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Value-Driven Innovations Critical to Healthcare Quality and Progress

We're experiencing a seismic shift in American healthcare, transitioning from a system that encourages care in high volume to one that assures we get better value for our dollars spent. This makes sense.
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We're experiencing a seismic shift in American healthcare, transitioning from a system that encourages care in high volume to one that assures we get better value for our dollars spent. This makes sense. After all, the United States spends more on healthcare than any other nation on the planet, so we should be getting more bang - in the form of better health outcomes and population well-being - for the buck.

This is easier said than done, however. The trick to injecting greater value into the healthcare system lies in finding the right balance between competing perspectives. Those who pay for healthcare - be they private insurers or public payers like Medicare - find value in steps that reduce medical costs, particularly in the short term. For patients, new treatments and technologies that improve health, reduce the likelihood of disability and enable longer, high-quality lives hold great value. Sometimes, these objectives align. Often, though, it's more complicated and the secret lies in finding the sweet spot that promotes both significant health gains and financial sustainability.

And we have a responsibility to raise questions about actions and decisions that may fail to strike that necessary balance. Decisions about the evidence to consider and the weight applied to conflicting evidence can lead to different conclusions, and understanding the perspective of the reviewer sheds light on the reasons behind these judgment calls.

There has been an increased spotlight of late on the Institute of Clinical and Economic Review (ICER), which has received a hefty infusion of grant money for its work evaluating the cost-effectiveness of medical tests, treatments and delivery system innovations. Ostensibly, ICER's research and recommendations are intended to help guide decision-making on the value of medical innovations, which can affect coverage and patient access.

When patient lives and health are at stake, it's vital that we evaluate the evaluators like ICER and better understand the priorities that guide the advice they provide. Let's consider the current subject of a preliminary ICER analysis, the CardioMEMS HF system. This is a new medical device that, once implanted in an appropriately indicated heart failure patient, provides real-time data on pressure changes within the heart. This enables a physician to make treatment adjustments to avoid the health problems that frequently lead to hospital readmissions (heart failure, the leading cause of readmissions among Medicare patients, is a primary target for reducing avoidable hospitalizations). Data presented recently at the 2015 American College of Cardiology annual scientific session shows the technology reduces cardiovascular mortality and hospitalization and readmission rates among certain heart failure patients.

ICER's draft analysis includes recommendations though that raises questions as to whether this innovation will be accessible to patients. In making its recommendations, ICER places greater weight on an FDA Advisory Panel's questions than the FDA's final decision in granting market approval and, although mentioning some private insurers' medical policies, omits Medicare's favorable reimbursement decisions that require finding a "substantial clinical improvement" over standard practice. Additionally, ICER even provided more weight on the FDA Advisory Panel than the five published, peer-reviewed publications that had their highest rating possible. These judgment calls led to conclusions regarding the benefit the technology may have to alternative management options for patients with congestive heart failure.

This raises questions on ICER's methods. The organization places a strong emphasis on cost - evaluating the short-term price tag of a new technology balanced against the offset gained by other medical cost savings. It doesn't take into consideration the clinical judgment of providers (in fact it's not clear at all whether ICER consults with any healthcare providers or patients with actual experience using the technologies under review), nor does it include consideration of Medicare's review of the evidence in its reimbursement determinations that found the CardioMEMS HF device represents a "substantial clinical improvement" over existing treatments and granting incremental payment. Likewise, it considers opinions of an FDA Advisory Panel over the published, peer-reviewed publications and FDA's actual determination that the technology as safe and effective for commercial use when evaluating all the evidence available. These are critical omissions. And what results is a limited spectrum of evidence that casts aside or simply does not seek much of the relevant information available, which then leads to a recommendation that could deny a new heart care option to heart disease patients and their doctors.

The purpose of my commentary isn't to make a case for any particular medical device. Rather, I hope it serves as a cautionary tale about the way we make this very necessary transition from volume-based healthcare to a value-focused system. Ideally, this shift toward value will bring about a healthcare environment that does more while costing less. Realistically, however, we can't afford to focus so intensely on cost savings that quality takes a distant back seat. The cautionary tale involving CardioMEMS HF highlights the pitfalls in using short-term cost as a final word on value that can improve lives and save dollars in the long run. It also demonstrates the need to understand how decisions on evidence to consider can affect the end result.

In assessing the affordability of medical progress, gains in health status and quality of life absolutely must be part of the equation.

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