Jennifer D. Oliva1Associate Professor of Law, Seton Hall University School of Law.
We are not very good at admitting past mistakes, especially on issues of race, and that has consequences.
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A part of the series, COVID-19 and Criminal Justice.
This Essay examines the federal government’s pandemic-provoked waiver of certain legal and regulatory barriers to evidence-based opioid use disorder (OUD) therapeutics, aimed at enhancing access to treatment while mitigating the risk of COVID-19. OUD is a highly stigmatized, chronic neurological disease with a poorly understood etiology. The prevailing approach in the United States has been to criminalize individuals with use disorder. U.S. drug policy has long been dominated by the antiquated view that OUD is a deviant moral failing that deserves prosecution, instead of a complex health care condition that demands evidence-based treatment. The persistence of such anti-scientific theories motivated the federal government’s creation of a surveil-and-supervise regulatory regime that isolates OUD treatment from the traditional health care delivery system. That regime continues to prioritize the policing of individuals with OUD over the provision of expansive access to care.
Prior U.S. drug crises were attributed to the alleged immoral nature of certain racial and ethnic minority groups. By contrast, the country’s current drug use and overdose dilemma has been characterized as a predominantly rural and suburban White American problem instigated by clinical overprescribing and the aggressive and fraudulent marketing of opioid analgesics. This popular narrative, which shifts blame for use disorder from the White “victim” to unscrupulous prescribers and Big Pharma, changed the focus of the solutions rhetoric from policing and punishment to public health interventions. Consequently, when the novel coronavirus began to sweep over the United States in the early months of 2020, federal health officials were amenable to policies aimed at enhancing access to OUD treatment. Federal agencies quickly waived several of the rigid legal requirements that attend to OUD treatment—and that have long obstructed access to OUD therapeutics—at the inception of the COVID-19 national health emergency.2See Stacey A. Tovino, COVID-19, Telehealth, and Substance Use Disorders, Ariz. St. L.J. Online (forthcoming 2020).
The federal government’s decision to waive certain access to treatment barriers for individuals with OUD was a long overdue and welcome development. There is no question that the agencies that oversee the draconian U.S. OUD therapeutic regulatory regime ought to make those waivers permanent post-pandemic. This Essay argues, however, that the benefits of the OUD-related COVID-19 waivers have disproportionately inured to individuals who use buprenorphine and are overwhelmingly White, at the expense of individuals who use methadone and are overwhelmingly persons of color. This is particularly problematic given that COVID-19 disparately impacts racial and ethnic minorities. This Essay also contends that the current pandemic reforms do not go far enough in eliminating access to treatment barriers. As a result, the Essay concludes by enumerating a dozen additional reforms beyond the COVID-19 waivers that the federal government and states should adopt to ensure more equitable access to evidence-based OUD treatment.
I. OUD in the Context of COVID-19
The United States has been ravaged for decades by a shape-shifting, polysubstance drug use crisis that has claimed over 840,000 lives since 1999. More than twenty million Americans suffer from substance use disorder (SUD), and drug poisoning is the country’s leading cause of unintentional injury deaths. On October 26, 2017, President Donald J. Trump declared the opioid crisis a national public health emergency. Tragically, preliminary data indicate that the United States is currently on track to witness the highest number of preventable drug overdose deaths ever recorded in a single calendar year in 2020.
The anticipated high rate of overdose deaths is, at least in part, because SARS-CoV-2, the novel coronavirus that causes the disease COVID-19, poses unique threats to people with OUD. Individuals with OUD are immunocompromised due to their health condition and often lack access to effective treatment as a result of stigma, financial insecurity, and distrust of health care professionals. They are more likely to experience food and housing insecurity because of their disease. They also have more frequent interactions with the justice system and, therefore, are at higher risk of being detained in shelters, jails, and prisons with high rates of COVID-19. Worse yet, states have begun to cut substance use disorder (SUD) treatment and harm reduction funding, despite the high demand for those services due to pandemic-related financial strain.
Perhaps counterintuitively, COVID-mandated social distancing further undermines the health of individuals with SUD. Social distancing complicates the ability of individuals to attend in-person support groups and to use drugs with others, which mitigate the risk of overdose. The illicit drug supply is increasingly dominated by more toxic and concentrated contaminants that enhance the risk of overdose. The pandemic has set the stage “for a long-term resurgence of addiction by exacerbating many of the conditions, including unemployment, low incomes and isolation, that contributed to the rise of the opioid [crisis] and ‘deaths of despair’” across the United States over the last twenty years. A May 2020 study predicts that COVID-19–related deaths of despair, including those attributable to drug overdose, alcoholism, and suicide, will claim between 27,644 and 154,037 lives before the pandemic abates and the American economy begins to recover.
Several states, including Rhode Island, Kentucky, Florida, Texas, and Colorado, experienced significant surges in drug overdose deaths during the first two quarters of 2020. In May 2020 alone, paramedics in West Virginia (which has long suffered the highest overdose rate per capita in the country) “responded to 923 calls about people suspected of suffering an overdose, a nearly 50% increase over last May and 200 calls more than in any other month in the last two years.” The Washington Post estimated that suspected overdoses increased nationally by 18 percent, 29 percent, and 42 percent in March, April, and May 2020, respectively. The overdose crisis has escalated at such a rapid clip during the pandemic that the American Medical Association released a brief in October 2020 dedicated to the issue. The American Medical Association documented increases in opioid-related mortality—largely due to illicitly-manufactured fentanyl and fentanyl analogs—in forty states since the onset of the pandemic. It also urged policymakers “to remove barriers to evidence-based treatment for those with a substance use disorder as well as for harm reduction services, including sterile needle and syringe services and naloxone.”
Unfortunately, it is entirely predictable that populations already embroiled in health crises will experience increasingly adverse health-related outcomes when a new health emergency, such as COVID-19, emerges. As anthropologist Clarence Gravlee explains, “[p]andemics always follow the fault lines of society—exposing and often magnifying power inequities that shape population health even in normal times.” Consistent with that basic principle of public health, COVID-19 has disproportionately imposed its mortality and morbidity burden on racial and ethnic minorities and other at-risk groups. Across the forty U.S. states that report COVID-19 deaths by race and ethnicity, Black Americans, Indigenous peoples, Pacific Islanders, and Latinx individuals are about three times as likely to die from the virus as their White counterparts. And, according to the CDC, racial and ethnic minorities have suffered disproportionately high COVID-19 hospitalization rates. Non-Hispanic Black Americans, Indigenous populations, and Latinx individuals are approximately 4.5 times more likely to be hospitalized for COVID treatment than non-Hispanic Whites.
In addition, and although opioid drug use has been characterized as a predominantly White suburban and rural problem, the largest per capita increases in opioid-related overdose deaths over the last several years have involved Black Americans, individuals who identify as Latino/Latina, and Indigenous peoples. While White overdose deaths decreased in Philadelphia by 3 percent in 2019, for example, Black and Latinx American deaths increased by 14 percent and 24 percent, respectively. St. Louis County experienced a similar trend. There, opioid overdose deaths decreased by 8 percent among all populations in 2019 but increased by 17 percent among Black men. In sum, COVID-19 and the drug overdose crisis have operated “syndemically” to wreak devastating health outcomes on racial minorities.3Editorial, Syndemics: Health in Context, 389 The Lancet 881, 881 (2017), (explaining that “[t]he hallmark of a syndemic is the presence of two or more disease states that adversely interact with each other, negatively affecting the mutual course of each disease trajectory, enhancing vulnerability, and which are made more deleterious by experienced inequities”).
II. U.S. Regulation of Evidence-Based OUD Therapeutics
Racial animus frequently drives American drug control policy and the country’s regulation and criminalization of opioids are illustrative of that truth. The very first U.S. drug control laws criminalized the importation, distribution, and use of opium by Chinese immigrant laborers, “whose opium consumption was blamed for crime, violence, lascivious behavior, and other social ills” throughout the American West. In the 1960s, the recreational use of heroin by urban youth and returning Vietnam War veterans was similarly characterized as a scourge fueling “inner-city” crime and poverty. The racialization of heroin use disorder as an urban “Black” problem was an impetus for the 1970s Nixonian War on Drugs and enactment of the country’s current drug control system: Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (the Controlled Substances Act (CSA)), and creation of the CSA’s law enforcement oversight authority, the Drug Enforcement Agency (DEA).
“The conservative Cato Foundation and liberal Center for American Progress both agree that Nixon’s War on Drugs . . . was an expensive failure, resulting in a period of [approximately] 50 years of a federal policy based on a false premise and a conscious avoidance of evidence-based research.” Since the CSA’s enactment, the U.S. prison and jail population, which is disproportionately composed of Black and Latinx people, has quadrupled, and the country is now the highest per capita incarcerator in the world. The DEA nevertheless continues to vigorously wage the War on Drugs pursuant to the Controlled Substances Act.
A. The Controlled Substances Act
The CSA confers on the DEA the broad authority to classify, control, and surveil the supply and distribution of controlled substances. The statute delegates to the agency the power to assign drugs into one of five schedules (I through V) based on their medicinal utility, safety, and potential for abuse. The CSA defines Schedule I controlled substances, including heroin, LSD, and cannabis, as drugs with “no currently accepted medical use in treatment in the United States”and “a high potential for abuse.” Schedule II drugs are those that have both a medicinal use and a high potential for abuse. Whereas heroin has always been classified as a Schedule I drug, most opioids—including hydrocodone, oxycodone, methadone, and fentanyl—are Schedule II controlled substances.
The scheduling designations that pertain to certain controlled substances appear to be disconnected from those drugs’ medicinal value and risk of abuse potential. It is difficult, for example, to understand why cannabis, a drug that reportedly has medicinal value and whose use has never resulted in a single reported overdose fatality, is an illicit Schedule I substance while cocaine, a drug that also has medicinal value but whose use has resulted in widespread dependency and death, is on Schedule II. It also is well-chronicled that “the movement to ban marijuana [was] based in large part on images of ‘reefer-mad Mexicans’ and alleged sexual abuses of White women by minority men” and not based in science. The disparate scheduling of opioids is similarly confounding without looking to non-science rationales. Otherwise, it is impossible to glean why heroin, which is associated with urban Black use, is controlled as a Schedule I drug but fentanyl, which is fifty to one hundred times more powerful than heroin but has no such racial association, is a Schedule II substance that can be prescribed for take-home use by any clinician with a DEA controlled substance registration.
The CSA’s treatment of two of the three therapeutics that the U.S. Food and Drug Administration (FDA) has approved to treat OUD—methadone and buprenorphine—raises additional questions. Federal law regulates these two drugs more stringently when they are used to treat OUD than it does all other similarly scheduled drugs, including, in the case of buprenorphine, other opioids that the CSA schedule deems to have a higher potential for abuse. The unique regulatory histories that pertain to methadone and buprenorphine, respectively, illustrate the ongoing tension between the United States’ traditional law-enforcement-centric criminalization approach to OUD and the movement toward an evidence-based harm-reduction tack. They also demonstrate that the federal government’s application of different levels of regulatory scrutiny to these drugs when they are used to treat OUD creates barriers to OUD treatment across populations and disparately impacts racial minorities, who are more likely to take methadone than buprenorphine.
Methadone is a Schedule II opioid agonist that was first synthesized in Germany prior to World War II. In 1947, the FDA approved methadone as an analgesic and antitussive under the brand name Dolophine. Two years later, doctors at the U.S. Public Hospital in Lexington, Kentucky began to use the drug to treat heroin withdraw on an experimental basis. In the 1960s, Dr. Vincent Dole and Dr. Marie Nyswander conducted a research study in New York City, which demonstrated that methadone was an effective maintenance treatment for heroin use disorder (HUD). The FDA approved methadone to treat HUD in 1972.
When methadone is used as an analgesic, it is regulated just like any other Schedule II controlled substance. When it used as an OUD therapeutic, however, methadone is the most stringently regulated licit drug in the United States. This is because the Nixon administration enacted various federal laws and regulations to control the distribution of methadone that far exceed the scope of FDA and DEA regulation of other controlled substances.
The FDA issued special regulations in 1972 alongside its approval of methadone to treat OUD. These regulations established the restrictive framework for methadone distribution and administration that remains in place today. The 1972 regulations “removed methadone from general distribution and established controls over its use, literally on a patient by patient basis, through physician registration and treatment programs with characteristics prescribed in the regulations.” The FDA confined methadone distribution to hospital pharmacies and agency-approved Opioid Treatment Programs (OTPs)—special facilities isolated from the traditional healthcare system that are often called “methadone clinics.”
The FDA regulations also required clinicians to seek and obtain program approval from the agency to administer methadone because prescribing the drug for OUD treatment was and remains illegal. The regulations limited the type of patient that OTPs could treat to individuals who had suffered OUD for at least two years, and set forth a number of other demanding requirements for programs and patients. The regulations mandated, for example, that OTP patients travel to the facility to orally ingest methadone under program supervision (1) every day (at least six times a week) for the first three months of treatment; (2) at least three times a week (with a limitation on take-home doses to two days) while in treatment from 90 days to two years; and (3) at least twice a week (with a limitation on take-home doses to three days) thereafter. The rules also required patients to submit to an in-person, pre-admission physical and interview, random weekly drug tests, and counseling, rehabilitative, and other social services to “help [them] become . . . well functioning member[s] of society.”
- limit the administration of methadone to certified and accredited OTPs;
- restrict patient eligibility to individuals who satisfy the DSM-IV criteria for OUD and have done so for at least one year, with exceptions for certain populations, including pregnant women, former patients, and individuals recently released from penal institutions;
- require OTPs to “provide adequate medical, counseling, vocational, educational, and other assessment and treatment services” to all patients;
- demand that patients submit to an initial in-person medical assessment, including a complete physical, within 14 days of admission to the program;
- mandate that patients participate in counseling services and submit to at least eight random drug tests a year; and
- limit methadone administration and dispensing to an oral form of the drug and set a cap on the initial dose at 30 milligrams.
The rules also remain relatively hostile to take-home use of methadone “[t]o limit the potential for diversion of opioid agonist treatment medications to the illicit market.” Programs are permitted to administer take-home methadone to patients when (1) the treatment program is closed on weekends or holidays or (2) the program’s medical director determines that a particular patient is eligible by evaluation of enumerated criteria, which include “[a]bsence of recent abuse of drugs (opioid or nonnarcotic), including alcohol,” “[r]egularity of clinic attendance,” “[a]bsence of serious behavioral programs at the clinic,” “[a]bsence of known recent criminal activity,” “[s]tability of the patient’s home environment and social relationships,” [l]ength of time in comprehensive treatment,” “[a]ssurance that the take-home medication can be safely stored in the patient’s home,” and “[w]hether the rehabilitative benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion.” Even patients who meet these criteria, however, are limited to (1) one take-home dose per week during the first 90 days of treatment; (2) two take-home doses per week during the second 90 days of treatment; (3) three take-home doses per week during the third 90 days of treatment; (4) six take-home doses between the 270th day of treatment and the one-year mark; (5) two-week take home doses after the first continuous year of treatment; and (6) a one-month supply of the medication after two years of continuous treatment so long as they continue to “make monthly visits.”
The rules that attend to methadone maintenance treatment for OUD are divorced from evidence-based best practices and medical efficacy. They, instead, reflect the stigma that has long been associated with OUD, the racialization of heroin use which escalated after World War II, the myth that OUD is not a legitimate medical condition, the misdirected suspicion that individuals who take methadone to treat OUD are just swapping one drug for another, and heightened concern that methadone is likely to be diverted. As a result, experts have advocated for amendments to the rules for decades.
The Institute of Medicine’s Committee on Federal Regulation of Methadone Treatment published a comprehensive report in 1995 evaluating the then-current methadone regulatory regime. Among other things, the Committee explained that:
[T]he current [OPT] regulations are predicated on a belief that the societal risks of methadone outweigh the societal benefits to such an extent that extraordinary controls are necessary above and beyond those applicable to any other therapeutic drug in the United States.
. . . [T]his belief underlying the current regulations is not valid in today’s environment and the regulations should be modified accordingly. The belief has its roots in the experience of the late 1960s and early 1970s, when knowledge of methadone was not extensive and the social risks associated with heroin use seemed largely confined to [individuals with OUD]. Today, however, we know much more about the risks and potential misuse of methadone. Although the drug can be abused, it is rarely a primary drug of abuse. Further, there is no apparent evidence of organized crime involvement in the street market for the drug.
Concluding that there was “no compelling medical reason for regulating methadone differently than all other medications approved by FDA, including schedule II controlled substances,” the Committee recommended “a careful readjustment of the regulatory controls so that communities can attain the full potential benefit of this effective means of treating opiate addiction . . . .” Aside from the minor adjustments that have been made to the OPT rules since 1972 and notwithstanding the proven effectiveness of methadone as an OUD therapeutic, such recommendations have largely fallen on deaf ears.4Jerome M. Jaffe & Charles O’Keeffe, From Morphine Clinics to Buprenorphine: Regulating Opioid Agonist Treatment of Addiction in the United States, 70 Drug & Alcohol Dependence S3, S5 (2003) (contending that “[s]ince 1970, clinicians have criticized the Federal regulations as a burdensome interference with the practice of medicine”).
Buprenorphine is a semisynthetic partial opioid agonist, which the FDA has approved as an analgesic and OUD therapeutic. The DEA controlled buprenorphine on CSA Schedule II from 1970 until 1985. Upon the FDA’s approval of buprenorphine as an analgesic in 1981, the DEA proposed moving the drug to Schedule V—the schedule comprised of controlled substances that have the lowest potential for abuse and dependence—due to its safety profile, which DEA accomplished by regulation in 1985. That rescheduling, however, was short-lived.
The federal regulatory requirements outlined above that attend to OTPs not only lack an evidence base, but also make it difficult for individuals with OUD to access efficacious treatment. Recognizing the need to expand OUD treatment beyond the confines of stringently regulated OTPs, Congress amended the CSA with the Drug Addiction Treatment Act (DATA) of 2000. That law permits certain qualified physicians to prescribe FDA-approved Schedule III, IV, and V opioid OUD medications outside of OTPs in the outpatient setting.
FDA approved two sublingual formulations of buprenorphine to treat OUD in 2002 and the DEA consequently moved the drug from Schedule V to Schedule III. As a result, and unlike methadone, certain practitioners are permitted to prescribe all FDA-approved formulations of buprenorphine in outpatient treatment settings so long as they complete an eight-hour training course and obtain a DEA waiver. DATA 2000 limited waiver eligibility to qualified medical doctors and restricted the number of individuals to whom those physicians could treat to thirty patients during the first year of certification and 100 thereafter. The Comprehensive Addiction and Recovery Act (CARA) of 2016, however, increased the number of patients that waivered physicians can treat to 275 and temporarily extended the eligibility to prescribe buprenorphine for OUD to qualified nurse practitioners (NPs) and physician assistants (PAs) who complete a 24-hour training. In 2018, Congress enacted the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which made CARA’s extension of eligibility to prescribe buprenorphine to NPs and PAs permanent and extended buprenorphine prescribing eligibility to nurse anesthetists, nurse midwives, and clinical nurse specialists. Buprenorphine nonetheless remains the most heavily regulated Schedule III controlled substance in the United States when it is prescribed to treat OUD.
D. OUD Therapeutic Efficacy and Access to Treatment
Research overwhelmingly demonstrates that methadone and buprenorphine are the best available treatments for OUD. The National Academy of Science’s Committee on Medication-Assisted Treatment for Opioid Use Disorder issued a report detailing its exhaustive study of methadone and buprenorphine in 2019. The Committee concluded that “[t]he verdict is clear: effective agonist medication used for an indefinite period of time is the safest option for treating OUD.” Specifically, the Committee found that methadone and buprenorphine treatment reduced mortality of individuals with OUD by up to 50 percent and was associated with “lower rates of other opioid use,” “improved social functioning,” “decreased injection drug use,” “reduced HIV transmission behaviors,” “reduced risk of HIV diagnosis,” “reduced risk of hepatitis C (HCV) infection,” and “better quality of life compared to individuals with OUD not in treatment.” The Committee further explained that methadone—the more stringently regulated of the two agonist therapeutics—was “associated with reduced levels of criminality for individuals with OUD” and “better retention in treatment and greater patient satisfaction than other medications for OUD.”
Unfortunately, access to effective OUD therapeutics remains limited “at all levels of the care cascade, including diagnosis, entry into treatment, and retention in treatment” by legal and regulatory barriers. As the Committee on Medication-Assisted Treatment for Opioid Use Disorder points out in its 2019 report, the “rigid and time consuming requirements” that attend to OTP methadone administration “impede [patients’] ability to find and maintain employment,” and “discourage providers from opening new treatment programs.” When combined with additional layers of regulation at the state and local level, including Medicaid reimbursement restrictions for methadone treatment, the methadone regulatory scheme has become so burdensome that expansive regions within several states lack a single operational OTP.5Linda Keslar, The Methadone Blind Spot, Proto (Apr. 26, 2018), (explaining that “[a]n estimated 2.4 million people in the United States are addicted to opioids, but only about 400,000 of them get methadone therapy, through some 1,550 federally licensed programs” and that “[o]nly a handful of commercial insurance plans have recently begun paying for the treatment, and a dozen or so states, mostly in the Great Plains and the Southeast, have directed their Medicaid programs not to cover methadone therapy at all”). West Virginia, for example, has the highest per capita overdose rate in the country but only nine in-state methadone clinics because it has had a standing moratorium on new OTPs since 2007. Wyoming does not have a single OTP.6Keslar, The Methadone Blind Spot. See also Christine Vestal, Long Stigmatized, Methadone Clinics Multiply in Some States, PEW (2018) (explaining that “laws and regulations in at least six . . . states — Georgia, Indiana, Louisiana, Mississippi, West Virginia and Wyoming — still curtail licensing of new methadone clinics, even though people with opioid addictions in large swaths of those states live too far from the nearest methadone clinic to commute” and that thirteen states proscribe Medicaid reimbursement for methadone treatment). “In addition to major geographic gaps in access, the majority of existing OTPs are running at more than 80 percent capacity.”
The 2019 Committee report also notes that the majority of clinicians who are waivered to prescribe buprenorphine treat far fewer patients than they are permitted to under current federal law. Worse yet, treatment coverage would remain woefully inadequate even if all waivered providers were prescribing at capacity, because only an estimated 50 percent of individuals with OUD would have access to treatment. As a result of the numerous barriers to methadone and buprenorphine access, only one in ten individuals with OUD in the United States receives treatment that includes an efficacious OUD therapeutic.
Disparities in access to OUD medications also exist across racial and ethics lines in the United States. Black Americans, for example, are dramatically less likely to receive buprenorphine for OUD treatment than their White counterparts. One study that evaluated 13.4 million buprenorphine prescriptions issued between 2012 and 2015 found that 12.7 million—or 95 percent—of those prescriptions were received by White patients while only 363,000 were provided to minority patients. As recently summarized by the National Academy of Science’s Committee on Medication-Assisted Treatment for Opioid Use Disorder:
African Americans with OUD in the United States have a long history of discrimination, social stigma, and criminalization, as well as limited access to some types of medication-based treatment. [I]n a study of treatment providers in New York City, higher rates of buprenorphine prescription were found in areas with lower concentrations of African American and Latino residents, whereas areas with greater concentrations had higher methadone treatment rates. A study of veterans with OUD . . . in 2012 confirmed that treatment choices about methadone versus buprenorphine appear to be a function of demographic characteristics rather than of a person’s medical, psychiatric, or service-use characteristics—patients who were African American, older, and urban residents were much more likely to receive methadone rather than buprenorphine.
Black Americans and other racial minorities also have less access to evidence-based OUD treatment and experience lower treatment completion rates and worse OUD-related health outcomes due to both implicit bias and compounding socioeconomic factors, including higher rates of unemployment and homelessness. As discussed in the next section, the COVID-19 pandemic provoked federal authorities to “waive” certain burdensome legal and regulatory requirements that impede access to OUD medications during the national public health emergency. Unfortunately, those temporary reforms do not go far enough to effectively mitigate the drug overdose crisis. Moreover, they benefit patients who are likely to initiate with buprenorphine—the overwhelming majority of whom are White—over patients who are likely to begin OUD treatment with methadone—the overwhelming majority of whom are racial minorities.
III. Pandemic Regulatory Reforms
On January 31, 2020, U.S. Department of Health and Human Services (HHS) Secretary Alex M. Azar II declared COVID-19 a public health emergency in the United States. Since that pronouncement, the Substance Abuse and Mental Health Administration (SAMHSA) has issued several directives and guidance documents that permit OUD patients and providers to satisfy various “in-person” treatment requirements through the use of telemedicine during the pandemic.7See, e.g., Tovino, COVID-19, Telehealth, and Substance Use Disorders (providing a comprehensive overview of the numerous telehealth rules pertaining to substance use disorders that the administration has enacted during the COVID-19 crisis). SAMHSA, for example, issued guidance on March 16, 2020 that permits “stable” OTP patients to receive 28 days of take-home OUD medication and “less stable” patients to receive a 14-day take-home supply. Three days later, SAMHSA exempted OTPs from the requirement to perform an in-person physical examination to initiate buprenorphine treatment, but did not extend that waiver to methadone initiation. The agency also explained that current methadone and buprenorphine patients could receive treatment via telehealth from either an OTP or a DATA-waivered prescriber during the pandemic. The DEA issued a letter dated March 31, 2020 supporting SAMHSA’s waiver of the buprenorphine in-person examination rule and reiterating its March 16, 2020 activation of the public health emergency exception in the Ryan Haight Act, which permits the administration and prescribing of OUD medications via telemedicine.
IV. Critique and Solutions
These temporary COVID-19-provoked access to OUD medication reforms are long overdue but insufficient for two reasons. First, because they waive the in-person initiation requirements for buprenorphine but not the in-person initiation mandate for methadone, they make it much easier and safer for individuals to initiate OUD treatment with buprenorphine than to do the same with methadone. Any scheme that makes it more difficult and dangerous for individuals to initiate OUD treatment with methadone is structurally problematic because, as explained above, individuals who initiate treatment with methadone are overwhelmingly more likely to be poor and/or racial minorities.8It warrants mention that patients who lack access to certain resources that prevent them from taking advantage of the temporary OUD telehealth rules, including mobile phones, computers, internet, and adequate data plans, are also more likely to be poor and/or racial minorities. As a result, these individuals are less capable of benefiting from the telehealth OUD waivers regardless of whether they seek methadone or buprenorphine treatment. This is particularly unconscionable at a time when the country is in the throes of two intertwined health crises—the COVID-19 pandemic and the drug overdose epidemic—that are disparately impacting people of color and individuals who are poor.
Second, and as already explained, the demanding requirements of the methadone and buprenorphine regulatory regimes are attributable to OUD stigma and clinical myths that have no basis in medical science. As a result, the COVID-19 OUD treatment reforms do not go far enough to reign in either COVID-19 exposure risk or mitigate the overdose crisis. The sheer scope of adverse health outcomes and deaths attributable to COVID-19 and the drug overdose crisis over the past ten months in the United States demand a different approach.
At the minimum, federal and state policymakers ought to adopt the following permanent reforms in addition to the current COVID-19 waivers to expand access to evidence-based OUD treatment:
- eliminate the in-person initiation requirement for methadone;
- eliminate mandatory random drug testing at OTPs for patients who are in compliance with program rules;
- repeal the prerequisite that individuals must suffer OUD for at least a year in order to be eligible for treatment at an OTP;
- repeal the requirement that OTP patients participate in counseling in order to receive treatment;
- authorize mobile, community-based OUD therapeutic treatment for individuals with OUD that do not have ready access to a treatment provider;
- eliminate the prior authorization requirements and reimbursement restrictions that apply to buprenorphine and methadone;
- repeal the Drug Addiction Treatment Act of 2000 (DATA) buprenorphine waiver requirements;
- extend enhanced telehealth equipment and reimbursements to OUD providers;
- provide adequate telehealth equipment and data plans to OUD patients;
- ensure that OUD providers are equipped with adequate personal protective equipment (PPE);
- expand syringe exchange programs; and
- legalize safe injection sites.
CDC data prove that Black, Latinx, and Indigenous Americans are more like to contract, be hospitalized with a serious illness, and die from COVID-19 than their White counterparts. Preliminary statistics from federal and state sources further demonstrate that the United States is poised to witness an extravagant number of drug overdose deaths this year and that those deaths will be disproportionately borne by racial and ethnic minorities. While the steps that the DEA and SAMSHA have taken to enhance access to evidence-based treatment for individuals with OUD are positive public health measures, they are woefully insufficient under the circumstances. It is beyond time to abandon our restrictive, anti-science approach to OUD treatment and follow the expert guidance that has long demanded systemic reform. Lives literally hang in the balance.
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Jennifer D. Oliva is Associate Professor of Law at Seton Hall University School of Law.
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