Throughout the past decade, the U.S. has seen a dramatic shift in addiction medicine research, clinical practice, and related stigma in seeking care. Throughout this piece, we will explore the top six trends related to treating the opioid crisis, and we’ll consider what may be next.
The Opioid Epidemic
Opioid addiction has existed for centuries. But deaths from opioid overdose in the U.S. have rapidly risen since the 1990s, which started as prescription opioids were prescribed more liberally for pain. A second wave of overdose deaths begin in 2010 with a rapid increase in deaths involving heroin. Then a third wave arrived in 2013, with an increase in deaths involving synthetic opioids, particularly fentanyl. In 2017, the U.S. federal government declared the opioid epidemic a public health emergency. Deaths have continued to climb, reaching as many as 128 everyday. And now, the opioid epidemic is significantly exacerbated by the COVID-19 pandemic.
With this context, let’s look at six trends that are driving improvement in treating the opioid overdose crisis.
Trend 1: Medication for Opioid Use Disorder is Now the Standard of Care
The U.S. Food and Drug Administration (FDA) has approved three medications for treatment of opioid use disorder (OUD): methadone, buprenorphine, and naltrexone. Medication for opioid use disorder (MOUD) (previously referred to as medication-assisted treatment, or MAT) is now THE evidence-based standard of care for treatment of OUD (you can read more about these medications here).
For many decades, abstinence-only treatment, alongside behavioral health support, was the de facto standard of care, largely due to the absence of evidence-based guidelines. However, the Substance Abuse and Mental Health Services Administration (SAMHSA) and American Society of Addiction Medicine (ASAM) have now taken authoritative stances that offering medication is the standard of care, as MOUD has clear superiority as a first-line treatment when compared to behavioral intervention only. This ultimately paves the way for holding providers and payors accountable.
The necessity to follow national and external standards of care was reaffirmed in Wit v. United Behavioral Health, a 2019 federal court decision in the Northern District of California. In this case, United Behavioral Health (the largest managed behavioral healthcare organization in the U.S.) rejected the insurance claims of thousands of patients seeking treatment for mental health and substance use disorders. The judge ruled that United Behavioral Health’s self-produced medical review criteria were flawed and did not meet generally accepted standards of care. The judge’s ruling further confirmed that standards of care are defined by medical societies through their guidelines.
Trend 2: Formalization of the Addiction Medicine Specialty
The past decade has seen dramatically increased focus on the field of addiction medicine, culminating in formalization of the addiction medicine specialty. In 2018, the Accreditation Council for Graduate Medical Education (ACGME) formally recognized addiction medicine as a subspecialty overseen by the American Board of Preventive Medicine. This allowed fellowship programs in addiction medicine to finally gain accreditation. And further, by joining the ACGME, addiction medicine fellowship programs are now eligible to receive money from the Centers for Medicare and Medicaid Services (CMS), the federal body that allocates funds to graduate medical education.
As more physicians have become board certified, this has facilitated research and faster practice improvement. For example, we’ve seen the evolution of micro-starts, the process of starting medication at very low initial doses. We also now understand that stopping medication treatment is not necessary when patients undergo medical procedures. Disease and treatment nomenclature has also improved. For instance, we have transitioned from “substance abuse” to “substance use disorder” and from “medication-assisted treatment (MAT)” to “medication for opioid use disorder (MOUD).” This helps people understand that medication is part of treatment (not assisting treatment), and also decreases stigma.
Trend 3: Expanding the Availability of MOUD
For more than 100 years, there have been extraordinary restrictions on prescribing practices for some medications that treat addiction. Methadone can only be dispensed from specially licensed treatment programs where patients report daily. Providers can only administer extended-release naltrexone on-site. Buprenorphine is the only medication that patients can take home, but prescribers must complete buprenorphine training to become “waivered.” And buprenorphine is the only medication with a limit on the number of patients a clinician can treat at once. These overly restrictive buprenorphine regulations have accordingly evolved in recent years:
- The Drug Addiction Treatment Act of 2000 allowed waivered physicians to treat 30 patients at a time. After one year, physicians could apply to SAMHSA to treat 100 patients.
- The Comprehensive Addiction & Recovery Act of 2016 expanded the definition of “qualifying other practitioner,” thereby allowing nurse practitioners, physician assistants, and other advanced practice clinicians to become waivered.
- In 2016, SAMHSA released its final rule on MOUD, which allowed physicians to request approval to treat up to 275 patients after prescribing at the 100 patient limit for one year. Clinicians have to be board certified in addiction medicine or addiction psychiatry, or provide MOUD in a qualified practice setting.
- The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018 allowed clinicians to treat up to 100 patients in the first year of holding a waiver, if they met the above criteria.
On January 14, 2021, the U.S. Department of Health and Human Services announced that buprenorphine waivers would no longer be required to prescribe for up to 30 patients at once, though neither SAMHSA nor the Drug Enforcement Administration (DEA) have supported this. It is not in the federal register and does not have an effective date. The announcement was likely premature but is part of a trend toward relaxing MOUD restrictions.
Trend 4: Incarceration and MOUD
With authoritative stances from SAMHSA and ASAM that medication is THE standard of care, MOUD is increasingly recognized as a medically necessary service for incarcerated persons.
Based on 2015-2016 data from the National Survey on Drug Use and Health, the chances of becoming involved in the criminal justice system are approximately three-to-five times higher for persons who use prescription and intravenous opioids. And nearly 30-45% of incarcerated persons report suffering signs of opioid dependence or addiction. These include severe cravings, withdrawal, and the inability to control their opioid use.
Further, the use of buprenorphine and methadone decreases opioid overdose deaths. Yet, 2018 data demonstrates that buprenorphine and methadone are offered to incarcerated individuals in only 14 U.S. states or territories (27% of jurisdictions).
Notably, legal standards mandate provision of evidence-based standards of medical care for incarcerated persons. This was challenged in the 1976 U.S. Supreme Court case, Estelle v. Gamble, where the court established that withholding medically necessary care from prisoners is cruel and unusual punishment, a violation of the Eighth Amendment. More recently, federal courts have held that failure to provide MOUD to incarcerated individuals violates the Americans with Disabilities Act (ADA).
In addition to reforming the criminal justice system in the U.S., which includes ending the War on Drugs, we must strive to provide MOUD in all states and territories, including within the criminal justice system (i.e. jails, prisons, probation, parole).
Trend 5: Harm Reduction and the Democratization of Naloxone
The FDA approved naloxone (Narcan) for treating opioid overdose in 1971, and as opioid overdose rates skyrocketed in the 1990s, some states piloted take-home naloxone kits for patients and families. The Centers for Disease Control and Prevention (CDC) estimated that more than 26,000 opioid overdoses were reversed by non-medical persons between 1996-2014. And since 2010, distribution of naloxone kits to laypersons has increased by 183%.
Other research offers convincing evidence that providing naloxone kits to laypersons saves lives. In fact, one study showed opioid overdose death rates to be 27-46% lower in communities that implemented overdose education and naloxone distribution, and thus, it is often standard practice for clinicians to distribute naloxone to patients at-risk of overdose. In some states, naloxone is freely accessible at pharmacies.
Throughout the past decade, syringe service programs, also referred to as syringe exchange programs and needle exchange programs, have become much more widely accessible. These programs provide access to sterile syringes and help appropriately dispose of used syringes. Many also provide additional supports like naloxone distribution and referral to substance use disorder treatment programs, among other services.
Trend 6: Telehealth
The COVID-19 pandemic has ushered telehealth into an entirely new era, and fortunately, telehealth expands the opportunity for patients struggling with OUD to find providers who meet their needs. And further, laws that govern telehealth and the treatment of OUD have changed throughout the past decade.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was developed to combat online pharmacies selling controlled substances. It required at least one in-person medical evaluation before prescribing controlled substances. Unfortunately, given that buprenorphine is classified as a controlled substance, the law created barriers for patients seeking telehealth treatment for OUD.
In 2019, Representative Doris Matsui (D-CA) introduced H.R. 4131: Improving Access to Remote Behavioral Health Treatment Act. It would have allowed certain community mental health centers to prescribe controlled substances via telehealth. This bill, however, never became law.
Then, in March 2020, as COVID-19 surged across the U.S., the DEA temporarily waived the requirement for an in-person medical evaluation prior to prescribing buprenorphine. And the Department of Health and Human Services also waived penalties for HIPAA violations. This allowed for online medical visits and has increased access to MOUD during the pandemic.
In 2020, Senators Rob Portman (R-OH) and Sheldon Whitehouse (D-RI) introduced S. 4103: Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act. It would permanently expand telehealth services for OUD to allow buprenorphine treatment following a virtual medical evaluation. S. 4103 has been referred to the Committee on Health, Education, Labor, and Pensions.
Many state restrictions on the use of telehealth for OUD treatment still exist, though some states are now implementing it broadly. Early accounts of effectiveness are promising, and studies comparing telehealth to in-person care are in progress.
Much Improvement, but a Long Way to Go
These themes in addiction medicine over the past decade reflect considerable progress, and as a result, the treatment of OUD is gradually starting to look more like treatment of other chronic conditions. These themes have helped to decrease stigma and shift the public consciousness to better understand that addiction is a medical condition, not a moral failure.
Though the COVID-19 pandemic exacerbates the opioid epidemic, we feel hopeful as we welcome a new decade of research, clinical practice, and ultimately, more and more people regaining control of their lives through recovery from opioid addiction.
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Rebekah L. Rollston, MD, MPH, is a Family Medicine Physician at Cambridge Health Alliance, Instructor in Medicine at Harvard Medical School, Affiliate Editor-in-Chief of the Harvard Primary Care Blog, Visiting Scholar in the Northeastern University Women, Gender, and Sexuality Studies Program, and Health Equity & Communications Physician Consultant at Bicycle Health. Her professional interests include social determinants of health & health equity, gender-based violence, sexual & reproductive health, addiction medicine, rural health, homelessness & supportive housing, and immigrant health.
Brian Clear, MD, FASAM, is board certified in Family Medicine and Addiction Medicine, and he serves as the Medical Director of Bicycle Health, a digital health startup that provides biopsychosocial treatment for patients with opioid use disorder via telehealth. Brian’s most immediate role at Bicycle Health is to ensure clinicians have the training, resources, and support needed to provide evidence-based and high-quality care to all patients. And more broadly, his focus is to improve quality of care for those experiencing problems related to opioid use. Brian is passionate about using technology to modernize the way healthcare is accessed and utilized by patients.
Kelly J. Clark, MD, MBA, DFAPA, DFASAM, is the Founder & President of Addiction Crisis Solutions, a company focused on transforming addiction care into evidence-based, cost-effective practice. Dr. Clark serves as Immediate Past President of the American Society of Addiction Medicine (ASAM), and she also serves on the Steering Committee of the National Academy of Medicine's Action Collaborative on the U.S. Opioid Epidemic as the Co-Leader of the Research, Data, and Metrics Working Group. Dr. Clark is Director of DisposeRX and a consultant to Path Healthcare and Bicycle Health. She has provided her expertise to the U.S. Presidential Opioid Commission, FDA, SAMHSA, the Office of Comptroller General, the Pew Trusts, National Safety Council, National Business Group on Health, and numerous provider and payer organizations.