Why GAO did this study. Misuse of prescription opioids can lead to overdose and death. In 2016, over 14 million Medicare Part D beneficiaries received opioid prescriptions, and spending for opioids was almost $4.1 billion. GAO and others have reported on inappropriate activities and risks associated with these prescriptions, such as receiving multiple opioid prescriptions from different providers. GAO was asked to describe what is known about CMS's oversight of Medicare Part D opioid use and prescribing. This report examines (1) CMS oversight of beneficiaries who receive opioid prescriptions under Part D, and (2) CMS oversight of providers who prescribe opioids to Medicare Part D beneficiaries. GAO reviewed CMS opioid utilization and prescriber data, CMS guidance for plan sponsors, and CMS's strategy to prevent opioid misuse. GAO also interviewed CMS officials, the six largest Part D plan sponsors, and 12 national associations selected to represent insurance plans, pharmacy benefit managers, physicians, patients, and regulatory and law enforcement authorities. What GAO Found. The Centers for Medicare & Medicaid Services (CMS) provides guidance on the monitoring of Medicare beneficiaries who receive opioid prescriptions to plan sponsors--private organizations that implement the Medicare drug benefit, Part D--but lacks information on most beneficiaries at risk of harm. (1) CMS provides plan sponsors guidance on how they should monitor opioid overutilization among Medicare Part D beneficiaries and requires them to implement drug utilization review systems that use criteria similar to CMS's. CMS's criteria focus on beneficiaries who (a) receive prescriptions of high doses of opioids, (b) receive prescriptions from four or more providers, and (3) fill the prescriptions at four or more pharmacies. According to CMS officials, this approach allows plan sponsors to focus their actions on those beneficiaries it determined to have the highest risk of harm from opioid use. (2) CMS's criteria, including recent revisions, do not provide sufficient information about the larger population of potentially at-risk beneficiaries. CMS estimates that while 33,223 beneficiaries would have met the revised criteria in 2015, 727,016 would have received high doses of opioids regardless of the number of providers or pharmacies. In 2016, CMS began to collect information on some of these beneficiaries using a higher dosage threshold for opioid use. This approach misses some who could be at risk of harm, based on Centers for Disease Control and Prevention guidelines. As a result, CMS is limited in its ability to assess progress toward meeting the broader goals of its Opioid Misuse Strategy, which includes activities to reduce the risk of harm from opioid use. CMS oversees the prescribing of drugs at high risk of abuse through a variety of projects, but does not analyze data specifically on opioids. According to CMS officials, CMS and plan sponsors identify providers who prescribe large amounts of drugs with a high risk of abuse, and those suspected of fraud or abuse may be referred to law enforcement. However, GAO found that CMS does not identify providers who may be inappropriately prescribing large amounts of opioids separately from other drugs, and does not require plan sponsors to report actions they take when they identify such providers. As a result, CMS is lacking information that it could use to assess how opioid prescribing patterns are changing over time, and whether its efforts to reduce harm are effective. What GAO Recommends. GAO recommends that CMS (1) gather information on the full number of at-risk beneficiaries receiving high doses of opioids, (2) identify providers who prescribe high amounts of opioids, and (3) require plan sponsors to report to CMS on actions related to providers who inappropriately prescribe opioids. HHS concurred with the first two recommendations, but not with the third. GAO continues to believe the recommendation is valid, as discussed in the report.
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