Crafting effective regulatory policies for psychedelics: What can be learned from the case of cannabis?

The turn of the century brought a resurgence of interest in psychedelics as a treatment for addiction and other psychiatric conditions, accompanied by extensive positive media attention and private equity investment. Government regulatory bodies in Australia, Israel, Canada and the United States now permit use of psychedelics for medical purposes. In the United States, citizen action and corporate financing have led to petitions and ballot initiatives to legalize psilocybin and other psychedelics for medical and recreational use. Given this momentum, policymakers must grapple with important questions that define whether and how psychedelics are made available to the public, as well as how companies produce and promote them. The current push to broaden the production, sale, and use of psychedelics bears many parallels to the movement to legalize cannabis in the United States and other nations-most notably, the use of poorly-evidenced therapeutic claims to create a de facto recreational market via the health care system. Experience with cannabis highlights the value of debating the question of legalization for nonmedical use as such rather than misrepresenting it as a medical issue. The lessons of cannabis policy also suggest a need to challenge hyping of psychedelic research findings; to promote rigorous clinical research on dosing and potency; to minimize the influence of for-profit industry in shaping policies to their economic advantage; and to coordinate federal, state, and local governments to regulate the manufacture, sale and distribution of psychedelic drugs (regardless of whether they are legalized for medical and/or recreational use).

Substance use disorder treatment carve outs in Medicaid managed care.

INTRODUCTION: Medicaid managed care organizations (MCO) play a major role in addressing the nation's epidemic of drug overdose and mortality by administering substance use disorder (SUD) treatment benefits for over 50 million Americans. While it is known that some Medicaid MCO plans delegate responsibility for managing SUD treatment benefits to an outside "carve out" entity, the extent and structure of such carve out arrangements are unknown. This is an important gap in knowledge, given that carve outs have been linked to reductions in rates of SUD treatment receipt in several studies. To address this gap, we examined carve out arrangements used by Medicaid MCO plans to administer SUD treatment benefits in ten states. METHODS: Data for this study was gleaned using a purposive sampling approach through content analysis of publicly available benefits information (e.g., member handbooks, provider manuals, prescription drug formularies) from 70 comprehensive Medicaid MCO plans in 10 selected states (FL, GA, IL, MD, MI, NH, OH, PA, UT, and WV) active in 2018. Each Medicaid MCO plan's documents were reviewed and coded to indicate whether a range of SUD treatment services (e.g., inpatient treatment, outpatient treatment, residential treatment) and medications were carved out, and if so, to what type of entity (e.g., behavioral health organization). RESULTS: A large majority of Medicaid MCO plans carved out at least some (28.6 %) or all (40.0 %) SUD treatment services, with nearly all plans carving out some (77.1 %) or all (14.3 %) medications, mainly due to the carving out of methadone treatment. Medicaid MCO plans most commonly carved out SUD treatment services to behavioral health organizations, while most medications were carved out to state Medicaid fee-for-service plans. CONCLUSIONS: Carve out arrangements for SUD treatment vary dramatically across states, across plans, and even within plans. Given that some studies have linked carve out arrangements to reductions in treatment access, their widespread use among Medicaid MCO plans is cause for further consideration by policymakers and other key interest groups. Moreover, reliance on such complex arrangements for administering care may create challenges for enrollees who seek to learn about and access plan benefits.

Statewide efforts to address the opioid epidemic: Results from a national survey of single state agencies.

BACKGROUND: Single State Agencies (SSAs) are at the forefront of efforts to address the nation's opioid epidemic, responsible for allocating billions of dollars in federal, state, and local funds to ensure service quality, promote best practices, and expand access to care. Federal expenditures to SSAs have more than tripled since the early years of the epidemic, yet, it is unclear what initiatives SSAs have undertaken to address the crisis and how they are financing these efforts. METHODS: This study used data from an internet-based survey of SSAs, conducted by the University of Chicago Survey Lab from January to December 2021 (response rate of 94 %). The survey included a set of 14 items identifying statewide efforts to address the opioid epidemic and six funding sources. We calculated the percentage of SSAs that supported each statewide effort and the percentage of SSAs reporting use of each source of funding across the 14 statewide efforts. RESULTS: Treatment of opioid-related overdose figured most prominently among statewide efforts, with all SSAs providing funding for naloxone distribution and all but one SSA supporting naloxone training. Recovery support services, Project ECHO, and Hub and Spoke models were supported by the vast majority of SSAs. Statewide efforts related to expanding access to medications for opioid use disorder (MOUD) received somewhat less support, with 45 % of SSAs supporting mobile methadone/MOUD clinics/programs and 70 % supporting buprenorphine in emergency departments. A relatively low proportion of SSAs (54 %) provided support for syringe services programs. State Opioid Response (SOR) funds were the most common funding source reported by SSAs (57 % of SSAs), followed by block grant funds (19 %) and other state funding (15 %). CONCLUSION: Results highlight a range of SSA efforts to address the nation's opioid epidemic. Limited adoption of efforts to expand access to MOUD and harm reduction services may represent missed opportunities. The uncertainty over reauthorization of the SOR grant post-2025 also raises concerns over sustainability of funding for many of these statewide initiatives.

Medicaid Managed Care Prior Authorization For Buprenorphine Tied To State Partisanship And Health Plan Profit Status, 2018.

Buprenorphine is among the most effective drugs for treating opioid use disorder, yet only a quarter of Americans who need it receive it. Requiring prior authorization has been identified as an important barrier to buprenorphine access. However, the practice remains widespread in Medicaid-the largest insurer of Americans with opioid use disorder. In this study, we examined how prior authorization for buprenorphine is related to plan structure and state political environment, using data on all 266 comprehensive Medicaid managed care plans active in 2018. We found substantial variation in prior authorization use across states, with all plans requiring prior authorization in eleven states and no plans requiring it in thirteen other states. We found that for-profit plans and those located in Republican states were more likely to impose prior authorization policies. Our findings suggest that managed care plans' decisions regarding use of prior authorization may be shaped by internal pressures to control costs, as well as by differing partisan stances regarding the need to prevent criminal diversion of buprenorphine.

Changes in Medicaid Fee-for-Service Benefit Design for Substance Use Disorder Treatment During the Opioid Crisis, 2014 to 2021.

Importance: Medicaid is the largest payer of substance use disorder treatment in the US and plays a key role in responding to the opioid epidemic. However, as recently as 2017, many state Medicaid programs still did not cover the full continuum of clinically recommended care. Objective: To determine whether state Medicaid fee-for-service (FFS) programs have expanded coverage and loosened restrictions on access to substance use disorder treatment in recent years. Design, Setting, and Participants: In 2014, 2017, and 2021, a survey on coverage for substance use disorder treatment was conducted among state Medicaid programs and the District of Columbia with FFS programs. This survey was completed by Medicaid program directors or knowledgeable staff. Data analysis was performed in 2022. Main Outcomes and Measures: The following were calculated for a variety of substance use disorder treatment services (individual and group outpatient, intensive outpatient, short-term and long-term residential, recovery support, inpatient treatment and detoxification, and outpatient detoxification) and medications (methadone, oral and injectable naltrexone, and buprenorphine): (1) the percentage of Medicaid FFS programs covering these services and medications and (2) the percentage of Medicaid FFS programs using utilization management policies, such as copayments, prior authorizations, and annual maximums. Results: This study had response rates of 92% in 2014 and 2017 (47 of 51 states) and 90% in 2021 (46 of 51 states). For the 2021 wave, data are reported for the 38 non-managed care organization plan-only states. Between 2017 and 2021, coverage of individual and group outpatient treatment increased to 100% of states, and use of annual maximums for medications decreased to 3% or less (n ≤ 1). However, important gaps in coverage persisted, particularly for more intensive services: 10% of Medicaid FFS programs (n = 4) did not cover intensive outpatient treatment, 13% (n = 5) did not cover short-term residential care, and 33% (n = 13) did not cover long-term residential care. Use of utilization controls, such as copays, prior authorizations, and annual maximums, decreased but continued to be widespread. Conclusions and Relevance: In this survey study of state Medicaid FFS programs, increases in coverage and decreases in use of utilization management policies over time were observed for substance use disorder treatment and medications. However, these findings suggest that some states still lag behind and impose barriers to treatment. Future research should work to identify the long-term ramifications of these barriers for patients.

State Funding For Substance Use Disorder Treatment Declined In The Wake Of Medicaid Expansion.

The US continues to grapple with an escalating epidemic of opioid-related overdose and mortality. State funds, which are the second-largest source of public funding for substance use disorder (SUD) treatment and prevention, play a critically important role in responding to this crisis. Despite their importance, little is known about how these funds are allocated and how they have changed over time, particularly within the context of Medicaid expansion. In this study we assessed trends in state funds during the period 2010-19, using difference-in-differences regression and event history models. Our findings reveal dramatic variation in state funding across states, from a low of $0.61 per capita in Arizona to a high of $51.11 per capita in Wyoming in 2019. Moreover, state funding declined during the period after Medicaid expansion by an average of $9.95 million in expansion states (relative to nonexpansion states), especially in states that expanded eligibility under Republican-controlled legislatures, where it declined by an average of $15.94 million. Medicaid substitution strategies, which, in effect, shift some of the financial burden for financing SUD treatment from the state to the federal level, may erode resources for broader system-level efforts that are urgently needed in the midst of the opioid epidemic.

Association of Selected State Policies and Requirements for Buprenorphine Treatment With Per Capita Months of Treatment.

Importance: Expanding the use of buprenorphine for treating opioid use disorder is a critical component of the US response to the opioid crisis, but few studies have examined how state policies are associated with buprenorphine dispensing. Objective: To examine the association of 6 selected state policies with the rate of individuals receiving buprenorphine per 1000 county residents. Design, Setting, and Participants: This cross-sectional study used 2006 to 2018 US retail pharmacy claims data for individuals dispensed buprenorphine formulations indicated for treating opioid use disorder. Exposures: State implementation of policies requiring additional education for buprenorphine prescribers beyond waiver training, continuing medical education related to substance misuse and addiction, Medicaid coverage of buprenorphine, Medicaid expansion, mandatory prescriber use of prescription drug monitoring programs, and pain management clinic laws were examined. Main Outcomes and Measures: The main outcome was buprenorphine treatment months per 1000 county residents as measured using multivariable longitudinal models. Statistical analyses were conducted from September 1, 2021, through April 30, 2022, with revised analyses conducted through February 28, 2023. Results: The mean (SD) number of months of buprenorphine treatment per 1000 persons nationally increased steadily from 1.47 (0.04) in 2006 to 22.80 (0.55) in 2018. Requiring that buprenorphine prescribers receive additional education beyond that required to obtain the federal X-waiver was associated with significant increases in the number of months of buprenorphine treatment per 1000 population in the 5 years following implementation of the requirement (from 8.51 [95% CI, 2.36-14.64] months in year 1 to 14.43 [95% CI, 2.61-26.26] months in year 5). Requiring continuing medical education for physician licensure related to substance misuse or addiction was associated with significant increases in buprenorphine treatment per 1000 population in each of the 5 years following policy implementation (from 7.01 [95% CI, 3.17-10.86] months in the first year to 11.43 [95% CI, 0.61-22.25] months in the fifth year). None of the other policies examined was associated with a significant change in buprenorphine months of treatment per 1000 county residents. Conclusions and Relevance: In this cross-sectional study of US pharmacy claims, state-mandated educational requirements beyond the initial training required to prescribe buprenorphine were associated with increased buprenorphine use over time. The findings suggest requiring education for buprenorphine prescribers and training in substance use disorder treatment for all controlled substance prescribers as an actionable proposal for increasing buprenorphine use, ultimately serving more patients. No single policy lever can ensure adequate buprenorphine supply; however, policy maker attention to the benefits of enhancing clinician education and knowledge may help to expand buprenorphine access.

Allocation of federal funding to address the opioid overdose crisis in the criminal legal system.

INTRODUCTION: The opioid overdose crisis remains a chief public health concern in the United States, and people involved in the criminal legal system are among the most vulnerable to opioid related harms. This study aimed to identify all discretionary federal funding allocated to states, cities, and counties targeting the overdose crisis for criminal legal system-involved populations in fiscal year (FY) 2019. We then aimed to assess the extent to which federal funding was allocated to states with the highest need. METHODS: We collected data from publicly available government databases (N = 22) to identify federal funding targeting opioid use disorder in criminal legal system-involved populations. Descriptive analyses examined the extent to which funding allocated per person in the criminal legal system-involved population was associated with funding need, proxied by a composite measure of opioid mortality and drug-related arrests. We created a generosity measure and dissimilarity index to assess the degree to which funding matched need across states. RESULTS: More than 590 million dollars were allocated across 517 grants by 10 federal agencies in FY 2019. About half of states received less than $100.00 dollars per capita in the state criminal legal system-involved population. Funding generosity ranged from 0 % to 504.2 %, with more than half of states (52.9 %, n = 27) receiving fewer dollars per opioid problem than the US average. Further, a dissimilarity index indicated that about 34.2 % of funding (~$202.3 million) would have to be reallocated to distribute funding more evenly across states. CONCLUSIONS: Results suggest that additional efforts are needed to more equitably distribute funds to meet the needs of states with more severe opioid problems.

Geographic variations in driving time to US mental health care, digital access to technology, and household crowdedness.

Rural residents face significant barriers in accessing mental health care, particularly as the demand for such services grows. Telemedicine has been proposed as an answer to rural gaps, but this service requires both access to appropriate technology and private space in the home to be useful. Our study documented longer travel time to mental health facilities in rural areas and greater barriers to digital devices for telemedicine access in those same areas. However, urban areas demonstrated greater household crowdedness than rural noncore areas when looking at private space within the home. Across ZIP Code Tabulation Areas located more than an estimated 30 minutes from the nearest outpatient care, 675 950 (13.1%) rural households vs 329 950 (6.4%) urban households had no broadband internet. The current Affordable Connectivity Program should target mental health-underserved communities, especially in rural America, where the scarcity of digital access compounds travel burdens to mental health care.

Coverage and Prior Authorization Policies for Medications for Opioid Use Disorder in Medicaid Managed Care.

Importance: Medicaid is a key policy lever to improve opioid use disorder treatment, covering approximately 40% of Americans with opioid use disorder. Although approximately 70% of Medicaid beneficiaries are enrolled in comprehensive managed care organization (MCO) plans, little is known about coverage and prior authorization (PA) policies for medications for opioid use disorder (MOUD) in these plans. Objective: To compare coverage and PA policies for buprenorphine, methadone, and injectable naltrexone across Medicaid MCO plans and fee-for-service (FFS) programs and across states. Design, Setting, and Participants: This cross-sectional study analyzed MOUD data from 266 Medicaid MCO plans and FFS programs in 38 states and the District of Columbia in 2018. Main Outcomes and Measures: For each medication, the percentages of MCO plans and FFS programs that covered the medication without PA, covered the medication with PA, and did not cover the medication were calculated, as were the percentages of MCO, FFS, and all (MCO and FFS) beneficiaries who were covered with no PA, covered with PA, and not covered. In addition, MCO plan coverage and PA policies were mapped by state. Analyses were conducted from January 1 through May 31, 2022. Results: Coverage and PA policies were compared for MOUD in 266 MCO plans and 39 FFS programs, representing approximately 70 million Medicaid beneficiaries. Overall, FFS programs had more generous MOUD coverage than MCO plans. However, a higher percentage of FFS programs imposed PA for the 3 medications (47.0%) than did MCOs (35.9%). Furthermore, although most Medicaid beneficiaries were enrolled in a plan that covered MOUD, 53.2% of all MCO- and FFS-enrolled beneficiaries were subject to PA. Results also showed wide state variation in MCO plan coverage and PA policies for MOUD and the percentage of Medicaid beneficiaries subject to PA. Conclusions and Relevance: This cross-sectional study found variation in MOUD coverage and PA policies across Medicaid MCO plans and FFS programs and across states. Thus, Medicaid beneficiaries' access to MOUD may be heavily influenced by their state of residency and the Medicaid plan in which they are enrolled. Left unaddressed, PA policies are likely to remain a barrier to MOUD access in the nation's Medicaid programs.

Identification and Treatment of Addiction in Medicaid Health Homes.

OBJECTIVE: Coordinated care models, such as the Medicaid health home, may be well positioned to identify and address addiction, yet little is known about the strategies health home plans use to identify and treat this condition. This study examined state requirements of active Medicaid health home plans. METHODS: Content analyses of all 35 active Medicaid health home plans were conducted to identify state requirements related to enrollment eligibility; provision of addiction screening, treatment, and prevention services; inclusion of addiction treatment professionals within the health home provider care team; and outcomes monitoring. RESULTS: Apart from health homes specifically focused on addiction, few states require health home plans to screen (44% of primary care-based and 33% of psychiatric health homes), treat (0% and 13%, respectively), and monitor treatment services for addiction (25% and 13%, respectively). CONCLUSIONS: Limited screening and treatment of addiction within health homes may limit the model's effectiveness in improving overall health.

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.

Availability of Medications for the Treatment of Alcohol and Opioid Use Disorder in the USA.

Despite high mortality rates due to opioid overdose and excessive alcohol consumption, medications for the treatment of alcohol and opioid use disorder have not been widely used in the USA. This paper provides an overview of the literature on the availability of alcohol and opioid used disorder medications in the specialty substance use disorder treatment system, other treatment settings and systems, and among providers with a federal waiver to prescribe buprenorphine. We also present the most current data on the availability of alcohol and opioid use disorder medications in the USA. These estimates show steady growth in availability of opioid use disorder medications over the past decade and a decline in availability of alcohol use disorder medications. However, overall use of medications in the USA remains low. In 2017, only 16.3% of specialty treatment programs offered any single medication for alcohol use disorder treatment and 35.5% offered any single medication for opioid use disorder treatment. Availability of buprenorphine-waivered providers has increased significantly since 2002. However, geographic disparities in access to buprenorphine remain. Some of the most promising strategies to increase availability of alcohol and opioid use disorder medications include the following: incorporating substance use disorder training in healthcare education programs, educating the substance use disorder workforce about the benefits of medication treatment, reducing stigma surrounding the use of medications, implementing medications in primary care settings, implementing integrated care models, revising regulations on methadone and buprenorphine, improving health insurance coverage of medications, and developing novel medications for the treatment of substance use disorder.

Are Policy Strategies for Addressing the Opioid Epidemic Partisan? A View from the States.

CONTEXT: In contrast to the Affordable Care Act, some have suggested the opioid epidemic represents an area of bipartisanship. This raises an important question: to what extent are Democrat-led and Republican-led states different or similar in their policy responses to the opioid epidemic? METHODS: Three main methodological approaches were used to assess state-level policy responses to the opioid epidemic: a legislative analysis across all 50 states, an online survey of 50 state Medicaid agencies, and in-depth case studies with policy stakeholders in five states. FINDINGS: Conservative states pursue hidden and targeted Medicaid expansions, and a number of legislative initiatives, to address the opioid crisis. However, the total fiscal commitment among these Republican-led states pales in comparison to states that adopt the ACA Medicaid expansion. Because the state legislative initiatives do not provide treatment, these states spend substantially less than states with Democratic control. CONCLUSIONS: Rather than persistently working to retrench all programs, conservatives have relied on policy designs that emphasize devolution, fragmentation, and inequality to both expand and retrench benefits. This strategy, which allocates benefits differentially to different social groups and obfuscates responsibility, allows conservatives to avoid political blame typically associated with retrenchment.

How Medicaid work requirements could exacerbate the opioid epidemic.

In 2018, the Trump Administration took the unprecedented step of allowing states to impose work requirements as a condition of Medicaid eligibility. States can apply for a demonstration waiver to require Medicaid beneficiaries aged 19-64 who do not meet exemption criteria (e.g., disability, caring for a sick relative) to participate in "community engagement" activities, which include employment, volunteering, and enrollment in a qualifying education or job training program. Debate thus far has focused primarily around the important issue of whether such requirements are legal. Less attention has focused on another serious concern - namely, that work requirements could exacerbate the nation's most urgent public health crisis: the opioid epidemic. Many enrollees with opioid use disorder who are unable to meet states' community engagement criteria will not qualify for an exemption from the work requirements, and risk being dropped from Medicaid enrollment. Refusing health insurance to individuals who are unable to meet work requirements could result in significant losses in coverage among a highly vulnerable population. Implementing new barriers to Medicaid coverage will hinder the effectiveness of massive state and federal investments in improving access to evidence-based addiction treatment.

Medicaid coverage in substance use disorder treatment after the affordable care act.

The Affordable Care Act (ACA) prompted sweeping changes to Medicaid, including expanding insurance coverage to an estimated 12 million previously uninsured Americans, and imposing new parity requirements on benefits for behavioral health services, including substance use disorder treatment. Yet, limited evidence suggests that these changes have reduced the number of uninsured in substance use disorder treatment, or increased access to substance use disorder treatment overall. This study links data from a nationally-representative study of outpatient substance use disorder treatment programs and a unique national survey of state Medicaid programs to capture changes in insurance coverage among substance use disorder treatment patients after ACA implementation. Medicaid expansion was associated with a 15.7-point increase in the percentage of patients insured by Medicaid in substance use disorder treatment programs and a 13.7-point decrease in the percentage uninsured. Restrictions in state Medicaid benefits and utilization policies were associated with a decreased percentage of Medicaid patients in treatment. Moreover, Medicaid expansion was not associated with a change in the total number of clients served over the study period. Our findings highlight the important role Medicaid has played in increasing insurance coverage for substance use disorder treatment.