On January 22, 2015, the HHS OIG released a report regarding CMS’s oversight of compounded sterile preparations (CSPs) used in hospitals. After reviewing oversight efforts at CMS and the entities that accredit hospitals to participate in Medicare—the Joint Commission, the American Osteopathic Association, Det Norske Veritas Healthcare, and the Center for Improvement in Healthcare Quality—the OIG determined that a lack of personnel and training prevented the oversight entities from effectively evaluating hospitals’ use of CSPs.

In 2012, a standalone compounding pharmacy prepared contaminated injections that caused a nationwide meningitis outbreak. Following the outbreak, the OIG found that most acute care hospitals use CSPs prepared by standalone compounding pharmacies, such as the injections that caused the meningitis outbreak. The OIG then reviewed the practices of the oversight entities regarding the use of CSPs in hospitals. The report reveals that, while the oversight entities address most of the recommended CSP-related practices some of the time, “only one oversight entity always reviews hospital contracts with standalone compounding pharmacies.” According to the OIG, the oversight entities also lack the personnel required to thoroughly review hospitals’ preparation and use of CSPs, and most of the oversight entities do not include pharmacists on hospital surveys. The OIG recommended that CMS ensure hospital surveyors receive training on safe compounding practices and amend their guidelines to address hospitals’ contracts with standalone compounding pharmacies. CMS agreed with these recommendations.

Reporter, Paige Fillingame, Houston, +1 713 615 7632, pfillingame@kslaw.com.