The risk of abuse and diversion of buprenorphine for opioid use disorder appears to be low in Medicare Part D OEI-02-22-00160 05-16-2023

16-05-2023 | OEI-02-22-00160 | Full report

KEY RESULTS

• Almost all Medicare Part D enrollees who received buprenorphine for the treatment of an opioid use disorder received the recommended amounts.
• Only a small number of participants received very large amounts of buprenorphine or received buprenorphine at the same time as receiving large amounts of other opioids.
• Most prescribers ordered buprenorphine for a limited number of Part D enrollees; very few had patterns that cause concern.
• These results further support the recent repeal of the waiver, which was in place, in part, to limit the diversion of buprenorphine.
• This report also provides background information and recommendations that can help the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (the Department) in their efforts to continue to improve access to buprenorphine, while ensuring that the risk of diversion and abuse 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 grapple with the opioid crisis, ensuring access to buprenorphine to treat opioids is critical. people with opioid use disorders.

Buprenorphine has been shown to reduce illicit opioid use and opioid-related overdose deaths. However, there are concerns about access to this potentially life-saving drug. Previous work by the Office of Inspector General (OIG) has shown the need to increase the number of Medicare enrollees receiving treatment for opioid use disorder. The OIG found that only 18% of Medicare enrollees diagnosed with an opioid use disorder were receiving medication to treat their opioid use disorder. Additionally, Black, Hispanic, and Asian/Pacific Islander Medicare enrollees are less likely to receive medications to treat their opioid use disorder than white enrollees.

At the same time, buprenorphine for the treatment of opioid use disorder – hereafter referred to as buprenorphine – has the potential for abuse and the risk of diversion. To address this risk, providers had to obtain a waiver from the Substance Abuse and Mental Health Services Administration (SAMHSA) to prescribe or administer buprenorphine in the office and were limited in the number of patients they could treat. This waiver is commonly referred to as a “data waiver” after the Drug Treatment Act (DATA) of 2000 which established the waiver program. In December 2022, the Consolidated Appropriations Act of 2023 repealed the waiver requirement and corresponding patient limits. This change is accompanied by a broader effort by the administration to expand access to treatment, in part, by removing barriers.

This data sheet provides information related to the abuse and diversion risk of buprenorphine in Medicare Part D in 2021, prior to the repeal of the DATA waiver. Buprenorphine prescribing has been limited, in part due to concerns about abuse and diversion. Yet, until now, there has been little information available on the extent to which buprenorphine can be diverted or diverted into Medicare. This fact sheet describes the use of buprenorphine and reviews several measures to assess the risk of abuse 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, before the repeal of the DATA waiver. We did not include claims for buprenorphine indicated for pain. Buprenorphine covered by Medicare Part D is usually prescribed in the office 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 participants received buprenorphine-naloxone combination products, which have a reduced risk of abuse or diversion; however, 16% of enrollees received buprenorphine monoproducts. Only a small number of participants received very large amounts of buprenorphine or received buprenorphine at the same time as receiving large amounts of opioids indicated for pain.

Most prescribers only ordered buprenorphine for a limited number of enrollees, which could provide an opportunity to increase access. In addition, very few prescribers had concerning patterns. Only 35 prescribers ordered buprenorphine for several Part D enrollees who either received very high levels of buprenorphine or received buprenorphine at the same time they were receiving large amounts of opioids.

WHAT THE OIG RECOMMENDS

Together, these results suggest that the risk of abuse and diversion of buprenorphine in Medicare Part D is low. These results further support the recent repeal of the DATA waiver which was in place, in part, to limit the diversion of buprenorphine. Repealing the waiver is an important step towards improving access to treatment.

In addition, the data in this report provides baseline information on the use and prescribing of buprenorphine 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 ensuring that the risk of abuse and diversion remains low.

Accordingly, we recommend that CMS (1) monitor the use of buprenorphine and share information, as appropriate, with Ministry partners; (2) educate providers about the use of buprenorphine 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 of the availability of buprenorphine combination products in Part D, which can minimize the risk of abuse and diversion; and (4) follow up with prescribers regarding the patterns of concern identified in this report. CMS agreed with three of our recommendations. Although he did not indicate whether he agreed with the other recommendation, he did indicate an ongoing activity which he felt met the need.