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3 Scope of Discarded Drugs from Single-Dose Vials
Pages 61-74

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From page 61...
... This calculation assumed that providers consistently use the mandatory JW modifier, which has not been verified empirically.1 Another analysis in 2016 estimated the money spent on discarded drugs in single-dose vials of cancer medications to be $1.8 billion (Bach et al., 2016) .2 Furthermore, the analysis suggested that the amount of money spent on discarded medications by public and private health care payers swelled to $2.8 billion when physician and hospital markups were included in the estimate (Bach et al., 2016)
From page 62...
... . 5 As described in Chapter 2, the JW modifier is the mechanism through which health care providers can bill and be reimbursed for the discarded portion of a single-dose vial in a way that formally documents the amount of drug that was discarded.
From page 63...
... The other looked at variations among physicians in their use of the JW modifier. The findings were then used to provide an estimate of the total nominal cost of discarded drugs -- that is, the amount of dollars represented by the discarded drugs under the assumption that the discarded drugs could be valued at the same per-unit cost as unused drugs in single-use vials -- and that number was compared with the total cost indicated by the JW modifier.
From page 64...
... The 8  The level of compliance is determined by whether the JW modifier was used at all and not related to the specific amount of discarded drug recorded. 9  MarketScan analysis will be discussed later in this chapter.
From page 65...
... (n=31) Percentage of claims with 25.3 1.9 5.83 1.49 the JW modifier, 2017 Percentage of claims with 26.9 1.4 6.74 2.16 the JW modifier, 2018 committee recognizes that in some cases, the JW modifier would not be reported because the entire contents of the vial were used in the treat ment of a single patient, or there was no discarded drug because the vial may have been shared between patients in accordance with United States Pharmacopeia guidelines.
From page 66...
... , there were few consistent patterns or substantial differences in terms of use of the modifier across regions,11 nor did the use of the JW modifier in urban versus rural areas follow any sort of consistent pattern.12 The analysis also examined the role of provider volume in terms of using the JW modifier. The rates of use were similar between health care providers with above and below the median number of claims for a particular drug and also between health care providers in the bottom 25th and top 25th percentiles of claims for that drug.13 The only consistent pattern identified across drugs was higher use of the JW modifier in physician office settings relative to hospital outpatient departments.14 Across the 40 drugs in the sample with at least 1 percent of claims with the JW modifier, a higher percentage of physician office settings used it for a given drug than hospital outpatient departments did.
From page 67...
... It is reasonable to assume that if a certain amount of a particular drug for a particular patient is marked with the JW modifier on one occa­sion, the modifier is likely appropriate in all instances of that patient receiving that drug within a relatively short period, since the dosage is based on weight or body size. Yet, an analysis of the five drugs with the greatest Medicare spending on claims with the JW modifier (Table 3-2, left panel)
From page 68...
... In this sample, the percentage of providers who never used the JW modifier varied across drugs, from 8 percent of those administering brentuximab vedotin to 70 percent of those administering infliximab.16 The large percentages of health care providers with more than 11 claims who used the modifier in some cases but not others present clear evidence that providers are using the JW modifier inconsistently from one drug to another. Equally important, over two-thirds of the providers with 11 or more claims for at least one of the 77 drugs never used the JW modifier at all.
From page 69...
... Even after including the estimated unreported spending, these figures are likely an underestimation because it is not possible to project potential spending for patient–drug combinations where the JW modifier was never used, which accounts for a sizable percentage of patient–drug combinations. Another approach to estimate costs of discarded drugs is to include only health care providers who used the JW modifier.
From page 70...
... , had the JW modifier in the claims. As Table 3-1 shows, the use of the JW modifier in weight-based drugs in the MarketScan database was substantially lower than the pattern found in the Medicare analysis, as not all private insurance claims require health care providers to use it.
From page 71...
... The $80.6 million figure was calculated using claims with the JW modifier. However, private payers grossly underused the JW modifier.20 The researchers imputed the potential additional spending on discarded drugs using the same approach described in the Medicare analysis by apply­ing a patient drug–specific ratio to the partially compliant group.
From page 72...
... It also raises a question whether payers will have sufficient realtime biometric data to verify the information submitted in claims with the JW modifier. The researchers analyzed payment variables from claims data to estimate the financial burden of discarded drugs for private payers and patients.
From page 73...
... KEY FINDINGS 1. Not all health care providers use the JW modifier, and among those health care providers that use the modifier, the JW modifier is not reported con sistently, even though it has been required by the Centers for Medicare & Medicaid Services since January 2017.
From page 74...
... CONCLUSIONS 1. Currently, attempting to estimate a single value for the cost of dis carded drugs from single-dose vials to the Medicare program using the JW modifier would be incomplete and underestimated because the modifier is underused by health care providers and the resulting data may not be representative.


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