Download Carelink

Medtronic CareLink Network
for Heart Failure Patients
MHA 6789: Medical Technology Evaluation and Market Research
May 13, 2004
John Curtis
Susan Maleret
Will Au-Yeung
Table of Contents
Introduction ........................................................................................................................ 2
Disease and Market Overview ............................................................................................ 3
Medtronic Carelink ............................................................................................................. 5
Cost Effectiveness .............................................................................................................. 8
Literature Review ........................................................................................................... 8
Cost Effectiveness Analysis ........................................................................................... 9
Regulatory barriers ........................................................................................................... 12
Conclusions ...................................................................................................................... 13
1
Introduction
Medtronic’s CareLink is a new technology solution to improve the care of
cardiac device patients with heart failure. Several demographic and economic factors are
converging to create an overwhelming need for new innovations and technologies that
improve the care of heart failure patients and save money.
The first demographic trend that contributes to the increasing number of heart
failure patients is the aging population. First, the baby boomer phenomenon is creating a
dramatic growth in the percentage of people within the US over 65. The AOA projects
the percentage to grow from 13 percent to over twenty-five percent by 20501. Second,
older patients are living longer. The US Department of Health & Human Services’
Administration on Aging projects that life expectancy for 65-year old individuals in
2050 will increase by 25 percent for males and 33 percent for women2.
Another trend factor is obesity. A recent survey in 2002 by the CDC indicated
that 29 states reported obesity prevalence rates of 20 to 24 percent. This contrasts
greatly with 1991 statistics, in which no state reported such prevalence rates. The
implication of these trends is that the prevalence of heart failure will increase as the
population gets older. In addition, these trends also contribute to other co-morbidities,
such as diabetes, which further complicates the patient’s treatments.
1
2
http://www.aoa.gov/prof/Statistics/online_stat_data/AgePop2050.asp
http://www.aoa.gov/prof/Statistics/future_growth/aging21/health.asp#Life
2
Disease and Market Overview
Heart failure is already a major burden on the community, due to the costs of care
and the poor quality of life and premature death of affected people. The disease
develops when the heart’s muscle becomes weakened after it is injured from another
event or disease, such as a myocardial infarction or hypertension. A heart undergoing
heart failure loses its ability to pump enough blood to supply the body’s needs. As a
result, the heart is not able to circulate enough blood throughout the body, leading to
shortness of breath, fatigue and fluid build-up in the legs and ankles.
Heart failure is typically straightforward to diagnose. The most commonly used
diagnostic test is an echocardiogram. This instrument measures the ejection fraction
(EF) of the subject. A person with heart failure typically has an EF less than 40%
(healthy hearts have an EF > 60%). Chest x-rays, a physical exam, an electrocardiogram,
and an exercise stress test are also used.
Heart failure is one of the most prevalent diseases in the geriatric population.
With this population increasing in number, size, and average age, the prevalence of the
disease is also on the rise. Over 4.8 million Americans currently suffer from congestive
heart failure. Each year, over 250,000 deaths are caused by heart failure, and 500,000
new cases are diagnosed. The number of new cases diagnosed each year is expected to
double within 5 years because of the increasing age and weight of the population.3
About 5% of the population between the ages of 60 and 69 suffer from heart failure, and
about 10% of the total population over 70 has the disease (See Appendix A).
3
National Health and Nutrition Examination Survey.
3
Furthermore, a recent study supported by the National Heart, Lung, and Blood Institute
(NHLBI) indicates that the risk, which increases continuously with increasing degrees of
body weight, is 34 percent higher for overweight individuals and 104 percent higher for
obese persons.4
Unfortunately, there is no cure for heart failure except for a heart transplant.
However, this procedure is not frequently done on older patients with complicating comorbidities, which is the typical population suffering from heart failure. Although
chronic, heart failure can be treated and partially stabilized if detected early. The current
treatment of choice is through medication. Many medications are available for
treatment, including diuretics, digoxin, ACE inhibitors, and beta-blockers.
A newer mode of treatment that complements the drug therapy mentioned above
is cardiac resynchronization therapy (CRT). CRT is indicated for patients with moderate
to severe heart failure. The therapy is designed to help the two lower heart chambers,
the right and left ventricles, beat at the same time in a normal sequence. This
synchronization helps the heart supply blood and oxygen to the body. Medtronic is a
leading provider of implantable CRT pacemakers and defibrillators. Clinical trials with
these devices have found that they improve patients’ quality of life, exercise capacity,
and functional class as measured by the New York Heart Association class, and can
reduce all-cause mortality and all-cause hospitalization for heart failure patients.5
4
http://www.nih.gov/news/pr/jul2002/nhlbi-31.htm
“Physicians now can use the internet to remotely monitor patients with Heart Failure,” Business Wire,
Dec. 22, 2003.
5
4
Heart failure devices are one of the fastest growing businesses in the heart device
industry. Overall Cardiac Rhythm Management (CRM) Division sales have increased
23 percent. This tremendous growth rate, coupled with a 20% growth rate in
implantable cardioverter defibrillators has lead to a growing capacity problem in the
follow-up clinics (See Appendix B). Medtronic forecasts that the number of cardiac
device patients will far outstrip clinics’ capacity in the next few years unless something
is done to combat this.
Medtronic Carelink
The Medtronic CareLink Network aims to relieve this capacity constraint by
reducing the time commitment of check-up visits and improving clinicians’ efficiency.
It is the first internet-based remote monitoring service for patients with implanted
cardiac devices, allowing important device and patient information to be remotely
monitored by medical professionals in a secure, timely, and cost-effective manner.
Patients can reliably transfer their device information from most locations within the
United States whether they are at home or on vacation. Today, more than 100,000
patients who have Medtronic ICDs can be monitored by the CareLink network.
Additional cardiac devices will be added to the system during the upcoming year.
The equipment that is located at the patient’s home includes the CareLink
monitor, which is a small computer (See Appendix C). To upload information from the
implanted device to the monitor, the patient swipes the antenna, which is shaped like a
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computer mouse, over the location of the device. The monitor then connects to a
Medtronic web server over standards phone lines and uploads the data.
The patient’s clinic accesses the information by signing into a secure website and
analyzing the information transmitted. The clinician’s website is protected by username
and password for use by authorized clinic personnel in order to protect patient
confidentiality. The information provided to the physician is identical to the data that
would be collected from the device in an in-office visit. Physicians are able to use the
data to monitor patients’ activity levels, heart rate, and existence of irregular heart
rhythms. Reggie Groves, vice president and general manager of Medtronic Patient
Management states, “As clinicians use the Medtronic CareLink Network for longer
periods of time and with more patients, we regularly are told that it’s becoming an
absolute necessity to their business, not to mention a great source of satisfaction for their
patients. They can’t imagine going back to the often-inefficient system of providing all
device checks in the clinic. We’re extremely pleased with the feedback we’re receiving
from our customers, and we are working closely with them to understand how we can
quickly adapt the Medtronic CareLink Network to add significant value to their
management of a wide range of patient conditions.”6
Because each person's heart response to stimulation is slightly different and can
change over time, doctors are able to plot the stored device data and track trends,
allowing them to be more proactive in therapy adjustments. In the future, this type of
“US FDA approves new devices for use with Medtronic’s Internet based heart device monitoring
system.” Medtronic press release, Feb. 19, 2004.
6
6
“predictive diagnostic” could prevent hospitalization and unnecessary visits leading to
increased cost savings for Medicare.
A future expansion of the CareLink platform will allow doctors to adjust the
patient's pacemaker remotely to respond to the patient changes. This will allow the
patient’s issue to be addressed immediately without having to come to the office. This
can be particularly helpful during weekends and off- hours and will increase patient’s
piece of mind, especially when traveling. When a clinic nurse calls back within thirty
minutes of downloading a device’s information, the patient not only receives immediate
adjustments to their therapy from the comfort of home or vacation, they are also
consoled in the comfort of knowing exactly what happened. This responsiveness will
improve patient care and increase patient satisfaction.
Families of CareLink patients and heart failure specialists can remain better
connected with the patient’s health status through CareLink. Upon approval, family
members will be granted access to their loved ones’ stored medical information. They
will also have access to an exclusive website with in-depth information about the
patient’s device and tips for living with the disease. In addition, the electronic
information could be automatically sent to multiple physicians that are caring for the
patient, thus increasing coordination and awareness throughout all the points of care.
This electronic health record allows for greater continuity of care, which can lead to
improved patient compliance and greater satisfaction.
A growing physician base is quickly discovering the many benefits of CareLink
for heart failure patients with CRT devices. However, the most important benefit, cost
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savings, has not been discussed. The following section will introduce the literature to
data supporting the cost savings claim. It will also provide a brief overview of what data
should be considered when analyzing cost effectiveness. Lastly, the section will provide
some recommendations on how Medtronic should proceed to better understand the true
cost savings.
Cost Effectiveness
Literature Review
The cost effectiveness of the Medtronic CareLink Network has not been studied
in detail to date. However, there are several published studies that support the costeffectiveness of electronic follow-up of implantable device patients and heart failure
patients without devices. Appendix D provides a synopsis of the results of these studies.
As you can see, the results are all positive yet varied depending on how the study was
conducted. The highlights are provided below:
o
Studies showed a range of $450 savings per year per patient (takes into account
only cost-savings due to follow-up efficiency) all the way up to a savings of
$38,629 (accounts for reduced hospitalization).
o
One study reported a 26% reduction in Medicare costs.
o
A 63-83% reduction in hospital admissions was reported with a 60% reduction in
hospital bed days of care.
o
CHF-related readmission charges were 86% lower.
8
o
One study reported a 40% reduction in ER visits
In summary, this data indicates that there is a high probability that Medtronic
could prove significant cost savings of their system if a proper study was designed and
executed. In the absence of this cost effectiveness study, a computation of a cost
effective ratio for the CareLink system has been attempted.
Cost Effectiveness Analysis
Costs
The costs for the Medtronic CareLink Network for the key players are shown
below:
Payors. The cost of reimbursement to payors is currently the same as an office visit.
Providers. First, Medtronic currently charges clinics a monthly fee of $17.50 per patient,
per month for a total of $210 per patient per year. This fee is used to rent the monitor
used by the patients and to cover costs associated with maintenance of the web site used
by the clinicians to check data uploads. Secondly, the clinic must also pay for the
clinician’s time to review the reports, although using the CareLink network may take less
time than the traditional office visit. Third, some time must be taken to train the
clinicians to use the CareLink service, although this is likely to be negligible when this
overhead is distributed over many patients.
Patients. There is little difference in costs for the patient versus the traditional office
visit. Patient co-pays are equivalent to the in-office visit. Additionally, basic patient
website access is provided with no cost to the patient.
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Costs Averted
According to Medtronic, one of the key cost saving features of using CareLink
rather than the traditional office visit is the time saved (See Appendix E). Medtronic
claims that a traditional office visit device check takes 20-30 minutes to complete. In
using the CareLink Network, this cycle time is reduced to 4-8 minutes for a savings of
12-26 minutes, or a savings of approximately 40-80%. If the $800 per office visit figure
is used, if even 50% of this cost was saved due to greater efficiency of the clinic, then
there is a potential savings of $1150 per patient per year.
Another significant cost savings in using CareLink is the transportation cost for
patients. Of course, this will vary depending on the distance that the patient must travel
for an office visit, but for patients in rural area, this can be a tremendous cost savings. In
one study in France, an average transportation cost savings of $222 per year was
achieved by using remote monitoring.7 A more exact way to calculate this savings
would be to track the patient’s zip code and the zip code of the clinic through the claims
data. Using a mapping program, one could determine the approximate number of miles
that each patient in the study population drove and determine a group average number of
miles saved.
Benefits of Intervention
Our team has not found any study that has published quality of life results for
patients participating in electronic remote monitoring of ICDs. Most studies focused
7
“Remote monitoring of implantable cardiac devices,” National Horizon Scanning Center, July 2003.
10
more on questions relating to whether the subject “liked” the telephone follow-up instead
of tracking whether the telephone monitoring made the patient “healthier”. In the
absence of data, it is our hypothesis that the CareLink network alone would create little
to no change in health states. Therefore, until this is proven otherwise, we will assume
that there is no change in Quality of Life Years (QALYs). Any potential gains would be
from a decrease in the disease affecting work and social activities due to the convenience
of using home monitoring or from decreased hospitalizations. From the opposite
perspective, there could be a decrease in quality of life for certain elderly patients who
are not comfortable using internet technology and who feel more secure seeing the
doctor and nurse in person.
Cost Effectiveness Analysis Conclusion
From this limited cost effectiveness analysis, it was found that the Medtronic
CareLink Network has the potential of $1162 in net cost savings per patient per year.
Cost savings included $1150 for reduced cycle times and potentially $222 in reduced
transportation costs per patient per year. There was also an increase in web site
maintenance fees by Medtronic for $210 per patient per year. Therefore, a net savings of
$1162 could potentially be found.
Unfortunately, this calculation misses the scientific rigor provided by healthcare
consultants. In order to create a more sound and compelling case, Medtronic must
engage in a study to collect specific data measuring the cost-effectiveness of this therapy
for heart failure patients. This study should include clinical studies of the cycle time for
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traditional in-office follow-ups versus using CareLink. Because most of the cost savings
could potentially come from reduced cycle times, this would be the most important
analysis. Medtronic should also conduct a study to determine the potential cost savings
for patients because of reduced transportation costs for clinic visits.
Regulatory barriers
Minimal regulatory barriers exist with this product. The product was FDA
approved in December 2001 for use with a small group of devices. Since then, more
devices that work with the CareLink system have been approved, including devices for
the treatment of heart failure. To date, there are several published articles that show that
the follow-up device checks using electronic monitoring are cost saving.
The primary challenge for this device has been reimbursement since there was no
precedent in early 2000 that provided reimbursement for “virtual” office visits.
Medtronic was proactive in pursuing this issue. They have approached coverage and
reimbursement on a local versus government level. To date, all but two states have
coverage. The local CMS carrier in approximately 50% of these states has agreed to
allow the use of existing CPT codes while the other half are covered with miscellaneous
CPT codes. 8 Appendix F provides a map showing current national reimbursement
coverage. It is interesting to note that the heaviest concentration of CareLink contracts
(contracts between Medtronic and the hospital to use CareLink services) are in states that
8
93741: Single-chamber ICD check without reprogramming and 93743: Dual-chamber ICD check without
reprogramming
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are covered with existing codes. This may be an indication that the miscellaneous codes
do not provide adequate reimbursement to entice physicians to participate.
It is
surprising that within two and a half years, only 136 (25 VA clinics and 111 other)
hospitals have signed up for the service. It is apparent that adoption of this technology is
the primary barrier that Medtronic has to face. A future recommendation would be to
do some customer research to understand what the largest barriers are and create some
post-market clinical studies to study this issue.
Conclusions
The Medtronic CareLink Network may represent a step forward in the care of
heart failure patients that are undergoing ICD therapy. Because of the increased
prevalence of heart failure and the capacity problems that clinics will be facing in the
future, issues of cost and capacity need to be addressed with this population. Medtronic
is seeking to address this problem through the CareLink Network by reducing cycle
times for follow-up device checks and eliminating transportation costs, and thereby
reducing costs for treating heart failure. However, Medtronic needs to conduct further
cost effectiveness studies to determine if the CareLink Network is truly cost saving, or if
costs saved are counteracted by unforeseen additional costs.
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Appendix A: Percentage of the Total Population Suffering from Heart Failure by
Age Group
12
10
Percent of
Total
Population
8
6
4
2
0
40-59
60-69
over 70
Age Group
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Appendix B: Implantible Cardiac Devices versus Clinic Capacities
15
Appendix C: CareLink Diagram
16
Appendix D: Summary of Cost Effectiveness Studies
Source
“Remote monitoring of
implantible cardiac devices,”
National Horizon Scanning
Centre, July 2003.
Find reference 26 from MJA
2003; 179:242-246
Using Info Tech to improve the
management of chronic disease
Find reference 27 from MJA
2003; 179:242-246
Chan AQ, Chun S. Costeffectiveness of wireless home
monitoring pacemaker. Abstract
101042 at the NASPE 23rd
Annual Scientific Sessions; May
2002
Dressing TJ et al.
Transtelephonic ICD follow-up
is better: more comprehensive,
less intrusive and more
desirable. Abstract 102834 at the
NASPE 23rd Annual Scientific
Sessions: May 2002
Statement of eHeatlh Initiative.
Subcommittee on Health of the
House Committee on Ways and
Means. “Eliminating Barriers to
Chronic Care Management in
Medicare” Feb. 25, 2003
Results
Cost effectiveness study carried out in France. A follow-up cost for
non- home monitoring patients was compared to the expected
follow-up cost of patients with home monitoring of ICDs. For each
visit, the cost for transportation was $128 US and medical costs
were $94 leading to a total cost of $222. Over 5 years, the reduction
in costs for follow-up visits was estimated at $2,200 if the number
of visits is reduced from 4 to 2 and $3,300 if reduced to 1 visit per
year.
83% decrease in the admission rate for those with CHF in the 3 rd quarter
of the year after intervention, compared with the 3 rd quarter of the year
before intervention (P=0.008)
Telecare group of patients with CHF was compared with patients
receiving usual care, mean CHF-related readmission charges were 86%
lower (US$5850 versus US$44479) with fewer CHF-related emergency
department visits (P=0.034).
95 patients. 92% success rate in transmitting data (using cellular
service). Using this technology would result in an annual savings of
$515 per patient and a 26% reduction in Medicare costs. Biotronik
sponsored study completed at Stanford.
124 patients. During the 12 month study, 570 transmissions were
received, revealing 54 episodes of ICD therapy, 22 aborted therapies due
to self-correcting arrhythmias, and 30 episodes of nonsustained
ventricular arrhythmias. The study also revealed 32 instances of
problems with the ICD or with the wires connecting it to the heart. For
patients with symptomatic transmissions necessitating treatment,
investigators said they could have a patient’s ECG in the emergency
room before the patient even arrived. According to Bruce Wilkoff, MD,
coauthor of the study, this technology allows physicians to “triage
gently” and monitor patients “more intensely yet less invasively.” St.
Jude sponsored study at the Cleveland Clinic. Note: No cost data
collected. However, this data documents the ability of transtelephonic
systems to catch and fix issues before they become problems.
The Dept. of Veterans Affairs recently published results from over 2
years of demonstration project showing a 40% reduction in emergency
room visits, 63% reduction in hospital admissions, 60% reduction in
hospital bed days of care and significant improvement in quality of life.
Results were for patients enrolled in eHealth enabled disease
management programs with major conditions that affect Medicare,
including heart failure.
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Appendix E: Office Visit vs. CareLink Workflows
18
Appendix F: Medtronic CareLink Network Reimbursement Status
5/10/04 - page 32
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