On June 16, 2014, the healthcare accrediting agency Joint Commission issued an alert to the healthcare industry describing the prevalence of unsafe injection practices and serious risks to patients that are occurring in both inpatient and outpatient settings. According to the Centers for Disease Control (CDC), at least 49 outbreaks have occurred since 2001 due to the mishandling of injectable medical products. The main focus of the alert implicates the reuse of single-dose vials of medications, which are intended to be used once for a single patient. Single-use vials often lack antimicrobial preservatives. By reusing the vials more than once, the potential risks for contamination and serious infections are countless. Additionally, multiple-dose vials that are misused carry substantial risks for serious, life-threatening infections that include hepatitis and meningitis.
At least 49 outbreaks have occurred since 2001 due to the mishandling of injectable medical products.
So, one might query, why wasn’t there any previous guidance from a federal agency regarding the safe and proper use of these injectable medications? Well, in fact, there was! Medicare has provided specific guidance on how to safely administer medications from single-dose vials. The Centers for Medicare and Medicaid Services (CMS) not only permits “wastage” of the remaining biological in the single-dose vial, but will reimburse the provider for the drug or biological that was discarded. Of course, this must be documented accurately in the patient’s record to receive the reimbursement (Section 1833(e) of the Social Security Act (SSA). For multi-dose vials, Medicare does not reimburse for drug wastage, since most of these drugs have a reasonable shelf life. When using multi dose vials, however, it is incumbent upon the provider to use proper infection control methods and not contaminate the contents.
Providers who do not bill for “wastage” but reuse the remaining medication/biological for another patient in order to enhance their reimbursement are not only placing themselves at risk for presenting false claims to the government, but unconscionably are placing their patients at risk. Even worse, there are some providers who bill for the wastage and reuse the left over medication in order to bill for another patient.