Choosing unwisely

In 2010, health care experts and the government declared war on waste. Guess what? Waste won.

Back in 2006, the influential Institute of Medicine initiated a series of hearings to understand why the U.S. had such poor health outcomes despite spending far more than other advanced industrial nations on healing the sick. In its final 2010 report, entitled “The Health Care Imperative: Lowering Costs and Improving Outcomes, the IOM estimated 30% of health care spending was unnecessary. Eliminating that waste and redirecting some of the freed up resources into addressing the unmet health and social needs of patients could dramatically improve the nation’s overall health, the report said.

The 2010 Affordable Care Act (aka Obamacare) incorporated much of that mindset by creating the Center for Medicare and Medicaid Innovation. Over the past 13 years, CMMI initiated over 40 pilot projects aimed at reducing waste and improving outcomes. Thousands of hospital systems and physician practices joined the “value-based care” movement by participating in those projects.

Many medical professional societies also jumped on board. In 2012, the ABIM (American Board of Internal Medicine) Foundation united nine specialty societies representing 375,000 or half the nation’s physicians behind its Choosing Wisely campaign, a voluntary effort aimed at convincing physicians to eliminate unnecessary care.

It initially highlighted 45 tests and treatments in common use for which there was no supporting evidence proving effectiveness. About 80 specialty societies eventually joined the campaign, many of which to this day routinely publish lists of five or more medical interventions that could be eliminated without harming patients’ health.

The movement was partially successful. More recent estimates suggest the level of wasteful spending has been cut in half. Though the Congressional Budget Office recently claimed CMMI programs, which focus exclusively on Medicare patients, failed to save the government money, overall growth in health care spending has not exceeded economic growth for most of the past decade (the brief COVID-19 recession of 2020-21 being the one exception). The prior decade, it had grown at a rate nearly twice that of GDP.

As a result, spending today stands at 17.4% of gross domestic product, exactly where it was in 2010. While most CMMI programs didn’t save money, the program clearly convinced some hospitals and physician practices that cost control had to be taken seriously (though not the ones owned by private equity firms; or specialty practices that profit from overuse of expensive interventions).

The limits of voluntarism

But there are limits to how far voluntarism on the part of the medical establishment can succeed in eliminating waste. A new report from the Lown Institute on overuse of stents for partially clogged arteries reveals that the incentives embedded in fee-for-service medicine, when coupled with the biases of both physicians and patients, are still more powerful than clear-cut medical evidence that an expensive procedure can provide no better outcome than taking a few cheap, generic pills.

Before getting into the details, allow me to relate a personal anecdote. One weekend afternoon a decade ago, a few months after starting a new, high pressure job at age 62, I began experiencing intense chest pains. After several hours of hoping it would go away, I panicked and went to my neighborhood hospital emergency room. Fifteen hours and one x-ray imaging test later, which showed a 50% blockage in one artery leading to my heart, they sent me home with a diagnosis of stable angina and orders to see a cardiologist. I was no longer in pain after a long night of on and off dozing on a hospital gurney.

Inside a cardiac catherization lab

Since I was commuting between two cities at the time, I made the appointment with a prominent cardiologist at an academic medical center in the city where I worked. After reviewing the first imaging test, he suggested I enroll in a clinical trial testing whether a coronary artery angiogram, where they sneak a camera probe from your thigh through the arteries feeding the heart, could more precisely determine the size of the blockage and, if it met the 70% threshold, justify insertion of a stent. The entire procedure is usually referred to as percutaneous coronary intervention or PCI in the medical literature.

A few weeks later, I went for the test. Again, the results were negative, this time showing just a 30% blockage. I went home relieved about my medical condition, but somewhat upset about the fact my insurer paid not just for the $5,000 ER visit, but nearly $20,000 for the duplicative PCI.

Prior to that test, there were at least two clinical trials that compared adding PCI and stenting in patients with at least a 70% blockage in one or more arteries to treating the condition with medical management alone. Drugs like statins, beta blockers and nitroglycerine (for relief of symptoms) are also effective at reducing hospitalizations and deaths from coronary artery disease, and, of course, are far less expensive.

The first trial, dubbed COURAGE for Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation, was published in 2007 in the New England Journal of Medicine. It found “As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.”

The second trial, dubbed BARI-2D for Bypass Angioplasty Revascularization Investigation 2 Diabetes, was published in 2009 in NEJM. All its participants had diabetes, who face greater risk of cardiovascular complications. It found: “Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy.”

More recent research has confirmed those studies. In the REVIVED (Revascularization for Ischemic Ventricular Dysfunction) trial, published a little over a year ago in NEJM, the researchers found: “Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure.”

Did test after test saying the same thing serve as a wake-up call for the cardiology profession? The Society for Cardiovascular Angiography and Interventions, whose 4,500 members perform most PCI operations and are among the best paid medical professionals, gave a slight bow in the direction of the medical evidence when it compiled its Choosing Wisely list. “Avoid PCI in stable, asymptomatic patients with normal or only mildly abnormal adequate stress test results,” the guideline said. But it said nothing about curtailing use in patients with between 70% and 90% blockage, which constituted most patients in the clinical trials.

Clearly, neither the evidence nor voluntary efforts at self-regulation had much impact on hospitals and intervention cardiologists, who financially benefit from continuing business as usual. Around the time the first two tests were published, there were about a million PCI operations leading to stenting in patients each year. The most recent estimates from market researchers state that number has remained essentially unchanged in the intervening 15 years.

The wages of waste

The Lown study, which was based on Medicare claims data and was released this week, estimated there were a quarter million unnecessary stent operations in the 2019-21 time period, about a 22% overutilization rate. They estimated the cost to Medicare over the three-year period was about $2.5 billion. Imagine the screening and treatment campaign the government could launch for the 40 million Americans with untreated hypertension (a primary cause of heart attacks, strokes and heart disease) with that much money.

Earlier this week, the Lown Institute, for which I’ve served as an adviser, brought together three experts: a clinician, a nurse and an insurance benefits manager; to discuss why this overuse persists despite medical evidence to the contrary. Dr. David Brown, who teaches at the Keck School of Medicine at the University of Southern California, said PCI and stents can play an important role for serious heart disease, but for minor blockages “we’re using a 20^th century model where it’s likened to a clogged pipe in your bathroom. Unfortunately, human anatomy is much more complicated than that. The science doesn’t support that model.

“When a patient is shown a coronary angiogram that shows a narrowing of an artery, there is an intuitive desire to make that go away,” he continued. “We have a fairly effective technology – stents – to make that go away. But it doesn’t reduce the risk of heart attack or death.”

Dr. Thomas Power, the medical director of cardiology at Carelon Medical Benefits Management, ticked off the financial incentives promoting overuse. “First you have the fee-for-service payment structure,” he said. “There may be some medical legal concerns. Consider a patient with stable chronic coronary disease who has an adverse outcome. We know it wasn’t caused by a lesion. But it may be difficult to convince a jury who buys into the hypothesis.”

Betty Rambur, a professor of nursing at the University of Rhode Island, expressed the broader concern. Not only is overtreatment endemic in health care, it may be a primary cause of nurse burnout, which is plaguing the profession, she said.

“Nurses are twice as likely to commit suicide as the general population right now. When I ask, the stories just pour out of them. They see all these things are being done that aren’t necessary and harm people. Errors happen, but how much more tragic is it when it didn’t need to be done in the first place.”