Impact of the 2021 US Federal X-Waiver Practice Guideline Change on the Prescribing of Buprenorphine and Naltrexone for Treating Opioid Use Disorder in Medicaid Population

OBJECTIVES: In April 2021, the United States Department of Health and Human Services released new federal practice guidelines and allowed physicians who wish to treat ≤30 patients with opioid use disorder (OUD) to obtain an “X-waiver” and forego required training. However, limited evidence exists in the impact of this practice guideline change on OUD treatment use in real world.

METHODS: This retrospective, interrupted time-series analysis compared quarterly number and dose of buprenorphine and naltrexone dispensed in the Medicaid population in 2018-2022 (pre-intervention: 2018Q1-2021Q1; post-intervention: 2021Q2-2022Q4) using the CMS State Drug Utilization Data (n=50 states and Washington D.C.). Segmented regression analyses with interrupted time-series were constructed to determine the impact of X-waiver practice change on level and trend changes in quarterly number and dose of buprenorphine and naltrexone dispensed. Subgroup analysis was conducted based on type of prescription coverage (managed care or fee-for-service). All analyses were conducted using SAS 9.4.

RESULTS: Compared to pre-intervention, there was no statistically significant changes in either level or trend in quarterly total number (P_level=0.30, P_trend=0.15) or dose (P_level=0.80, P_trend=0.67) of buprenorphine dispensed in the Medicaid population after the X-waiver practice change. Similarly, we observed no significant changes in either level or trend in quarterly total number (P_level=0.17, P_trend=0.84) or dose (P_level=0.23, P_trend=0.06) of naltrexone dispensed in the same population. Results from subgroup analysis also found no change in levels of buprenorphine and naltrexone through either managed care or fee-for-service plans. The trend in quarterly total dose of buprenorphine from fee-for-service plans even decreased P_trend=0.01 after the X-waiver practice change.

CONCLUSIONS: Our findings indicated that the removal of X-waiver training in federal practice guidelines had no impact on access to OUD treatments including buprenorphine and naltrexone in the Medicaid population. Changing federal practice guidelines alone does not improve patients’ access to OUD medication treatments.