Qualitative Assessment of Barriers to Buprenorphine Access: The Role of Pharmacies.

BACKGROUND: Patients continue to face challenges accessing medication for opioid use disorder (MOUD) despite attempts to loosen prescribing restrictions and streamline service provision. Past research has mainly focused on potential barriers surrounding prescribing practices for buprenorphine, but has had limited investigation into the role of pharmacies. OBJECTIVE: This study investigates the role of both pharmacists and pharmacies in creating or circumventing barriers to accessing buprenorphine for individuals in Georgia seeking medication for opioid use disorder (MOUD). METHODS: Semi-structured interviews of pharmacists across 12 access and no access pharmacies were used to create a codebook of 179 discreet statements. The (N = 12) 20-35-minute phone interviews included questions addressing substance use, pharmacy practices, treatment, harm reduction, and psychoeducation. RESULTS: Pharmacists widely agreed that opioid use has caused negative effects on community members (N = 11), that buprenorphine formulation stocking decisions are made based on patient needs (N = 11), and that buprenorphine is relatively easy to stock (N = 10). Additionally, respondents generally stated that buprenorphine is a helpful tool for treating opioid use disorder (OUD) (N = 12) but some reported positive experiences while others reported challenging or negative experiences with patients receiving buprenorphine (N = 7). Finally, few (N = 4) pharmacists agreed that they could benefit from extra training despite many asserting that training is important to inform their own practice (N = 8). CONCLUSION: Results from respondents generally show that training may be beneficial for pharmacists to develop an enhanced understanding of addiction and treatment. Enhanced effort to stock different formulations or dosages of buprenorphine and develop relationships with prescribers may increase community access.

Introduction of Medicare coverage in opioid treatment programs: Findings from the first three years.

BACKGROUND: Prior to January of 2020, there was no Medicare reimbursement for services delivered in opioid treatment programs (OTPs). OTPs are the only authorized providers of opioid use disorder (OUD) treatment with methadone, a critical tool to address the opioid overdose crisis. While prior research has examined the availability of MOUD other than methadone for Medicare beneficiaries, research has not identified organizational and local Medicare beneficiary characteristics associated with Medicare insurance acceptance among OTPs. OBJECTIVES: This study has two objectives: 1) to determine the extent to which OTPs began accepting Medicare insurance in the first three years following the new Medicare OTP benefit; and 2) to identify organizational characteristics and local Medicare beneficiary characteristics associated with OTP acceptance of Medicare. METHODS: We used data from the 2021-2023 National Directory of Drug and Alcohol Abuse Treatment Facilities to examine OTP acceptance of Medicare. We used logistic regression to identify organizational characteristics and local Medicare beneficiary characteristics associated with OTP acceptance of Medicare (n = 4630 OTPs). RESULTS: By 2022, about 78.7 % of OTPs accepted Medicare, compared to only 41.1 % of non-OTPs. The odds of Medicare acceptance were lower among for-profit OTPs, compared to non-profit OTPs, and higher among OTPs that accepted Medicaid and private insurance. Additionally, the odds of accepting Medicare were lower for OTPs located in the Northeast, Midwest, and South, compared to OTPs located in the West. Finally, the odds of accepting Medicare were higher for OTPs located in counties with higher percentages of Non-Hispanic White Medicare beneficiaries. CONCLUSIONS: We found high rates of Medicare acceptance among OTPs in the first three years of the Medicare OTP benefit, suggesting increased access to OUD treatment via OTPs for Medicare beneficiaries. While promising, results indicate potential geographic and racial/ethnic disparities in access to OTPs.

Missed Opportunities: Substance Use Hotline Operator Uncertainty of State Buprenorphine Prescribing via Telemedicine.

OBJECTIVES: We examined substance use hotline operator certainty of each US state and Washington, DC's endorsement of buprenorphine (initiation and continuation) prescribing via telemedicine. METHODS: Between March and May 2021, we called hotlines in 50 US states and Washington, DC, requesting information on whether practitioners in that state could initiate or continue buprenorphine treatment for opioid use disorder (OUD) via telephone or video conference. We compared operator responses to state implementation of buprenorphine telemedicine initiation. This study was designated as not human subjects research by the Boston University Institutional Review Board. RESULTS: We spoke with operators in 47 states and Washington, DC. Operators could not be reached in Alaska, California, and Montana. Most operators were uncertain (don't know, probably yes, probably no) whether the state permitted buprenorphine initiation (81%, n = 39) or continuation (83%, n = 40) via telemedicine. Practitioners could initiate buprenorphine prescribing via telemedicine in 7 states (100%) where operators were certain practitioners could initiate buprenorphine, 1 state (100%) where the operator was certain practitioners could not, and 6 states (86%) where operators indicated practitioners probably could not. CONCLUSIONS: Most US states and Washington, DC, expanded the role of telemedicine in OUD treatment. However, most operators expressed uncertainty and sometimes communicated inaccurate information regarding whether practitioners could initiate buprenorphine treatment via telemedicine. There is an urgent need for policy mandates institutionalizing the role of telemedicine, and of buprenorphine specifically, in OUD treatment and for resources to train and support substance use hotline operators in this evolving policy environment.

Changes In County-Level Access To Medications For Opioid Use Disorder After Medicare Coverage Of Methadone Treatment Began.

In 2020 Medicare began reimbursing for opioid treatment program (OTP) services, including methadone maintenance treatment for opioid use disorder (OUD), for the first time. Methadone is highly effective for OUD, yet its availability is restricted to OTPs. We used 2021 data from the National Directory of Drug and Alcohol Abuse Treatment Facilities to examine county-level factors associated with OTPs accepting Medicare. In 2021, 16.3 percent of counties had at least one OTP that accepted Medicare. In 124 counties the OTP was the only specialty treatment facility offering any form of medication for opioid use disorder (MOUD). Regression results showed that the odds of a county having an OTP that accepted Medicare were lower for counties with higher versus lower percentages of rural residents and lower for counties located in the Midwest, South, and West compared with the Northeast. The new OTP benefit improved the availability of MOUD treatment for beneficiaries, although geographic gaps in access remain.

The effect of cancer exemption in mandatory-access prescription drug monitoring programs among oncologists.

To address the opioid epidemic, some states mandate that prescribers review a state-run prescription drug monitoring program (PDMP) database before prescribing opioids. We used Medicare Part D prescriber data from 2013 (baseline) to 2019 to examine the association between state mandatory-access PDMPs, with and without a cancer exemption, and changes in the percent of oncologists' patients with any opioid fill per year, stratified by oncologists' baseline prescribing volume. Among 9746 medical or hematologic oncologists, the proportion of patients prescribed opioids declined after states implemented mandatory-access PDMPs without a cancer exemption overall (-0.49 percentage point, 95% confidence interval = -0.78 to -0.20 percentage point) and among those with above-median baseline prescribing, but not in states with a cancer exemption (-0.16 percentage point, 95% confidence interval = -0.50 to 0.18 percentage point) or with below-median baseline prescribing. Carefully designed mandatory-access PDMPs with cancer exemptions minimize unnecessary reductions in prescription opioid treatments among oncology patients in need of pain management.

Demographic and socioeconomic correlates to buprenorphine access in pharmacies.

BACKGROUND: Research has focused on buprenorphine prescribing with limited attention to the role of pharmacy access to buprenorphine for opioid use disorder. OBJECTIVE: This study examines demographic and socioeconomic correlates to buprenorphine access in Georgia pharmacies. METHODS: A 5-question (12 potential subqueries) telephone administered survey was used to investigate access and stocking patterns of specific dosages and formulations of buprenorphine in Georgia pharmacies (n = 119). Descriptive statistics characterized physician and pharmacy demographics and buprenorphine stocking practices. Correlations between various factors including buprenorphine stocking practices, geographic, and sociodemographic characteristics were identified using nonlinear regression models. RESULTS: The majority of pharmacies stocked the most commonly prescribed 8/2 mg dosage strength of buprenorphine/naloxone films and tablets (69.0% and 63.0%, respectively). Other strengths were less likely to be readily available. Pharmacies in Suburban Census tracts were 77.0% more likely to stock any type of buprenorphine monotherapy [odds ratio (OR) = 1.77, t = 2.37, P < 0.05] and 58.1% more likely to stock the 8 mg buprenorphine monotherapy formulation [OR = 1.58, t = 2.15, P < 0.05] than Urban tracts. Pharmacies in areas with above-average non-White populations were 29.6% more likely to stock a monotherapy product [OR = 1.30, t = 2.16, P < 0.05], and those in areas with above-average poverty rates were more likely to stock the 8 mg/2 mg buprenorphine/naloxone tablets [OR = 1.04, t = 2.02, P < 0.05]. There were no additional differences across the sample in formulation or dosage strengths. Pharmacists who endorsed challenges dispensing buprenorphine (23.3%) cited issues around insurance coverage, payment difficulty, prior authorization issues, and low stock of specific formulations. CONCLUSIONS: Results suggest that low availability of certain dosages or formulations of buprenorphine in local pharmacies could obstruct access for patients. Future research should address barriers to supplying buprenorphine and collaborative measures between pharmacists and prescribers to improve access.

Availability of Medications for Alcohol Use Disorder Treatment in Medicare Part D, 2014-2018.

OBJECTIVE: Despite increases in alcohol-related mortality, excessive drinking, and alcohol use disorder (AUD) among older adults, the availability of medications for alcohol use disorder (MAUD) for Medicare Part D beneficiaries has not yet been examined. METHOD: Prescription data from the Medicare Part D Public Use File were aggregated to the county-year level for the years 2014 to 2018. Descriptive statistics and paired t tests were used to examine changes in the availability of MAUD from 2014 to 2018. Two-part multivariable regression models were used to examine the association between county-level characteristics and MAUD availability. RESULTS: The percentage of counties across the U.S. offering any MAUD increased by 10% over the study period. The mean number of MAUD providers in counties with at least one provider increased by 1.81 providers over the study period, from 3.51 providers per county in 2014 to 5.32 providers in 2018. A higher percentage of counties had access to oral naltrexone, which was offered by at least one provider in 23% of counties in 2014 and 33% of counties in 2018. However, a majority (65%) of counties did not have any MAUD providers in 2018. Regression results showed a significant association between MAUD availability and census region, racial/ethnic composition of counties, AUD rate, and year. CONCLUSIONS: The low rates of MAUD availability for Medicare Part D beneficiaries are concerning given that older adults are particularly vulnerable to negative health implications associated with AUD. Targeted efforts are needed to appropriately address increasing AUD prevalence, morbidity, and mortality among older adults enrolled in Medicare.

National Estimates of Mental Health Needs Among Adults With Self-Reported CKD in the United States.

Introduction: Among adults with chronic kidney disease (CKD), comorbid mental illness is associated with poorer health outcomes and can impede access to transplantation. We provide the first US nationally representative estimates of the prevalence of mental illness and mental health (MH) treatment receipt among adults with self-reported CKD. Methods: Using 2015 to 2019 National Survey on Drug Use and Health (NSDUH) data, we conducted an observational study of 152,069 adults (age ≥22 years) reporting CKD (n = 2544), with no reported chronic conditions (n = 117,235), or reporting hypertension (HTN) or diabetes mellitus (DM) but not CKD (HTN/DM, n = 32,290). We compared prevalence of (past-year) any mental illness, serious mental illness (SMI), MH treatment, and unmet MH care needs across the groups using logistic regression models. Results: Approximately 26.6% of US adults reporting CKD also had mental illness, including 7.1% with SMI. When adjusting for individual characteristics, adults reporting CKD were 15.4 percentage points (PPs) and 7.3 PPs more likely than adults reporting no chronic conditions or HTN/DM to have any mental illness (P < 0.001) and 5.6 PPs (P < 0.001) and 2.2 PPs (P = 0.01) more likely to have SMI, respectively. Adults reporting CKD were also more likely to receive any MH treatment (21% vs. 12%, 18%, respectively) and to have unmet MH care needs (6% vs. 3%, 5%, respectively). Conclusion: Mental illness is common among US adults reporting CKD. Enhanced management of MH needs could improve treatment outcomes and quality-of-life downstream.

Medicaid expansion and opioid overdose mortality among socioeconomically disadvantaged populations in the US: A difference in differences analysis.

BACKGROUND: Opioid-related overdoses are a major cause of mortality in the US. Medicaid Expansion is posited to reduce opioid overdose-related mortality (OORM), and may have a particularly strong effect among people of lower socioeconomic status. This study assessed the association between state Medicaid Expansion and county-level OORM rates among individuals with low educational attainment. METHODS: This quasi-experimental study used lagged multilevel difference-in-difference models to test the relationship of state Medicaid Expansion to county-level OORM rates among people with a high-school diploma or less. Longitudinal (2008-2018) OORM data on 2978 counties nested in 48 states and the District of Columbia (DC) were drawn from the National Center for Health Statistics. The state-level exposure was a time-varying binary-coded variable capturing pre- and post-Medicaid Expansion under the Affordable Care Act (an "on switch"-type variable). The main outcome was annual county-level OORM rates among low-education adults adjusted for potential underreporting of OORM. FINDINGS: The adjusted county-level OORM rates per 100,000 among the study population rose on average from 10.26 (SD = 13.56) in 2008-14.51 (SD = 18.20) in 2018. In the 1-year lagged multivariable model that controlled for policy and sociodemographic covariates, the association between state Medicaid Expansion and county-level OORM rates was statistically insignificant. CONCLUSIONS: We found no evidence that expanding Medicaid eligibility reduced OORM rates among adults with lower educational attainment. Future work should seek to corroborate our findings and also identify - and repair - breakdowns in mechanisms that should link Medicaid Expansion to reduced overdoses.

Availability of Medications for the Treatment of Alcohol Use Disorder in U.S. Counties, 2016-2019.

OBJECTIVE: Although numerous studies have examined the geographic availability of medications for opioid use disorder, none have measured the availability of medications for alcohol use disorder (MAUD) in the United States. We examined county-level trends in MAUD offerings in the specialty substance use disorder treatment system and compared MAUD availability with local geographic characteristics and alcohol use disorder treatment need. METHOD: We constructed annual county-level measures of MAUD availability for 2016-2019 using the National Directory of Drug and Alcohol Abuse Treatment Facilities, determining the number of outpatient facilities offering MAUD in each county (n = 12,568). Two-part, multivariable regression models estimated the association between MAUD availability and temporal trends, census region, urbanicity, and prevalence of excessive drinking. RESULTS: Availability of MAUD increased significantly over the study period. By 2019, 38% of U.S. facilities offered at least one MAUD, 40% of counties had at least one specialty treatment facility offering MAUD, and counties with at least one facility had an average of 3.36 MAUD facilities. Availability was significantly higher in urban counties and in the Northeast (both p < .01), but not in counties with higher prevalence of excessive drinking. CONCLUSIONS: We observed large increases in the availability of MAUD in the U.S. specialty treatment system from 2016 to 2019. Although these results are encouraging, a majority (60%) of U.S. counties did not have a specialty outpatient treatment facility that offered MAUD in 2019. Additional efforts are needed to improve availability of MAUD, especially in rural counties and in the southern and midwestern United States.

Association of prescription drug monitoring program laws with bedridden and missed work days.

OBJECTIVE: To examine the relationship between optional and must-use prescription drug monitoring programs (PDMPs) and markers of disability. DATA SOURCES: Nationwide data from the National Health Interview Survey for 2006-2015. STUDY DESIGN: Generalized difference-in-difference models with state-specific time trends were used to assess the relationship between PDMPs and two outcomes: missed days of work and bedridden days. DATA COLLECTION/EXTRACTION METHODS: All respondents above the age of 18 years with complete data on key measures were included. A subpopulation of respondents who had a recent surgery or injury was identified. PRINCIPAL FINDINGS: We found an increase of 3.3 and 5.9 bedridden days associated with optional and must-use PDMPs, respectively, for respondents reporting a recent injury or surgery (p-values <0.05; unadjusted population average 12.2 bedridden days). Increases in days of missed work were not statistically significant. CONCLUSIONS: Implementation of PDMPs was associated with negative unintended consequences in the injury/surgery subpopulation. The association between bedridden days and PDMPs suggests a gap between clinical trials showing equivalence of opioids and nonopioids for pain treatment and real-world results. As increasingly tighter opioid restrictions proliferate, evidence-based strategies to address pain without opioids in the acute pain population likely need to be more widely disseminated.

Medicaid Expansion and Availability of Opioid Medications in the Specialty Substance Use Disorder Treatment System.

OBJECTIVE: Research has examined the effect of Medicaid expansion on access to physicians with buprenorphine waivers, but less attention has been paid to Medicaid's impact on opioid use disorder medication availability within the specialty substance use disorder treatment system. To address this gap in the literature, this study examined the impact of Medicaid expansion on availability of opioid medications in specialty programs. METHODS: This study used data from the National Survey of the Substance Abuse Treatment Services (2002-2017), containing all known substance use disorder treatment programs in the United States, to examine the effect of Medicaid expansion on the availability of opioid use disorder medications by treatment program ownership type (publicly owned, private for profit, and private nonprofit) among opioid treatment programs (OTPs) and non-OTPs. RESULTS: The effects of Medicaid expansion were limited to nonprofit and for-profit OTPs. Medicaid expansion was associated with 135.1% and 57.5% increases in the number of nonprofit and for-profit OTPs offering injectable naltrexone, respectively, and with a 64.4% increase in the number of nonprofit OTPs offering buprenorphine. Nonprofit and for-profit OTPs compose <10% of the treatment system, indicating that improvements in opioid use disorder treatment associated with Medicaid expansion were limited to a small share of the specialty system. CONCLUSIONS: The limited impact of Medicaid expansion on the specialty treatment system may perpetuate disparities in the accessibility and quality of opioid use disorder treatment for Medicaid enrollees and fail to alleviate high rates of opioid use disorder and opioid overdose deaths in this vulnerable population.

Gaps In Access To Opioid Use Disorder Treatment For Medicare Beneficiaries.

In 2016 only 13.8 percent of substance use disorder treatment programs offered medication treatment for opioid use disorder for older adults who used Medicare to pay for treatment. With increasing demand for treatment among older adults and a rapidly aging population, improved access to medication treatment for this population is needed.

How protected classes in Medicare Part D influence U.S. drug sales, utilization, and price.

When the Medicare Part D prescription drug benefit was implemented in 2006, six drug classes were designated "protected classes." Because responsibility for obtaining favorable drug prices depends on private insurers' abilities to negotiate with pharmaceutical manufacturers using the threat of formulary exclusion, the protected class designation could undermine the insurers' ability to control spending and utilization of drugs in these six classes. I estimate the effect of the protected class policy on U.S. national drug sales, utilization, and price using 2001-2010 IMS Health National Sales Perspectives data and Verispan Vector One: National data and controlling for drug and year fixed effects. I find that protected status beginning in 2006 led to $112-121 million per drug per year higher U.S. sales for drugs in protected classes relative to unprotected drugs. Greater sales were driven by the antidepressant, antipsychotic, anticonvulsant, and antineoplastic classes. Subsequent analyses on a subset of drugs reveal that increases in both price and quantity are responsible for the growth of sales in protected class drugs. These results are important for informing the recent and ongoing deliberation by the Medicare program over whether to remove several classes from protection.

Relationship of County Opioid Epidemic Severity to Changes in Access to Substance Use Disorder Treatment, 2009-2017.

OBJECTIVE: The study measured the association between local opioid problem severity and changes in the availability of substance use disorder treatment programs, including the distance required for travel to treatment. METHODS: A two-part, multivariable regression estimated the number of treatment facilities in the county (per 100,000 residents) and the number of miles to the nearest program (for all treatment programs, programs offering opioid use disorder medication, and programs accepting Medicaid) using data from the 2009-2017 National Directory of Drug and Alcohol Abuse Treatment Facilities. The unit of analysis was the county-year (N=28,270). RESULTS: The probability of having at least one treatment program meeting the established criteria was greater in counties with a high-severity opioid problem than in counties with a low-severity problem, and the probability improved over time. In counties with a high-severity problem, the probability of having a treatment program offering buprenorphine, methadone, or both was 60.3% higher than in counties with low-severity problems. Between 2009 and 2017, the likelihood of having a treatment program that accepts Medicaid grew by 25.3%. For counties without treatment programs, the distance to the nearest program improved markedly over time, but there were no differences between distance to treatment in high-, moderate-, and low-severity status counties. CONCLUSIONS: The treatment system has reduced structural barriers to treatment where it is most needed. However, these findings do not imply that the treatment system has sufficient capacity to address the present scope of the opioid crisis. Policy makers should leverage this responsiveness to incentivize additional improvements in access.

Prescription Drug Monitoring Programs Produce a Limited Impact on Painkiller Prescribing in Medicare Part D.

OBJECTIVE: To measure the impact of prescription drug monitoring programs (PDMPs) on prescribing of opioid and nonopioid painkillers. DATA SOURCE: 2010-2013 physician-level Medicare Part D prescribing data released by the Centers for Medicare and Medicaid Services and Propublica. STUDY DESIGN: Using difference-in-differences models with physician-level fixed effects, the study compares prescribing in states with and without PDMPs for opioid and nonopioid analgesics, oxycodone, hydrocodone, and opioids by controlled substances Schedules II-IV. PRINCIPAL FINDINGS: Prescription drug monitoring programs were associated with a 5.2 percent decrease in days supply prescribed per physician for oxycodone in addition to smaller reductions for hydrocodone and opioids overall (2.8 percent and 2 percent, respectively) and a small increase in prescribing for Schedule IV opioids. PDMPs were not associated with changes for nonopioid analgesics or other opioids in Schedules II and III. The effects of PDMPs were negated in states where statutes explicitly did not require use of the PDMP. CONCLUSIONS: Prescription drug monitoring programs have a modest effect targeted at the high-profile drug oxycodone among the Medicare Part D population and an even smaller effect for hydrocodone and opioids in general. The findings suggest some substitution toward lower schedule opioids. Substantially addressing the widespread opioid abuse problem will require enhancing existing PDMPs or implementing new policies.