Examining Removal of Federal Waiver Restrictions to Prescribing Buprenorphine in Primary Care

Abstract

Background:

Buprenorphine reduces the mortality associated with opioid use disorder (OUD) and may be prescribed in primary care. In January 2023, the requirement for a federal waiver to prescribe buprenorphine for OUD was removed. This study examines the impact of the waiver removal on buprenorphine prescribing in primary care.

Methods:

This retrospective cohort study used electronic health record data from 32 primary care clinics in Washington and Idaho. The sample included all patients 18 or older who had a primary care visit between January 2022 and December 2023. We described the number of patients who received buprenorphine in the year prior and the year following the removal of the waiver. We used generalized estimating equations with exchangeable correlation structure to estimate the odds ratio of receiving buprenorphine after the removal of the federal waiver.

Results:

A total of 56,003 patients met inclusion criteria and were included in the sample. The overall sample was 58.9% female, 75.8% White and mean age was 49.3 years. During the 2-year study period, 986 (1.8%) patients received buprenorphine. In our sample, we did not find a significant change in buprenorphine prescribing the year after the removal of the federal waiver after adjusting for sociodemographic characteristics (OR = 1.08, 95% CI 0.98-1.20). No significant interactions were found between the time period relative to the federal waiver removal and sociodemographic characteristics.

Conclusions:

Buprenorphine prescribing did not increase the year after the removal of the federal waiver, suggesting this regulatory change was insufficient to increase buprenorphine prescribing in primary care.

Introduction

The opioid crisis has transformed over the past decade and overdose deaths remain at record high levels.¹ Treatment with buprenorphine improves health outcomes,² decreases mortality³ and is the most effective treatment for opioid use disorder (OUD) available in primary care.⁴ Buprenorphine treatment has been effectively implemented in many primary care settings yet most primary care providers still do not prescribe buprenorphine.⁵ Until recently physicians were required to complete 8-hours of additional training (or 24 hours if a nurse practitioner or physician assistant) and obtain a waiver from the Drug Enforcement Administration (DEA) to prescribe buprenorphine for OUD. In January 2023, the requirement for a waiver was eliminated⁶ and additional training to prescribe buprenorphine was no longer required. Removal of the waiver eliminated a barrier for prescribers to increase treatment of buprenorphine for OUD, particularly in primary care by nonspecialists. In national samples across treatment settings, no meaningful increase in buprenorphine prescribing after the removal of the waiver was found,^7–11 but the impact on primary care remains to be examined. The aim of this study was to describe buprenorphine prescribing before and after the removal of the waiver in primary care clinics and patients across two states.

Methods

This retrospective cohort study used electronic health record data from 20 primary care clinics in Washington and 12 primary care clinics in Idaho. The sample included all primary care patients 18 or older who had a primary care encounter between January 2022 and December 2023. The primary outcome was receipt of buprenorphine based on buprenorphine orders in the medical record. Patients were not required to have a diagnosis of OUD in the medical record as substance use disorders are often are underrecognized, particularly in some minoritized groups.¹² We used descriptive statistics to describe patient sociodemographic and clinical characteristics and the number of patients who received at least one buprenorphine prescription in the one year before the removal of the federal waiver (January 1, 2022–December 31, 2022) and the one year following removal of the federal waiver (January 1, 2023–December 31, 2032). We used generalized estimating equations (GEE) with exchangeable correlation structure to estimate the odds ratio (OR) of receiving buprenorphine after removal of the waiver compared with before removal of the waiver controlling for age, sex, race, ethnicity, patient rurality,¹³ comorbidity¹⁴ and social deprivation.¹⁵ To further examine the association between the removal of the waiver and receipt of buprenorphine, we tested the interaction between each sociodemographic factors (age, sex, race, ethnicity, patient rurality,¹³ comorbidity¹⁴ and social deprivation¹⁵) and the time period relative to the removal of the waiver, fitting separate models for each sociodemographic factor without adjusting for additional covariates. Statistical analyses were performed using R version 4.3.1. This study was approved by the University of Washington Institutional Review Board.

Results

A total of 56,003 patients met inclusion criteria and were included in the sample. The overall sample was 58.9% female and 75.8% White, and mean age was 49.3 years. The sample was 97.6% urban and had a mean comorbidity score of 1.37. During the two-year study period, 986 patients (1.8%) received buprenorphine, 78.1% of whom had an OUD diagnosis documented in the medical record. Table 1 describes the overall sample and the sample that received buprenorphine. Of these patients who received buprenorphine, 735 received buprenorphine in the year before the removal of the waiver and 812 in the year after the removal of the waiver. There were no statistically significant differences in patient characteristics between the patients who received buprenorphine in the one year before the removal of the waiver compared with the 1 year after.

Table 1.

Characteristics of All Primary Care Patients versus Primary Care Patients Who Received Buprenorphine (2022–2023)

	Overall Sample	Received Buprenorphine
	n = 56,003	n = 986
Age (mean, SD)	49.3 (18.6)	47.0 (15.0)
Gender
Female	32,958 (58.9%)	403 (40.9%)
Male	23,045 (41.1%)	583 (59.1%)
Race
White	42,440 (75.78%)	772 (78.30%)
Asian	5,150 (9.20%)	25 (2.54%)
Black or African American	6,471 (11.55%)	127 (12.88%)
Other	1,942 (3.47%)	62 (6.29%)
Ethnicity
Hispanic or Latine	6,840 (12.2%)	68 (6.9%)
Not Hispanic or Latine	49,163 (87.8%)	918 (93.1%)
Rurality
Rural	1,351 (2.41%)	29 (2.94%)
Urban	54,652 (97.59%)	957 (97.06%)
SDI score (mean, SD)	47.0 (22.7)	52.1 (23.0)
Comorbidity score (mean, SD)	1.37 (2.38)	1.73 (2.44)
OUD diagnosis documented
No	54,491 (97.3%)	216 (21.9%)
Yes	1,512 (2.7%)	770 (78.1%)

SDI Score: Social Deprivation Index (SDI)¹⁹ is a composite measure of area level deprivation based on seven demographic characteristics. Rurality: Rurality was calculated using the Rural-Urban Commuting Area Codes.²⁰ Urban was defined as 1.0, 1.1, 2.0, 2.1, 3.0, 4.1, 5.1, 7.1, 8.1 and 10.1, and other codes as rural. Comorbidity Score: Comorbidity was calculated using the Revised Charlson Comorbidity Index²¹ which is standardized measure of the burden of medical conditions based on estimated yearly total costs of care. Scores for specific conditions are summed for an overall index score.

Abbreviations: OUD, opioid use disorder; SD, Standard deviation.

We found no significant change in buprenorphine prescribing in the one year after the removal of the waiver after adjusting for sociodemographic characteristics. Buprenorphine prescribing after the removal of the waiver trended up, but this finding was not statistically significant so may have been due to random variation (OR = 1.08, 95% CI 0.98-1.20).

We found no significant interactions between the time period relative to the federal waiver removal and sociodemographic characteristics (Figure 1). After the removal of the waiver, buprenorphine prescribing trended up in Asian patients, whereas buprenorphine prescribing trended down in non-White and non-Hispanic patients, but these findings were not statistically significant.

Figure 1.

Forest plot of interactions of sociodemographic characteristics on buprenorphine prescribing for after waiver removal versus before waiver removal. Abbreviations: OR, odds ratio; CI, Confidence Interval.

Discussion

In this sample of primary care patients less than 2 percent of patients received buprenorphine during the 2 year study period. Buprenorphine prescribing did not significantly increase in the year after removal of the federal waiver suggesting this regulatory change was not sufficient to cause a short-term increase buprenorphine prescribing in primary care. This is consistent with the literature in general populations^7–11 and supports the need to address additional barriers to increasing buprenorphine prescribing in primary care.¹⁶

Barriers to increasing buprenorphine prescribing in primary care exist at the patient level (stigma, misinformation, negative previous treatment experiences, care that is not patient centered),^17–20 provider level (stigma, inadequate training, time constraints)¹⁷ and health systems level (lack of behavioral health services, lack of institutional support, health care inequities).²¹ Given a comprehensive, multi-level approach is likely needed, future research should identify and test strategies to address these multilevel barriers.²²

This study had several important limitations. The time window may not have been not long enough to detect the full impact of the removal of the waiver as it generally takes longer than one year to see a change in practice.²³ While the sample included a clinics across 2 states, the sample was predominantly urban and findings may not generalize to other regions or in rural areas where access to buprenorphine is more limited.²⁴ Future studies should examine the impact of the removal of the federal waiver in a primary care sample that it more rural and geographically diverse. The mean comorbidity score in the sample was low so findings may not generalize to other patient populations who may be more medically complex. We did not require patients who received buprenorphine to also have a diagnosis of OUD to be included in analyses so some patients in our sample may have been receiving buprenorphine for pain only. Since the waiver did not impact buprenorphine prescribing for pain this could have led to us failing to detect a change in buprenorphine prescribing for OUD. Our analyses did not control for additional factors that may have contributed to changes in buprenorphine prescribing during the study period, such as changes in the drug supply (eg, the rise of fentanyl) and late impacts of the COVID-19 pandemic that may have impacted health care utilization and access to buprenorphine. Our study examined buprenorphine prescribing at the patient level, future research could explore the impact of the waiver removal at the provider level.

While regulatory changes removing waiver requirements allowed any clinician with a DEA license to prescribe buprenorphine for OUD, this change was not associated with significant increases in buprenorphine prescribing in primary care. To improve health outcomes and decrease mortality associated with OUD, future research should explore approaches to identifying and overcoming barriers to prescribing buprenorphine in primary care while simultaneously addressing equity issues in buprenorphine treatment.