Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018

ObjectiveBuprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions.MethodsWe first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA. We then used National Drug Codes to identify each drug in the Medicaid State Drug Utilization Data and extracted annual utilization rates and spending between 2002 and 2018 by drug and according to whether a brand-name or generic version was dispensed. We compared these trends to market and regulatory factors that affected competition, which we identified through searching the Federal Register, Westlaw, PubMed, and Google News.ResultsBrand-name buprenorphine-naloxone sublingual tablet and film formulations (Suboxone) were dispensed 2.7 times more (n = 634 213 140) and reimbursed 4.4 times more (n = $4 440 556 473) than all other formulations combined (n = 237 769 689; $1 018 988 133). We identified numerous market and regulatory factors that contributed to an estimated 9-year delay in generic versions of the tablet formulation and 6-year delay for generic versions of the film formulation.ConclusionsBrand-name buprenorphine formulations have been widely used in Medicaid, leading to substantial costs, in part because generic versions were delayed by multiple years owing to market and regulatory factors. Timely availability of low-cost generics could have helped encourage OUD treatment with buprenorphine during the height of the opioid crisis.     

Effects of Regulation on Methadone and Buprenorphine Provision in the Wake of Hurricane Sandy

Hurricane Sandy led to the closing of many major New York City public hospitals including their substance abuse clinics and methadone programs, and the displacement or relocation of thousands of opioid-dependent patients from treatment. The disaster provided a natural experiment that revealed the relative strengths and weaknesses of methadone treatment in comparison to physician office-based buprenorphine treatment for opioid dependence, two modalities of opioid maintenance with markedly different regulatory requirements and institutional procedures. To assess these two modalities of treatment under emergency conditions, semi-structured interviews about barriers to and facilitators of continuity of care for methadone and buprenorphine patients were conducted with 50 providers of opioid maintenance treatment. Major findings included that methadone programs presented more regulatory barriers for providers, difficulty with dose verification due to impaired communication, and an over reliance on emergency room dosing leading to unsafe or suboptimal dosing. Buprenorphine treatment presented fewer regulatory barriers, but buprenorphine providers had little to no cross-coverage options compared to methadone providers, who could refer to alternate methadone programs. The findings point to the need for well-defined emergency procedures with flexibility around regulations, the need for a central registry with patient dose information, as well as stronger professional networks and cross-coverage procedures. These interventions would improve day-to-day services for opioid-maintained patients as well as services under emergency conditions.     

Treating Opioid Dependence with Buprenorphine in the Safety Net: Critical Learning from Clinical Data

Research has examined the safety, efficacy, feasibility, and cost-effectiveness of buprenorphine for the treatment of opioid dependence, but few studies have examined patient and provider experiences, especially in community health centers. Using de-identified electronic health record system (EHRS) data from 70 OCHIN community health centers (n = 1825), this cross-sectional analysis compared the demographics, comorbidities, and service utilization of patients receiving buprenorphine to those not receiving medication-assisted treatment (MAT). Compared to non-MAT patients, buprenorphine patients were younger and less likely to be Hispanic or live in poverty. Buprenorphine patients were less likely to have Medicaid insurance coverage, more likely to self-pay, and have private insurance coverage. Buprenorphine patients were less likely to have problem medical comorbidities or be coprescribed high-risk medications. It is important for providers, clinic administrators, and patients to understand the clinical application of medications for opioid dependence to ensure safe and effective care within safety net clinics.     

Methadone Maintenance and State Medicaid Managed Care Programs

Coverage for methadone services in state Medicaid plans may facilitate access to the most effective therapy for heroin dependence. State Medicaid plans were reviewed to assess coverage for methadone services, methadone benefits in managed care, and limitations on methadone treatment. Medicaid does not cover methadone maintenance medication in 25 states (59 percent). Only 12 states (24percent) include methadone services in Medicaid managed care plans. Moreover, two of the 12 states limit coverage for counseling or medication and others permit health plans to set limits. State authorities for Medicaid and substance abuse can collaborate to ensure that appropriate medication and treatment services are available for Medicaid recipients who are dependent on opioids andto construct payment mechanisms that minimize incentives that discourage enrollment among heroin-dependent individuals.     

Opioid Agonist Treatments and Heroin Overdose Deaths in Baltimore,Maryland, 1995–2009

Objectives. We examined the association between the expansion of methadone and buprenorphine treatment and the prevalence of heroin overdose deaths in Baltimore, Maryland from 1995 to 2009.Methods. We conducted a longitudinal time series analysis of archival data using linear regression with the Newey–West method to correct SEs for heteroscedasticity and autocorrelation, adjusting for average heroin purity.Results. Overdose deaths attributed to heroin ranged from a high of 312 in 1999 to a low of 106 in 2008. While mean heroin purity rose sharply (1995–1999), the increasing number of patients treated with methadone was not associated with a change in the number of overdose deaths, but starting in 2000 expansion of opioid agonist treatment was associated with a decline in overdose deaths. Adjusting for heroin purity and the number of methadone patients, there was a statistically significant inverse relationship between heroin overdose deaths and patients treated with buprenorphine (P = .002).Conclusions. Increased access to opioid agonist treatment was associated with a reduction in heroin overdose deaths. Implementing policies that support evidence-based medication treatment of opiate dependence may decrease heroin overdose deaths.Heroin overdose death is a major public health problem throughout the world.1–4 Factors thought to be related to the prevalence of heroin overdose death include the availability and purity of heroin on the streets,5–8 periods of brief incarceration or detoxification that lower opioid tolerance,9–14 and the availability and penetration of opioid agonist treatment.1,15–17 Among public health treatment strategies to reduce opioid overdose deaths are increasing opioid agonist maintenance treatments, such as those involving methadone and buprenorphine; using depot naltrexone18; and distributing naloxone.19,20In Baltimore, Maryland, throughout the 1990s, heroin use and addiction were associated with an alarming number of overdose deaths, and from 1990 to 1997 drug overdose deaths increased by 426%, an increase that exceeded that of all the other 26 major US cities reporting to the federal Drug Abuse Warning Network during the same period.21 Starting in 1998, city and state leaders and local foundations renewed efforts to expand access to drug abuse treatment to reduce the impact of heroin and other drug addiction. The city obtained increased state and city funding for drug abuse treatment and reformed zoning laws to ease the opening of new drug abuse treatment programs. Through these efforts, the city’s methadone treatment capacity increased significantly over the next 6 years.With the passage of the Drug Abuse Treatment Act of 2000 and the Food and Drug Administration’s approval of buprenorphine for the treatment of opioid dependence,22 buprenorphine became available through private physician offices and in some community health centers in Baltimore. Maryland added buprenorphine to its Medicaid formulary in 2003 and organized efforts to enroll patients in Medicaid. In late 2006, the Baltimore City Health Department and the local substance abuse authority, the Baltimore Substance Abuse Systems, Inc., funded an initiative to expand access to buprenorphine treatment through formerly drug-free outpatient clinics and physicians’ offices by providing funding for Baltimore City physicians to obtain training and the necessary federal license to prescribe buprenorphine. This initiative integrated buprenorphine into the Baltimore Substance Abuse Systems, Inc.–funded network of drug-free outpatient clinics and created a system, overseen by the local nonprofit Baltimore Healthcare Access, to transfer stabilized buprenorphine patients to primary care physicians in community health centers and other primary care sites for ongoing care. From 2006 through 2009, the number of patients treated with buprenorphine in Baltimore City increased substantially.Through the efforts to expand methadone treatment in regulated opioid treatment programs and the increase in availability of buprenorphine treatment outside such programs, the number of patients treated with these evidence-based medications nearly quadrupled from 1995 through 2009. Meanwhile, heroin overdose deaths declined from a peak of 312 in 1999 to 118 in 2009. We examined the association between the increase in the number of patients treated with methadone and buprenorphine and the decline in heroin overdose deaths. We used archival data obtained from various public and private sources to examine the association between heroin overdose deaths and the increase in methadone and buprenorphine patients, controlling for the average purity of seized heroin in Baltimore City from 1995 through 2009.     

The content and comprehensiveness of hepatitis C education in methadone maintenance and drug-free treatment units

Although drug users are at elevated risk for hepatitis C virus (HCV) infection, many are uniformed or misinformed about the virus. Drug treatment programs are uniquely situated to provide comprehensive risk-modifying educational programs for decreasing HCV transmission, a strategy advocated in the most recent National Institutes of Health Consensus Development Conference Statement on the Management of Hepatitis C. Given the large proportion of patients that inject drugs in methadone maintenance treatment programs and the high prevalence of HCV among drug injectors, we compared a nationwide sample (N=246) of methadone maintenance treatment programs and drug-free programs regarding the content and comprehensiveness of HCV education. All of these programs provide HCV education to at least some of their patients. Results indicated that, compared to drug-free programs, methadone maintenance treatment programs cover a significantly greater number of HCV-related topics, and that a significantly greater proportion of the methadone programs cover specific topics (e.g., how to avoid transmitting HCV, the importance of testing for HCV, treatment options if HCV positive). Of special concern is that fewer than three quarters of the drug-free programs address what to do if co-infected with human immunodeficiency virus (HIV) and HCV and how to maintain health if HCV positive, and only about half of the drug-free and methadone maintenance treatment programs educate HCV-positive patients about the importance of obtaining vaccinations for hepatitis A and B. Drug treatment programs need to educate patients about the proactive steps these individuals can take to deal with HCV, provide critically needed HCV services, and encourage patients to make full use of these services.     

Value for the money spent? Exploring the relationship between expenditures, insurance adequacy, and access to care for publicly insured children

This study examines the relationship between total state Medicaid spending per child and measures of insurance adequacy and access to care for publicly insured children. Using the 2007 National Survey of Children's Health, seven measures of insurance adequacy and health care access were examined for publicly insured children (n = 19,715). Aggregate state-level measures were constructed, adjusting for differences in demographic, health status, and household characteristics. Per member per month (PMPM) state Medicaid spending on children ages 0-17 was calculated from capitated, fee-for-service, and administrative expenses. Adjusted measures were compared with PMPM state Medicaid spending in scatter plots, and multilevel logistic regression models tested how well state-level expenditures predicted individual adequacy and access measures. Medicaid spending PMPM was a significant predictor of both insurance adequacy and receipt of mental health services. An increase of $50 PMPM was associated with a 6-7 % increase in the likelihood that insurance would always cover needed services and allow access to providers (p = 0.04) and a 19 % increase in the likelihood of receiving mental health services (p < 0.01). For the remaining four measures, PMPM was a consistent (though not statistically significant) positive predictor. States with higher total spending per child appear to assure better access to care for Medicaid children. The policies or incentives used by the few states that get the greatest value--lower-than-median spending and higher-than-median adequacy and access--should be examined for potential best practices that other states could adapt to improve value for their Medicaid spending.     

An evaluation of the impact of maternity care coordination on Medicaid birth outcomes in North Carolina.

BACKGROUND. Care coordination is an important component of the enhanced prenatal care services provided under the recent expansions of the Medicaid program. The effect of maternity care coordination services on birth outcomes in North Carolina was assessed by comparing women on Medicaid who did and did not receive these services. METHODS. Health program data files, including Medicaid claims paid for maternity care coordination, were linked to 1988 and 1989 live birth certificates. Simple comparisons of percentages and rates were supplemented by a logistic regression analysis. RESULTS. Among women on Medicaid who did not receive maternity care coordination services, the low birth weight rate was 21% higher, the very low birth weight rate was 62% higher, and the infant mortality rate was 23% higher than among women on Medicaid who did receive such services. It was estimated that, for each $1.00 spent on maternity care coordination, Medicaid saved $2.02 in medical costs for newborns up to 60 days of age. Among the women who did receive maternity care coordination, those receiving it for 3 or more months had better outcomes than those receiving it for less than 3 months. CONCLUSIONS: These results suggest that maternity care coordination can be effective in reducing low birth weight, infant mortality, and newborn medical care costs among babies born to women in poverty.     

Reconsidering the effect of Medicaid on health care services use.

OBJECTIVE: Our research compares health care use by Medicaid beneficiaries with that of the uninsured and the privately insured to measure the program's effect on access to care. DATA SOURCES/STUDY SETTING: Data include the 1987 National Medical Expenditure Survey and the Survey of Income and Program Participation for 1984-1988. STUDY DESIGN: We predict annual use of ambulatory care and inpatient hospital care for Medicaid beneficiaries receiving AFDC cash assistance and compare it to what their use would be if uninsured or if covered by private insurance. Comparisons are based on multivariate models of health care use that control for demographic and economic characteristics and for health status. Our model distinguishes among Medicaid beneficiaries on the basis of eligibility to account for the poor health of beneficiaries in some eligibility groups. PRINCIPAL FINDINGS: AFDC Medicaid beneficiaries use considerably more ambulatory care and inpatient care than they would if they remained uninsured. Use among the AFDC Medicaid population is about the same as use among otherwise similar, privately insured persons. Use rates differ substantially among different Medicaid beneficiary groups, supporting the expectation that some beneficiary groups are in poor health. CONCLUSIONS: Although Medicaid has increased access to health care services for beneficiaries to rates now comparable to those for the privately insured population, because of lower cost sharing in Medicaid we would expect higher service use than we are finding. This suggests possible barriers to Medicaid patients in receiving the care they demand. Enrollment of less healthy individuals into some Medicaid beneficiary groups suggests that pooled purchasing arrangements that include Medicaid populations must be designed to ensure adequate access for the at-risk populations and, at the same time, to ensure that private employers do not opt out because of high community-rated premiums.     

Medicaid's prior authorization program and access to atypical antipsychotic medications

State Medicaid programs use prior authorization (PA) to control drug spending by requiring that specific conditions be met before allowing reimbursement. The extent to which PA policies respond to new developments concerning medication safety is not known. In April 2005 the Food and Drug Administration (FDA) issued an advisory describing increased mortality among elderly people with dementia taking atypical antipsychotics. More than a year later, no state had changed its PA policy in response. We discuss the roles of Medicaid and other insurers in responding to emerging drug safety issues and their challenges in weighing drug risks and benefits.     

Medicaid Coverage and Access to Publicly Funded Opiate Treatment

This observational study examines changes in access to methadone maintenance treatment following Oregon's decision to remove substance abuse treatment from the Medicaid benefit for an expansion population. Access was compared before and after the benefit change for two cohorts of adults addicted to opiates presenting for publicly funded treatment. Propensity score analysis helped model some selective disenrollment from Medicaid that occurred after the benefit change. Logistic regression was used to compare access to methadone by cohort controlling for client characteristics. Opiate users presenting for publicly funded treatment after the change were less than half as likely (OR = 0.40) to be placed in an opiate treatment program compared to the prior year. Further analysis revealed that those with no recent treatment history were less likely to present for treatment after the benefit change. These results have implications for states considering Medicaid cuts, especially if the anticipated increases in illegal activity, emergency room utilization, unemployment, and mortality can be demonstrated.Wyndy L. Wiitala, PhD, is a research associate at RMC Research Corporation, 111 S.W. Columbia, Suite 1200, Portland, OR 97201-5843, USA. Phone: +1-503-2238248. E-mail: wwiitala@rmccorp.com.Katherine E. Laws, is a research associate at RMC Research Corporation, 111 S.W. Columbia, Suite1200, Portland, OR 97201-5843, USA. Phone: +1-503-2238248. Fax: +1-503-2238399. E-mail: klaws@rmccorp.com.     

Medicaid expansion under health reform may increase service use and improve access for low-income adults with diabetes

Medicaid's key role in financing diabetes care will grow when many low-income uninsured people with diabetes gain eligibility to the program in 2014 under the Affordable Care Act. Using a national data set to describe current health care use and spending among the nonelderly, low-income adult population, we found that adult Medicaid beneficiaries with diabetes had total annual per capita health expenditures more than three times higher ($14,229 versus $4,568) than those of adult beneficiaries without diabetes. At the same time, Medicaid facilitates financial protection and care access among beneficiaries with diabetes. Low-income adults with diabetes who were uninsured used fewer services, spent more out of pocket, and reported worse access than did their peers who were covered by Medicaid. Uninsured adults with diabetes who gain Medicaid coverage under health reform are likely to enter the program with unmet needs, and coverage is likely to result in both improved access and increased use of health care.     

Trends in Medicaid physician fees, 1993-1998

This study uses data on Medicaid physician fees in 1993 and 1998 to document variation in fees across the country, describe changes in these fees, and contrast how they changed relative to those in Medicare. The results show that 1998 Medicaid fees varied widely. Medicaid fees grew 4.6 percent between 1993 and 1998, lagging behind the general rate of inflation. This growth was greater for primary care services than for other services studied. Relative to Medicare physician fees, Medicaid fees fell by 14.3 percent between 1993 and 1998. Medicaid's low fees and slow growth rates suggest that potential access problems among Medicaid enrollees remain a policy issue that should be monitored.     

Retention in publicly funded methadone maintenance treatment in two western states

This study examined individual and system characteristics associated with retention in methadone maintenance treatment among Medicaid-eligible adults in treatment for opiate use in Oregon and Washington. Logistic regression was used to examine the contributions of predisposing, need, and enabling characteristics on 365 day retention in methadone maintenance treatment. Older patients, patients with a history of methadone maintenance treatment, and persons with stable Medicaid eligibility had higher rates of retention than did patients with disabilities, polysubstance users, and those with an arrest record. In Oregon, which delivers methadone maintenance treatment through managed care, retention rose sharply from 28% to 51% between 1994 and 1998 and then leveled off. During the same time period, retention in Washington State grew from 28% to 34%. The higher rates of retention in Oregon, in part, can be explained by differences in service delivery influenced by financing. Faced with long waiting lists, Washington providers were more than twice as likely to administratively discharge patients for rule violations as their Oregon counterparts. Given the importance of retention, policies and practices that influence retention should be carefully considered. Because Medicaid eligibility has a dramatic impact on retention, policies that help extend eligibility or stabilize eligibility among individuals actively engaged in treatment should be carefully considered.     

The complex relation between access to opioid agonist therapy and diversion of opioid medications: a case example of large-scale misuse of buprenorphine in the Czech Republic

Opioid agonist therapy (OAT) has been available in a standard regime in the Czech Republic since 2000. Buprenorphine is the leading medication, while methadone is available only in a few specialised centres. There is an important leakage of buprenorphine onto the illicit market, and the majority of Czech opioid users are characterised by the misuse (and injecting) of diverted buprenorphine medications. Most prescribed buprenorphine for OAT is not covered by current national health insurance schemes, and patients have to pay considerable prices to afford their treatment. This affordability barrier together with limited accessibility is likely the leading factor of limited coverage of OAT and of recent stagnation in the number of patients in the official treatment programmes in the Czech Republic. It also encourages doctor shopping and the re-selling of parts of their medication at a higher price, which represents the main factor that drives the Czech illicit market for buprenorphine, but at the same time co-finances the medication of clients in official OAT programmes. Improving access to OAT by making it financially affordable is essential to further increase OAT coverage and is one of the factors that can reduce the illicit market with OAT medications.     

Long-term outcome of chronic drug use: the Amsterdam Cohort Study among Drug Users

In the present study, mortality rates and prevalence of abstinence from illicit drugs among persons with a history of addiction to heroin, cocaine, and/or amphetamines were estimated along the drug-using career time scale. Follow-up data on drug use and vital status were analyzed for participants in the Amsterdam Cohort Study among Drug Users (n = 899; 1985-2002). Participants in the study were primarily recruited at low-threshold methadone outposts. It was estimated that at least 27% of drug users had died within 20 years after starting regular drug use; for half, death had been due to causes unrelated to human immunodeficiency virus. A favorable trend towards abstinence with increasing time since initiation of regular use was observed. However, among those alive, the estimated prevalence of abstinence for at least 4 months from the above drugs and methadone was only 27% at 20 years since initiation. A higher age at initiation, a calendar year of initiation before 1980, and a Western European ethnic origin were associated with higher prevalence of abstinence. These results indicate that the concept of "maturing out" to a drug-free state does not apply to the majority of drug users. Further studies on determinants of individual transitions in drug use are important in order to establish evidence-based intervention strategies.     

Access to specialty care and medical services in community health centers

Although community health centers (CHCs) provide primary health services to the medically underserved and poor, limited access to off-site specialty services may lead to poorer outcomes among underinsured CHC patients. This study evaluates access to specialty health services for patients receiving care in CHCs, using a survey of medical directors of all federally qualified CHCs in the United States in 2004. Respondents reported that uninsured patients had greater difficulty obtaining access to off-site specialty services, including referrals and diagnostic testing, than did patients with Medicaid, Medicare, or private insurance.