The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder Appears to Be Low in Medicare Part D

KEY RESULTS

• Almost all Medicare Part D enrollees who received buprenorphine for the treatment of opioid use disorder received the recommended amounts.
• Only a small number of enrollees either received very high amounts of buprenorphine or received buprenorphine at the same time as they received high amounts of other opioids.
• Most prescribers ordered buprenorphine for a limited number of Part D enrollees; very few had patterns that raise concern.
• These findings further support the recent repeal of the waiver-which was in place, in part, to limit diversion of buprenorphine.
• This report also provides baseline information and recommendations that can assist the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (the Department) as they work to continue to improve access to buprenorphine, while also ensuring that the risk of diversion and misuse remains low.

WHY OIG DID THIS REVIEW

Opioid-related overdose deaths in the United States remain a concern, with an estimated 82,310 deaths in 2021. As the country continues to struggle with the opioid crisis, it is essential to ensure access to buprenorphine to treat individuals with opioid use disorder.

Buprenorphine has been shown to decrease illicit opioid use and opioid-related overdose deaths. However, there are concerns about access to this potentially life-saving medication. Previous Office of Inspector General (OIG) work has shown a need to increase the number of Medicare enrollees receiving treatment for opioid use disorder. OIG has found that just 18 percent of Medicare enrollees with a diagnosis of opioid use disorder received medication to treat their opioid use disorder. Furthermore, Black, Hispanic, and Asian/Pacific Islander Medicare enrollees are less likely to receive medication to treat their opioid use disorder than are White enrollees.

At the same time, buprenorphine for the treatment of opioid use disorder—hereafter referred to as buprenorphine—has the potential for misuse and is at risk for diversion. To address this risk, providers were required to obtain a waiver through the Substance Abuse and Mental Health Services Administration (SAMHSA) to prescribe or administer buprenorphine in office-based settings and were limited in the number of patients they could treat. This waiver is commonly referred to as the "DATA waiver" after the Drug Addiction Treatment Act (DATA) of 2000 that established the waiver program. In December 2022, the Consolidated Appropriations Act, 2023, repealed the waiver requirement and the corresponding patient limits. This change comes alongside a wider effort by the Administration to expand access to treatment, in part, by eliminating barriers.

This data brief provides information related to the risk of misuse and diversion of buprenorphine in Medicare Part D in 2021—prior to the repeal of the DATA waiver. Prescribing of buprenorphine has been limited, in part, due to concerns related to misuse and diversion. Yet, up until now, there has been little information available on the extent to which buprenorphine may be misused or diverted in Medicare. This data brief describes the use of buprenorphine and looks at several measures to assess the risk of misuse and diversion of buprenorphine in Medicare.

HOW OIG DID THIS REVIEW

We focused this review on Medicare Part D claims for buprenorphine indicated for the treatment of opioid use disorder in 2021—prior to the repeal of the DATA waiver. We did not include claims for buprenorphine indicated for pain. Buprenorphine covered by Medicare Part D is generally prescribed in office-based settings and filled at retail pharmacies.

WHAT OIG FOUND

Almost all Medicare Part D enrollees who received buprenorphine to treat their opioid use disorder received the recommended amounts. Most enrollees received buprenorphine-naloxone combination products, which have a reduced risk of misuse or diversion; however, 16 percent of enrollees received buprenorphine monoproducts. Only a small number of enrollees received very high amounts of buprenorphine or received buprenorphine at the same time as they received high amounts of opioids indicated for pain.

Most prescribers ordered buprenorphine for only a limited number of enrollees, which could provide an opportunity to increase access. Further, very few prescribers had patterns that raise concern. Only 35 prescribers ordered buprenorphine for multiple Part D enrollees who either received very high levels of buprenorphine or received buprenorphine at the same time as they received high amounts of opioids.

WHAT OIG RECOMMENDS

Together, these findings suggest that the risk of misuse and diversion of buprenorphine in Medicare Part D is low. These findings further support the recent repeal of the DATA waiver which was in place, in part, to limit diversion of buprenorphine. The repeal of the waiver is a significant step towards increasing access to treatment.

Further, the data in this report provide baseline information about buprenorphine utilization and prescribing that can assist CMS, the Department, and others as they implement changes related to the repeal and take other steps to improve access to buprenorphine, while also ensuring that the risk of misuse and diversion remains low.

Accordingly, we recommend that CMS (1) monitor the use of buprenorphine and share information, as appropriate, with Departmental partners; (2) inform providers about buprenorphine use and the low risk of diversion to encourage providers to treat more Part D enrollees who have opioid use disorder; (3) take steps to inform providers about the availability of buprenorphine combination products in Part D, which can minimize the risk of misuse and diversion; and (4) follow up on the prescribers with concerning patterns identified in this report. CMS concurred with three of our recommendations. While it did not indicate whether it concurred with the other recommendation, it did indicate ongoing activity it felt was responsive.