HERC Health Economics- 14 -Department of Veteran Affairs

HERC-062012

**Department of Veteran Affairs**

**HERC Health Economics Seminar**

**Peter Groeneveld**

**Implantable Cardioverter-Defibrillators in VHA and Healthcare Cost Growth: 2001-2010**

**HERC-062012**

Moderator:  It looks like we are just at the top of the hour here.  So to introduce our presenter for today, Peter Groeneveld will be presenting for your today.  

Peter is a staff physician at the Philadelphia VA Medical Center with the Center for Health Equity Research and Promotion, CHERP, the assistant professor of medicine at the Perelman School of Medicine at the University of Pennsylvania.  Peter, can I turn things over to you?

Peter Groeneveld:  Sure.  Heidi, thank you so much for that introduction and thank you so much for joining us today, particularly those of you on the Eastern part of the United States where we’re broiling under about a hundred degree heat.  I hope you’re in the air conditioning today.

And I’ll be speaking about implantable cardioverter-defibrillators in the Veterans Health Administration and health care Cost growth over the decade 2001 to 2010.  I am, as Heidi mentioned, a research associate at the Philadelphia VA Medical Center in the HSRD Center of Excellence called CHERP.  I am also on the faculty in general internal medicine at the University of Pennsylvania School of Medicine.  

First some acknowledgements, I would like to tout the hard work of my extraordinary research team at CHERP, including Diane Richardson, our senior statistician, Elina Medvedeva, who is our spectacular programmer analyst, and Brent Roberts, who is our outstanding data administrator at CHERP.  I am also very grateful for the research support provided to make this study possible that came from the QUERI program via their rapid response project program. 

This was Award #09-117.  I am also extremely grateful for the help of Paul Heidenreich,     Barry Massie, [Angie Sahay] and others at the VA Chronic Heart Failure QUERI in Pal Alto and in San Francisco. This assistance with this project was very key to its successful conclusion.  

I have no conflicts of interest to disclose.  And now will get started on the science.  Some background for those of you who are unfamiliar with the device that will be the topic of today’s talk, so implantable cardioverter-defibrillators, or ICDs are  an implantable device that have been guideline recommended therapy since 2005 for patients with chronic heart failure, or CHF, and reduced left ventricular ejection fraction.  

This is actually comprises nationwide maybe about a million or more patients with heart failure who would meet the clinical classification that would make this device guideline recommended.  The device is implanted in the patient’s chest, wires lead down into the patient’s heart, monitor the heart for irregular life-threatening heart rhythms to shock the heart back into a regular rhythm when an irregular rhythm is detected. 

They are life saving because one of major causes of death among patients with heart failure is the occurrence of ventricular arrhythmia or irregular heart rhythms.  The device has undergone a tremendous amount of innovation over the 25 years that they have been in existence.  And today and in the United States several hundred thousand of patients have these devices implanted and live for years with these devices.

Chronic heart failure which is the disease enemy which this device is primarily designed for is very common among veterans and certainly common among veterans over sixty-five.  And large numbers of veterans with heart failure are likely to be eligible for the defibrillator.  

Not all veterans with heart failure need this device but veterans with heart failure and a low ejection fraction that has not responded to maximal medical therapy are thought to be optimal, and who have a reasonable expected life span otherwise are thought to be reasonable candidates.

However, it’s unknown how many veterans who are enrolled in VHA with heart failure have received these devices during the past decade. 

And this is also relevant to VA from an economic perspective because these devices are quite expensive.  The device itself costs between $25,000 and $35,000.  And in fact there has been a number of innovations with the device.  

And I should back up to say that I am going use the term ICD to describe not just the original single lead implantable defibrillators, but really to encompass a family of devices including devices with multiple leads that lead into the heart that resynchronize the heart’s contractile activity. Those are called cardiac resynchronization therapy defibrillators.  

I am going to call all of those devices ICDs in this talk just to be simple, but I am really referring to a family of different devices, some of which are more complex than others.  And so back to this slide the more complex these devices are obviously the more expensive they tend to be.

  And of course there is required physician expertise, facility, specialization, nursing expertise, cardiac care unit, monitoring and other expenses involved in the implantation of the device.  There is a reasonable amount of high technology required to monitor these devices, and so all of these come with costs.  And it is unclear, therefore, how defibrillators have impacted VA health care costs over the past ten years.  

Likewise it is important to realize that a number of veterans come into the VA health care system having received a defibrillator implanted elsewhere that might have been under private insurance coverage.  And that private insurance was lost and so the veteran comes to VA.  It may be because the veteran is dully enrolled in both say the Medicare program and VA, and has the defibrillator implanted under Medicare, but then transfers the predominance of their care to VA.

 And so VA becomes the incumbent provider taking care of a veteran who has an implantable device.  The irony of course is that oftentimes the VA physician was not the one to decide whether the device was an appropriate therapy or not, but since the device is implanted that point is moot, and VA must simply provide the ongoing care often for years of patients who have these devices.  

That entails additional health care costs and those prior to our project largely have gone unmeasured.  And so this sort of sets the stage for our study objectives.  So the first study objective is simply to count the total number of dual-enrolled veterans, meaning veterans who are enrolled in both Medicare and VHA who received ICDs during 2001 to 2010.  

We focused on dual-enrolled veterans because there is this important—two really for two reasons.  One is because heart failure, and advanced heart failure and the appropriateness of this device is more common in the elderly population.  It’s a slight majority, but it is a majority of the recipients in this country or sixty-five and older.  

And furthermore there is this important interplay as I just discussed between the Medicare program, or an outside insurer and VA that we really wanted to focus on.  So there are veterans under the age sixty-five who received defibrillators, but the focus of the study predominantly was among those veterans who were sixty-five and older.  

Those individuals are Medicare eligible by definition of being over sixty-five and the fraction of those that are enrolled in VHA was the cohort for this study.  So furthermore we wanted to quantify the fraction of veterans with ICDs who received their devices at VA as opposed to receiving it outside of VA, and then to determine the total number of veterans unique, as we call them, unique social security numbers living with an ICD who receive ongoing device care at VA.  

Some other study objectives kind of going beyond the description of the patient population was to determine the costs of VA health care attributable to ICD implantation within VA and to ongoing device care.  And a secondary aim was to measure the rate of VA ICD implantation among historically disadvantaged groups of veterans, specifically racial minorities, and veterans with low socioeconomic status.  

This is the mission of my Center of Excellence.  The E in CHERPS stands for equity and our focuses is on disparities.  And so this was our attempt to take a first pass at seeing how these expensive devices are used in disadvantaged groups of veterans.  

The data for this study were primarily the medical SAS datasets that are currently on Austin information system, and combining all of those data with VA fee basis data which records care that was delivered outside of VA that VA pays for on a per claim basis.  In addition, we used VIReC’s VA-Medicare merged data.  

As many of you on the call probably know VA has negotiated that use agreement with Medicare to obtain the Medicare claims of veterans who have been enrolled in VHA, but received Medicare, so exactly this dual-enrolled cohort of veterans.  So we obtained all the Medicare claims from veterans who were either living with a defibrillator or had a defibrillator implanted either in VA or in Medicare.  And I will describe in more detail our selection criteria in a moment.   

So this is a combination broadly speaking of VA administrative data and Medicare administrative data.  So identify defibrillator implantation as well as continuity care in VA we use the following selection criteria.  ICD implantation was identified by the appearance of a relevant ICD-9 code or CPT code. 

And I’m going to break for a moment just to highlight that when I say ICD-9 here I am not referring to defibrillators. I’m referring to the International Classification of Diseases, Ninth Revision.  There’s an unfortunate overlap in acronyms on the presentation which I could not avoid.  However, when I say ICD-I that is of course the codes, not the device.  I’ve also italicized it in the presentation to avoid confusion.   In any event the appearance of these codes in either the VA as hospitalization, surgery, procedure datasets or in the fee basis administration datasets the appearance of codes indicating defibrillator implantation was an indicator that the patient received an ICD in VA or at a partner facility paid for by VA. 

ICD continuity care actually is a little bit more tricky to identify because of the occasional random appearance of codes that are inappropriate, i.e. they don’t actually record the care that happened.  So therefore we require that a patient would be identified as having continuity care for their device. 

What I mean by continuity care of course is once they should have the defibrillator they need to have routine device evaluations determining the effect of the appropriateness of the device function, the amount of energy left in the battery to check for any possible complications, et cetera.  So there’s an ongoing series of outpatient visits that occur for all defibrillator patients. 

So to identify those patients we require patients either to have an outpatient claim with a single relevant ICD-9 or CPT code, and again relevant meaning that it’s a code that clearly indicates defibrillator care was given, whether this a series of codes I’d be happy to share those with interested parties off line.  So we only require one of those if the patient had a confirmed implant prior to that outpatient visit, thinking that that was probably not—the appearance of one code was probably not an error. 

However, there were instances where patients did not have a documented implantation and had a single outpatient encounter where they had a defibrillator relevant code and that had no further evidence in the record at all, either Medicare or VA that they had a defibrillator. Those patients we treated with some skepticism and so we required those patients to have at least two distinct outpatient encounters with relevant diagnosis of a procedure codes.  And this is a technique that has been used by various other studies and administrative data in some sense to increase the specificity of the search criteria and remove potential, the inevitable occurrence of noise in the administrator records.  

We used very similar search criteria for the Medicare data, again looking at Medicare hospitalization records for the relevant ICD-9 codes.  There actually aren’t facility CPT codes in the hospital records and outpatient facility claims that are both ICD-9 and CPT codes.  We searched both of those sets for the relevant codes.  Continuity care was again identified in very analogous fashion to VA data by the appearance of either one code on an outpatient claim subsequent to a confirmed implantation, or the requirement for two distinct outpatient claims with relevant defibrillator codes for patients with no documented prior implant.  

So cost attribution, and this is part of the reason this talk is sponsored by HERC, cost attribution in VA is of course challenging in that VA records do not ostensibly produce a cost measure that is indicative of the per units cost of health care.  Most administrator records in VA do not drive billing and so there is no need for VA records that necessarily indicate the cost of care, as it is different in Medicare of course where the claims that we study are a direct result of the billing process and every claim has a cost attribute.  

Those of you in the know are aware that there are several ways in which this cost problem can be addressed.  We decided to use HERC’s average cost datasets, which are a comprehensive measure and methodology for mapping on the cost of care to VA health care encounters, both inpatient and outpatient. 

We used a one to-one match between those costs datasets and records in the medical SAS datasets.  In addition we use the fee basis records, which do in fact have the paid cost, at least the amount that VA paid for health care.  Those costs were rolled up together in the following manner, dividing costs into either the cost of ICD-9 implantation or the cost of continuity care.  

ICD implantation costs included the cost of hospitalization at the time of ICD implant plus any other defibrillator related encounters within the thirty days after implantation.  There were at least some instances where patients would obviously have to return because of complications with the device or had some relatively soon after implant.  

Most procedure outpatient visits we arbitrarily attributed all those costs to the event implantation.  After thirty days again arbitrarily we assigned any further costs related to the defibrillator as an ICD continuity cost.  

The selection of thirty days is entirely arbitrary.  There is nothing medical or physiological that occurs with the device in that time.  However different cutoffs, forty-five days, ninety days really did not change the distribution of these costs one way or the other.  

Some of you may be wondering, so to save your wondering, about one half into the patient is a highly complicated hospital stay in which an ICD was implanted, but a number of other expensive things happened.  This could be an exacerbation of congestive heart failure that resulted in a long-term stay in an intensive care unit, and then an even longer hospital stay that was eventually completed within defibrillator implant and what say a hospital day forty-two.  

So you may wonder were all those costs attributed to implantation.  And the answer is no.   What we did was kind of map Medicare’s diagnosis-related group costs for uncomplicated ICD implantation to those particular complicated hospital costs.  

So if the cost to VA of a hospitalization was $525,000 we attributed the ICD implantation cost simply to that year’s DRG costs for an uncomplicated ICD implantation.  Again I would be happy to engage in conversation later about your thoughts on that cost attribution.

In some sense it is the most conservative way to attribute cost because certainly the complications of hospitalization can be derived from the ICD implantation.  They are not necessarily irrelevant, but our methodology tried to be as conservative as possible on attributing on health care costs to defibrillators.  

Some words on the identification of race and socioeconomic status, so many of you who do disparities research in VA are undoubtedly aware that the identification of veterans’ race has become quite complicated over the last ten years, mostly due to the absence of a trustworthy data in the VA datasets identifying veteran’s race.  Fortunately because we were focused on a cohort of veterans who were dually enrolled in Medicare and VA, and among the many niceties of Medicare data are that the Social Security Administration surveys all enrollees, of both Social Security and Medicare, and asked, responded and indicated their race.  And they get about a 99% response rate.  

So we had a very good dataset for Medicare in the Medicare enrollment database indicating the race of veterans in our cohort.  Socioeconomics then is of course even more difficult to measure with accuracy at the individual level.  

There is always some interesting conversation that happen on the HSR&D listserv about how to identify low income veterans using VA data.  There is probably no perfect method of doing so and there is no exact measure as such in existing in VA data.  

We approximated the veterans’ socioeconomic status by identifying each veteran’s residential zip code and mapping those zip codes to a zip code level median income as reported on the 2000 U.S. census.  There were all kinds of issues involved in this, of course the ecological fallacy that an individual’s income may not necessarily be well represented by their residential zip codes median income.  

We were well aware that.  At the same time this was in many senses just a broad strokes separation of veterans into plausible groups of low income and non-low income.  The way we did this in a very binary fashion was to simply assign those veterans who are living in the zip codes that comprise the twenty-five percent of the population with the lowest median income in 2000 as low-SES veterans, so again veterans coming from areas that comprise twenty-five percent around twenty-five percent of the population with the lowest median income as reported on the 2000 census.  And again that assignment was entirely binary so....

Let me turn now to some results.  So these are the rates of ICD implants.  And I am pretty sure, and I apologize for not verifying, but I believe this is the entire population of ICD implants, not just the sixty-five and older, but is the entire population of ICD implants.  

Between the years 2001 and 2010 occurring in VA, and what you can see here if I bring my arrow on the screen is that in 2001 before a number of earth-breaking studies were released and indicated that defibrillators were advisable, and in fact guideline recommended, there would be for patients with advanced heart failure.  And in 2001 less than 1,000 veterans per year were receiving defibrillators in VA.  The numbers was around 750.  

That rapidly increased until 2005 where about 2,300 veterans per year received defibrillators.  And again this is not a surprise because in 2003 and in 2005 some major randomized control trials were published indicating the appropriate instance of defibrillator therapy for what is termed primary prevention of sudden cardiac death in patients with chronic heart failure.  

There is a little bit of a drop off, perhaps the exhaustion of the VA providers put in so many more defibrillators in 2005.  However the steam was regained and in fact over the 2008 to 2010 period a remarkably similar number of devices to the tune of about 2,250 per year were implanted at the VA, so a great period of growth in the first half of the of the decade, a period of stability in the second half of the decade.  

As you might expect therefore there have been an increasing number of veterans who have, who are in the VA health system who are living with a defibrillator.  And for those of you who remember practicing medicine at the VA in the 1990s, and I have practiced there since 1995, a patient with a defibrillator was a rare entity in the 1990s, was this very rare sea of patients in VA with a defibrillator mainly because the criteria for receiving a defibrillator in the 1990 was that you would have had to survive a sudden cardiac death event, or to have a ventricular arrhythmia that put you at high risk for sudden cardiac death.  

And so that population by definition is quite small, but as you can see during the decade of the 2001 to 2010 there was tremendous growth in the number of veterans living with a defibrillator, growth from about 6,000 in 2001 to over 25,000 veterans nationwide in 2010.  And again these are veterans actually receiving care through the VA.

Move along to the percent of ICD implants that occur among dual eligible veterans in VA, you’ll notice that my data notes stop in 2008 rather than 2010 because we had VA data through 2010 but we only had Medicare data through 2008.  So all of the slides involving dual eligible veterans will only be 2001 to 2008. 

VA implanted about ten percent to begin of all the defibrillators among veterans who were dually enrolled in both VA and Medicare.  And that population I just actually asked the folks at VIReC what the percent of veterans is.  And that percentage is actually about thirteen percent it turns out. 

So the number of veterans who get, and what do I mean by that?  About thirteen percent of dual-enrolled veterans get primarily obtain their medical care at VA.  About eighty-seven percent of dually-enrolled veterans primarily obtain their medical care outside of VA and Medicare. 

There may be some amount of going back and forth.  However if we look at who received in that population who received their defibrillator in VA the percentage peaked around ten percent, then dropped to around eight percent and has sort of slowly grown back to around nine to nine and half percent by 2008.  So one way of thinking about this is about one in ten to one in eleven veterans who have a choice in some sense about where they’re getting the defibrillators are getting their defibrillators implanted at VA. 

Now to this issue which I discussed before about where do the defibrillators in VA come from, meaning of all those patients who I mentioned who are walking around VA hospitals with defibrillators, how many of them had those defibrillators implanted by VA physicians?  So the way we approach this because we needed a cohort of patients who had a number of years prior data, and we need entire data in both Medicare and VA, so we took the cohort of veterans living with defibrillators in 2006 to 2008, which were the latest years of our data. 

And then we looked back at both VA data and Medicare data.  So we could look as far as 2001 in Medicare data.  And I think we looked back as far as 1998 in VA data to try to determine where those veterans had received their defibrillator.  We were looking for an implant claim. 

And so a couple of observations which I thought were striking from this search, first of all only sixty percent of veterans living with a defibrillator in ’06 to ’08 who were getting continuity care for that defibrillator in VA had an identifiable claim for an implant.  And so there are many possibilities.  

And I’ll just suppose the possibility that veterans implanted in themselves showed up to VA having done their own self-care.  That’s probably not what happened.  

There is a possibility that they received a defibrillator outside of either Medicare or VA, paid for by private insurance.  That’s certainly possible.  

They could have received a defibrillator in VA, but as part of what is called contracted care.  This is care in which VA contracts for specific health care services with a partner organization usually at an affiliated university.  And unfortunately those encounters are not captured in VA data.  In fact I’m not sure exactly where they’re captured outside of the institutional records of the affiliate. 

So if defibrillators were implanted under contracted care they would be invisible to us.  Likewise defibrillator implants would be invisible if they occurred in Medicare among HMO enrollees.  Medicare right now about twenty-four to twenty-five percent of Medicare enrollees are HMO enrollees are in the Medicare, what used to be Medicare Part C, now Medicare Advantage.  

Those veterans up until very recently and then changed in 2009 I believe there were no claims generated from that care because there was no billing that occurred in the HMO mechanism in Medicare.  By definition those patients were not fee for service.  There were no bills. And so that care would also be invisible.  

So those are at least some of the explanations.  I guess the fourth explanation of course would be that these patients received their defibrillator prior to the windows of our data, so prior to 2000 in Medicare, or prior to 1990, prior to 2001 in Medicare, prior to 1998 in VA. 

Somewhat less likely I think that the other explanation simply because defibrillator implants were relatively rare in the 1990s and to live a long period of time with a defibrillator is also is becoming more typical, but is less typical of the type of recipients who received defibrillators in the 1990s. Okay so and I missed the key point. 

A large percentage of veterans for whom we could identify a source of their ICD, a large percentage of those veterans received their ICD outside of VA.  In fact we could only verify the twenty-six percent of veterans with a defibrillator receiving continuity care at VA received that defibrillator implanted by VA physicians.  

Now you can site for yourselves how to apportion that forty percent for whom we don’t have records.  My guess is going to be that even with the appropriate assignment of that forty percent that more than half of the defibrillators in among veterans receiving care at VA were implanted outside of VA.  So I’ll let you ponder the meaning of that. 

Let’s move on to cost.  The per patient implantation cost for veterans, and this is using 2010 dollars, thousands of dollars, so these are inflation against the costs, rose from about $50,500 in 2001 to about $64,600 in 2010.  So again this is every time a device is implanted how much does it cost the VA, and these costs that are entirely encompassed in a thirty-day window of time. 

And so the remarkable thing is the costs have gone up by about thirty percent.  This is not surprising in many ways because even though the devices are manufactured by a number of companies that in competition with one another and the VA is a good purchaser, a large volume purchaser of devices, they tend to get good prices, the complexity of the devices has increased.  The amount of expertise needed has been reemphasized over and over.  And hence the cost impact of an implant has been rising over time, even at the per-patient level.   

Continuity costs interestingly enough remained relatively flat.  In 2001 there were relatively few implants so there is a little bit of noise on this end of the scale, but in general the average continuity cost really stayed pretty flat, around $775 per patient device, very low.  

However many of these patients are simply monitored via telephone.  Their devices communicate electronically with their VA providers.  So the cost of those encounters, the unit costs are actually fairly low, but there was no evidence that we could find that the continuity care for ICD patients had increased with time. 

The total fiscal impact on VA however was relatively striking.  And this is if you add all the costs of implantation to the costs of continuity care the increase in total cost to the VA attributable to defibrillators has risen from about $43 million in 2001 to $166 million in 2010.  That is as you know about a fourfold increase.

There is this blip here in 2005 perhaps related to all that enthusiasm about implants in the year that it was determined that these devices are relevant for much larger population.  Nevertheless we’ve even exceeded that amount in recent years.  And the costs, the total costs to VA now are approaching about a sixth of $1 billion every year.  

Turning now to some of the work we did to try to ascertain disparity in the use of defibrillators, these lines indicate the percentage of ICD recipients again among dual-enrolled veterans in VA, and that’s the yellow line, and in Medicare that’s the blue line, who are African-American, and a couple of observations.  First of all in VA the percentage here of ICD recipients who were black exceeded ten percent in 2001 and has actually significantly increased actually from 10.6 percent to about 13.4 percent, so over one in eight veterans in 2008 receiving a defibrillator in VA are African-American.  

In Medicare the percentage is much lower.  About five percent of again dual-enrolled veteran recipients of ICDs in Medicare were African-American in 2001 and then slightly increased about six percent in 2008. 

Now how do these percentages relate to the number of eligible patients for defibrillators?  So I would love to be able to give you a good answer to that question because if we had indications of how many patients were actually eligible for the device that would give us a tremendous insight into whether there is racial disparity or not.  

I can’t do that because those data simply don’t exist.  I can give you a proxy measure for the percentage of African-American veterans with heart failure in VA who may be eligible for defibrillators.  And that proxy measure, and if you’re a cardiologist please hold your tongue to the end or at least it’s a good thing this is mute, is the proxy measures of hospitalized heart failure veterans who are black, and I will hasten to add that this is not a criteria for ICD implant.  

There are many veterans hospitalized for heart failure who do not make criteria for defibrillators.  Nevertheless it is a proxy measure for veterans with advanced heart failure.  And you can see that about in 2001 about fifteen percent of hospitalized heart failure veterans were black.  That percentage has dropped down to twelve percent.  

I’m going to propose, and I’d be happy to debate the point that that is a close proxy to identify the number of veterans with advanced heart failure of reduced ejection fraction who may be ICD eligible.  Again I don’t think these numbers are trustable to decimal places by any means.  Nevertheless I think there is some evidence here that the VA is doing a reasonable job at serving the needs of minority veterans with high technology care. 

Moving on to socioeconomic status of somewhat a similar story, remember I assigned—we assigned arbitrarily veterans to high or low socioeconomic status based on their residential zip code.  In broad strokes twenty-five percent of the U.S. population lives in low-SES zip codes. 

The veteran population is actually slightly lower on average socioeconomic class in the U.S. population and the VA enrolled population and the VA enrolled population who gets care at VA is even higher.  Among device implant recipients in VA over thirty percent of veterans were from low socioeconomic status zip codes in 2001.

That number declined by a few percent significantly so to twenty-eight percent in 2008.  I’ll give you the analogous percentages to the prior slide of the number of veterans who were hospitalized with heart failure who were from low socioeconomic status zip codes.  

Again take this with a grain of salt.  I understand these are not measures of device appropriateness.  Nevertheless it appears that there is relatively close association between the percentage of low-SES veterans getting—the percentage of ICD recipients who are low-SES and the percentage of advanced heart failure patients who are low-SES. 

And again this percentage is much higher than the percentage of Medicare veterans, veterans getting their care, dual-enrolled veterans getting their care in Medicare who received their devices paid for by Medicare.  I find these two slides encouraging in that the mission of VA is of course to meet the needs of veterans who are historically disadvantaged.  And so the fact that these yellow lines exceed the blue lines I actually think is a strong statement the VA’s mission is being accomplished. 

So some conclusions, the VA ICE implant rate increased substantially from 2001 to 2005, plateaued at approximately 2,250 implants a year.  As I tell my research assistants that means that VA is implanting about fifty devices nationwide every week with a broad strokes approximation.  

So there are a lot of these devices being implanted across VA.  The number of unique veterans in VA with defibrillators has increased astronomically really from a very rare occurrence in the 1990s at the beginning of the decade of the odds to now where a defibrillator in a veteran is incredibly commonplace.  Thirty thousand veterans likely if the projection continues in 2012 are going to VA and have a device. 

And I think that actually has a tremendous amount of implications as we think about end of life care for veterans who have been active device, various other reasons why the device impacts a patient’s psychological wellbeing, et cetera.  So I actually think is a cohort of veterans that will provoke a lot of interesting discussions in hospital wards and in clinics about how to manage life with an implantable device. 

Sizeable numbers of veterans with ICDs had the devices implanted outside VA.  And this is relevant because in many senses, and I see the use an irreversible decision.  That’s not entirely true, but it’s a difficult to reverse decision. 

And so the clinical decision to implant the device in many cases with veterans who have been made by a non-VA physician, but a VA physician is responsible for the care of that device in that patient going forward.  So that’s sort of a remarkable phenomenon.  There’s no real analogy to that with pharmaco therapy for example where a VA physician can stop a drug, but it’s actually quite difficult to stop a device.  It’s doable, but it’s very hard. 

Turning to the economics the average implant cost to VA increased by about thirty percent, as I mentioned in the results.  The total fiscal burden to VA of defibrillator care increased from about $43 million to $166 million.

And if you take the portion of that cost that is derived from implants that occurred outside VA at least $14 million and maybe more than that, maybe substantially more is derived from veterans who received their care outside of VA.  So again VA is in many senses in a great deal of examples paying the cost for decisions that were not originally made by a VA physician.

Some thoughts on minority veterans, so the percentage of VA ICD recipients who were black increased significantly from 2001 to 2008. The VA implants more defibrillators in a higher percentage of black veterans than the Medicare program does.  And VA’s ICD implant percentage in 2008 is reasonably close to the percentage of hospitalized VA patients with heart failure who are black.  

In terms of low socioeconomic status the percentage of ICD recipients in VA from low-SES zip codes decreased slightly over time.  Nevertheless VA implanted defibrillators in a higher proportion, or I should say again the defibrillators implanted in VA were more likely to be going into patients from low-SES areas than were the defibrillators implanted in the veteran population cared for by Medicare.  The low-SES ICD implant rates in the VA were similarly comparable to the percentage of VA hospitalized heart failure veterans from low-SES areas.  

It’s worthwhile to acknowledge the some limitations of this study.  VA records of course may not accurately capture all ICD implantations.  And those of you who may be involved in some of the efforts within VA to be more rigorous about capturing implantations, I know there are efforts headed up by my colleague in Denver, Paul Varosy, in forming a CART-like database, the excellent database that has been in existence for a long while, capturing the use of a percutaneous coronary intervention in VA, is now being expanded to defibrillators, devices implanted in the electrode physiology lab. 

So really we didn’t have access to those kinds of data.  And there is reason to believe that implants are missed in VA because frankly because no one has necessarily paid based on the accuracy of VA data.  And so if a VA hospital encounter is missing the code for a defibrillator implant, well in the private sector that’s going to cost the hospital thousands of dollars in unrecouped reimbursement from an insurer, but in VA that’s just there is no economic indication to that. 

Cost attribution as we discussed to ICDs is inexact.  There are issues of course with determining how much of the costs of a complicated patient’s care is attributable to a device and how much is attributable to their underlying condition such as heart failure or other complicating conditions. 

Obviously many of these patients are quite ill with many chronic conditions.  And so it’s certainly possible the costs were measured with error.  We in almost every circumstance where we had a choice tried to be as conservative as possible in attributing a device cost to the device itself.  So I really do think that we are closer to the lower bound of cost estimates rather than the upper bound. 

And lastly and sort of sadly there are no indicators of appropriate use for defibrillators in either VA or Medicare data.  And so from all these data it’s uncertain whether ICDs were underused or overused.  

And it’s certainly relevant in the discussions of use of defibrillators in racial minority patients or low-SES patients.  I cannot tell you that because I don’t know if the rates of use were appropriate or whether minority veterans are getting too many or too few devices, et cetera.  There are simply no indicators as yet for appropriate use. 

Some thoughts on the impact of these findings to VA, this is obviously a QUERI project so the goal of the rapid response program is to come up with data in a given form, decision making, either clinical or management decisions making in VA.  One of the most important observations I have in that regard is that defibrillators were a source of huge cost growth in VA that were unlikely to have been anticipated in 2001. 

If VA administrators were asked well what are going to be the primary sources of cost growth, there may have been some vague thoughts to the idea that medicine is going to change, but it is exactly this phenomenon as which illustrates how technology drives health care cost increases.  Defibrillators were largely experimental in the 1990s, were a very rare event particularly in VAs.

Now they’ve become commonplace and they remain quite expensive.  And so the growth and the use of this it really isn’t brand new, but I’ll call it brand new technology to the extent where thousands of veterans now have this as a routine element of their cardiac care, has had tremendous economic impact on VA. 

And nevertheless I will point out some other things that despite that growth there are no widely available sources in VA.  And I know some of you on the call may be working on this problem.  I think it’s critical.  

There are no widely available sources in VA about clinical appropriateness of ICD implants.  We don’t know how many veterans are receiving care in our health system and are currently appropriate patients for a defibrillator that have not been approached by their provider to have the conversation about that therapy.  

Likewise we don’t have a good measure of the clinical appropriateness of the devices that were implanted.  There have been some very good studies and I would point you to the heart failure QUERI and to some of those data that have given at least a look in that direction, but there really is no ongoing mechanism that I am aware of just yet.  And I think the CART program may provide it, but there are no ongoing mechanisms to discern whether the devices that are going into veterans in VA are appropriate. 

Third impact is that VA often inherits the care of decisions made outside of VA.  And to the extent that that occurs with implantable technology that is going to have a tremendous impact on VA’s costs.  

As health care moves away from simply the prescription of orally bio-available medications to various implant systems and other technology assist devices which are literally integrated with a patient, the VA is going to be responsible for the care of high technology and is going to have to bear that cost.  So I am going to pose this as sort of a harbinger of things to come in regards to implantable insulin pumps, to neurologic defibrillators to all of the really remarkable devices that patients will be living with in the future. 

So I kind of close with some because I need to leave time for questions.  VA really faces a technology imperative.  Costly devices are going to continue to come into play.  VA obviously needs to balance the need of practice state-of-the-art medicine and to provide that care equitably among both veterans from disadvantaged groups as veterans from majority groups in a way that is equal, but limits the costs such that every dollar spent of VA health care is a high value dollar. 

And so this is my last slide.  I think I’ve hammered the point home excessively that ICD implantation rates, the number of veterans with ICDs and the costs have risen tremendously over the decade.  I am encouraged by our first look whether VA is delivering equitable care in this regard.  It appears to be doing so.  There is a lot more work that needs to be done and some better data would help tremendously to help us understand the appropriate use of these expensive devices. 

So I’ve expanded my time talk one minute into question time, but I’d be happy to take additional questions at this point. 

Moderator:  Thank you so much.  And for our audience if you have any questions please use the Q&A screen and Go to Webinar to submit those questions into us.  The Q&A screen is located on the dashboard that’s on the right-hand side of your screen.  

You can use that orange arrow at your upper right-hand corner to open or and collapse it against it the side of your screen right near the bottom of that is a place for you to submit your questions.  

We do have one question and one comment pending here.  So we will start with the question.  Do we have any idea if the SES of patients receiving the majority of their care outside the VA differs from the SES who get their care primarily through the VA?

Peter Groeneveld:  I’m going to—so well that question I can’t answer.  So it is certainly true, and again you have to believe these proxy measures for SES, right, because neither Medicare nor VA asked individual veterans or individual Medicare beneficiaries how much, what’s their household’s income.  So we have to do this proxy. 

VA cares for a disproportionately higher number of veterans from low-SES locations.  And so in some sense it would be a surprise if VA did not implant more devices in low-SES veterans.  

Nevertheless a proportion—the proportional difference in those populations is not as great as the difference in ICD implant rates.  And what I mean by that is VA seems to be implanting devices in low-SES veterans disproportionately higher than you would expect given the proportion of those veterans who get their care at VA, so excellent question.  Yes the VA takes care of more veterans from low-SES areas, but the implant rates actually exceed the expectation as far as that goes. 

Moderator:  Great.  Thank you.  The comment we have here I believe that the CART team is working on a CART EP product which I assume will capture appropriateness data.  

Peter Groeneveld:  Yeah.  I hear that.  And again I wonder if it’s Paul Varosy who actually wrote that comment. If not I will give Dr. Varosy a shout out.  He is an electrophysiologist at the Denver VA and has been intently involved in trying to create an analogous data collection mechanism similar to the American College of Cardiologists, a national cardiovascular data registry which captures implant information on all defibrillators.  I won’t say all, but on most defibrillators implanted outside of VA.

So this would be a comprehensive database capturing healthcare information.  And so my understanding is that that is well on its way to fruition.  And I think that will provide some very helpful data.

There are some caveats.  And of course one is the self-reporting of appropriateness criteria by physicians and I am a member of the oversight committee for the research use of the MCDR dataset for defibrillators, so I like that dataset.  I’ve done research on that dataset. 

I do not know how accurate asking physicians who are implanting devices whether that was an appropriate implantation or not, which is essentially what the dataset is asking.  I don’t know how accurate that assessment is.  What we have noticed is when there are publications suggesting that there is an implant that many devices are not implanted under criteria the number of records that say yes it is appropriate has increased.  

The second thing that is really important though is to remember is that registry will not capture the veterans who do not receive implants.  And those implants are the ones we are really sort of also interested in.

What I mean is the number of heart, veterans with heart failure who meet all the clinical criteria, but have not been offered a device or have not had that discussion—some veterans very rightly turned the device down after weighing the pros and cons, but we don’t have a good measure yet or a good dataset which indicates here are the heart failure patients in the VA.  Here is a measure of their ejection fraction.  Here is whether they are on a reasonable proxy of maximal medical therapy.  Here are the contraindications.  

This is in the future of registry based medicine, which is sort of to monitor disease cohorts in a population and determine to some extent how well our health system is doing, is meeting the health needs of our population.  And that I suspect is coming, but again it will take a tremendous initiative and there are cost concerns frankly because sort of the last thing the VA needs is to figure out they need to go implant another 20,000 defibrillators in the next twelve months.  I don’t think there’s money in the budget for that. 

Moderator:  I don’t think there’s money in the budget for much these days.  

Peter Groeneveld:  Yeah.  

Moderator:  Thank you.  The next question that we have here, of the approximate 2,500 veterans who get an ICD each year any idea of how many of these dually enrolled?

Peter Groeneveld:  Oh yeah.  So that’s actually a great question.  So we actually it turns out about eighty-five percent of those veterans are dual enrolled, so as again the heart failure being a more common disease as the incidence of heart failure goes up exponentially as a patient ages.

The median age of a defibrillator recipient in the United States is the late sixties it turns out. 

So and it turns out for VA implants a lot of these are occurring among elderly veterans.  So I believe the percentage, and I don’t have it at my fingertips, but I believe the percentage is around to eighty to eighty-five percent.  

Moderator:  Great. Thank you.  Another comment here, one thing the VA really needs is a capturable measure of ejection fraction. 

Peter Groeneveld:  Yes.  I couldn’t agree with you more.  And there has been some tremendously positive efforts in this regard by the heart failure QUERI, in particular Barry Massie and Paul Heidenreich, who are the co-directors of the heart failure QUERI, had pushed hard to try to get that particular measure into the CPRS VistA package.  

Ironically in some sense VistA and CPRS is very well designed to capture particular types of data.  And this is exactly the type of data it is very poorly designed to capture because ejection fraction really is the last measure.  It really isn’t a vital sign and in fact so it is a number which we would like to put into a field, but it doesn’t fit nicely into the data structures around which CPRS is designed. 

And of course the other thing that makes it hard is most of these data are collected on ejection fraction on text form reads of echocardiograms and nuclear medicine studies where there’s a whole variety.  And for those of you who have tried to do natural language processing on these types of reports and radiology you know what I’m talking about. 

There’s a whole variety of language that are used to describe ejection fraction.  So some reports will say the ejection fraction is between forty-five and sixty percent.  It’s mildly reduced, almost normal.  And there are all kinds of things which are very hard to translate into a number.  And so there are a variety of barriers.  

I think it is eventually going to happen.  And it may even be made a quality measure such that in some sense the seventh or eighth vital signs since I think we’ve already exhausted the fifth and sixth vital signs or the seventh and eighth vital signs for patients with heart failure is going to be what is their best estimate of ejection fraction and how old is that estimate. 

Moderator:  Great.  Thank you.  And that is all of the questions and comments that we have received.  We are just about at the top of the hour.  Did you have any final remarks you wanted to make before we close out?

Peter Groeneveld:  Well so my only encouragement if in this topic or in topics of this nature are of interest to you I really encourage you to visit the VA heart failure QUERI website.  They have some excellent reports on the demographics and the demographics of the heart failure population in VA and the initiatives that are ongoing to improve heart failure care.  

You can sign up for the heart failure clinical care network within VA.  And so they scratch my back.  I scratch theirs.  It’s a great organization and if this is an area of interest to you I highly recommend visiting the heart failure QUERI website. 

Moderator:  Fantastic.  Thank you so much for plugging that and also, Pete, I really want to thank you for the—oh we just got a request for the URL for the heart failure QUERI site.  And I will actually send that link out to everyone.  

And you will receive an e-mail from HSR&D cyberseminars tomorrow that will have your archive link for this cyberseminar.  And I will include the URL for the heart failure QUERI site in there so you’ll have the direct link.  So just watch for that in your e-mail tomorrow.  

But, Pete, I want to thank you for taking the time to put your session together here and present for us.  We very much appreciate the time that you put into this.  

Peter Groeneveld:  Great.  Thanks, Heidi.  It’s been a pleasure. 

Moderator:  Oh wonderful and thank you to our audience.  You’ve got a couple comments here in the questions that your session was great and helpful.  So we really appreciate that you put the time into this.  

For our audience as you leave the session today you will get a popup for a feedback form.  If you could take a few moments to fill that out we would appreciate it.  We definitely take all of your comments into consideration for our current and upcoming sessions.  

So thank you very much and this will formally conclude today’s HSR&D cyberseminar.  Thank you, everyone.  

**[End of Recording]**

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