Criminalization of Substance Use Disorder

Federal law has long prohibited medical providers from prescribing effective medications to people with opioid use disorder that prevent painful withdrawal symptoms without being subject to onerous restrictions.

In the early 1900s, cities across the country ran treatment programs that provided medications to people with opioid use disorder. The primary recipients were middle- and upper-class women and disabled Civil War veterans. As young immigrant men began to develop opioid use disorder, however, political leaders sought to punish people with the condition instead of providing medical care.

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SAMHSA, Treatment Improvement Protocol (TIP) 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs, at 12-14 (2005), https://bit.ly/2PowN55 (“During the late 19th and early 20th centuries, U.S. society generally viewed iatrogenic addiction among women and disabled war veterans sympathetically as an unfortunate medical condition and treated these groups with tolerance and empathy, particularly because neither group presented major social problems. Doctors usually prescribed more opioids for these patients…The initial treatment response in the early 20th century continued to involve the prescriptive administration of short-acting opioids. By the 1920s, morphine was prescribed or dispensed in numerous municipal treatment programs…The tolerance and empathy shown toward Civil War veterans and middle-aged women evaporated; negative attitudes toward and discrimination against new immigrants probably colored views of addiction…[S]ociety’s response was to turn from rudimentary forms of treatment to law enforcement…[T]he widely held perception that people with addictions generally were members of a White criminal underclass or a Chinese minority has been portrayed as an underlying motivation for the statute.”).

In 1914, President Woodrow Wilson enacted the Harrison Narcotics Tax Act, which is recognized as the beginning of the criminalization of substance use disorder and a primary reason that substance use disorder is still treated largely outside the healthcare system today. The Harrison Narcotics Tax Act, which regulated the manufacture, distribution, and prescription of opioids, allowed a doctor to distribute opioid medication “in the course of his professional practices.”

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Harrison Narcotics Tax Act, Pub. Law No. 63-223, 38 Stat. 786 (1914), https://govtrackus.s3.amazonaws.com/legislink/pdf/stat/38/STATUTE-38-Pg785.pdf.

But, the Treasury Department interpreted this law to prohibit doctors from prescribing these medications to patients with substance use disorder. The Treasury Department used the justification that substance use disorder was not a disease and that people with substance use disorder could not be patients. The Treasury Department arrested thousands of doctors for treating patients with medications for opioid use disorder.

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SAMHSA, Treatment Improvement Protocol (TIP) 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs, at 14 (2005), https://bit.ly/2PowN55 (“Although this provision permitted physicians to prescribe or dispense opioids so long as they kept the required records, Treasury interpreted the act as a prohibition on physicians prescribing opioids to persons with addictions to maintain their addictions. (Treasury was the agency responsible for enforcing the Harrison Act as well as prohibition laws.) Treasury’s position appeared to be that addiction is not a disease and the person with an addiction, therefore, was not a patient. It followed that any physician prescribing or dispensing opioids to such individuals was not doing so in the course of his professional practice. In 1919, the United States Supreme Court upheld Treasury’s interpretation. This interpretation and enforcement of the Harrison Act effectively ended, until well into the 1960s, any legitimate role for the general medical profession in medication-assisted treatment for Americans who had drug addictions.”); Herbert D. Kleber, M.D., Methadone Maintenance 4 Decades Later, 300(19) JAMA (2008), https://jamanetwork.com/journals/jama/fullarticle/182898 (“Between 1919 and 1935, approximately 25,000 physicians were indicted under the Harrison Act and 10% were imprisoned.”).

In 1974, President Nixon enacted the Narcotic Addict Treatment Act, which required doctors to obtain a special registration from the DEA to dispense medications for opioid use disorder.

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Narcotic Addict Treatment Act of 1974, Pub. Law No. 93-281 (1974).

The regulations under this act created opioid treatment programs (commonly known as methadone clinics). Under these regulations, medications designated as controlled substances could be prescribed to people with substance use disorder only through opioid treatment programs. These programs are limited in number and difficult to access because they require daily visits often hours from a person's house.

Medical providers have known for over 100 years that medications like buprenorphine are an effective treatment for opioid use disorder. But lawmakers have restricted their use based on an outdated view of substance use disorder as a personal choice or moral failing, instead of as a chronic, treatable medical condition.

Drug Addiction Treatment Act of 2000 (“DATA 2000”)

Twenty-five years later, the Secretary of Health and Human Services identified buprenorphine as a critical treatment to prevent an opioid epidemic in the United States. Recognizing the safety of the medication and the need for it to be broadly available through primary care practices, the Secretary requested that Congress ensure buprenorphine would not be subject to the onerous restrictions of the Narcotic Addict Treatment Act of 1974. Congress subsequently passed DATA 2000.

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Drug Addiction Treatment Act of 1999, Hearing Before the Subcommittee on Health and Environment of the Committee on Commerce, 106th Congress 10-20 (Jul. 30, 1999), https://www.govinfo.gov/content/pkg/CHRG-106hhrg58503/pdf/CHRG-106hhrg58503.pdf (“One expected result of S. 324 is that the number of physicians in private practice who are likely to treat this population with new anti-addiction medications, e.g., buprenorphine/nx, if approved by the FDA, is likely to increase considerably…As in all forms of medicine, it is critically important to allow physicians and patients to have access to as many forms of treatment as may be available, and to choose the best match for each individual…In our view, to consign new treatment medications, with enhanced safety and less diversion potential solely into the existing methadone clinic system would be a serious public health mistake. S. 324 would permit incremental treatment expansion to proceed in a manner which is not overburdened by Federal, state, and local requirements as is the case with methadone clinic regulation. This treatment expansion cannot occur if new anti-addiction drug products are only permitted to be dispensed through the existing methadone clinic system, because it is a limited and closed capacity system.”).

In the 1990s, buprenorphine had proven to be an effective medical treatment for opioid use disorder in Europe. France, which was experiencing a heroin epidemic, removed restrictions on prescribing buprenorphine similar to what the U.S. has now and allowed healthcare providers to prescribe the medication in the normal course of their medical practices. Within three years, opioid overdose deaths decreased by 79%.

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Kevin Fiscella, MD, MPH, Sarah E. Wakeman, MD, Leo Beletsky, JD, MPH, Buprenorphine Deregulation and Mainstreaming Treatment for Opioid Use Disorder: X the X Waiver, 76(3) JAMA Psychiatry 229-30 (2018), https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2719455 (“Removing buprenorphine prescribing regulations in France yielded increases in its use by persons with OUD. Notably, deaths from opioid overdoses in France declined 79% over the subsequent 3 years.”).

The intent of DATA 2000 was to ensure that primary care physicians could prescribe buprenorphine for opioid use disorder in the normal course of their medical practice. But, instead it imposed significant barriers to care. Under DATA 2000, physicians had to take an 8-hour training on buprenorphine, apply for a special registration from SAMHSA and the DEA, and limit the number of patients with opioid use disorder they could treat to only 30 patients at a time.

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Drug Addiction Treatment Act of 2000, Pub. Law No. 106-310 (2000).

The original justification for these restrictions was to prevent diversion. Today 40% of counties do not have a single healthcare provider who can prescribe buprenorphine.

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HHS, Geographic Disparities Affect Access to Buprenorphine Services for Opioid Use Disorder (2020), https://oig.hhs.gov/oei/reports/oei-12-17-0240.pdf?utm_source=newsletter&utm_medium=email&utm_campaign= newsletter_axiosvitals&stream=top (“Fully 40 percent of counties in the U.S. did not have a single health care provider with a waiver permitting them to prescribe the opioid addiction treatment drug buprenorphine in an office setting.”).

And in those areas where there are providers, the wait time for an appointment is often weeks or months. Patients, desperate to stop using heroin and fentanyl, are sometimes forced to find this medication from friends or on the street.

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HHS, Nat’l Institutes of Health, Buprenorphine misuse decreased among U.S. adults with opioid use disorder from 2015-2019 (Oct. 15, 2021) https://www.nih.gov/news-events/news-releases/buprenorphine-misuse-decreased-among-us-adults-opioid-use-disorder-2015-2019 (“The study also found that people who received no drug use treatment and those who lived in rural areas were more likely to misuse the medication.”).

For these reasons, increasing access to buprenorphine treatment actually reduces its misuse - a fact that the DEA has recognized.

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HHS, Buprenorphine misuse decreased among U.S. adults with opioid use disorder from 2015-2019 (“Data from a nationally representative survey indicate that in 2019, nearly three-fourths of U.S. adults reporting buprenorphine use did not misuse the medication in the past 12 months. In addition, buprenorphine misuse among people with opioid use disorder trended downward between 2015-2019, despite increases in the number of people receiving buprenorphine treatment…[T]hese findings highlight the urgent need to expand access to buprenorphine treatment, because receipt of treatment may help reduce buprenorphine misuse.”); Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 114 (2019), https://www.nap.edu/catalog/25310/medications-for-opioid-use-disorder-save-lives (“Importantly, the rates of both misuse and diversion decline as buprenorphine availability increases.”); DEA, Economic Impact Analysis of Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder, at 19 (Jan. 2018), https://docs.house.gov/meetings/IF/IF14/20180517/108343/HMKP-115-IF14-20180517-SD004.pdf (“However, the primary reason for prescription buprenorphine (Subutex) and buprenorphine combined with naloxone (Suboxone) diversion is the failure to access legitimate addiction treatment. This finding suggests that increasing, not limiting, buprenorphine treatment may be an effective response to the diversion of buprenorphine.”).

Based on this evidence, the National Academies of Sciences, Engineering and Medicine has said that this policy is now outside the bounds of evidence.

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Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 12 (2019) https://bit.ly/2NJnNXQ (“These policies are not supported by evidence, nor are such strict regulations imposed on access to life-saving medications for other chronic diseases.”).

DATA 2000 Amendments

Soon after it became law, Congress recognized that DATA 2000 would not increase access to buprenorphine enough to prevent significant numbers of opioid overdose deaths. Since 2005, Congress has repeatedly loosened the restrictions on medical providers under the DATA 2000 waiver by:

Expanding the Type of Providers Who Can Obtain a DATA 2000 Waiver

• 2016 Comprehensive Addiction and Recovery Act (“CARA”): Allowed nurse practitioners and physician assistants to hold a DATA 2000 waiver to treat up to 30 patients at a time until October 2021.
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  Comprehensive Addiction and Recovery Act of 2016 (“CARA”), Pub. Law 114-198, 130 Stat. 720-23 (2016), https://www.congress.gov/114/plaws/publ198/PLAW-114publ198.pdf.
• 2018 SUPPORT Act: Allowed nurse practitioners and physician assistants to hold a DATA 2000 waiver permanently. Allowed clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives to hold a DATA 2000 waiver until October 2023.
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  Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (“SUPPORT”) Act, Pub. Law 115-271 § 3201, 132 Stat. 3843-44 (2018), https://www.congress.gov/115/plaws/publ271/PLAW-115publ271.pdf.

Increasing Patient Limits

• 2005 Amendment: Eliminated 30 patient limit for medical group practices.
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  Pub. Law 109-56, 119 Stat. 591 (2005), https://www.congress.gov/109/plaws/publ56/PLAW-109publ56.pdf
• 2006 Amendment: Allowed physicians to treat up to 100 patients at a time after holding a DATA 2000 waiver for at least one year.
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  Pub. Law 109-469 § 1102, 120 Stat. 3540 (2006), https://www.congress.gov/109/plaws/publ469/PLAW-109publ469.pdf.
• 2018 SUPPORT Act: Allowed certain physicians who held a 100-patient DATA 2000 waiver for one year to treat up to 275 patients. Allowed nurse practitioners and physicians assistants who held a 30-patient DATA 2000 waiver for one year to treat up to 100 patients.
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  Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (“SUPPORT”) Act, Pub. Law 115-271 § 3201, 132 Stat. 3843-44 (2018), https://www.congress.gov/115/plaws/publ271/PLAW-115publ271.pdf.

Exempting Certain Providers from the DATA 2000 Waiver

• 2020 Easy MAT Act: Allowed practitioners to dispense a three-day supply of buprenorphine to initiate treatment without obtaining a DATA 2000 waiver.
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  Further Continuing Appropriations Act, 2021, and Other Extensions Act, Pub. Law No. 116-125 § 1302, 134 Stat. 1046 (2020) (provisions known as the “Easy MAT Act”).

Executive Action

Recognizing that these amendments have not increased access to buprenorphine to the extent needed to stem the overdose crisis, the Biden Administration issued lauded Practice Guidelines in April 2021 that removed some components of the DATA 2000 Waiver.

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Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, 86 F.R. 22,439 (Apr. 28, 2021).

Under the Practice Guidelines, healthcare providers who treat up to 30 patients with opioid use disorder at a time no longer need to take mandatory training on buprenorphine or certify their ability to refer patients to counseling and ancillary services. Before they can prescribe buprenorphine to patients with opioid use disorder, healthcare providers must still apply for a special registration with the federal government - a process that can take 2-3 months - and are subject to limits on the number of patients they can treat and inspection of their patient records. If they treat more than 30 patients at a time, healthcare providers must still take 8-24 hours of training on the medication and comply with the counseling referral requirement. These actions follow President Biden's call to remove undue restrictions on prescribing buprenorphine in his plan on the opioid crisis.

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Biden for President, The Biden Plan to End the Opioid Crisis (2020), https://joebiden.com/opioidcrisis/ (calling to “[m]ake Medication Assisted Treatment (MAT) available to all who need it, reaching universal access no later than 2025 [by]…[r]emoving undue restrictions on prescribing medications for substance use disorder. For example, drugs containing buprenorphine were approved by the FDA in 2002 but a relatively small number of doctors or medical personnel are certified to prescribe them.”); SAMHSA, Statement Regarding X-Waiver, https://www.samhsa.gov/sites/default/files/statement-regarding-xwaiver.pdf ("HHS and ONDCP are committed to working with interagency partners to examine ways to increase access to buprenorphine, reduce overdose rates and save lives.").

In issuing the Practice Guidelines, the Biden Administration noted that the remaining restrictions are legislative and only an act of Congress can remove them.

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See SAMHSA, FAQs About the New Buprenorphine Practice Guidelines (Apr. 27, 2021) (“Why not just eliminate the X waiver? Removal of the requirement to apply for a waiver to treat those with OUD with buprenorphine, as set forth in the Controlled Substances Act (CSA), requires legislative action.”).

The Biden Administration’s actions follow similar steps initiated by the Trump Administration in January 2021 to remove barriers to buprenorphine.

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U.S. Dep't Health and Human Svcs., HHS Expands Access to Treatment for Opioid Use Disorder (Jan. 14, 2021), https://www.hhs.gov/about/news/2021/01/14/hhs-expands-access-to-treatment-for-opioid-use-disorder.html

Indeed, both President Trump's and President Biden's former Directors of the Office of National Drug Control Policy have called for Congress to pass the Mainstreaming Addiction Treatment Act.

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Jim Carroll, To save lives from addiction, Congress should pass the MAT Act, Washington Examiner (May 16, 2022), https://washex.am/3NCTdYI; Regina LaBelle, After a brutal year of overdose deaths, the US needs urgent, coordinated action, The Hill (Jan. 3, 2022), https://bit.ly/3ycCCpe.

These actions from both the Biden and Trump Administrations demonstrate the broad, bipartisan support for removing the federal restrictions on prescribing buprenorphine.

This history shows there has been broad consensus for twenty years to ensure buprenorphine is widely available in primary care settings. DATA 2000 was itself a recognition that medical providers need to be on the front lines of treating opioid use disorder and every amendment to the act has tried to expand the number of medical providers who can prescribe this lifesaving medication.

The Mainstreaming Addiction Treatment Act will ensure medical providers can prescribe a medication that prevents painful withdrawal symptoms associated with opioid use disorder just as they prescribe medications for other chronic conditions. It is one of the single most important reforms needed to integrate substance use disorder treatment fully into the healthcare system where it belongs.