LAUSR

Gold is a precious metal with a high market price. When goldsmiths create a piece of jewelry, small shreds of gold often are not used. However, these precious shreds do not go to waste; they are carefully collected, melted, and used to craft subsequent jewelry. Similarly, many medications have a high market price and should be considered to be precious. However, what happens to unused injectable drugs that are left over in singledose vials? Are they carefully collected, or are they wasted? Significant wastage often occurs, perhaps unintentionally encouraged by legislation that permits payment for wastage. With the current interest in the high societal cost of medications, it is important to understand policies and processes related to decreasing wastage and thus saving societal resources. In this article, we explore the legislation that allows payment for wastage of injectable medications. The Centers for Medicare & Medicaid Services (CMS) pays for wasted medications. Historically, physicians and hospitals were given the option to provide a single bill or to bill the used drug and wasted drug separately using a special billing code, called the JW modifier, for the wasted drug. In January 2017, new rules were introduced that mandated that hospitals bill separately for discarded drugs using the JW modifier.1 The reason for this policy update was likely to increase transparency regarding payments for wasted drugs, perhaps in light of a recent lawsuit in which fraud was alleged regarding the manipulation of doses and vial sizes of drugs, such as intravenous iron sucrose (Venofer), by Davita, a company providing dialysis services.2 In an out-of-court settlement, Davita agreed to pay the US government $495 million for allegedly violating the False Claims Act when it continuously discarded medicines and then billed CMS. The policy updates in 2017 constitute a definite improvement regarding transparency, but do they go far enough in aiming to protect and preserve finite societal resources? Drug wastage is of economic importance. Of note, Bach et al3 recently estimated that oversized vials for cancer drugs may lead to $3 billion of overspending each year. Real-world data from Canada4 have reinforced these claims, demonstrating the problems and potential solutions for drug wastage owing to oversized vials. Furthermore, a recent analysis5 demonstrated the potential to save $0.8 billion annually by a small change in the dose of pembrolizumab, a cancer immunotherapy drug; however, this model was dependent on waste avoidance. Does allowing payment for wastage, even when performed transparently, encourage or discourage wastage? We would argue that it encourages wastage. In the same policy update for 2017,1(p2) CMS “encouraged physicians, hospitals and other providers and suppliers to care for and administer drugs and biologicals to patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner.” One could interpret this to mean that hospitals should carefully schedule patients to maximize vial sharing. Perhaps,certaindrugsshouldbeprovidedonly1dayperweek, in particular the drugs that lead to significant wastage owing to oversized vials, such as bortezomib.3 However, the language used by CMS appears to be nonenforceable and nonbinding. Hospitals that do not make any effort to share vials may be exposing themselves to the risk of a lawsuit for violating the False Claims Act. To better understand how the updated 2017 CMS wastage policy was interpreted nationally, we conducted a series of exploratory qualitative interviews of 10 pharmacists across the United States. These pharmacists were located in large and small centers and academic and community settings. We found a wide variety of practices regarding billing for waste, vial sharing, and use of the JW modifier. We found that some hospitals share single-dose vials among patients, whereas others do not. We are unaware of any hospital that makes specific scheduling efforts to maximize such vial-sharing opportunities. We also became aware of opportunities for hospitals to inadvertently or even fraudulently bill for wastage and at the same time share vials. Although everyone we spoke to was acutely aware of the high cost of some injectable medications, actual practices and policies differed at every setting. Ultimately, a hospital that is allowed to bill for a drug, whether infused or wasted, has an economic incentive to continue to waste drugs and bill for them. From the perspective of society’s resources, hospitals ideally would make special attempts to schedule patients carefully and maximize the opportunities for vial sharing and waste minimization. However, the effort required to do this, coupled with nonbinding legislation and potential loss of institutional revenue, makes this outcome unlikely. Just as a goldsmith has an incentive to minimize waste, we propose that appropriate incentives should be implemented for hospitals to minimize waste. A few options are available. CMS could make binding requests for efficient drug use. Perhaps efficient drug use could include a list of drugs that are clinically appropriate to infuse only on certain days of the week. This list could appropriately incorporate the drugs that are known to lead to significant wastage owing to oversized vials. The mandatory use of the JW waiver was a step forward to increase transparency, but further steps are needed to remove the incentive to waste resources. Society’s health care resources are finite, and it is incumbent on policy makers to ensure that appropriate policies are in place that lead to minimization of waste. VIEWPOINT