of time. For example, Blue Cross Blue Shield policy
in Montana greatly differs in scope from the policy in
Texas, and neither has been updated with new codes.31,32
If a payer has no policy or a policy that has not been
updated, a conversation with the payer should be documented with the participants in the conversation, date,
and time. Each question asked should be documented
along with the payer’s representative’s response. This
document should be retained on file.
Documentation
It is preferable to consent patients or their surrogate(s)
for ECMO prior to initiation of therapy unless emergent
circumstances prohibit such interaction. Discussion
should include a realistic assessment of ultimate outcome.
Patients’ decision-makers should be aware of complications, including bleeding, infection, machine failure,
and stroke (both hemorrhagic and embolic). The consent should also list conventional therapy as an option
that was declined.
With the new codes, cannulation and initiation of
therapy are best documented in separate notes and may
be billed by different providers. On a daily basis, a separate ECMO note should be created documenting the
management of ECMO. Other critical care assessments
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and plans should be documented in a separate critical
care note.
Conclusions
There has been continued growth of ECMO for both
respiratory and cardiopulmonary support in the adult
population. Although evidence continues to expand
supporting the efficacy of ECMO, it continues to be seen
by some as a salvage therapy. It is important for providers
to understand the management and have institutional
support to provide therapy or consider transfer of patients
receiving ECMO to centers prepared to provide such
care. Prior to initiation of therapy, a realistic discussion
of outcome and risks should be documented. The new
ECMO codes provide greater clarity in the services provided, and clear documentation and coding is required
to receive appropriate reimbursement for therapy.
Acknowledgments
Financial/nonfinancial disclosures: The authors have reported to
CHEST that no potential conflicts of interest exist with any companies/
organizations whose products or services may be discussed in this
article.
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