Device therapy and hospital reimbursement practices across European countries: a heterogeneous scenario

Abstract

As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diag-nosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the 'real world' through a variable spectrum of practices. These may range from the situation where reimburse-ment may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a trans-parent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.

Full text

Device therapy and hospital reimbursement
practices across European countries: a
heterogeneous scenario
Giuseppe Boriani1*, Haran Burri2, Lorenzo G. Mantovani 3, Nikos Maniadakis 4,
Francisco Leyva5, Joseph Kautzner 6, Andrzej Lubinski7, Frieder Braunschweig 8,
Werner Jung9, Ignacio F. Lozano 10, and Giovanni Fattore11
1
Institute of Cardiology, University of Bologna, Via Massarenti 9, 40138 Bologna, Italy;
2
Cardiology Service, University Hospital of Geneva, Geneva, Switzerland;
3
Faculty of Pharmacy,
CIRFF/Center of Pharmacoeconomics, University of Naples Federico II, Naples, Italy;
4
Department of Health Services Management, National School of Public Health, Athens,
Greece;
5
Centre for Cardiovascular Sciences, Queen Elizabeth Hospital, University of Birmingham, Birmingham, UK;
6
Department of Cardiology, Institute for Clinical and
Experimental Medicine, Prague, Czech Republic;
7
Department of Interventional Cardiology, Medical University of Lodz, Lodz, Poland;
8
Department of Cardiology, Karolinska
Institutet, Karolinska University Hospital, Stockholm, Sweden;
9
Schwarzwald-Baar Klinikum, Academic Hospital of the University of Freiburg, Freiburg, Germany;
10
Unidad de
Arritmias, Hospital Universitario Puerta de Hierro, Madrid, Spain; and
11
CERGAS, Bocconi University, Milan, Italy
As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diag-
nosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with
the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for
funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the
implementation of CIEDs in the ‘real world’ through a variable spectrum of practices. These may range from the situation where reimburse-
ment may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is
adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective
technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility
to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies
are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also
important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a trans-
parent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Keywords Cardiac resynchronization therapy †Diagnosis-related groups †Implantable cardioverter defibrillator †
Pacemaker †Reimbursement
Introduction
On the basis of evidence derived from randomized clinical trials,
specific recommendations regarding treatment with a cardiac
implantable electrical device (CIED) are available in international
consensus guidelines.
1,2
However, the implementation of device
therapy in clinical practice is largely incomplete and growing inter-
est is dedicated to analysis of all the multiple factors that may
modulate the access to therapy in appropriately selected
patients.
3–5
The various factors that may affect the implant rate of CIEDs
include lack or inadequate implementation of specific guidelines,
lack of screening programmes and imperfect referral pathways,
limited number of cardiac catheterization laboratories or implant-
ing physicians, as well as the specific type of device analysed. In
addition, the population demographic structure, socio-economic
status, ethnic status, patient’s cultural status, and patient’s culture
may have an influence on actual CIEDs implantation rates.
3,6
In
this complex scenario, it is likely that also the variability in reimbur-
sement practices for CIED and for specific types of CIEDs may
have an impact in conditioning or modulating the use of device
therapy or other invasive procedures in different organizational
or socio-political contexts.
3,7–10
Moreover, the above factors
may also impact on the availability of invasive or non-invasive diag-
nostic procedures used to establish a diagnosis that is associated
with the indication for a CIED implant.
*Corresponding author. Tel: +39 051 349858; fax: +39 051 344859, Email: giuseppe.boriani@unibo.it
Published on behalf of the European Society of Cardiology. All rights reserved. &The Author 2011. For permissions please email: journals.permissions@oup.com.
Europace (2011) 13, ii59–ii65
doi:10.1093/europace/eur080
at ESC Member (Europace) on July 30, 2014http://europace.oxfordjournals.org/Downloaded from

The aim of the present study is to provide a general overview of
the diverse patterns of reimbursement practices in a sample of
European countries, with specific focus on reimbursement for
CIEDs.
Funding in healthcare
European healthcare systems present a variety of financial and
institutional arrangements, often reflecting domestic pathways.
Hospital financing is no exception as different methods have
been used with global budgets, activity-based financing (diagnosis-
related group, DRG-like systems) being the most popular nowa-
days. In addition, the methods for remuneration of physicians are
also variable, including both wages and remuneration with fee for
service, sometimes combined.
8
It is beyond the scope of this
article to enter the complex field of healthcare financing, but the
variability existing in healthcare financing across Europe should
be taken into account when reimbursement practices for specific
hospital activities involving use of electrical devices are analysed.
Diagnosis-related groups
The evolution of medicine and the increase in complexity of pro-
cedures performed in hospitals in the last decades have prompted
the creation of patient classification systems which, as a common
basis, relate the characteristics of in-hospital-treated patients to
the resources used. The methods used to classify patients across
Europe were often derived from the Health Care Financing Admin-
istration system introduced in 1983 for the Medicare system in the
USA. Initially developed as an information tool to monitor quality
and use of services, patient classification systems later became pro-
spective payment systems, named DRGs.
9,11
In recent years, new
versions have been implemented which adjust for the severity of
diagnosis and/or other co-morbidities: the Ms-DRG (Medicare-
Severity DRGs) and Apr-DRG (All Patient Refined DRGs)
systems. Today, the objective of DRG systems is to classify hospital
cases into one of 500 –1000 groups, thus creating a patient
classification system that relates the type of patients treated to
the resources that they consume. These data are not only used
as information for analysis—as a matter of fact, in most European
countries a DRG system or similar grouping systems have been
introduced as instruments for hospital reimbursement.
9
The methods for paying hospitals for inpatient care have thus
evolved over time from per diem or line-item budgets to global
budgets and then again to case-based payment (mainly through
variants of DRGs).
8
A wide variety of reasons may explain the
introduction of DRGs in European countries: to control costs
for care, to provide a clear payment system for both public and
private hospitals, to stimulate competition among hospitals, and
to reduce waiting times.
12
Hungary was one of the first European
countries to introduce DRGs, beginning in 1987, with full
implementation in 1993.
8,9
Since the adoption of DRG systems, the link between financial
and clinical aspects has become well established. From the clinical
point of view, appropriate attention has to be paid to the appli-
cation of a DRGs paradigm. Diagnosis-related groups, by definition,
are ‘groups or classes of patient episodes designated by codes or
terms which describe to a greater or lesser degree of specificity
a diagnosis or a procedure’.
11
Assessment of the impact of
DRGs in the countries of the European Union suggests that
implementation of DRGs is associated with increased levels of hos-
pital activity in the short term,
13 –15
but may also result in cost
shifting,
16
growth in readmission rates and ‘up-coding’ (‘DRG
creep’),
11,14,17
or cream-skimming.
8
These are the reasons for a
series of periodic revisions to DRG systems in several countries.
They also imply a need to monitor the quality of in-hospital care
in tandem with the implementation of DRG-based reimbursement
of hospitals.
In Table 1, we summarize the role of DRG systems for funding
in-hospital care for 19 European countries. Specifically, we
report in detail for each specific country whether the DRG
system and its tariffs play a predominant role in funding (if the
system covers at least 50% of total funding for inpatient providers),
or whether, conversely, a DRG-related system exists but is used
primarily for information purposes with limited or no role in finan-
cing. We also report if the original US DRG system is used, or if a
different system has been developed. Since it is difficult to obtain
up-to-date and accurate information on this topic, and in particular
................................................................................
Table 1 Funding for in-hospital care in 19 European
countries and role of diagnosis related group systems
for funding hospital care, with regard to public and
private hospitals, respectively
Country DRG system
for public
hospitals
DRG system
for private
hospitals
DRG system
Austria No No LDF
Belgium No No APR-DRG
Czech
Republic
Yes Yes ALFA-DRG
Denmark
a
No No Dk-DRG
Finland
a
No No NORD-DRG
France Yes Yes GHS
Germany Yes Yes G-DRG
Greece No No USA DRG
Hungary Yes Yes HBCS
Ireland No No Australian
AR-DRG
Italy
a
Yes, with
budget caps
Yes, with
budget caps
USA DRG
Netherlands Yes Yes DBC
Norway
a
No No NORD-DRG
Poland Yes Yes Procedure list
Portugal Yes Yes USA DRG
Switzerland Yes No (Yes as
from 2012)
AP-DRG; Swiss
DRG (2012)
Spain No Yes/No USA AP-DRG
v23.0
Sweden
a
No No NORD-DRG
UK Yes Yes HRG
a
Countries with a predominantly mixed system (diagnosis related groups and
global budget).
G. Boriani et al.ii60
at ESC Member (Europace) on July 30, 2014http://europace.oxfordjournals.org/Downloaded from

on the one-dimensional use of DRGs for funding allocation versus
multi-factorial funding allocation, the picture we present has to be
considered in general terms.
Reimbursement for implantable
electrical devices across Europe
Indications for therapy with implantable devices for brady or
tachyarrhythmias, sudden death prevention, cardiac resynchroniza-
tion in heart failure, or for the purpose of arrhythmia monitoring
are today well described and graded in terms of recommendation
levels and scientific evidence, summarized in international consen-
sus guidelines.
1,2
Furthermore, in most countries, national physician
societies or health agencies have issued national guidelines, trans-
ferring evidence from the literature and international guidelines
into the specific context of healthcare organization in their
country. While international guideline recommendations typically
focus on published scientific evidence and clinical expert judge-
ment but pay less attention to cost-effectiveness aspects, more
and more national guideline documents incorporate information
on the cost effectiveness of treatments in the grading of rec-
ommendations for their clinical application (e.g. guidelines from
the National Institute for Health and Clinical Excellence, UK, and
Swedish Board of Health and Welfare).
However, while international and national European guidelines
for device therapies come to similar conclusions, the rates of
device implantation vary considerably from country to
country
4,18 –22
as well as from region to region,
6,22
for all the
various types of CIEDs. While heterogeneity in implant rates has
been a subject of evaluation and investigation,
6,18,19
limited atten-
tion has been dedicated to heterogeneity in reimbursement mech-
anisms across the various European countries. In Table 2,we
report a summary of the predominant reimbursement methods
in specific European countries for CIEDs, with regard to both
implantable pulse generators (IPGs) and implantable cardioverter
defibrillators (ICDs). The complexity of European healthcare
systems is enhanced in most countries by variations in reimburse-
ment practices between public and private hospitals, or between
payers, as well as by variations according to geographic regions
(e.g. in Italy) or hospital type.
23
Table 3shows specific data on the actual state of reimbursement
in various European countries, including indications on the speci-
ficity of the DRG tariff for the type of CIED (single-chamber, dual-
chamber, or biventricular device) and on inclusion of the cost for
device purchase in the DRG tariff. As shown, the scenario of reim-
bursement for electrical devices confirms a substantial variability,
with some countries not differentiating the tariff for reimburse-
ment according to the type of implanted device.
Reimbursement for in-clinic device
check and for remote monitoring
of implantable electrical devices
All CIEDs require periodic checks, as indicated by the recent Heart
Rhythm Society/European Heart Rhythm Association (EHRA)
Expert consensus document.
24
The in-office device check is
included in the list of reimbursed outpatient services in almost
all European countries; usually it is coded and reimbursed using
specific tariffs that include control and reprogramming. A substan-
tial variability between the countries is present in this case too,
since some countries have specific codes for single or dual
chamber and others use a single code for all types of CIEDs, as
reported in Table 4.
Current technologies now allow for remote follow-up of CIEDs.
This may represent a more efficient way of organizing CIEDs
follow-up, by reducing the workload of routine follow-up visits.
As shown in Table 5, there is a substantial variability across
Europe with regard to reimbursement of remote CIEDs follow-up,
with definition of specific tariffs only in a few countries. Healthcare
payers may be reluctant to reimburse remote device management
due to lack of robust economic analysis and evidence of improved
patient outcome, despite acknowledging the strategy to be safe.
25
In the USA, Medicare and Medicaid have expanded reimbursement
for remote device monitoring for all states since 2006. Reimburse-
ment rates may vary from state to state, and are in some instances
the same as an in-office visit without device programming.
In patients with heart failure, some devices provide dedicated
diagnostic features for the monitoring of fluid retention and
disease state, aiming to improve the maintenance of stable com-
pensation. These features open the perspective of remote
disease management by CIEDs.
26
The possibility to establish a
specific reimbursement for disease management of heart failure
patients by remote monitoring should be the subject of
................................................................................
Table 2 Models existing across Europe for
reimbursement to healthcare providers of implantable
pulse generators and implantable cardioverter
defibrillators
Case payment
(DRGs)
predominant
Mixed model
(DRGs a
component in
some)
Reimbursement list
(DRGs may co-exist)
Germany Austria Belgium
Hungary Czech Republic Czech Republic
(reimbursement list for
highly innovative
product in centres of
excellence)
Italy (on a regional
basis)
Denmark France
Netherlands Finland
Poland Greece
Portugal Hungary
Switzerland Ireland
UK Italy (on a regional
basis)
Norway
Sweden
Spain
Device therapy and reimbursement ii61
at ESC Member (Europace) on July 30, 2014http://europace.oxfordjournals.org/Downloaded from

investigations considering that this activity may have an impact on
chronic outpatient care.
Reimbursement practices and
funding of innovation
Since patients are usually not able to directly cover the expenses
for their healthcare, coverage, and reimbursement practices are
crucial in conditioning the way that new medical technologies
are used in daily practice.
27
In many countries, it is not well
defined how and how often updating of DRG tariffs will occur.
This is relevant with regard to implementation of innovative
devices or device features. When an innovative device/procedure
becomes available, generally at an increased price for purchasing,
the application of current DRG codes and tariffs to new more
expensive devices may be problematic or may fail, despite formal
approval of the new device, for purely financial reasons.
28
As a
consequence, different reimbursement mechanisms can result
either in acceleration or in slowing of the adoption and
implementation of innovative and more expensive technologies.
In such a situation, the decisions on how to identify new technol-
ogies, devices, or procedures that are subject to coverage and
reimbursement strongly influence clinical practice and profoundly
influence the scenario that supports medical innovation, creating
either incentives or disincentives for manufacturers to propose
innovations. In fields with rapid technological evolution, it is impor-
tant to adapt reimbursement practices to innovative, more sophis-
ticated technological advancements, thus allowing implementation
of these innovations in clinical practice as soon as evidence of
benefit is available.
10,27
At the same, it is essential that any inno-
vation is adequately evaluated in terms of net clinic benefits and
cost effectiveness. In the absence of any facilitation or adaptation
of the system, the implementation of innovative medical technol-
ogies with a higher price in comparison with the currently used
technology remains a challenge. If the extra costs are not reim-
bursed, hospitals will not find any incentive to adopt a new tech-
nology, except for marketing reasons or for research purposes,
and the unadapted DRG systems might result in slowing down
technological innovation.
......................................................... .........................................................
...............................................................................................................................................................................
Table 3 Methods for reimbursement of implantable pulse generators and implantable cardioverter defibrillators to
healthcare providers across Europe
Country Reimbursement system IPGs ICDs
Specificity for
device type
Inclusion of the device
in the DRG tariff
Specificity for
device type
Inclusion of the device
in the DRG tariff
Austria LKF (AU ver. of DRG) SC, DC, CRT-P Yes All ICD, CRT-D Yes
Belgium List price (only device) SC, DC, CRT-P
a,b
No SC, DC, CRT-D
b
No
Czech
Republic
Specific tariff available for
each procedure
SC, DC, CRT-P No SC, DC, CRT-D No
Denmark Global budget
+NORD-DRG
No Yes No Yes
Finland Global budget
+NORD-DRG
No Yes All ICD, CRT-D Yes
France List price (only device) SC, DC, CRT-P
b
No SC, DC, CRT-D
b
No
Germany DRG SC, DC Yes SC, DC, CRT-D Yes
Greece Global budget n/a n/a n/a n/a
Hungary DRG No No No No
Ireland Global budget +DRG No n/a No n/a
Italy Global budget +DRG No Yes No Yes
Netherlands Global budget +DRG No No No Yes
Norway Global budget
+NORD-DRG
No Yes All ICD, CRT-D Yes
Poland DRG (procedure list) SC, DC Yes No Yes
Portugal DRG No Yes No Yes
Switzerland AP-DRG; Swiss-DRG from
2012
SC, DC, CRT-P Yes SC, DC, CRT-D Yes
Spain Global budget No No No No
Sweden Global budget
+NORD-DRG
No Yes All ICD, CRT-D Yes
UK DRG SC, DC, CRT-P Yes No No
SC, single-chamber; DC, dual-chamber; n/a, not available.
a
Third lead not reimbursed.
b
Leads reimbursed on top of the device.
G. Boriani et al.ii62
at ESC Member (Europace) on July 30, 2014http://europace.oxfordjournals.org/Downloaded from

Alternative options to support innovation may include separate
or additional budgets for funding innovation. Some countries with
DRG funding have channels to support the introduction of
innovative, more expensive technologies. These solutions include
the activity supported by Neue Untersuchungs- und Behandlungs-
methoden in Germany, Integrated Care contracts in Germany,
special funds dedicated to financing innovative and expensive tech-
nologies in France, regional initiatives in Italy, etc. However, these
processes may not be well understood by stakeholders and
implementation of technology may have some limitations. We
feel that lack of a systematic approach in this field opens up
space for discussion in the European Commission on the most
effective ways for promotion of novel technologies, including
specific incentive programmes.
For CIEDs, accumulation of clinical evidence requires a relatively
long time period. Therefore, one option for coverage of promising
technological innovations, including devices, that would not other-
wise meet full standards of available evidence is ‘coverage with evi-
dence development’ — a policy proposed in the USA by Medicare
in 2005.
29
This policy is targeted at diminishing the logjam between
innovation and evidence-based medical policy, allowing a formal
option for coverage of promising technologies that includes collec-
tion of longitudinal data for a better understanding of the risks,
benefits, and costs of the new treatment options.
29,30
Conclusions
As in other settings, also in the field of clinical use of CIEDs, the
implementation, in various ways, of DRGs has created a new scen-
ario in most healthcare systems in Europe. Diagnosis-related group
systems are primarily financial tools that also have the aim of pro-
moting efficiency and improving the use of resources. However,
there are a variety of ways in which DRG systems are used for
funding the activity of centres implanting CIEDs, particularly with
regard to how specific types of devices are reimbursed.
.................... ....................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
Table 4 Reimbursement for in-office follow-up of
implanted electrical devices
Country IPG ICD CRT
Single Dual Single Dual
Belgium ×
.
.
.
.
.
.
.
.
.
×
.
.
.
.
.
.
.
.
.
×.
.
.
n/a
Czech Republic ×× ×
Denmark ×
Finland ×.
.
.
×
.
.
.
.
.
.
.
.
.
×
.
.
.
.
.
.
.
.
.
n/a
France ××n/a
Germany ×
Italy ×
Netherlands ×.
.
.
×.
.
.
n/a
Norway ×
Portugal ×.
.
.
×.
.
.
×
Spain ×
Sweden ×.
.
.
×.
.
.
×
Switzerland ×.
.
.
×.
.
.
×.
.
.
×.
.
.
n/a
UK ×
The presence of specific reimbursement according to the characteristics of the
implanted device or the lack of specific reimbursement are indicated.
×, availability of reimbursement.
...............................................................................................................................................................................
Table 5 Reimbursement of in-clinic device check and current availability of tariffs for reimbursement to hospitals of
remote device check across Europe
Availability of a tariff for
reimbursement of in-clinic
device check
Availability of a tariff for
reimbursement of remote
device check
Availability of a tariff for procurement
of hardware and service for remote
device check
Belgium ×No No
Czech Republic ×No No
Denmark ×No No
Finland ×No No
France ×No Price premium on selected systems
Germany ××No
Italy ×No No
Netherlands ×No No
Norway ×No No
Portugal ××No
Spain n/a n/a No
Sweden ××No
Switzerland ×No No
UK ×No No
×, availability of reimbursement.
Device therapy and reimbursement ii63
at ESC Member (Europace) on July 30, 2014http://europace.oxfordjournals.org/Downloaded from

The variability of reimbursement across Europe has to be taken
into account when trying to interpret the effective implementation
in specific regional or national contexts of consensus guidelines on
indications to implant specific types of CIEDs. It is likely that the
specific type and method of reimbursement may influence the
implementation of device therapy in daily ‘real-world practice’
through a variable spectrum of effects, often poorly understood
and sometimes undesirable. These influences may range from the
situation where reimbursement may, in combination with other
factors, constitute a true barrier to widespread implementation
of consensus guidelines, to situations where reimbursement
appears to be adequate and, finally, to situations where reimburse-
ment may be adequate for most standard devices but is not fully
adequate to allow prompt implementation of effective technologi-
cal innovations.
The heterogeneity in reimbursement systems between Euro-
pean countries also affects how in-office check of CIEDs is
covered and, above all, the possibility to pay for remote follow-up
of CIEDs. Despite the potential for improving the efficiency of
device clinics, remote device checks are currently reimbursed
only in a minority of countries.
In the field of medical devices, refinement of DRG systems and
adoption of new strategies and policies are needed to sustain and
enhance those effective technological innovations that may be ben-
eficial for specific patient populations, allowing an improvement in
patients’ outcome and quality of life, with an affordable absorption
of economic resources. It is important that physicians are deeply
involved in the development and deployment of DRGs, and that
each country DRG agency has a transparent approach to planning,
communication, and engagement with stakeholders, along with
robust and transparent prioritization mechanisms for updating
codes and tariffs. Data quality assessment is also essential for
DRG systems. For this reason, it is imperative to ensure a high
degree of accuracy and compliance in clinical coding (diagnosis,
co-morbidity, and procedure) and also in cost measurement and
allocation. Necessarily, this requires strong efforts including invest-
ments in education and in database systems.
Acknowledgements
The authors thank Rachele Busca and Ben Brown, from Medtronic
International, Tolochenaz, (Switzerland), for their help in data
collection.
Conflict of interest: H.B. Consulting fees/honoraria from
Medtronic, Boston Scientific, Biotronik, and Sorin. Research
grants from Medtronic, Boston Scientific, Biotronik, Sorin, and
St Jude Medical. F.L. Consulting fees/honoraria from Medtronic,
St Jude Medical, and Sorin. Research grants from Medtronic,
St Jude Medical, and Sorin. J.K. Consulting fees/honoraria from
Biotronik, Boston Scientific, Medtronic, St Jude Medical. F.B.
Consulting fees/honoraria from Medtronic, Biotronic, Sorin, and
Boston Scientific. Research grants from Medtronic. W.J. Consulting
fees/honoraria from Biotronik, St Jude Medical, Medtronic, Boston
Scientific, and Hansen Medical. I.F.L. Consulting fees/honoraria
from Boston Scientific and St Jude Medical.
References
1. Vardas PE, Auricchio A, Blanc JJ, Daubert JC, Drexler H, Ector H et al. Guidelines
for cardiac pacing and cardiac resynchronization therapy. The Task Force for
Cardiac Pacing and Cardiac Resynchronization Therapy of the European
Society of Cardiology. Europace 2007;9:959–98.
2. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS
et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac
Rhythm Abnormalities: a report of the American College of Cardiology/American
Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2008;51:
e1– 62.
3. Al-Khatib SM, Sanders GD, Carlson M, Cicic A, Curtis A, Fonarow GC et al. Pre-
venting tomorrow’s sudden cardiac death today: dissemination of effective thera-
pies for sudden cardiac death prevention. Am Heart J 2008;156:613 –2.
4. Boriani G, Ricci R, Toselli T, Ferrari R, Branzi A, Santini M. Implantable cardiover-
ter defibrillators: from evidence of trials to clinical practice. Eur Heart J Suppl 2007;
9:I66– 73.
5. Rossenbacker T, Priori S, Zipes DP. The fight against sudden cardiac death: con-
sensus guidelines as a reference. Eur Heart J Suppl 2007;9(Suppl._I):I50 –8.
6. Boriani G, Berti E, Biffi M, Marino M, Sassone B, Villani GQ et al. Implantable elec-
trical devices for prevention of sudden cardiac death: data on implant rates from a
‘real world’ regional registry. Europace 2010;12:1224– 30.
7. Lau CP, Tse HF, Mond HG. The impact of reimbursement on the usage of pace-
makers, implantable cardioverter defibrillators and radiofrequency ablation.
J Interv Card Electrophysiol 2006;17:177 –81.
8. Thomson S, Foubister T, Mossialos E. Financing Health Care in the European
Union. Challenges and Policy Responses. World Health Organization 2009, on
behalf of the European Observatory on Health Systems and Policies. Accessed
on November 10, 2010 at www.euro.who.int/__data/assets/pdf_fi
9. Schreyo¨gg J, Stargardt T, Tiemann O, Busse R. Methods to determine reimburse-
ment rates for diagnosis related groups (DRG): a comparison of nine European
countries. Health Care Manag Sci 2006;9:215 –23.
10. Schreyo¨gg J, Ba¨umler M, Busse R. Balancing adoption and affordability of medical
devices in Europe. Health Policy 2009;92:218 –24.
11. Goldfield N. The evolution of diagnosis-related groups (DRGs): from its begin-
nings in case-mix and resource use theory, to its implementation for payment
and now for its current utilization for quality within and outside the hospital.
Qual Manag Health Care 2010;19:3 –16.
12. Ettelt S, Thomson S, Nolte E, Mays N. Reimbursing highly specialised hospital ser-
vices: the experience of activity-based funding in eight countries. A report com-
missioned by the Department of Health and prepared by the London School of
Hygiene and Tropical Medicine. 2006. Accessed on November 10, 2010 at www.
lshtm.ac.uk/publications/list.php
13. Dismuke CE, Sena V. Has DRG payment influenced the technical efficiency and
productivity of diagnostic technologies in Portuguese public hospitals? An empiri-
cal analysis using parametric and non-parametric methods. Health Care Manag Sci
1999;2:107– 116.
14. Louis DZ, Yuen EJ, Braga M, Cicchetti A, Rabinowitz C, Laine C. Impact of a
DRG-based hospital financing system on quality and outcomes of care in Italy.
Health Serv Res 1999;34:405 –15.
15. Mikkola H, Keskimaki I, Hakkinen U. DRG-related prices applied in a public health
care system – can Finland learn from Norway and Sweden? Health Policy 2001;59:
37– 51.
16. Jo¨nsson B. Cost sharing for pharmaceuticals – the Swedish reimbursement
system. Pharmacoeconomics 1996;10(Suppl. 2):68–74.
17. Rogers R, Williams S, Jarman B, Aylin P. HRG drift and payment by results. BMJ
2005;330:563–4.
18. Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A et al. The
European cardiac resynchronization therapy survey. Eur Heart J 2009;30:2450 –60.
19. Merkely B, Roka A, Kutyifa V, Boersma L, Leenhardt A, Lubinski A et al. Tracing
the European course of cardiac resynchronization therapy from 2006 to 2008.
Europace 2010;12:692– 701.
20. Vardas P, Auricchio A, Wolpert C. The EHRA White Book 2010. The Current
Status of Cardiac Electrophysiology in ESC Member Countries. Accessed on
November 10, 2020 at www.escardio.org/communities/EHRA/publications/
Documents/ehra-white-book-2010.pdf
21. Wolpert C, Lubinski A, Bissinger A, Merkely B, Priori S, Brugada J. Barriers to
implementation of evidence-based electrical therapies and the need for
outcome research: role of European registries. Europace 2011;13(suppl. 2):
ii18– 20.
22. Camm AJ, Nisam S. European utilization of the implantable defibrillator: has 10
years changed the ‘enigma’? Europace 2010;12:1063 –9.
23. Cappellaro G, Fattore G, Torbica A. Funding health technologies in decentralized
systems: a comparison between Italy and Spain. Health Policy 2009;92:313 –21.
24. Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM et al. HRS/
EHRA expert consensus on the monitoring of cardiovascular implantable
G. Boriani et al.ii64
at ESC Member (Europace) on July 30, 2014http://europace.oxfordjournals.org/Downloaded from

electronic devices (CIEDs): description of techniques, indications, personnel,
frequency and ethical considerations. Heart Rhythm 2008;5:907 –25.
25. Vinck I, Stroobandt S, Gerkens S, De Laet C. Remote monitoring for patients with
implanted defibrillator. Technology evaluation and broader regulatory framework.
Health Technology Assessment (HTA) and Health Services Research (HSR).
Brussels: Belgian Health Care Knowledge Centre (KCE). 2010. KCE Reports
136C. D/2010/10.273/55.).
26. Boriani G, Diemberger I, Martignani C, Biffi M, Valzania C, Bertini M et al.
Telecardiology and remote monitoring of implanted electrical devices: the
potential for fresh clinical care perspectives. J Gen Intern Med 2008;23(Supp l. 1):
73– 7.
27. Boriani G, Maniadakis N, Auricchio A, Vardas P. Health economics and outcomes
research: a new challenge and field of action for the European Heart Rhythm
Association. Europace 2010;12:601– 3.
28. Rogowski WH, Hartz SC, John JH. Clearing up the hazy road from bench to
bedside: a framework for integrating the fourth hurdle into translational medicine.
BMC Health Serv Res 2008;8:194.
29. Tunis SR, Pearson SD. Coverage options for promising technologies: Medicare’s
‘coverage with evidence development’. Health Aff (Millwood) 2006;25:1218 – 30.
30. Reed SD, Shea AM, Schulman KA. Economic implications of potential changes to
regulatory and reimbursement policies for medical devices. J Gen Intern Med 2008;
23(Suppl. 1):50 –6.
Device therapy and reimbursement ii65
at ESC Member (Europace) on July 30, 2014http://europace.oxfordjournals.org/Downloaded from