Release Date: November 6, 2006
Editor's Note:
The use of implantable cardioverter
defibrillators (ICDs) for the primary prevention of sudden cardiac death in
patients with left ventricular (LV) dysfunction was demonstrated to
significantly reduce mortality risk in the Multicenter Automatic Defibrillator
Implantation Trials (MADIT I and II), the Sudden Cardiac Death in Heart Failure
Trial (SCD-HeFT), and has been supported by several additional trials and
meta-analyses. The results of these studies led the Centers for Medicare &
Medicaid Services (CMS) last year to expand Medicare coverage of ICDs for
primary prevention patients with LV dysfunction. However, coverage is routinely
provided only for Medicare patients receiving single-chamber ICDs (dual-chamber
devices are covered only if justified), and patients must be entered into a new
registry designed to track patient and device characteristics. The expansion in
coverage led to a dramatic increase in the number of ICDs implanted for primary
prevention; however, at the same time, important questions have been raised
about the real-world use of the devices and the ultimate cost-effectiveness of
ICD therapy. To gain a perspective on current policy and practice issues,
Medscape talked to Mark D. Carlson, MD, University Hospitals of Cleveland,
Cleveland, Ohio, who is chair of the Heart Rhythm Society's (HRS) Task Force on
device safety. According to Dr. Carlson, there are a number of challenges ahead,
but with new initiatives in place to refine our knowledge base and improve
physician and patient awareness, the field is definitely moving in a positive
direction.
Medscape: As you know, the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) employed single-chamber, shock-only ICDs, and coverage guidelines provided by the Centers for Medicare and & Medicaid Services (CMS) also encourage the use of single-chamber devices when possible. However, there are some instances in which dual-chamber or cardiac resynchronization therapy (CRT) devices may be more appropriate. How is this all playing out in clinical practice today?
Dr. Carlson: SCD-HeFT employed only single-chamber ICDs, and the clinical benefit shown was with these single-chamber ICDs. It is possible that some of the patients in the trial would have benefited even more from dual-chamber defibrillators or even CRT devices, but of course the trial was designed and began before CRT came along. I think the CMS reimbursement policy enables physicians to provide the appropriate therapy for patients who can benefit most. That means if a patient does not have a need for an atrial lead, we should not subject him or her to any additional risk or expense associated with implanting one. On the other hand, if the evidence indicates that an atrial lead is indicated, it will be covered.
The real question we must ask then is which patients benefit from the addition of an atrial lead. In general, 2 groups of patients may benefit: those with a bradycardia indication for pacing and, potentially, those with atrial tachyarrhythmias. The DAVID (Dual Chamber and VVI Implantable Defibrillator) trial taught us that in patients with heart failure and structural heart disease, frequent ventricular pacing can have a negative impact on left ventricular (LV) systolic dysfunction and can aggravate heart failure. So patients whose heart rates may be low and who require pacing a fair amount of the time may very well benefit from having an atrial lead and device programming to minimize ventricular pacing, rather than a single-chamber device. Within that group are patients who have sinus node dysfunction and patients who may require drugs that slow the sinus rate to the point that they would benefit from pacing. For example, this may include patients who experience sinus bradycardia or sinus pauses when they receive beta blockers.
We also know that ventricular pacing can have an adverse effect with regard to atrial fibrillation (AF). Patients who are paced in the ventricle alone are more likely to experience more frequent AF, earlier recurrence of AF, or experience the first onset of AF. We know that in patients with a bradycardia indication for pacing, atrial-based pacing can decrease the risk for recurrent AF or AF onset. So patients with AF may benefit from an atrial lead as well.
However, the issue becomes challenging with less clear-cut cases. This includes patients who haven't had an AF episode, but who may be at risk of developing AF; patients who have borderline sinus node function; those who are likely to need drugs; and those who may be able to increase their dose of beta blocker if they had an atrial pacemaker. Sometimes we don't know whether the atrial lead will benefit these patients until we implant the device. Those cases can be challenging for us.
Finally, there is some evidence that an atrial lead can enhance the ability of an ICD to discriminate between supraventricular and ventricular arrhythmias, making it less likely that a patient will receive an inappropriate shock for supraventricular tachycardia or atrial fibrillation. Certainly, examining the atrial electrograms can assist us in determining, in retrospect, whether ICD therapy was delivered for a ventricular arrhythmia or for atrial fibrillation.
Medscape: What do you see as CMS's attitude toward this?
Dr. Carlson: CMS is not excluding the use of dual-chamber devices in patients who need them. If we implant an atrial lead, we need to document the reason for it very clearly. If we can document the reason and it's a good reason, it's my understanding that CMS will provide appropriate compensation for that and that physicians and their patients won't be penalized.
Medscape: Do most physicians who are implanting these devices understand this?
Dr. Carlson: The physicians with whom I've interacted understand that, but I think that it's a learning curve. Of course, I've had the benefit of working closely with people in CMS and the leadership of the Heart Rhythm Society (HRS) and people who've been very close to the policy process, so I'm coming at this with perhaps more access to information than some implanting physicians. I think that there are physicians -- electrophysiologists and other implanting physicians -- who may not understand that under the appropriate circumstances and with the appropriate documentation, they can implant atrial leads in their patients.
Medscape: As you mentioned, dual-chamber ICDs are now available with algorithms that reduce the amount of right ventricular pacing, and some studies have shown that patients who receive these devices may have better outcomes than those who receive a single-chamber device. After results of the DAVID trial came out, a lot of physicians switched to using single-chamber ICDs in their primary prevention patients. Will these new results cause a resurgence in the use of dual-chamber devices?
Dr. Carlson: I don't think that there's a single trial out there that's going to cause a sea change in clinical practice. However, I expect that we will be accumulating data over the next several months and years, and if that evidence continues to indicate that atrial-based pacing with minimal ventricular pacing is associated with better outcomes, then I would expect the practice and the practice guidelines to change.
Medscape: At that point, would you expect CMS to revisit that issue?
Dr. Carlson: I've been very impressed that the people at CMS are doing their best to provide evidence-based reimbursement guidelines, and I think that their guidelines to date have followed the evidence to a large extent. There are areas in which the evidence is very strong for or against a particular therapy, and there are areas in which it's less clear. However, I think that CMS is doing its best to provide appropriate reimbursement when the evidence is clear and trying not to penalize people when the evidence is less clear and additional information is being accumulated.
Medscape: When CMS issued its proposed cuts in inpatient reimbursement earlier this year, it seemed that the agency was targeting specialty cardiac hospitals, in particular, with large cuts in reimbursement for ICD implantation. Although the final cuts were scaled back considerably, what kind of pressure did this put on physicians and hospitals?
Dr. Carlson: The initial proposed rule was much more dramatic than the final rule. It's my understanding that almost every sector, whether it be patients, physicians, hospitals, or manufacturers, is much more comfortable with the final rules than they were with the proposed rules. Although some of the specialty hospitals were particularly concerned about reimbursement, these concerns were not specific to or limited to specialty hospitals. The proposed cuts would have affected other hospitals with large cardiovascular programs as well. It was my understanding that they would have had perhaps a greater effect on specialty hospitals where the percentage of cardiovascular activities is even higher, but it would have affected our institution and many others with strong cardiovascular programs.
The concerns voiced by many were that these changes could have or would have made these activities either less economically attractive or, in fact, economically unattractive to many hospitals, and that it could have decreased access to needed therapy for many patients. The proposed cuts certainly had the potential to do so in ways that affected some populations to a greater extent than others -- perhaps geographically and maybe even socioeconomically. So I think that the industry -- and by that I mean medical centers, hospitals, physicians, patients, and manufacturers -- were more comfortable with the new, final rule.
Medscape: From what I understand, the final rule is not necessarily the final word on this. CMS is going to be looking at ways to reduce cost in the years ahead -- although maybe not quite as drastically as was first proposed. Do you have a belief for why CMS would propose such a drastic reduction in the first place for ICDs? Is there a general belief that ICDs are being overused, or is there something else going on?
Dr. Carlson: I think that CMS is very interested in how technologies are used once they are approved, and the extent to which device therapies are used in a manner that is supported by the clinical trials that led to market approval. This is of particular interest with regard to ICDs, and it's one of the reasons for the new NCDR (National Cardiovascular Disease Registry) ICD registry that has been developed under the direction of the American College of Cardiology and the Heart Rhythm Society. CMS is very interested in determining whether the patients who are receiving ICDs are similar to those who were enrolled in the clinical trials and whether the outcomes for these patients are similar to the outcomes reported in the clinical trials.
Sometimes, when new therapies, including drug therapies, are developed we experience "indication creep," and patients, who for very good reason might not have been included in clinical trials, receive the therapy. In many cases this is very appropriate, but some at the CMS have expressed concern that this could happen with ICDs and that these additional patient populations may not benefit as much as those in the trials, or may not benefit at all.
Medscape: What is the status of the NCDR ICD registry? How many hospitals are currently participating?
Dr. Carlson. To date, approximately 61,000 ICD patient implants have been enrolled in the NCDR ICD registry. Currently, 1379 hospitals are participating in the registry, and 94% of those are enrolling all of their patients who are receiving ICDs, not just the Medicare primary prevention patients. Of course, that's extremely important if we are to understand how well these devices are working. If we're only enrolling Medicare patients who, in general, are older than the average population, we might not be able to show the same benefits that we would otherwise.
Medscape: How does CMS intend to use the data from the registry, and how might the data influence reimbursement?
Dr. Carlson: I'm hopeful, and I believe, that the registry will show that many patients are benefiting from these devices and that CMS will continue to provide access to patients who can benefit. CMS has indicated that it will not restrict coverage or payment on the basis of registry data. But if the data indicate that there are specific groups that don't benefit from the devices, we need to know that, too, and we as physicians need to be able to make adjustments in our practice on the basis of the data.
Medscape: Are the registry data going to be strong enough to support those kinds of decisions, or would you take that information and say "we need a randomized trial"?
Dr. Carlson: This raises a very, very good point. In general, registries are better at generating questions than they are at answering them. The reason for this is that registries are not randomized trials, and they're not, in general, designed with the ability to answer specific hypotheses. There is no control group to which one can compare the group that received therapy. Certainly we wouldn't want to jump to the wrong conclusions on the basis of registry data if those data contradict the answers that we've gained from several well-run and well-designed clinical trials. I don't want to exclude the possibility that there are questions that can be answered by the registry; there well may be. However, I suspect that we're going to find that the results generate more questions than answers.
Medscape: What about device performance data from the registry?
Dr. Carlson: Well, I think that it's important to remember that the NCDR ICD registry is not designed to be a stand-alone device performance registry. It's not designed to be able to pick up low-frequency device malfunctions when used alone. The HRS Task Force recommended that device performance data be gathered, with the understanding that the data would be one component of a more extensive and complex system and that it could add additional information. However, we never intended to imply that the NCDR ICD registry is poised to become the "device registry." It's a patient registry, really.
Medscape: The recently finalized HRS Task Force guidelines on dealing with and reporting device malfunctions recommend that the ICD-NCDR registry be modified to include the collection of long-term, longitudinal data. Are there firm plans in the works to do this?
Dr. Carlson: This is something that's been under discussion since the inception of the registry, but it's a complex issue. Devices are implanted at one of several sites, but they're followed at many more. The implanting center is not necessarily where patients are followed, so accessing these longitudinal data is not as simple as it may seem.
The collection of longitudinal data is also associated with substantial cost, and the question of who will pay that cost is another subject of discussion. Of course, the potential candidates include almost everybody who's involved in healthcare -- the federal government, third-party payers, health plans, manufacturers, patients, and physicians -- and if you look at who can benefit from these data, it's the same list. In one way or another, patients and physicians are already involved in paying for this and will continue to be involved in terms of time spent, whether it's reimbursed or not.
The HRS is leading a task force of these stakeholders to examine this, and I'm hopeful that some agreement can be reached because I do believe that the collection of longitudinal data could potentially provide some interesting and useful information that could be useful.
Medscape: Will the registry lead to greater quality-control oversight of hospitals that are implanting ICDs?
Dr. Carlson: I think that all of us have an interest in using the data to enhance quality. The hospitals will be able to use the data to examine their own programs, compare their programs with other like programs, and identify areas for improvement. I think that's one of the strongest reasons to do this -- we'll be able to look for opportunities for improvement -- at the implanter level, at the facility level, and at the national level.
Medscape: Would you support the establishment of CMS-recognized "centers of excellence" -- institutions and physicians identified as having performed a certain number of procedures -- for ICD and pacemaker implantation, similar to the system in place for obesity surgery?
Dr. Carlson: I am not sure that there is sufficient evidence to support that today. The HRS created guidelines for training and experience required to implant these devices, and both the HRS and the ACC are strongly encouraging the facilities where these devices are implanted to use those guidelines. It's clear that outcomes are related to experience -- it's absolutely clear, but the question is complex. We want to make sure that patients have access to the therapy, and we want to make sure that access continues to be appropriate over time so that as populations shift geographically, patients continue to have access. However, we want patients to have access to the highest quality care as well. So I think that it's possible that the ICD registry may help us to understand that better going forward, but I don't know that we're near being able to make any recommendations on centers of excellence yet.
Medscape: Let's talk about another recommendation included in the HRS Task Force guidelines: the elimination of the word "recall" from ICD and pacemaker device malfunction communications. This is a change that has been strongly endorsed by both healthcare providers and manufacturers, and the US Food and Drug Administration (FDA) said recently that it was considering taking this step. Is this an important step forward, and if so, why?
Dr. Carlson: The recommendation to eliminate the term recall with respect to implantable cardiac rhythm devices is one of the most important recommendations coming out of the HRS Task Force. We believe that the current nomenclature system, with respect to ICDs and pacemakers, is not working in the best interest of patients; it is not good for the public health of America.
To many patients and physicians, the term recall has certain connotations that indicate that the product should be retrieved and returned, regardless of the severity of the problem. That's simply not the case for the vast majority of device advisories. Oftentimes, the risk of explanting a device and implanting a new one greatly exceeds the risk for that device having a malfunction, even if nothing else were done to mitigate the problem. In many cases, the malfunctions that exist, even if they were to occur, can be dealt with in other ways -- for example, by following the patient more frequently, either in the clinic or using remote monitoring; by reprogramming the software in some cases; or by providing patients with additional tools that enable them to check their device periodically. These are all things that we've done in response to some of the most recent advisories that have helped patients to either correct the problem or have enabled them to monitor their device in order to ensure that their device does not have a problem. We've seen in the literature that there's the potential that patients can be harmed by removing devices that might not necessarily need to be removed.
Medscape: Much has been said lately in the press about the recent slowdown in ICD implantations in the United States. In your opinion, is this due primarily to fallout from the high-profile malfunction issues of the past year, or does it signal a more permanent trend: Maybe, as some have suggested, the "low-hanging fruit" has been picked and there is not going to be the same number of patients going forward that we've seen in the past?
Dr. Carlson: I think that what has happened is that the rate of rise in ICD implantations has declined, or at least has not met the expectations of some, and there are a couple of possible reasons for this. It is possible that low-hanging fruit has been harvested and that we've got a situation that may be similar to Wolf-Parkinson-White syndrome, in which we ablated many of the patients and now we're only seeing the new patients who are entering the system. However, I don't think that's necessarily the case with ICDs.
It takes time for physicians and patients to adopt new therapies. We've seen this with almost every medical therapy for coronary artery disease and heart failure that we've encountered over the last 10 or 15 years. It took years for physicians and patients to embrace the use of beta blockers after a heart attack. The percentage of patients today who are on these drugs is approaching the guidelines, but it has taken years and significant resources and educational programs, involving both physicians and patients, to achieve that goal. The same has been true of aspirin therapy and statin therapy to lower cholesterol, and the same was true of ACE [angiotensin-converting enzyme] inhibitors. These are all therapies that have been shown in multiple clinical trials to be effective, both after myocardial infarction and now in patients with heart failure, but the road to achieving acceptance by physicians and patients has been a long one.
I am not surprised that it's taking some time and education to achieve the same outcomes with heart failure device therapy. This is particularly true because we're now providing ICD therapy to a population of patients who have never experienced the event that we're trying to prevent, ie, sudden cardiac death. Adoption of these types of therapies doesn't happen overnight, but it doesn't mean that we should stop trying either. We know from many clinical trials that there are many people out there who can benefit from these devices, and we just need to keep educating physicians to do what is best for their patients and patients to do what is best for their health.
Supported by an independent educational grant from St. Jude Medical.
A long-awaited cost analysis from the landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) has concluded that prophylactic use of conservatively programmed, single-lead implantable cardioverter defibrillators (ICDs) for primary prevention of sudden cardiac death in heart failure (HF) patients is an "economically efficient" way to improve patient outcomes, provided that the devices are implanted in stable, moderately symptomatic patients (particularly New York Heart Association [NYHA] class II) and that patients survive at least 8 years following implantation.
The cost analysis, published this July in the journal Circulation,[1] is one of the most comprehensive to date on the subject of ICD cost-effectiveness. Using data from the 2521-patient SCD-HeFT, researchers employed statistical modeling methods to estimate treatment-specific medical costs up to 14 years post implant and compared these costs among the study arms. Age-based modeling was used to estimate the life expectancy of each study patient, and cost-effectiveness was expressed as the incremental lifetime costs required to add 1 year of life with ICD therapy relative to placebo/medical therapy alone.
The statistical modeling allowed the researchers to estimate ICD outcomes and costs well beyond the 5-year SCD-HeFT clinical follow-up. SCD-HeFT enrolled patients with NYHA class II/III HF and a left ventricular ejection fraction (LVEF) ≤ 35% who were on optimal medical therapy. Patients were randomized to receive ICD therapy, amiodarone antiarrhythmic drug treatment, or placebo. Over a 5-year follow-up, the study demonstrated a significant 7% absolute reduction in all-cause mortality and a 23% decline in relative risk in the ICD arm vs placebo arm, whereas those who received amiodarone showed no mortality benefit over placebo.[2] When subgroup analyses were performed, it was discovered that the majority of the ICD mortality benefit was obtained by patients with less severe, NYHA class II disease, who showed a 46% reduction in relative risk. NYHA class III patients demonstrated no significant mortality benefit from ICD therapy.
As summarized in the Table, the SCD-HeFT analysis revealed no evidence that ICD patients had significantly more hospitalizations, major cardiac procedures, or outpatient visits over the first 5 years of follow-up than patients in the placebo arm. The estimated cumulative medical costs (total hospital costs, including device costs, plus physician fees) at 5 years averaged $42,971 for placebo, $49,338 for amiodarone, and $61,938 for patients in the ICD arm (P < .0001 for ICD vs placebo). Taking into account projected life expectancy, the lifetime cost for patients in the ICD arm was $158,840, compared with $79,028 for the placebo arm. Thus, the lifetime incremental cost of ICD implantation was estimated at $79,812 ($62,420 with 3% discounting).
| Amiodarone (n = 845) |
P Value Amiodarone vs Placebo | Placebo (n = 847) |
P Value ICD vs Placebo | ICD (n = 829) | |
|---|---|---|---|---|---|
| Resource use: | |||||
| Hospitalizations | 2.63 | .671 | 2.73 | .646 | 2.830 |
| ED visits | 1.39 | .378 | 1.23 | .453 | 1.36 |
| CABG surgeries | 3.2 | .954 | 3.3 | .139 | 1.3 |
| Cost: | |||||
| Hospital costs | $31,466 | .83 | $30,691 | < .0001 | $46, 804 |
| Physician fees | $1404 | .51 | $1504 | < .0001 | $2392 |
| Outpatient costs | $2762 | .97 | $2757 | < .0001 | $3716 |
| Medication costs | $13,706 | < .0001 | $8019 | .001 | $9026 |
| Total costs | $49,338 | .08 | $42,971 | < .0001 | $61,938 |
ICD = implantable cardioverter defibrillator; ED = emergency department; CABG = coronary artery bypass graft
ICD cost-effectiveness, expressed as the incremental lifetime cost to save a life-year relative to placebo, was $38,389 (95% confidence interval, $25,217-$80,160). This cost varied depending on survival time. A 5-year survival yielded a cost-effectiveness ratio of $127,503 per life-year, which declined to $88,657 at 8 years and $58,510 at 12 years. On the basis of this analysis, if patients survive at least 8 years following implantation, the cost-effectiveness ratio falls below $100,000; if survival continues to 14 years, the cost-effectiveness ratio falls below $50,000 per life-year added. A cost-effectiveness ratio of $50,000 is a benchmark used to identify therapies that provide good value, and a ratio of $100,000 or more is typically considered a poor value for the money, the study authors explained. When NYHA class II patients were analyzed separately, the analysis yielded an even better discounted ICD cost-effectiveness ratio of $29,872, due to the greater survival benefit in this group.
The researchers also performed a variety of other cost analyses that considered assumptions on the basis of more "real-world" parameters. Physicians in the SCD-HeFT employed a low-cost, single-lead ICD programmed to shock-only mode, and the devices were implanted on an outpatient basis -- 2 cost-efficient practices that are rarely followed in the United States today. To account for higher initial costs, the study researchers increased the initial device plus implantation cost in their model by 25% and 50%, yielding cost-effectiveness ratios of $41,814 and $45,239, respectively. When the post-5-year costs in the ICD arm were increased by 50% to reflect the possibility of an increase in late complications, the ratio grew to $52,072. They also increased the cost of 5-year battery replacements by 25% (which they point out is equal to the current cost of a dual-chamber ICD), producing a cost-effectiveness ratio of $41,782. Simultaneously increasing initial costs by 25%, battery replacement costs by 25%, and follow-up ICD costs by 50% yielded a ratio of $58,892 -- still well below the 100,000 threshold, but slightly above the $50,000 cutoff.
The study authors concluded that a conservatively programmed, single-lead ICD implanted in patients on optimal medical therapy who have stable, moderately symptomatic HF is cost-effective on the basis of currently established benchmarks. They pointed out that this was one of several ICD cost-analysis substudies published over the past several years, not all of which have reached similar positive conclusions. The Multicenter Automatic Defibrillator Implantation Trial I (MADIT I),[3] for example, found that ICDs were highly cost-effective, whereas the Canadian Implantable Defibrillator Study (CIDS)[4] reached the opposite conclusion. However, other primary prevention trials, including MADIT II,[5] have demonstrated cost-effectiveness ratios similar to that uncovered in SCD-HeFT. The study authors conceded that trials, such as MADIT II and the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation (DEFINITE), did not observe a difference in cost-effectiveness between class II and class III patients, but they pointed out that the cost-effectiveness conclusions from SCD-HeFT parallel the clinical results, leading to the conclusion that ICD therapy is "most compelling" for NYHA class II patients.
In an accompanying editorial, Lynne Warner Stevenson, MD,[6] of Brigham and Women's Hospital and Harvard Medical School (Boston, Massachusetts), called the SCD-HeFT cost analysis "elegant" and the most detailed offering to date on ICD cost-effectiveness. Although Dr. Stevenson conceded that the findings of SCD-HeFT are fairly consistent with other ICD cost analyses, she also provided an alternative analysis that takes into account the rate of appropriate shocks and the duration of survival after a shock. Using this model, she postulated that "ICDs for primary prevention . . . may be less cost-effective than other recommended heart failure therapies, which are prescribed to modify disease progression and symptoms, decreasing costly hospitalizations as well as mortality.[6]" Specifically, Dr. Stevenson mentioned cardiac resynchronization therapy (CRT) and HF disease management programs as 2 approaches that may be more cost-effective than ICD therapy. "Devices such as the resynchronization pacemaker that improve survival and improve symptoms sufficiently to decrease hospitalizations could easily come in under the $40,000 threshold . . . when high-responder populations are chosen," she wrote.
According to Dr. Stevenson, it is important that factors, such as rate of appropriate device firing and duration of survival after a shock, be determined in the real-world ICD patient population, who are older and have more comorbidities than patients enrolled in the trials. She pointed to the new American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR) for ICDs as one potential source of such data that could further refine cost-effectiveness estimates and help direct the most effective use of ICD therapy. According to Dr. Stevenson, with data such as these, "it should still be possible to identify the right patients at the right time for ICD implantation to deliver enough bangs for the bucks."
Supported by an independent educational grant from St. Jude Medical.
In January 2005, the Centers for Medicare and Medicaid Services (CMS) issued its final National Coverage Determination expanding the indications for implantable cardioverter defibrillators (ICDs) in primary prevention heart failure (HF) patients. Although the final rule was widely applauded in the HF community, the agency included 1 major caveat: Patients receiving ICDs for primary prevention outside of an investigational device exemption (IDE)-approved clinical trial must be entered into a national registry database in order to be eligible for Medicare coverage.
As a result of the agency's registry requirement, the American College of Cardiology and the Heart Rhythm Society recently partnered to develop a new, more data-inclusive ICD-NCDR (National Cardiovascular Disease Registry) designed to take the place of the existing QNet registry. The transition to the new registry, which was approved by CMS, was completed in April 2006, and it is currently being implemented in over 1200 US hospitals.
The goal of CMS in mandating registry enrollment is to better define real-world patient eligibility for ICDs, compare registry data with data from controlled trials, determine whether patient outcomes vary due to patient or provider characteristics or type/model of device implanted, and determine whether the therapy is cost-effective in the Medicare patient population. However, the implications for providers could go much further, not only changing how clinicians deal with ICD patient data, but potentially ushering in a new era of performance oversight and data-driven coverage decisions in the electrophysiology arena. The ultimate objective is improved patient care, according to speakers who participated in a special registry session at this year's Heart Rhythm 2006: The 27th Annual Scientific Sessions of the Heart Rhythm Society, held May 17-20 in Boston, Massachusetts. The session, entitled "How Can the ICD Registry Improve Care," detailed potential registry benefits as well as drawbacks that could affect providers in the months ahead.
Alfred E. Buxton, MD, of Brown Medical School (Providence, Rhode Island), who chaired the ICD Registry Database Committee, told session attendees that the new registry is one more indicator that benchmarking to grade hospital and physician performance is here to stay. There is no doubt that greater oversight of provider performance is coming, according to Dr. Buxton, who said that the new registry is already catching the attention of payers other than CMS, and likely will be mandated in the near future by a wide range of payers as well as state regulators and health systems.
For some this may seem like a daunting prospect, but Dr. Buxton asserted that benchmarking is important, both to payers and providers, and has the potential to result in improved patient care. Not only does it help caregivers determine whether they are improving patient care and outcomes, he said; it also assists providers in meeting state regulations and payer requirements (thus leading to preferred provider status), and enables them to detect inefficiencies in their operations and improve their resource utilization.
With these points in mind, the new registry, which will follow a wide range of variables, has the potential to offer many positives for physicians and for clinical practice in general, according to Dr. Buxton, who provided a list of potential benefits. Of note, the data could offer insight on the degree to which clinicians are managing disease according to evidence-based medicine, he explained. Moreover, the registry will enable clinicians to compare their outcomes with those of other physicians, and it could serve as the hospital and physician response to "pay for performance" initiatives being proposed by health plans. Other potential benefits noted by Dr. Buxton included the ability to highlight a product's performance outside of clinical trial constraints and provide a detailed view of the short-term morbidity, mortality, and resource utilization associated with a particular disease. The registry data are open to all, Dr. Buxton said, and physicians can request specific data analyses by submitting a written request to the Research and Publications Committee.
Variables being collected in the ICD-NCDR:
Regardless of these positives, the ICD-NCDR is also fraught with a number of dilemmas in design and implementation that could potentially limit its usefulness. One problem, according to Mark D. Carlson, MD, of University Hospitals of Cleveland (Cleveland, Ohio), who detailed registry drawbacks for session attendees, is the short time frame provided to set up the registry, which leaves little time for beta testing. In addition, there is no mechanism for gathering highly sought-after longitudinal, long-term follow-up data in the registry, Dr. Carlson said, and even if there were, it would be difficult to determine all of the adverse events that are related to device implantation.
Some of the stated goals of CMS are to use the registry data to compare outcomes with regard to patient, device, and provider characteristics; determine the cost-effectiveness of the therapy; and determine whether periodic reporting of quality benchmark comparisons improves patterns of care and patient outcomes. However, Dr. Buxton noted in his presentation that these goals may be difficult to attain without long-term follow-up data. Other unsettled issues pointed out by Dr. Carlson include questions of who will pay the extra cost for the clinician time and resources needed to manage data entry, and whether the data will be entered in a reliable manner that minimizes the potential for variability between centers.
The registry is currently set up to encourage physicians to enter comprehensive data not only as required for primary prevention, Medicare patients, but for all of their ICD patients (including non-Medicare and secondary prevention patients). Also, both Dr. Carlson and Dr. Buxton noted that the vast majority of providers surveyed to date said that they plan to do so. Participating hospitals will receive a report card detailing how well their performance compares with other hospitals, but the degree of detail in this report will depend on how much data are submitted by the hospital -- an incentive designed to encourage more detailed reporting, Dr. Carlson said. In addition, the registry is likely to be subject to regular quality-control audits, according to Dr. Buxton, which may include random sampling of sites and patient records.
Perhaps the most pressing long-term concern among providers is how CMS will eventually use the data that it collects from the registry. According to Dr. Carlson, CMS has said that it will not use the information to determine individual payments for individual patients, but the agency could use it to help guide future coverage decisions. A listing of questions that CMS hopes to answer with registry data, along with a summary of current CMS coverage criteria, are summarized below.
Group A:
Group B:
Group C:
Covered:
Excluded:
Supported by an independent educational grant from St. Jude Medical.
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Mary Thompson
Medical writer, Scottsdale, Arizona
Disclosure: Mary Thompson has disclosed no relevant financial relationships.
Mark Carlson, MD, MA
Professor of Medicine, Associate Vice President of Governmental Relations, Case Western Reserve University School of Medicine, Cleveland, Ohio; University Hospitals, Case Medical Center, Cleveland, Ohio
Disclosure: Mark D. Carlson, MD, MA, has disclosed that he is to be the future Chief Medical Officer and Senior VP for Clinical Affairs at St. Jude, effective November 13, 2006, and he has received grants for educational activities from Medtronic and Boston Scientific. Dr. Carlson has also disclosed that he has served as an advisor or consultant to St. Jude and Boston Scientific and owns stock, stock options, or bonds in Cameron Health.
Robert Chevrier
Program Director/Site Editor, Medscape, Inc.
Disclosure: Robert Chevrier has disclosed no relevant financial relationships.
Ariana Del Negro
Associate Editorial Director, Medscape Cardiology
Disclosure: Ariana Del Negro has disclosed no relevant financial relationships.
David Good
Editorial Director, Medscape Cardiology
Disclosure: David Good has disclosed no relevant financial relationships.