Learning from Past Success
What the CT scanner’s remarkable success (and emerging problems) can teach us about the implementation of medical innovations
There are many barriers to medical innovation; it is a lengthy, high-risk endeavor that often results in failure or limited rewards. Many stakeholders are involved in the medical innovation process, including inventors, investors, physicians, hospitals, patients, insurers, and regulatory agencies. Inventors and investors may be focused on maximizing profit, while physicians and hospitals may want innovations that make their practice more efficient, more productive, more profitable, or less error-prone. Patients want higher quality care for a lower price, while insurers must consider the innovation’s costs that they may have to reimburse. Of course, it can be very difficult for a medical innovation to satisfy these competing interests.
The FDA is also heavily involved in the medical innovation process; it focuses not just on the safety of new innovations, but on their cost-effectiveness relative to existing technologies as well. The agency is perhaps the most formidable, albeit necessary, barrier to innovation in the healthcare space. In addition to the time it takes to bring a medical innovation from a concept to a final product, the FDA’s approval process can add years to the time that entrepreneurs and investors must wait before revenue offsets research and development costs. There is also a large risk that a medical innovation does not get approved at all; this uncertainty and the large amount of time and money required to bring a new medical innovation to market can ward off many potential entrepreneurs and investors.
There is no doubt that much could be done in terms of legislation to spur medical innovation, such as providing additional funding or incentives for innovators, especially the ones who work on innovations that may not be very profitable. But even though it is both challenging and expensive to bring a medical innovation to market, the United States is still a hot spot for medical innovation, thanks to ample investment and a high potential for reward. The National Institutes of Health, America’s leading medical research agency, received over $30 billion in federal funding in 2015, nearly ten times the amount that the European Union allocated for medical research that year. Private sector spending on medical research and development is also far greater in the U.S. While the United States healthcare system is certainly flawed (and justly criticized) for its high costs, these costs offer a particularly high potential for return on investment, which helps drive innovation.
In addition to contributing to more diagnostic procedures and treatments than any other country, the U.S. holds more Nobel Prizes in medicine and physiology than all European countries combined. Americans have contributed to the development of many diagnostic services like neuroimaging, cancer screening protocols, and HIV testing, as well as medical treatments like cataract extraction, antidepressants, and broad-spectrum antibiotics. These innovations have saved countless lives, improved patient outcomes, and, in many cases, lowered costs.
The U.S. is continuing this tradition of innovation; the ingenuity and hard work of American researchers and inventors has led to advancements in the fields of genetic testing, regenerative medicine, and big data. But these medical innovations are not yet widely adopted in the American healthcare system. Millions of dollars spent, years of research, and the arduous FDA approval process mean nothing if hospitals choose not to adopt medical innovations. Of course, hospitals must consider many factors when deciding what to invest in. For a hospital to adopt a medical innovation, it must both perform better or more efficiently than the technology it is replacing and make financial sense to implement. Learning how now-ubiquitous technologies like the CT scanner were able to fulfill both criteria can help us anticipate potential implementation challenges of upcoming medical innovations.
The CT scanner (short for X-ray computed tomography scanner) is a powerful diagnostic tool that allows physicians to accurately assess patients’ hard and soft tissue without surgery. The scanners combine hundreds of X-ray images, taken from many angles in quick succession, to generate a 3D image. Dr. Robert Ledley is widely credited for the invention of the whole-body CT scanner. In 1973, Dr. Ledley led a team of researchers to improve existing scanners that could only scan the brain. Ledley’s whole-body scanner proved to be much more useful for diagnostic medicine, as it allowed physicians to diagnose a larger array of medical problems.
After perfecting the scanner’s design in 1974, Dr. Ledley founded DISCO, the Digital Information Science Corporation, and began selling the scanners to early-adopting hospitals for $300,000 each. As other companies began working on CT technology, competition drove down prices and offered hospitals more scanner choices, which contributed to their rapid adoption. All 50 states had a CT scanner by the end of 1977, and by 1980, there were an estimated 1,471 functional units in use in the U.S. CT scanners are now very prevalent in the United States: over 10,000 are in use today. Over the last 40 years, CT scanners have also drastically improved in functionality, yet are now less expensive, adjusting for inflation. Today, the most basic CT scanner models cost, on average, $400,000, and are vastly superior to Ledley’s 1974 scanner.
Physicians are sometimes dubious of new medical innovations; years of successfully using existing medical technology can make them resistant to change. But the CT scanner was enthusiastically embraced by both hospitals and physicians, and was quickly hailed as one of the most useful medical innovations in diagnostics. What made CT scanners so popular? In addition being more pleasant for patients than earlier diagnostic methods, CT scanners helped physicians make much more accurate diagnoses, which improved patient outcomes. And for hospitals, they were highly profitable and easy to implement.
Early anecdotes of the CT scanner’s life-saving success also helped it garner the support of the medical community. In its late testing phases, Dr. David McCullough, a pediatric neurosurgeon at Georgetown University Hospital, used the scanner on a four-year-old boy who had hurt his head after falling off his bicycle. The images confirmed Dr. McCullough’s suspicions of a brain hemorrhage, and showed the precise location of the source of bleeding. Dr. McCullough was then able to quickly stem the bleeding and drain excess blood, which saved the boy’s life. This story and others about the CT scanner’s capabilities spread quickly, resulting in Ledley’s induction into the National Inventors Hall of Fame, and the rapid increase in worldwide demand for the full-body CT scanner.
CT scanners also were in high demand because they were far less risky than the diagnostic procedures they replaced. Dozens of clinical studies were completed shortly after CT scanners were implemented, which all showed that the scanners had no significant safety concerns, and were highly accurate in detecting abnormalities. CT scans were also more comfortable and less invasive than earlier diagnostic tests. Before CT scanners and other modern neuroimaging techniques, physicians diagnosed brain abnormalities using pneumoencephalography. This radiographic technique required physicians to drain most of the patient’s cerebrospinal fluid and replace it with a gas (either helium, oxygen or air) before X-raying, to ensure a clear picture. Side effects of pneumoencephalography included strong headaches and severe vomiting.
CT scanners also helped physicians make much more accurate diagnoses. The scanner’s high contrast ratio provided more detailed views of soft tissue, bone, brain matter, muscles, ligaments, and blood vessels, which made it an incredibly versatile diagnostic tool. In addition, the scanner’s 360-degree method of scanning gave physicians 3D views of the inside of the patient that could be inspected at any angle — a much more sophisticated way to analyze patients compared to older methods like traditional X-rays and ultrasound. As CT scanners became more common, physicians began scanning patients with symptoms characteristic of muscle and bone disorders, cancer, heart disease, brain abnormalities, and internal infections. Such an in-depth assessment of these symptoms previously required exploratory surgery, which often required patients to spend several days in the hospital to recover.
CT scanners also proved to be very useful in emergency departments, primarily for evaluating trauma patients. As evidenced in the anecdote about the four-year-old boy, CT scanners can help physicians quickly and easily determine the location of internal bleeding or swelling in the brain, abdomen, or thoracic cavity. If an abnormality is detected, the scans help physicians confidently administer treatment. If the treatment requires surgery, detailed CT images function as ‘maps’ that surgeons can study before beginning surgery, which increases their chances of success.
While CT scanners are relatively costly to both install and maintain, implementing them in hospitals is not particularly challenging. While hospitals may need to implement hundreds of EKG machines or kidney dialysis machines to adequately serve all patients, most small and medium-size hospitals require just one CT scanner. Unlike implementing a new electronic health records system or a hospital-wide protocol change, adding a CT scanner to a practice does not drastically alter provider workflow. And since they are useful and relatively easy to operate, physicians usually favor their addition.
When used appropriately, CT scanners showed early evidence of improving patient outcomes while being cost-effective, which incentivized medical insurance companies to cover a large portion of patients’ scanning costs. Cost-effectiveness is a tricky concept to define in healthcare simply because it is difficult to put a dollar amount on a medical innovation’s contributions to patient health and longevity. Yet, there is an assessment tool designed to do exactly that. The value of medical innovations like the CT scanner can be assessed by dividing the innovation’s per-patient cost by the number of quality-adjusted life-years (QALYs) it adds to the average patient’s life. While the United States doesn’t officially use QALYs to assess the value of medical innovations, it is still a useful tool for hospitals, insurers, and policymakers to deal with the fact that there are simply not enough resources to provide every patient with the highest quality care. The international standard for the value of one QALY is $50,000; if a medical procedure or test costs less than $50,000 per QALY gained, insurers generally consider it worth the cost.
Medical innovations with unfavorable (high) cost-to-QALY ratios include annual pap smears, which cost $800,000 per QALY. Since many vaccines lower healthcare costs, their cost per QALY is considered negative. CT scanners are less cost-effective than vaccines, but much more cost-effective than annual pap smears. For young adults with a 30% likelihood of neurologic disease (determined by assessing abnormal neurological symptoms), long-term survival data has shown that CT scanners cost $20,290 per QALY. And for patients at risk for lung cancer, CT scanning to detect cancerous nodules is highly cost-effective at just $2,500 per QALY.
The CT scanner’s success was not due to just its superior diagnostic abilities and ease of implementation. For better or for worse, one of the main reasons hospitals were so quick to adopt them was the fact that they were, and continue to be, a massive revenue driver for hospitals. While costs and profits from CT scans vary widely across the United States, hospitals often charge thousands of dollars, even though performing a CT scan usually costs only a few hundred dollars. For example, Duke University Healthcare System charges $6,208 for a CT scan that costs just $498 to perform. CT scanners can also generate revenue for hospitals through the “treatment expansion effect.” Since CT scanners improve diagnostic capability, they increase the need for surgeries or treatments that might not have been performed otherwise, which serve as additional sources of income for hospitals.
Unfortunately, the qualities that made the CT scanner so successful are now contributing to its abuse. Its potential for profit has led some to inappropriately prescribe CT scans, which can lower their cost effectiveness and drive up healthcare costs. In addition, both public and private insurance plans that reimburse a majority of CT scan expenses give patients little reason to refuse such an easy, painless diagnostic test. From 1996 to 2010, despite modest increases in the number of CT scanners installed in hospitals, the percent of patients receiving CT scans nearly tripled. Today, approximately 15% of patients receive a CT scan during a hospital visit.
When used appropriately, CT scanners can save lives, but when used indiscriminately, patients have a much lower chance of benefitting. For example, when used in emergency rooms on patients experiencing dizziness with no trauma, CT scanners rarely detect any anomalies, and are very cost-ineffective. Some hospitals even offer “preventive” scans to any patient that requests one, regardless of disease risk — a very cost-ineffective practice. An increase in CT scanner use may also be the result of physicians aiming to protect themselves from malpractice lawsuits; a CT scan is an easy way for physicians to avoid liability for failing to identify a severe condition. If these inappropriate uses of CT scanners continue, their cost-effectiveness will surely plummet.
In addition to putting a financial burden on the American healthcare system, improper use of CT scanners unnecessarily exposes patients to high levels of ionizing radiation at doses 150 to 1,100 times higher than traditional methods of medical imaging. The National Cancer Institute estimates that CT scans contribute to 29,000 additional cancer cases per year in the U.S.These cancer concerns have led to the formation of the “Image Gently” and “Image Wisely” campaigns, which urge physicians and patients to use CT scanners only when absolutely necessary. Organizations like the American College of Radiology have also condemned CT scanner overuse, stating “The ACR, at this time, does not believe there is sufficient evidence to justify recommending total body CT screening for patients with no symptoms or a family history suggesting disease.” To prevent harm to Americans and guarantee that CT scanners remain cost-effective, healthcare providers and regulatory agencies ought to ensure that they are used only when medically necessary.
From a health perspective, the CT scanner was successful because it improved the quality of life for millions of patients in a cost-effective manner. From an economic perspective, the CT scanner was successful because it provided an easy way for hospitals to generate profit. In the American healthcare system, medical innovations that are profitable are much more likely to be adopted than those that only improve quality of care. In order to bring more innovations that improve care quality into the healthcare space, researchers, inventors, entrepreneurs, investors, and policy-makers ought to seriously consider both their effectiveness and the motivations of the hospitals that may be implementing them.
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