Methadone Treatment for Opioid Use Disorder Improving Access Through Regulatory and Legal Change: Proceedings of a Workshop (2022) / Chapter Skim
Currently Skimming:
Appendix C: Commissioned Papers
Appendix C: Commissioned Papers
Pages 135-168
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 135... ...
Appendix C Commissioned Papers 135
|
From page 136... ...
Stigma has the deleterious effect of alienating patients and potential patients from a valuable source of help -- Black patients, as Andraka-Christou has noted, suffer a "trifecta of stigmas" by virtue of being Black, having an opioid use disorder, and being a methadone patient.1 Researchers who focus on structural barriers to access and popular stigma against methadone maintenance treatment (MMT) make the argument that in no case are matters made better by the onerous restrictions on methadone and the regimes of surveillance required by federal regulation.
|
From page 137... ...
MMT regulations, structural barriers and popular stigma against methadone maintenance and its patients are powerful deterrents to those seeking help. I begin by briefly outlining the early years of methadone maintenance politics and policy, from roughly 1969 to 1975, to show how the FDA responded to multiple concerns regarding addiction and drug-related crime, methadone's actual ability to rehabilitate, the possibility of street diversion, and the potential for government abuse and social control.
|
From page 138... ...
Dole asserted that he had treated many women whose pregnancies were entirely normal while on methadone, but worried that these women otherwise would have continued to use heroin had they been denied the treatment.5 Less than a year later, in early April 1971, the FDA relaxed its regulations on methadone maintenance, upgrading its status from an "investigative new drug" to a "new drug application." Gone were those provisions of the 1970 model protocol, which excluded pregnant women, people under the age of 18 years, and those with physical or mental illness. Additionally, private physicians also were allowed to dispense methadone on a maintenance basis.
|
From page 139... ...
system of methadone maintenance were "a more humane and cheaper response than continual criminalization."6 Some of the April 1971 relaxations were retracted a year later, in early April 1972, when the FDA again decided that children below age 18 should not be treated with methadone. In the 1972 regulations, the FDA also restricted methadone prescription to "a closed system" of clinics in which new patients in their first 3 months would be closely supervised when administered methadone.
|
From page 140... ...
In a matter of just a few years, a fairly dominant consensus in the Black public sphere viewed methadone maintenance as anathema to the main political programs of the previous two decades. Although in Black political culture methadone maintenance has held a generally unenviable place of distrust and derision, Black opinion on methadone or narcotic maintenance was not monolithically negative, nor was it uniformly consistent over time.
|
From page 141... ...
In the way that simplistic analogies rarely do much to illuminate the nuance of a controversy, opponents argued that methadone maintenance made as much sense as providing gin to an alcoholic to cure him of his compulsive use of whisky. Since at least the 1920s, theories of addiction ranged in emphasis from deviance and mental illness to sociological conditions of deprivation, but few if any conceived of rehabilitation as implying anything but drug abstinence.
|
From page 142... ...
If, however, physical, psychological, and social costs of drug use for the person and the community are ‘the problem,' then methadone may well contribute to the problem rather than to the solution."17 Coupled with this logical challenge was the widespread suspicion of what social critics of the time called the "medical–industrial 12 See, for example, Daniel Casriel and Thomas Bratter, "Methadone Maintenance: A Questionable Procedure," Journal of Drug Issues 4 (1974) ; "Methadone a Form of Genocide: Ex-Addict," New York Amsterdam News, 10 May 1969; Rev.
|
From page 143... ...
lack freedom movement."22 Cognizant of the long history of the popular White association of Black Americans with crime and deviant behavior, and suspicious of methadone maintenance as a convenient technological fix to inconveniently complex social problems, many White and Black Americans therefore wondered which aspect of methadone -- addiction recovery or crime reduction -- was most attractive to its proponents. The suspicion was not unwarranted.
|
From page 144... ...
The 1969 report of the National Commission on the Causes and Prevention of Violence gave significant space to the perceived connections between narcotic addiction and non-violent as well as violent crime, recommending that "more and better [treatment] facilities be established and that research and testing of treatment programs receive high priority [and that]
|
From page 145... ...
Americans who had become weary, even resentful, of the politics of antiwar mobilizations, civil rights, gender equality, and economic rights, and distrustful of the post-1933 alliance among organized labor, civil rights, and the Democratic Party.31 Many who were following the politics of heroin addiction and methadone understandably expressed concern at the potential abuses of the new treatment modality, and whether massive funding simply tempered a wider agenda of racial control.32 Washington Post columnist William Raspberry opined that "methadone is not so much a means for treating addicts as a way of fighting crime" whose effectiveness in crime reduction would obviate the need for actual treatment from "psychiatrists, social workers, placement specialists and the rest."33 In two days of hearings on methadone maintenance, U.S. House of Representatives Delegate Walter E
|
From page 146... ...
Meanwhile, leaders of the community-based programs often maintained a caricaturist perception of methadone maintenance as being simply and only the delivery of narcotics to people with addictions. Certainly, many clinics lacked effective supportive services, but rather than critique individual clinics, methadone's most vociferous critics roundly condemned the whole treatment modality.
|
From page 147... ...
To speculate about what might have or might have not happened under a different presidential administration, or within a different regulatory structure, is relatively simple compared with the exercise of imagining how methadone maintenance might have emerged without the 350 years of history which preceded it. This consideration, however, is perhaps the most important in future drug policy.
|
From page 148... ...
"'You're Nothing but a Junkie': Multiple Experiences of Stigma in an Aging Methadone Maintenance Population." Journal of Social Work Practice in the Addictions 8, no.
|
From page 149... ...
"Methadone Maintenance as Law and Order." Society 9, no.
|
From page 150... ...
Methadone Maintenance and Drug Policy under the Nixon Administration." Journal of Policy History 29, no.
|
From page 151... ...
"'Don't Judge a Book by Its Cover': A Qualitative Study of Methadone Patients' Experiences of Stigma." Substance Abuse: Research and Treatment 11 (2017)
|
From page 152... ...
waiver authorities under the Controlled Substances Act; Health and Human Services Office of Inspector General (HHS OIG) authorities related to the antikickback statute; statutory and constitutional checks on state and opioid treatment program (OTP)
|
From page 153... ...
159 Conclusion .................................................................................................................... 159 Introduction A 2019 National Academies Report explained that although methadone is an effective treatment for opioid use disorder, significant and inequitable barriers impede access.1 This paper surveys possible pathways through which federal administrative agencies could overcome or mitigate some barriers to quality methadone treatment, without the need for legislation.
|
From page 154... ...
create the category of "Opioid Treatment Programs (OTPs) ," 39 set rules governing OTPs,40 and provide for accreditation bodies to oversee OTP operations.41 Dooling and Stanley point out that CSA "plainly gives SAMHSA broad authority to establish the standards practitioners must follow in order to be registered," which includes the power to change those standards.42 Davis and Carr also read the statute to grant SAMHSA broad discretion and call for a variety of changes in the current regulatory requirements.43 In addition to SAMHSA's standard-setting authority, CSA gives the Drug Enforcement Administration (DEA)
|
From page 155... ...
ref=Link&mc_cid=9754583648&mc_eid=51fa67f051. 50 See HHS OIG, SAMHSA's Oversight of Accreditation Bodies for Opioid Treatment Programs Did Not Comply with Some Federal Requirements (A-09-18-01007)
|
From page 156... ...
The Department of Justice's Office of Civil Rights, which has reportedly discussed an "Opioid Initiative," may be the best positioned federal agency unit to explore these pathways. First, because the U.S.
|
From page 157... ...
plans must now cover methadone, but they may currently limit that coverage with cost-sharing requirements for beneficiaries and/or utilization management (including prior authorization, step therapy, and utilization review) .68 Utilization management can be a significant barrier to medication-assisted treatment (MAT)
|
From page 158... ...
By requiring more uniform and comprehensive submission of data regarding utilization management practices, CMS could position itself to assess the scope of inappropriate barriers and enforce or strengthen existing requirements. More broadly, Medicaid is subject to two major administrative authorities that offer pathways to address social determinants that fuel the epidemic and impede access to treatment.81 Section 1115 empowers CMS to grant federal matching payments for state costs that are not ordinarily matchable through the program.82 The statute does not require these payments to be budget neutral.83 North Carolina has received a waiver under this authority, for example, to pay for housing, transportation, and other supports aimed at the social determinants of health.84 CMS has issued reports surveying steps that states have taken and might take to support housing for people with substance use disorder through the Medicaid program.85 For any states interested in addressing social and economic barriers to methadone treatment, section 1115 holds the potential to serve as a significant source of funding and flexibility.
|
From page 159... ...
87 https://innovation.cms.gov/innovation-models/integrated-care-for-kids-model. 88 Daniel Polsky et al., Private Coverage of Methadone in Outpatient Treatment Programs.
|
From page 160... ...
However, a fairly narrow regulatory approach limits methadone access. Methadone currently may be dispensed for the treatment of OUD only in federally approved opioid treatment programs (OTPs)
|
From page 161... ...
granted an exemption allowing alternate delivery protocols of medication.5,6 In June 2021, DEA issued an exemption to the rules for certifying mobile medication units to allow OTPs an additional treatment pathway to reach their patients.7 Additionally, the Centers for Medicare & Medicaid Services issued payment and reimbursement guidelines that allowed OTP reimbursement for MOUD treatment provided by telehealth under certain circumstances.8 In this section, the author examines early evidence from methadone innovations introduced in response to the COVID-19 pandemic. Telehealth and E-Health Telehealth and e-health implemented for OUD treatment, where regulation allows, can include replacing in-person counseling for methadone or buprenorphine treatment programs with audio or audiovisual appointments, as well as prescribing MOUD electronically.9 Data on the effects of allowing clinical oversight of telehealth patients receiving MOUD in OTPs are limited.
|
From page 162... ...
Mobile Treatment and Outreach Prior to a regulatory shift by DEA in 2007, mobile medication units were a permissible way to dispense methadone in rural communities and other hard-to-reach populations outside of a traditional OTP setting. In a scoping review of these programs, Chan, Hoffman and colleagues found no evidence that these programs significantly decreased treatment quality.
|
From page 163... ...
and MOUD, including methadone, demonstrated significant increases in initiation of ART and viral suppression, as well as significant reduction in attrition rates.24 Another review of these integrated HIV care models has shown the potential for reducing HIV transmission rates, though it is difficult to determine the extent to which that reduction in use resulted from MOUD treatment itself rather than the integration of ART and other HIV care with MOUD.25 While there is no systematic scoping review of the HCV and MOUD literature, a study of a program in Bronx, NY, that concurrently offered HCV treatment and methadone treatment showed promising results for potential treatment retention for both disorders and suggested concurrent treatment might be particularly apt for injection drug users who have demonstrated psychosocial vulnerability.26 A New Haven, CT, study found that a full integration of HCV and MOUD services at an existing OTP was feasible and that program support from both clinicians and administrators was important for replicability.27 Both of these studies are limited by their geographic scope and observation of only a single OTP in each case. This review did not identify any integration efforts between SEPs and methadone treatment at the point of syringe exchange, but multiple studies considered the efficacy of SEP referrals compared with other pathways.
|
From page 164... ...
That study's results are limited by the small patient count for this first trial, with only 20 patients enrolled.36 Office-Based Methadone A scoping review of office-based methadone, delivering treatment in office settings like general practice or primary care, by McCarty and colleagues identified 18 studies of patients treated with officebased methadone, including observational and clinical studies. These studies were limited to only stable methadone patients, and consistently found patient value and treatment satisfaction for office-based care and treatment outcomes, including low rates of drug use, comparable to OTP care.
|
From page 165... ...
REFERENCES 1. Substance Abuse and Mental Health Services Administration.
|
From page 166... ...
Chan B, Bougatsos C, Priest KC, McCarty D, Grusing S, Chou R Opioid treatment programs, telemedicine and COVID-19: A scoping review.
|
From page 167... ...
Concurrent group treatment for hepatitis C: Implementation and outcomes in a methadone maintenance treatment program. Journal of Substance Abuse Treatment.
|
From page 168... ...
Wu L, John WS, Morse ED, et al. Opioid treatment program and community pharmacy collaboration for methadone maintenance treatment: Results from a feasibility clinical trial.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.