Leo Beletsky. The Journal of Law, Medicine, and Ethics. Volume 44, Issue 2-3, 2018.
Introduction
Signed into law in 2016, the landmark 21st Century Cures Act is as complex as it is divisive. For some stakeholders, including patient groups and representatives of regulated industries, the Act represented a major leap forward in pharmaceutical innovation, human subjects protections, and numerous other provisions. For other observers, this legislation was characterized as a major rollback in important regulations, which would leave patients worse off and the payers holding the bag. The one element of the Act that was relatively uncontroversial covered a number of provisions related to addressing the opioid crisis.
This was by design. Provisions related to this issue were not part of the original legislation and were added to win over additional members of Congress who needed to be brought along to support the legislation. Many of the statute’s provisions were intertwined with the Comprehensive Addiction Recovery Act (“CARA”) passed previously, but that legislation was stripped of much of its funding for opioid crisis response. Faced with a mounting death toll and political liability, Congress responded to the palpable pressure to deliver a meaningful piece of legislation to address the crisis by retooling the 21st Century Cures Act to fulfill that role. At this early stage, what is known about the impact of the widely-heralded opioid crisis response elements of the law? This article will explore how the Act promised to address the crisis, provide a preliminary overview of what it has delivered so far, and articulate implications for future legislation intended to address the national overdose emergency.
The Opioid Crisis and Its Political Significance
The United States is in the midst of a major drug overdose crisis, driven primarily by opioid drugs. In 2016—the year 21st Century Cures Act was signed into law—at least 64,000 Americans died of drug overdoses. After years of double-digit annual gains, life expectancy is declining largely due to drug poisonings. The impact of the crisis has been disproportionately concentrated among certain groups, closely aligning with disadvantage and lack of opportunity among working-class whites and Native Americans. Nevertheless, there is marked regional variation in the sociodemographic impact of the crisis, underscoring the reality that no population group, economic stratum, or geographical region has been immune. The crisis was recently estimated to have cost the U.S. at least half a trillion dollars in 2015, and has continued to worsen considerably since then.
Although there have been opioid-related drug crises in the past, this crisis is truly a 21st Century phenomenon. Starting right around 2000, deaths involving prescription analgesics nearly doubled the opioid overdose rate in a decade. Many observers attribute this initial phase of the crisis to spiking rates of opioid prescriptions. Increased exposure to opioid medications can indeed precipitate poisonings through a variety of mechanisms. However, even when taking these drugs as directed, a variety of environmental, genetic, and other factors make some patients susceptible to iatrogenic dependence and problematic consumption practices; up to 8% may even transition to severe substance use disorder (“SUD”), or “addiction” in the course of opioid pharmacotherapy. Defined by compulsive and increasingly risky consumption practices despite negative consequences, severe SUD is a significant risk factor for overdose. It is worth noting that other risk factors, like returning to opioid use after detoxification or another period of abstinence also function as important predictors of risk. Thankfully, the opioid antidote naloxone is available to reverse opioid overdoses, completely reviving the victim in most cases.
Spurred by a complex interplay of pharmaceutical industry practices, gaps in prescriber training and pain management tools, and demand for analgesia (broadly defined), the annual number of opioid prescriptions in the U.S. peaked at approximately 65 million in 2010. With this massive level of population exposure, even a small rate of iatrogenic addiction can translate to a large number of individuals at risk of developing SUD. Inundating the environment with opioid medications through poorly-calibrated, inappropriate, or at times totally venal prescribing, also potentiates problematic use among individuals other than the patient. In fact, substantial majorities of prescription drug misuse involves medications that were diverted from friends or family, rather than prescribed directly.
Towards the end of that decade, opioid use across the U.S. began a marked transition towards illicitly-manufactured drugs, primarily heroin. A complex combination of push-and pull-factors catalyzed this transition. On the one hand, policy and programmatic responses to what was then called “the prescription drug crisis” were focused on restricting the prescription opioid supply. This included the advent of soft and hard regulatory instruments to reduce opioid “over-prescribing,” diversion, and misuse resulting, at the extreme, in involuntary tapering or patient abandonment. Strengthening surveillance through prescription drug monitoring programs (“PDMPs”) also became a core component of the response, as did reformulation of drugs to make them harder to crush and inject, and the threat and actualization of prosecution of unscrupulous prescribers, or “pill mills.” PDMPs in particular became a widely-heralded tool of prescription drug control, but the evidence of benefit as an opioid overdose prevention tool is decidedly mixed. As the dynamics of the prescription drug supply shifted, many users dependent on—or addicted to—opioids and lacking access to adequate support systems had one place to turn for alternatives: the black market.
On the other hand, “pull factors” played an important role in this transition. The low price and wide availability of heroin on America’s streets indubitably shaped consumer preferences, whether as a reaction to, or independent of, measures to restrict access to prescription drugs. Despite decades of concerted investment in domestic and international interdiction, enforcement, and suppression, heroin had become purer, cheaper, and more accessible throughout the United States. Finally, broader factors like health care and health insurance access, the changing nature of employment and opportunity, the shock of the 2008 financial crisis, and various other social and economic phenomena all contributed to the transition of opioid consumption to the black market.
Whatever its causes, this transition proved the critical inflection point in the opioid crisis’s current trajectory. Once exposed to black market products, opioid users’ overdose risk is substantially shaped by fluctuations in the clandestine supply chains. Simultaneous increased demand and scale-up in interdiction efforts set the economic conditions for the advent of more potent and cheaper synthetic opioid alternatives. Used to cut other products or sold on their own, illicitly-synthesized products like fentanyl have wrought utter devastation: after rising at around 10% per year between 1999 and 2006, the overdose rate precipitously accelerated to 18% between 2014 and 2016. The death rate specifically attributable to synthetic drugs like fentanyl shockingly doubled just within a one-year period, from 2015 to 2016. In a growing number of communities, the overwhelming proportion of overdose fatalities now involve fentanyl or other illicitly-manufactured synthetics.
Narratives that endeavor to explain the trajectory of the opioid crisis are conflicting and, at times, controversial. But two positive elements of this otherwise morbid story are beyond dispute. The first is that opioid use disorder is treatable, and its effective treatment can help bend the curve of the crisis by substantially reducing overdose risk. The second is that, despite pronounced disparities, this crisis has impacted most Americans, both on individual and community levels, regardless of racial, economic, or other characteristics. This profound impact has made the crisis one of the very few bipartisan issues of our polarized political moment and created intense pressure on all levels of government to remedy what is largely seen as an uncontrolled calamity. Together, the availability of solid treatment modalities and the political will to deploy them produced the 21st Century Act’s opioid crisis provisions—the legislative response that serves the subject of this article. Before turning to the Act, it is useful to first situate the role of drug treatment in the opioid crisis.
The Treatment Gap and the Opioid Crisis
U.S. health care is anomalous in many ways. America spends by far the most per capita on health care, with little to show for that investment no matter how success is measured. Prescription drugs cost far more to American consumers than their counterparts in peer countries. Those who invoke “opioid over-prescribing” as the principal culprit behind the opioid crisis often emphasize the fact that the U.S. consumes much more than its demographic fair share of opioid medications, but pharmacotherapy is generally more actively utilized in the U.S. than elsewhere.
Indeed, opioid pain therapy is prescribed at much higher rates in the U.S. than in peer nations, but this must be put in context. Prescription of other psychoactive therapeutics is similarly highly-elevated, including benzodiazepines (for the treatment of mood disorders), amphetamines and methylphenidate (for the treatment of attention deficit disorders), as well as medications to treat a myriad of other health issues. On balance, Americans look to pharmacotherapy to fix their physical and emotional problems, even if that means being on multiple medications with complex, poorly-understood, and risky interactions.
For all of the talk about opioid over-prescribing, the reality is that that Americans also severely underutilize opioids. Leaving aside the evolving inadequacy of opioid pain therapy, a key domain of opioid under-prescription is in treatment of opioid use disorder (“OUD”). Opioid agonist therapy (“OAT”) is the gold standard in such treatment. Engaging patients on OAT using methadone and buprenorphine (especially the buprenorphine-naloxone combination, e.g. Suboxone®) effectively staves off OUD withdrawal symptoms, controls cravings, and stabilizes patients, helping them regain control of their lives. Much like other chronic and relapsing conditions, OUD typically requires long-term (even life-long) treatment. Decades of research have demonstrated these medications to be safe, effective, and cost-effective for treating OUD. Methadone and buprenorphine maintenance have been positively evaluated across a variety of geographical and institutional settings, demonstrating unequivocal public health, social, family, and crime-prevention benefits.
Of vital relevance in the current crisis, OAT holds enormous overdose prevention potential. Methadone or buprenorphine pharmacotherapy slashes OUD patient risk of overdose mortality (ranging from 50% to upwards of 80%). This therapy is also enormously cost effective, providing as much as $58 savings for every dollar spent. Patients treated with the opioid antagonist naltrexone (including its injectable, long-acting form Vivitrol®) also experience a decrease in overdose risk. This third Food and Drug Administration (“FDA”)-approved treatment option for OUD functions through a different pharmacokinetic mechanism, blocking the psychoactive effect of opioids. It bears emphasis that Vivitrol® and other antagonists have thus far been shown to be inferior to OAT and far less cost-effective, although the evidence base is still evolving. Nonetheless, taken together, OAT and naltrexone therapy are bundled into the term “medication-assisted treatment,” or MAT.
The crucial bottom line is that many of the overdose deaths precipitated by OUD are preventable with the right pharmacotherapy. For those who are especially vulnerable to fatal drug poisoning, the stakes for access to OAT are particularly high. People reentering society after a period of forced abstinence, including incarceration, involuntary drug treatment, or other forms of custodial settings, face devastating odds of overdose death, estimated at upwards of 120 times that in the general population. Provision of methadone in correctional settings, coupled with linkages to treatment in the community vastly cuts “fatal reentry” among formerly-incarcerated individuals.
Native Americans generally face dismal access to health care services. Even though Native Americans are frequently screened for SUD, substance use treatment coverage is scarce, exacerbated by barriers to health and other service access more broadly. When it comes to OAT, Native Americans are not the only racial and ethnic group that faces access disparities: gradients in access to office-based buprenorphine have been noted across racial and sociodemographic groups.
Another population that is disproportionately impacted by overdose morbidity and mortality is people who inject drugs (“PWID”). Prevalent exposure to the black market drug supply, compounded by risk of non-medical consumption practices, make this group especially vulnerable to drug poisonings. Injection carries with it additional risks of acquiring HIV, hepatitis C virus (“HCV”), and other infectious diseases like endocarditis. In the context of the current crisis, rates of HIV and HCV have spiked across the U.S., especially in particular regions where former prescription drug users have recently begun initiating injection drug use. Access to OAT is conclusively proven to protect PWID from both overdose and infectious disease risk, magnifying its public health and economic benefit in this population. Syringe access programs have demonstrated value in helping link PWID to treatment resources.
Veterans also face a higher prevalence of OUD and overdose risk. This is linked to elevated levels of physical injury, including combat-related injury. It is also related to exposure to emotional trauma and post-traumatic stress disorder.
Each month’s U.S. overdose death toll now tops the total number of people killed in the tragic events of 9/11. It is therefore especially tragic that only an estimated 10% of those who are at high risk of overdose because of OUD, receive any substance use treatment. This “treatment gap” is even more stark when considered in light of the fact that only a dismal 21% treatment facilities offer the gold standard of care—OAT. Many of these centers do not accept public insurance, or any form of health insurance for that matter. Equally appalling is that access to OAT to individuals in custodial settings is almost totally lacking. Instead, suboptimal abstinence-based modalities—or totally unproven treatment interventions—remain persistently wide-spread. In response to the crisis, some jurisdictions have even moved to coerce patients into abstinence-based programs through involuntary commitment, drug courts, and other carceral mechanisms.
The paucity of OAT access is another key way in which U.S. health care stands out among its peers. The reasons behind this gap involve uniquely American historical, attitudinal, and legal underpinnings that are beyond the scope of this article. Starting at the dawn of the last century, much of American policymaking on the issue of maintenance therapy was substantially shaped by a combination of racial and xenophobic prejudice, stigma, and misguided conflation of substance use and morality. Dating back to the 1914 Harrison Narcotics Tax Act and subsequent jurisprudence, federal law has barred the prescription of opioids for the purpose of withdrawal management or maintenance. Notably, almost exactly 100 years ago, the landmark Webb v. United States U.S. Supreme Court decision set the tone for opioid maintenance policy in the U.S. by barring any prescription for morphine for “the purpose of keep[ing a patient] comfortable by maintaining his customary use;” the court deemed that only prescriptions that constituted an “attempted cure” constituted a legitimate use of a provider’s prescribing privileges.
Russia and several other countries have adopted an absolute ban on OAT, with unequivocally devastating results. Luckily, over time, the U.S. has carved out several important exceptions from the misguided maxim articulated by the Supreme Court in Webb 100 years ago. First, patients can receive methadone maintenance in specialized opioid treatment programs (“OTPs”), but federal regulations mandate that methadone is only available through directly-observed therapy that requires daily patient visits (in most cases). These programs must also provide counseling and comply with numerous federal, state, and local regulations, translating to documented logistical, timing, siting, and other barriers to access. Methadone maintenance therapy (not pain therapy) is generally prohibited from office-based care settings, but can be legally initiated in emergency departments. However, this potential remains largely unrealized. With Russia being a tragic exception, the rigidity and restrictiveness of U.S. regulation of methadone maintenance is anomalous among its peer nations.
By contrast, buprenorphine maintenance is sanctioned in both OTP and office-based settings, but prescribers face numerous requirements in order earn this privilege. Physicians must undergo eight hours—and allied health professionals 24 hours—of instruction towards a “waiver.” After receiving the waiver, prescribers are limited to 30 patients in their first year of prescribing and up to 275 thereafter. Conversely, OTPs can prescribe buprenorphine without facing a patient cap. Despite the availability of the office-based prescribing for buprenorphine access, this mechanism is severely underused. The supply of waivered physicians is insufficient and is not evenly distributed. Nationwide, access to OTPs that provide access to maintenance therapy is severely lacking.
As a result, nearly two decades into this crisis, individuals affected by OUD continue to contend with countless barriers in accessing maintenance therapy. The HIV/AIDS “cascade of care” provides a useful framework that links diagnosing, engaging, and sustaining patients in treatment using the heuristic of 90-90-90 targets. The success of this model in stemming the tide of HIV cases lays bare the gaps in the current clinical response to OUD, where we are failing to diagnose, engage, and sustain significant proportions of OUD-impacted individuals. In other words, we are failing patients at every step.
One important contributor to the treatment gap is the lack of integration of OUD care into primary care settings. Addiction often co-occurs with other health conditions, especially trauma and adverse childhood experiences, so provision of OUD services should be woven into the fabric of broader wrap-around care. Frustratingly few primary care providers receive adequate training in this realm. Many providers harbor stigma towards substance users, perceiving them as undesirable and a difficult patient population. When practitioners refer SUD-affective individuals to treatment services elsewhere, long waitlists often pose a difficult—and, at times—deadly challenge. Treatment access gaps are exacerbated by broader problems in how health care facilities and other health resources are distributed, with broad swaths of health care deserts, especially in rural and other underserved locations.
Most relevant to this analysis are the regulatory and financial factors contributing to dismal OAT access, which robs the U.S. public of the overdose prevention it potentiates. Survey research suggests that cost remains a major barrier. State and federal funding earmarked for OUD care has not kept up with demand, and has actually declined in real dollars in recent years. Those constraints may also result from lack of health insurance, under-insurance, or elements in coverage such as copays, lifetime caps, and pre-authorization requirements that put timely treatment out of reach. Legislative efforts, such as those in the Affordable Care Act (“ACA”), to address these problems through parity mandates lack enforcement; upwards of 30% of health plans do not provide parallel coverage for SUD care as mandated. Current attempts to dismantle the ACA and other health insurance regulation on the federal and state levels further threaten to undermine this already flawed framework.
It is indeed no accident that many of the groups that face a disproportionate burden of opioid overdose and OUD are also more likely to be uninsured or under-insured. For instance, people re-entering the community from correctional settings have typically had their health insurance revoked or suspended, thanks in part to an antiquated provision in the Social Security Act that bars Medicaid or Medicare coverage from correctional inmates. With an estimated 40% of SUD-affected individuals eligible for Medicaid or Medicare, public health insurance coverage policies for these programs related to OAT are an important determinant of access. Inexplicably, a third of U.S. states bar Medicaid coverage for methadone. West Virginia—a state with the highest rate of opioid overdose—is among the states prohibiting such coverage; it also sets a lifetime cap on buprenorphine access at typical therapeutic dosage. Contrast that with Massachusetts, whose Medicaid program covers methadone and does not require prior authorization or counseling for buprenorphine. Numerous other barriers in public insurance policies across the U.S. are well-documented, with coverage, reimbursement, and authorization provisions literally all over the map.
There are numerous reasons why only about half of the relatively few practitioners waivered to provide OUD treatment in office-based settings actually choose to do so. Even fewer treat a substantial number of OAT patients, and still fewer reach the patient limit. Financing and insurance barriers, such as pre-authorization, compliance paperwork, counseling, and drug testing requirements play a significant deterrent role. Engaging in buprenorphine prescribing exposes the health care practice to intensified scrutiny by the DEA and state regulators, including possible surveillance through prescription drug monitoring and other means. Costly audits and investigations that are triggered by buprenorphine prescribing carry the risk of professional and business detriment. Finally, providers may lack adequate training and understanding of SUD and its treatment, often sharing broader societal stigma towards people who use drugs and ideological or philosophical preference for abstinence-only modalities.
Despite its unequivocal benefit, provision of OAT is not the only way to vastly reduce risk of fatal overdose among those with OUD. Provision of naloxone to patients and other members of the community has been shown to improve overdose mortality at the population level. Lay distribution has also proved cost-effective, in contrast to the increasingly popular but yet unproven distribution programs targeting police.
It is a uniquely American paradox that there are fewer barriers to getting one’s hands on opioid analgesics than treatment for OUD, which those analgesics may ultimately spark. Thankfully, there are many clear opportunities to increase access to OAT, with the most promising advancing integration in primary care settings, reducing insurance and regulatory barriers, improving training, and reducing stigma. The 21st Century Cures Act promised to address many of these issues. Did it deliver? Before answering that question, I first turn to the overview of how the Act came to address this topic, what mechanisms it articulated, and how those provisions were translated into federal agency action.
The 21st Century Cures Act as a Remedy to the Opioid Crisis
The Legislation
The legislative scope of the 21st Century Cures Act is broad, with provisions addressing a diverse set of issues ranging from the FDA drug approval process to research funding to the regulation of human subjects’ protections. With other articles in this Symposium issue ably training their attention on other domains of this legislation, a detailed overview of the Act is beyond the scope of this analysis. Various seemingly-tangential provisions of the Act could have a direct or indirect impact on the current, or future drug crises. For example, retooling FDA pre-market approval process through reforms advanced by the Act may inadvertently undercut the agency’s regulatory power and create the risk of dangerous adverse reactions or other downstream drug-related harms. However, rather than speculate on these more attenuated or hypothetical points, this analysis focuses on the elements of the legislation expressly related to addressing today’s opioid overdose crisis.
Many of its provisions most relevant to addressing the opioid crisis, the 21st Century Cures Act is corollary to CARA. First introduced in 2015, CARA was expressly focused on substance use and the opioid crisis, advancing a number of innovative programmatic and legal mechanisms. In the context of the broader political environment of the 114th Congress, CARA became moderately contentious and received numerous amendments, which included stripping it of much of its funding. Ultimately, the bill passed with broad bipartisan support and was signed into law by President Barack Obama in July 2016.
Partisan disagreements about funding within CARA opened the door for the 21st Century Cures to take on the role of the Obama Administration’s key legislation to address the opioid crisis. With pharmaceutical regulation and research as its original focus, the Act became a vehicle for a number of SUD and mental health-related provisions originally intended for CARA. The bundling of these provisions helped inject new life and bring momentum to the previously stalled 21st Century Cures Act, reframing it as an important contribution to the Obama legacy. Thanks in no small part to this transformation, the Act passed with overwhelming bipartisan support and was signed by the President just before he left office, characterized as one of his Administration’s major legislative accomplishments in this domain.
So what did the 21st Century Cures Act actually promise to do to address the opioid crisis? In the realm of SUD treatment and overdose prevention funding, the Act first and foremost delivers a substantial injection of resources, with $1 billion approved over a two-year (2017-2018) period. Broadly categorized under needs assessment, prevention, treatment and recovery support, the Act contemplates a number of potential uses for the funding, including increasing MAT capacity, provider training, public outreach, monitoring and calibrating prescription opioid prescribing, and treatment navigation services. The legislation authorizes the Department of Health and Human Services Secretary to determine how funds are to be apportioned, based on the population burden imposed by the crisis. It is notable that, although MAT access is featured prominently as a goal in this appropriation of funding, the 21st Century Cures Act contains no particular guidelines on prioritizing expenditures. The Act also authorizes (or re-authorizes) funding for a range of specific grant programs focused on SUD care and mental health treatment, including the integration of SUD treatment and other behavioral health services with primary care offered by community health centers.
The Act’s applicable provisions trained on the opioid crisis also provide a number of additional reforms and initiatives. The Act articulates changes to Medicaid reimbursement rules related to SUD and mental health treatment by eliminating archaic prohibitions against billing for behavioral or mental health and medical care services on the same day. It also builds on previous legislation including the Affordable Care Act in strengthening the reporting and enforcement of SUD parity requirements. It also seeks to clarify, without substantially reforming, the interface of the Health Insurance Portability and Accountability Act and 42 C.F.R. Part 2 rules related to patient privacy and care coordination in the context of SUD service utilization. On top of the $1 billion, the 21st Century Cures Act also includes modest additional funding to integrate criminal justice and health-based responses to problematic substance use. Finally, it promulgates changes to the structure and staffing of the Substance Abuse and Mental Health Services Administration (“SAMHSA”), in particular by adding a new leadership position of Assistant Secretary for Mental Health and Substance Use and a Chief Medical Officer to guide this agency.
Although all of the provisions of the 21st Century Cures Act focused on the opioid crisis are noteworthy, the major standout among them was the long-sought appropriation of $1 billion in funding for SUD treatment and related activities. This is evidenced by the fact that, when signing the Act, the President himself spoke of the primacy of the funding provision as the Act’s principal achievement. With the commitment of $500 million per year for two years, this was the single largest dedication of resources specifically earmarked for addressing the opioid crisis among a variety of existing programs promulgated by the Centers for Disease Control and Prevention, the Department of Justice, SAMHSA, and other agencies.
In view of the above discussion of the role of the treatment gap in contributing to the crisis, the most significant promise of the Act in addressing the crisis does indeed appear to be the injection of new resources for OUD treatment, especially for OAT access. Provision of naloxone and coordination of treatment access, especially for justice-involved individuals hold additional promise. For the foregoing reasons, I will focus my analysis of the implementation of opioid crisis provisions primarily focusing on this program.
Cures Funding in Focus: Opioid STR
In implementing the primary funding provision of the 21st Century Cures Act, SAMHSA had to contend with a very rapid timeline. To distribute the funds, the agency formulated the grant mechanism called the Opioid State Targeted Response (“STR”) Program. The program’s stated aims were “to address the opioid crisis by increasing access to treatment, reducing unmet treatment need, and reducing opioid overdose related deaths through the provision of prevention, treatment and recovery activities targeting OUD.” Funds “would be awarded to states and territories via formula based on unmet need for opioid use disorder treatment and drug poisoning deaths.”
In its grant announcement, the agency outlined the specific parameters for the states in the use of these funds. These parameters required the grant recipients to conduct an initial needs assessment to “demonstrate the critical gaps in availability of treatment for OUDs in geographic, demographic, and service level terms,” and then to use these assessments to inform the design and implementation of service activities designed to close the treatment gap for OUD. It required a rapid transition from assessment to action, with a four-month maximum timeline from the initial funding of the project to start of service delivery. Under the terms, 80% of the disbursed funds were to be used for “opioid use disorder treatment and recovery support services.”
When describing specific allowable activities, the grant announcement was nonetheless noncommittal in its prescriptions. Under its required activities, the announcement listed a range of specific elements within the categories of prevention, treatment, and recovery support. Despite the well-understood dismal levels of access to, and financing for, MAT (and especially to OAT) in most jurisdictions, the announcement articulated the requirement that the states track “the number and location of opioid treatment providers in the state, including providers that offer opioid use disorder services” and then use its assessments to understand the funding and other gaps in opioid misuse prevention, treatment, and recovery activities.
The announcement went on to require that states “provide assistance to patients with treatment costs and develop other strategies to eliminate or reduce treatment costs for under-and uninsured patients,” critically glossing over the glaring issue that many states’ public health insurance policies are substantially to blame for the under- or un-insurance of OAT in particular. The most operative focus of this mechanism, however, was on “implement[ing] or expand[ing] access to clinically appropriate evidence-based practices … for OUD treatment.” Under this rubric, the announcement did not distinguish between OAT and OUD therapy using naltrexone. Finally, the announcement required that the funds be spent on the provision of “treatment transition and coverage for patients reentering communities from criminal justice settings or other rehabilitative settings.” Despite a clear intention to boost MAT and repeated invocation of “evidence-based” modalities, the mechanism never specifically prohibited funds from supporting abstinence-based or other unscientific treatment approaches.
In addition to outlining required elements, SAMHSA also provided a litany of allowable activities under this mechanism. These include training providers, including physicians and allied health professionals, in SUD treatment and overdose prevention; the use of electronic decision support and clinical tools, including PDMPs to improve OUD diagnosis and treatment; purchase and distribution of naloxone in “high need communities,” but with focus on first responders and service providers; and improving treatment access by “reducing the cost of treatment” and addressing other structural barriers.
In all, the Opioid STR framework represented an action-oriented, reasonably promising mechanism to address some of the most glaring gaps in how the opioid crisis is being addressed in the United States. But it is often the case that the promise of policies and programs is not matched by reality. This has proven especially true in the realm of SUD and other behavioral health issues, where legislative, programmatic, and grant-making action is often stymied by a mixture of stigma, administrative complexity, and convoluted regulatory and oversight architecture. For instance, policies designed to institute insurance parity and prevent discrimination against patients on OAT have shown to be stubbornly ineffective. The next section considers what is known, at this early stage, about the actualization of the Opioid STR mechanism, and how this bodes for its future impact.
Implementation of STR: Preliminary Findings
In order to secure Opioid STR funding, participating jurisdictions were required to submit an application by mid-February 2017. To better understand the priorities outlined by the states in the applications, we conducted a textual analysis of the publicly-available application summaries of the individual state grant awards. Although not completely dispositive about how the grantees will ultimately choose to use the funding, these initial statements provide a useful proxy indication of the applicants’ intentions and priorities.
State Intentions and Priorities
Our analysis of all 50 states and Washington D.C.’s applications indicates a wide range of funding amounts and priorities. Notable regional differences exist in the intended apportionment of the resources. States in the Northeast and South reported larger grants, on average, than states in other regions. A number of patterns in stated funding priorities also emerge from these documents.
States clearly heeded SAMHSA’s call to increase OAT access using the funds, but this uptake was by no means universal. Only slightly more than half (53%) of the published statements from Southern states made some mention of scaling up OAT, including intentions to do so through increasing prescriber capacity, opening new venues, or other means, as compared to much higher proportions of states in other regions. States were approximately evenly-split on the intention to use the funds to improve access to naloxone, with about 47% overall providing some mention of naloxone access in the community and 31% articulating the intention to fund first responder access and/or training.
Substantial proportions of the states expressly mentioned their intention to improve OAT access as part of the reentry process—a vital measure addressing a highly vulnerable and neglected population. Despite this issue serving as a core element in the STR funding announcement, however, only 42% of Southern states and 46% of mid-Western states articulated interest in addressing this issue. And this, it would seem, is the best-case scenario. When it comes to addressing the special vulnerability of other key groups who did not receive special mention in the announcement, few states’ funding statements articulated interest in other highly-vulnerable groups, including pregnant and parenting women (27% overall), veterans (12% overall) and PWID (10% overall).
Unfortunately, stated interest in improving OAT access inside correctional settings (as opposed to upon reentry) appeared low, with 12% of states overall providing mention of this measure. Conversely, interest in using the STR funds to expand or otherwise support the implementation of PDMP or other prescription monitoring measures was much more prominent, with 31% of states overall stating the intention to do so.
STR-Funded Programming: Preliminary Findings
At time of writing, less than a year has passed since the initial Opioid STR awards were disbursed to the states. Therefore, in compiling the information about the implementation of this mechanism, this analysis relies on fragmented, but illustrative documentary evidence gleaned from external and internal documents.
As an initial matter, there has been considerable consternation about how the funding has been allocated. In disbursing the grants, SAMHSA had based the funding formula on incidence and prevalence of overdose. States like New Hampshire with a relatively small population but high overdose burden felt that they were due a larger share of the funding. After the voicing of these concerns, SAMHSA nonetheless decided not to amend the formula for the second cycle of Opioid STR funding. This led to the introduction of House legislation H.R.4190 Federal Opioid Response Fairness Act to change the formula to one that integrates a different calculation of the state’s overdose burden.
Some of the states hardest-hit by the overdose crisis also represent examples of states that are using the most sizable portions of their STR funding in ways that appear unlikely to align with the spirit (or, in some cases, the letter) of 21st Century Cures Act. In Indiana, despite proposing to increase the number of providers offering OAT services, the budget narrative neglects to mention any initiatives specifically related to OAT access. The state budgets for “residential providers,” but does not offer any description on the nature of treatment. Simultaneously, the budget allots $150,000 to specifically train providers in abstinence-based treatments such as Dialectical Behavior Therapy and 12-Step modalities. Although it is possible that some detail has been ignored, the budget narrative outlines the distribution of the entire grant amount without any mention of the promised expansion of OAT.
The Kentucky Opioid Response Effort (“KORE”) does support a number of evidence-driven programs, including OAT coverage, syringe access, and distribution of naloxone in the community. The same initiative, however, also supports “COR 12” Training developed by the Hazelden Betty Ford Foundation. Despite their claims otherwise, 12-Step modalities are not rooted in evidence of addressing identifiable overdose morbidity or mortality endpoints. The plan also singles out Vivitrol® access for support, including direct purchasing of Vivitrol® with grant funds.
One of the most troubling elements of Kentucky’s initiative is its funding contribution to the “enhancement” of the Kentucky All Schedule Prescription Electronic Reporting (“KASPER”) program to integrate data on controlled substance convictions with prescription monitoring records. It is difficult to see how this initiative could enhance patient care in SUD diagnosis, prevention, treatment, and recovery support. Instead, such integration of criminal justice data with prescription history may result in discrimination against criminal justice-involved individuals and reduce help-seeking among these and other already underserved individuals.
In Minnesota, 32 STR-funded initiatives are currently operational, only two of which are related to office-based opioid therapy (“OBOT”) and the expansion of waivered OAT providers. Minnesota is also notable for its “Rule 25,” a prerequisite provision which mandates all individuals receiving publicly-funded substance use treatment to undergo a “chemical use assessment” by a designated assessor. Each individual thus assessed receives ratings in categories such as “readiness for change.” Of all the listed STR services, only one program specifically provides funding to expand access to Rule 25 assessors for the general population, and thus publicly-funded treatment services. However, increased funding towards developing Rule 25 services raises separate concerns, as in the absence of a clear rationale for this pre-authorization mechanism to publicly-funded services, such allotment could be better spent on actual treatment services.
North Carolina’s budget narrative for STR grant distribution describes an array of much-needed evidence-based treatment and recovery services, including the purchase of buprenorphine and methadone for OAT, opportunities for MAT provider education and expanded peer recovery services. On the other hand, this same STR budget proposes distributing almost half a million dollars on the development of the state’s existing PDMP, and outlines the salary of a Drug Control Unit Inspector with STR funds.
In absence of a comprehensive dataset, these case studies represent a sampling of the issues in the mismatch about the letter and spirit of the 21st Century Cures Act’s opioid crisis funding and its implementation. Emerging evidence of STR fund disbursement on non-scientific treatment highlighted above was likely behind the announcement in December 2017 clarifying the position of SAMHSA in how it expected STR funds to be spent. This communication specifically outlined the position of the newly-appointed Assistant Secretary for Mental Health and Substance Use—a position also created by the 21st Century Act—that all STR treatment funds should be directed to MAT programming, not other modalities.
Pending a full accounting of the state grantee activities, it is impossible to know to what extent the states’ activities aligned with these directives, either before or after they were issued. Although it is certainly important, we need not wait until that full accounting to posit the gaps and missed opportunities in this program, and in the 21st Century Cures Act itself. The concluding section endeavors to do just that.
Implications and Prognoses
As the surging incidence of drug overdose deaths in America entered its second decade, a twist of political fate cast the 21st Century Cures Act in the unexpected role as one of the principal federal responses to the opioid crisis. This analysis has focused on understanding whether the Act has done—or can be reasonably expected to do—what it was intended to do. Limited preliminary analysis of state-level implementation identified a number of indicators that Opioid STR funds may be being invested in suboptimal—and potentially harmful—ways. This includes spending on abstinence-based OUD treatment programs and navigation services tied to these programs. The dominance of unscientific treatment modalities remains one of the most formidable barriers to bringing the opioid crisis under control, constituting a public health, health care quality, and consumer protections disaster. It is therefore especially disheartening that taxpayer resources continue to support such programs.
Also of concern are likely sizable expenditures on surveillance and monitoring programs like PDMPs, whose value in improving prevention, treatment, and recovery support for OUD is unproven. PDMPs already receive generous funding from federal, state, and private sources, despite mixed evidence of benefit. Disbursement of STR funds on monitoring efforts such as the bundling of criminal justice data with patient prescribing records is especially troubling.
The full extent of the gaps between the letter, spirit, and implementation of the funding provisions of this Act will need to be assessed when full information is available on how states actually spent their STR grants. But based on intentions expressed in the applications and fragmented budgetary information available at the time of writing, states will be unlikely to take full advantage of the funding to address critical vulnerability among some of the highest at-risk groups, including reentering individuals, despite a clear directive to do so. With notable patterns of transition to injection drug use and emerging HIV and HCV epidemics in numerous jurisdictions, grantees appeared to heed little attention to treatment and support programming specifically focused on reducing the harms of injection drug use.
Conversely, although joint “task forces” to address substance were not listed on the original funding announcement, STR spending on these initiatives appears likely to prove substantial. Task forces have become increasingly popular as a focal point to overcome fragmentation of data streams and programmatic systems in opioid response. Despite their theoretical promise, many of these entities have been dominated by law enforcement institutions, as a result advancing carceral and wasteful responses to the crisis, especially in hard-hit states. Thus, the value of these expenditures to advance treatment and recovery of individuals with OUD is unclear.
Many of the issues surrounding the implementation of 21st Century Cures Act’s funding provisions lay bare missed opportunities at the planning stage. The power of the purse should have empowered SAMHSA to place rigid parameters on STR funds. Given that first responders have access to other established resource streams to support their naloxone access, STR funds could have come with specific directives that states supply naloxone to members of the general public. Drug users, their families and service providers are most likely to serve as lay rescuers and have been shown to deploy naloxone to effectively reduce population-level overdose mortality.
Similarly, such provisions could have restricted funding more expressly to MAT, in contrast to abstinence-based treatment modalities. Additionally, given the emerging evidence base and limited resources, the Agency would be on solid footing in expressing clear preference for OAT, rather than the less cost-effective opioid antagonist alternatives. In some ways, the consistent failure of government agencies at all levels to express a preference for OAT is an illustration of the stigma that pervades U.S. policy in OUD treatment arena.
Similarly, SAMHSA could have used the power of the STR purse to incentivize state-level policy reform. The Medicaid reforms contained in the 21st Century Curses Act were quite limited and did not relate to reforming counterproductive state policies related to OAT. Tying STR funding to some reconsideration of bans on Medicaid coverage for the states where they exist would have been the low-hanging fruit for such action. If limited just to new STR resources, such action would almost certainly overcome the “overwhelmingly coercive” standard under National Federation of Independent Business v. Sebelius.
But in drawing conclusions about whether the 21st Century Cures Act has lived up to this role, it is also appropriate to assess this legislation along another metric: what are the missed opportunities for this, and similarly-situated legislation? Given the enormity of the treatment gap, the Act likely contained far too little money to make a significant difference on a national stage. Whether one subscribes to one or the other extreme in the widely divergent impact estimates of the opioid crisis on the American economy (ranging from $70 to $500 billion) the crisis exerts an enormous economic cost. An annual investment of $500 million over two years is hardly an adequate response to this challenge, especially viewed in contrast with other expenditures approved by Congress, such as those directed to the military budget. The well-documented effectiveness and cost effectiveness of OAT makes the paltry size of this investment especially shortsighted.
It is not just the size of the investment that is problematic, it is also its structure and duration. In design terms, OUD care is provided best when integrated into other systems of care. Provision of special grants, whether through STR or other mechanisms, feeds a parallel, separate but unequal framework for OUD treatment. Instead, federal government resources would be better spent on boosting overall functionality, quality, and affordability of health care that integrates OUD and other SUD services. Considerable additional effort should also be expended on monitoring and enforcement of existing laws and policies designed to advance treatment and recovery in the United States. This includes laws mandating parity insurance coverage for SUD services and prohibiting discrimination against people engaged in MAT and others affected by addiction and mental health conditions.
On an operational level, limiting the Act funding to two years imposed major problems in planning and implementation of the program, as well as its sustainability. Some programs are already facing the prospect of limited funding duration, including an innovative law enforcement assisted diversion (“LEAD”) program in North Carolina. The sustainability of the Act’s funding and other provisions is made even more uncertain because the Act builds on ACA and other legislation now under threat of repeal. Will the mechanisms like parity and the existence of federally qualified health centers on which the 21st Century Cures Act provisions rest be dismantled? Some of these provisions, like privacy rules for care coordination are already being rolled back.
Given that the role of the Act as a legislative response to the opioid crisis was somewhat of an afterthought, perhaps it is unfair to hold the Act to such a high standard. A number of legislative proposals on Capitol Hill promise to inject billions in additional funding into STR and analogous mechanisms. Addressing structural and operational gaps identified in this and other analyses would increase the positive impact of the proposed efforts. Only time will tell whether lessons about the limitations of the 21st Century Cures Act have been learned in the design of these future legislative and regulatory efforts. Meanwhile, as we dither, the crisis rages on.
Conclusion
Although standard-of-care practices in opioid addiction treatment have long been established, this health care space continues to operate as a heterogeneous patchwork of modalities and philosophies of care. Many SUD programs—both private and public—presently deliver ineffective services not rooted in science, and at times implemented using coercion. Tragically, this failure to follow best practices contributes to high rates of relapse and dangerously-elevated patient overdose risk, fueling the current crisis.
In the context of the mounting overdose toll, the landmark 21st Century Cures Act included a number of provisions intended to expand and improve substance use treatment in the United States. In 2017, Congress approved the first installment of funds totaling over $500 million to support these efforts. This paper presented a preliminary analysis of the ways in which state and federal agencies have used these investments. Drawing on emerging data, the implementation of the Act indicates a number of missed opportunities and potentiates negative consequences flowing from the implementation of this landmark legislation.