Care that provides little or no benefit to the patient, with possible harm, is often referred to as low-value care.
One of the most common denial categories in healthcare is “medical necessity.” We generally think about it in terms of medical necessity for inpatient admission, or medical necessity for a joint replacement or cataract extraction. Medical necessity can also be applied to blood tests and X-rays, doctor visits and medications. But recently, the issue of medical necessity is being viewed on a much larger scale, looking at the overall effects of medical necessity on healthcare spending and healthcare safety. A recent article from Modern Healthcare magazine illustrates this well: “Spines ’R’ Us: The Evidence and Business behind Spinal Fusions.” The subheading states that “spinal surgeries are one of the most costly that hospitals perform – and for many patients, the evidence of their benefits is scant.”
While headlines are written to attract readers, in this case the article was behind a paywall, so I did not read it, but it does not take much imagination to determine what the premise is. Are episodes like this isolated, or is this a larger problem? The evidence suggests it is an issue.
As I write this, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) just released a report titled “Medicare Overpaid $636 Million for Neurostimulator Implantation Surgeries.” In this report, the OIG found that more than 40 percent of such procedures may have been medically unnecessary. Scant details are provided, but the premise is that many of the patients did not have medical necessity for a costly and invasive procedure.
In a study published earlier this year, it was found that minimally invasive surgery for cervical cancer continued to be performed at a high rate, despite compelling evidence from a 2018 study by MD Anderson Cancer Center that the minimally invasive technique was associated with poorer outcomes. The data also showed that the continuation of this potentially harmful procedure was much more common at non-academic medical centers.
While unnecessary and less effective surgeries get a lot of attention, medically unnecessary care can also occur when patients undergo simple tests, but at a much higher volume. Care that provides little or no benefit to the patient, with possible harm, is often referred to as low-value care.
The incidence of low-value care was addressed in a recent study published in the Journal of the American Medical Association (JAMA) Internal Medicine titled, “Low-Value Care at the Actionable Level of Individual Health Systems.” This study looked at 41 low-value services provided to Medicare beneficiaries, such as PSA testing in men over 70 years old, bone density scans performed once every two years, and routine preoperative EKG and laboratory testing. The overuse of such tests is not a new issue; the Choosing Wisely program was initiated to attempt to reduce such testing. But these authors went one step further. They attributed each patient to the health system where they received the majority of their primary care services and “scored” the health systems by how much low-value care was provided. The study included a table listing all 541 health systems, with their overall scores and performance on each test.
Before you look up your health system and either start bragging about your performance because you did well or criticizing the methods because you did poorly, note that the authors themselves point out the many limitations of such a study. The analysis was based on claims data and not chart review, limiting the ability to determine “exceptions to the rules.” The attribution of patients to a single health system is also limiting in that a patient may get their primary care from a physician affiliated with one system, but their specialists affiliated with another system are the ones who order the low- value care. Nonetheless, it offers an interesting look at the continuing use of low-value care, and an opportunity for readers to review the list of 41 services to educate themselves about what medical care should and should not be provided.
Finally, many count on government agencies to ensure that medical products sold in the U.S. are safe and effective, including the Food and Drug Administration (FDA), which ensures that drugs being prescribed actually work. But another recent article from JAMA Internal Medicine discusses the shortcomings of the FDA accelerated approval process. This process has been in the news recently with the approval of the new medication for Alzheimer’s disease, despite the Advisory Committee recommending that the drug not be approved. In this viewpoint, the authors point out that many of the drugs approved via the accelerated approval process subsequently had confirmatory trials that demonstrated no clinical benefit, yet they remain on the market and are still prescribed. They also note the lack of a requirement for clinical end points for these confirmatory trials, relying instead on surrogate end points, which do not always correspond to improvement in overall survival or quality of life.
Every day, every person in healthcare faces the question of whether the care they are providing, reviewing, billing, or arranging is medically necessary. The data suggests that in some instances, the answer is “no.” While I do not expect anyone to stand up in front of a doctor and proclaim that they cannot proceed with a surgery, we do owe it to our patients to have processes in place to ensure that the care they are receiving is safe, effective, and medically necessary.
Programming Note: Listen to Dr. Ronald Hirsch every Monday as he makes his Monday Rounds of Monitor Mondays, 10 Eastern and sponsored by R1RCM.