Only one in five of the estimated 2.1 million people aged 12 years or older living with opioid use disorder (OUD) in 2017 received OUD services. Among them, less than 40% received any medications for OUD.1 One reason for this is the limited number of authorized buprenorphine providers as a result of the restrictions imposed by the Drug Addiction Treatment Act of 2000 (DATA 2000). As of July 31, 2019, fewer than 70 000 prescribers in the United States possessed the DATA 2000 required waiver to prescribe buprenorphine, and approximately 74% were under a 30-patient limit. Just a portion of practitioners with waivers ever actually prescribe buprenorphine. Furthermore, waivered providers are distributed unevenly across the United States,2 and many operate as “cash-only practices.” In 2017, 46.4% of US counties had no known availability of any medications for OUD.2 Although opioid response initiatives have started to reduce overdose deaths, access to evidence-based, low-threshold OUD treatment has lagged because of federal requirements that no longer align with medical practice.
On April 8, 2019, 18 states, 3 US territories, and the District of Columbia, in an effort organized by New York and supported by the Association of State and Territorial Health Organizations, sent a letter to US Health and Humans Services secretary Alex Azar urging the federal government to take immediate action to substantially revise and reduce these barriers to treatment. Since then, two more states (Utah and Montana) have joined the effort. Four months later, the National Association of Attorneys General submitted a similar request to Congress, signed by 37 states and the District of Columbia.
RESTRICTIONS OF THE ACT
The gold standard of OUD treatment is three highly effective medications: methadone, long-acting naltrexone, and buprenorphine. Methadone has the strongest evidence base for decreasing opioid use, overdose deaths, and related infectious disease transmission while also increasing social functioning and continued participation in treatment. The drawback, however, is that methadone is available only from clinics that are highly regulated, poorly distributed regionally, and require that the patient make frequent, often daily, trips to the clinic.3 Naltrexone is far less regulated. It may be prescribed or administered by any health care provider licensed to prescribe medication. However, abstinence from opioids for a week or more is required before initiating naltrexone, which is a challenge to many living with OUD.
Research on buprenorphine finds that it is associated with the same protective advantages as methadone, and, unlike naltrexone, buprenorphine can be initiated soon after opioid withdrawal begins. Buprenorphine can be offered in a wide range of settings.3 Still, health care practitioners licensed to prescribe medicine must meet several additional requirements before they are authorized to prescribe buprenorphine.
Buprenorphine offers the most flexibility for patients and providers, but DATA 2000 restricts its availability. It requires providers to first obtain a waiver by completing 8 to 24 hours of additional training and then limits the number of patients they can treat to 30 patients the first year, and then to 100 and 275 patients in the second and third years, respectively. By contrast, France has no such requirements, and the introduction of buprenorphine there was associated with a 79% reduction in opioid overdose deaths.
THE ROLE OF STATES
Waiver regulations are impeding efforts to promote widespread implementation of buprenorphine in many states. New York is supporting hospitals’ efforts to screen for OUD in emergency departments and initiate buprenorphine onsite. Unwaivered prescribers may offer buprenorphine under the emergency exception to an earlier version of DATA 2000 dating back to 1974, 21 CFR1306.07(b), which allows for the administration of medications to mitigate withdrawal for three days. To receive the medication, the patient must make burdensome daily visits to the emergency departments. Outdated requirements such as these obstruct treatment initiation for patients at risk for overdose.
States and local municipalities are increasingly providing naltrexone, methadone, and buprenorphine to incarcerated individuals suffering from OUD. Patient limits often hamper these efforts. Jails with limited staff and large populations living with OUD may find the effectiveness of new treatment programs hindered while staff await waivers and patient cap increases.
ELIMINATING THE ACT
Many patients are likely to benefit from counseling. There is strong evidence, however, that patients can benefit from methadone and buprenorphine without counseling beyond that associated with medical management. Most studies show little difference between those randomized to counseling and those receiving only the medication regarding reductions in opioid use, drug injection, and psychiatric symptoms.4 Guidance from the Substance Abuse and Mental Health Services Administration acknowledges that the “medical management” buprenorphine prescribers provide has an intrinsic psychosocial component that benefits patients and that prescribers should offer referrals as needed.
Diversion and Safety
Many medications can be diverted and misused. However, buprenorphine has rarely been implicated in overdose deaths. In fact, the over-the-counter antihistamine diphenhydramine is more likely to be involved in an overdose death.5 Furthermore, although some buprenorphine may be used for intoxication, most buprenorphine obtained without a prescription is used to self-medicate withdrawal. Stringent control of buprenorphine and suboptimal dosing have both been noted as factors that increase the likelihood of diversion.6
Stigma and Fear
DATA 2000 requires additional registration with the Drug Enforcement Administration. The possibility of unscheduled Drug Enforcement Administration inspections discourages some from pursuing the waiver. Reports of reputable prescribers being targeted is likely affecting providers’ willingness to apply for waivers and to prescribe after waivers are issued. Increased availability of buprenorphine supports the Drug Enforcement Administration’s mission to reduce the supply of illicit controlled substances by decreasing demand for these substances and reducing the stigma attached to treatment.7
There may be waivered practitioners who provide little care other than prescriptions and who accept only cash, not insurance. It is possible, however, that an increase of primary care providers who are unwilling to become known as “buprenorphine doctors” but willing to prescribe to their existing patients would decrease the profitability and appeal of setting up such practices.
Education
Opioid agonists should be on par with medications used for treating other chronic illnesses. Some providers are concerned about eliminating extra educational requirements connected to the waiver process. Standardized education about all substance use disorders and treatment should be integrated into all levels of medical training. For those who are already practicing, readily available training on all addiction medications, corresponding to the needs of different specialists and practitioners, is necessary. Many states are now mandating education on opioid prescribing and pain management, whereas others are making it voluntary. All such education should include information on treating OUD.
Health Care Engagement
Low-threshold treatment creates system entry points. A patient of one of the authors was a homeless man on parole with untreated HIV and 37 years of heroin injection. He started buprenorphine without the requirement of abstinence or counseling. Twelve years later, he is still on buprenorphine, has an undetectable viral load, participates in outreach to people who use drugs, and maintains housing.
CONCLUSIONS
Health care providers and people living with OUD confront multiple challenges in providing and obtaining buprenorphine, but removing the waiver will be a major step toward normalizing the treatment of OUD, expanding access to that treatment, and generally overcoming the obstacles to providing treatment. State policymakers and health care providers cannot continue to fight with their hands tied by outdated federal requirements.
ACKNOWLEDGMENTS
We acknowledge the work of the 24 states and territories that signed the letter to Secretary Azar requesting deregulation of buprenorphine and honor their dedication to fighting the opioid epidemic. We thank the New York State Department of Health Buprenorphine Working Group for highlighting this issue.
CONFLICTS OF INTEREST
The authors have no financial disclosures to make.
REFERENCES
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