DES Add Over $1.5 Billion in Medicare Costs to Health Care System

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The cost impact on the US Medicare system imposed by drug-eluting stents (DES) over the 4-year period after the devices were introduced was substantial, amounting to over $1.5 billion, with the greatest impact from patients with stable coronary artery disease (CAD), according to a research letter published online April 25, 2011, ahead of print in Archives of Internal Medicine.

The study was originally presented in May 2010 at the annual American Heart Association’s Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke meeting in Washington, DC.

Researchers led by Peter W. Groeneveld, MD, MS, of the University of Pennsylvania School of Medicine (Philadelphia, PA), looked at Medicare payments from 2002 to 2006 for 1.98 million Medicare beneficiaries with CAD, of whom 4.5% had a recent AMI, 3.4% had a recent noninfarction ACS, and 92% had no recent ACS (stable disease). To capture expenses downstream of major CV procedures and events, the researchers accounted for all facility and health care provider payments, including non-CV costs, in their analysis. Costs were inflated to 2006 dollars using the consumer price index.

After DES were introduced in 2003, their use increased to 23% in AMI patients, to 29% in noninfarction ACS patients, and to 1.1% in stable CAD patients. Overall inflation-adjusted cost increases from 2002 through 2006 among the 3 groups ranged from 4.7% to 11.7%. On multivariable regression analysis, each 1% increase in DES use translated to mean per-patient cost increases ranging from $28 in AMI patients (P = 0.009) to $35 in noninfarction ACS patients (P < 0.001) to $133 in stable CAD patients (P = 0.003).

These estimates allowed the researchers to calculate increases attributable to DES from 2002 to 2006 specific to each group (table 1).

Table 1. Mean Per Patient Costs

Despite the relatively small increase in DES use in the stable CAD group, these patients comprised by far the majority of the study population, and the fraction of DES cost growth attributable to these patients (68%) was disproportionately large. As such, patients with stable disease accounted for the biggest increase in DES-attributable annual costs on a national basis ($1.1 billion), compared with AMI patients ($236 million) and noninfarction ACS patients ($269 million). The overall cost increase for all CAD patients attributable to DES was $1.57 billion.

“Drug-eluting coronary stents substantially increased costs for Medicare beneficiaries with CAD,” the researchers conclude. Especially “troubling” is the cost amplifying effect of DES among stable patients, they add, “since the limited efficacy of [PCI] among patients without ACS, whether or not DES are used, would not justify sizeable DES-related cost increases among patients without ACS.”

Study May Not Represent Current Practice

In a telephone interview with TCTMD, William S. Weintraub, MD, of the Christiana Care Health System (Newark, DE), noted that “the individual costs [cited in the study] seem reasonable. DES cost more up front.” However, he disagreed with the paper’s overall conclusion, citing a number of concerns with the study.

“They’re talking about the costs of DES, but it’s not clear to me that they’re also capturing the savings from not doing additional procedures,” Dr. Weintraub said, adding that exactly which downstream nonprocedural costs were captured for DES is not made clear, nor how that was accomplished.

Also, the study period ends in 2006, the high-point for DES use in the United States. After this, use of the devices fell precipitously after fears were raised over stent thrombosis, and PCI use fell in stable patients following the COURAGE trial. “This is relatively early in the DES period,” Dr. Weintraub said. “The paper may not fully capture the decrease. Non-ACS PCI has fallen since then by probably about 15%.”

Overall, though, Dr. Weintraub noted that the paper assesses cost, not cost-effectiveness.

“My feeling right now is that by avoiding downstream procedures, DES are probably dollar neutral. We may have lots of problems in this country with health care costs and we may be doing too many procedures, but I don’t think DES are part of the problem,” he said. “The study is food for thought, but there’s no reason to panic that we’re breaking the bank. However, we do need to act responsibly and in our patients’ and society’s interest.”

Getting to $1.5 Billion

Dr. Groeneveld, however, maintained in a telephone interview with TCTMD that “there’s a reason costs are going up in this country for health care, and it has to do with technology.”

He explained that the length requirements of the research letter did not allow the full description of all the downstream costs that factored into the overall cost analysis. “Our paper highlights the issue that it’s not always just about the cost of the new thing itself, it’s the other stuff that goes along with it,” he said. “If you do the math just on the numbers of new procedures and the cost of the device, that doesn’t get you to $1.5 billion.”

Rather, the majority of the cost comes from all the additional diagnostic imaging procedures, clinician visits, elective hospitalizations, and medication expenses, Dr. Groeneveld said, noting, “There’s a certain smaller component that was the actual cost of the device itself, but the bulk was outside the procedural cost.”

Regarding any cost savings from DES in avoiding subsequent procedures, Dr. Groeneveld cited unpublished data from his group while asserting that any such effect has not been sizeable. “It’s not at all clear to me from the data we have that the impact of DES in reducing target lesion revascularization rates has had a huge impact on cost. That would be my bottom line,” he said. “I think there’s been some impact, but whatever cost savings there have been downstream have been overwhelmed by the additional enthusiasm for using PCI in new patients.”

And while DES use did decline after the study period, it has rebounded significantly in recent years, Dr. Groeneveld noted, while overall rates of PCI have not dropped that drastically. “When we looked at Medicare data through 2008, there was a small decline, but not a tremendous decline, in overall revascularization procedures,” he said.

The Added Cost of Non-DES Patients

Commenting on the study in an e-mail communication with TCTMD, David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart and Vascular Institute (Kansas City, MO), pointed out that “it appears that some of the cost increases that are being attributed to drug-eluting stents may relate to patients who did not even undergo coronary revascularization, and it is not entirely clear how this might occur. I would be curious to understand what proportion of the increased cost is actually attributable to patients who did not undergo revascularization.”

“That’s exactly the issue,” responded Dr. Groeneveld. He explained that while patients who receive DES normally go through a pathway starting with a cardiologist and including diagnostic procedures, a visit to the cath lab, and PCI, many patients go through parts of this process without ever receiving an intervention.

“There’s all these other patients going through the pathway, but they don’t show up in the bottom line for DES costs because they don’t get treated,” Dr. Groeneveld said. “However, because DES exist, there are more patients getting nuclear imaging, more getting diagnostic catheterization. There were just more people being sent through the pathway to determine if they were treatment candidates, and those are part of the cost picture as [Dr. Cohen] points out.”

The Right Kind of Appropriateness

Dr. Cohen noted that his own research found that the introduction of DES was associated with increased Medicare costs on the order of about $500 million per year among all patients undergoing revascularization, mostly due to increased PCI procedures after the introduction of DES. Nevertheless, “to me, the real question . . . relates more to the appropriateness of the incremental PCI procedures themselves, rather than a direct indictment of drug-eluting stents as the root cause,” he said.

“There’s appropriateness on all kinds of levels,” Dr. Groeneveld responded. “Are we sending the right people for diagnostic testing? Are we sending the right people to cardiac catheterization? The problem with DES was not the technology itself, which is a reasonable innovation for which the inventors should be applauded. It is the fact that the cardiovascular community adopted it far beyond the evidence as to how it should be appropriately used. It never made any sense to use DES in 90% of PCI. That was just wrong.”

Ultimately, evidence-based medicine needs to have “teeth” to it, he added, especially in how new technologies are utilized. “People are going to have to have a better defense of off-label use of new technologies,” Dr. Groeneveld said. “New technology changes all aspects of medicine and generally makes it more expensive [instead of merely replacing a previous technology]. You multiply all the new technologies in the pipeline and this is why Medicare is in big trouble.”

 

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Source:
Groeneveld PW, Polsky D, Yang F, et al. The impact of new cardiovascular device technology on health care costs [research letter]. Arch Int Med. 2011;Epub ahead of print.

 

 

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