Research & Policy

Federal barriers to prescribing buprenorphine (the X-Waiver).

Overview

  • All medical providers with a standard controlled medication license can prescribe buprenorphine to people in pain, but federal law prohibits them from prescribing buprenorphine to people with opioid use disorder without being subject to bureaucratic requirements that impede access to care.

  • Physicians, advanced practice registered nurses, and physician assistants must apply for special approval from the federal government, adhere to strict limits on the number of patients they can treat, and take 8-24 hours of training on the medication in certain circumstances.

  • It can take 2-3 months for medical providers to obtain federal approval to prescribe buprenorphine for opioid use disorder.

  • No other medical condition in the country is subject to these limits. As a result, only about 1 in 10 medical providers have obtained federal approval to prescribe buprenorphine for opioid use disorder.

Eligible medical providers

Federal law allows the following licensed medical providers to apply for a federal waiver to prescribe buprenorphine for opioid use disorder:

  • Physicians 

  • Nurse practitioners

  • Physician assistants

  • Certified nurse specialists (only through October 2023)

  • Certified registered nurse anesthetists (only through October 2023)

  • Certified nurse midwives (only through October 2023)

Restrictions on medical providers

To prescribe buprenorphine to patients with opioid use disorder, medical providers must obtain what is referred to as a DATA 2000 waiver or an X-waiver. Under that process, they must:

  1. complete an 8-24 hour training course led by a designated medical association or prove that they have other certifications listed under the law (only if they intend to treat more than 30 patients with opioid use disorder at a time),

  2. have the ability to provide or refer patients to counseling, all FDA-approved drugs for the treatment opioid use disorder, and other services (only if they intend to treat more than 30 patients with opioid use disorder at a time),

  3. notify the Secretary of Health and Human Services (“HHS”) of their intent to prescribe buprenorphine,

  4. wait up to 45 days for a determination from the Secretary of HHS,

  5. apply for a special identification number from the DEA (which starts with an “X”),

  6. adhere to limits on the number of patients they can treat at one time (detailed below), and

  7. subject their patient records and offices to DEA inspection.

Advanced practice registered nurses and physician assistants may also need to be supervised by a physician who has completed an 8-hour training course led by a designated medical association (or who holds other certifications listed under the law) if required by their state.

Patient limits

Federal law restricts the number of patients with opioid use disorder that medical providers can treat with buprenorphine. The limits are as follows:

Patient Limits.PNG

Effect of federal barriers

In the midst of the overdose crisis, we are in the tragic and self-defeating position of having more federal restrictions on the prescription of effective medical treatments for opioid use disorder than on the prescription of opioids themselves. Indeed, there is no other medical condition in the country for which medical treatment is subject to federal registration requirements and patient limits.
1
Christine Vestal, “Waiting Lists Grow for Medicine to Fight Opioid Addiction,” The Pew Charitable Trusts (Feb. 11, 2016), https://bit.ly/31dXQCQ (“No other medication requires a special license, and no other disease is subject to a patient limit, argued Dr. Kelly J. Clark, president-elect of the American Society of Addiction Medicine.”).


The federal restrictions discourage medical providers from treating patients with opioid use disorder. Providers have noted that subjecting their patient records and offices to DEA inspection is intimidating.
2
Nat’l Acad. of Sciences, Engineering, and Medicine (“NASEM”), Consensus Study Report: Medications for Opioid Use Disorder Save Lives, Nat’l Acad. Press, at 120-21 (2019) https://bit.ly/2NJnNXQ (“Waivered providers have also reported that the DEA’s approach can be ‘threatening,’ and some buprenorphine-waivered providers feel that they are unfairly scrutinized by the DEA. More recent aggressive enforcement strategies by the DEA and several state attorneys general—including increases in raiding, auditing, and launching criminal investigations of waivered providers—perpetuate the fear of such surveillance that has been articulated by waivered and non-waivered providers.”); Letter from American Medical Assoc. (“AMA”) to Sec. Alex Azar (Jun. 2, 2019), https://bit.ly/3cgj9u8 (“Physicians are extremely reluctant to invite the scrutiny of the DEA by pursuing a waiver to treat OUD patients with buprenorphine. They fear that the DEA would take punitive action in response to innocent mistakes, and that DEA agents with weapons would enter their practices and frighten patients and staff. The DEA is a law enforcement agency, not a health care agency. Waivered physicians who have experienced DEA audits have expressed concerns that DEA auditors do not understand medical records and do not conduct audits appropriately. They have also described the DEA’s approach as ‘threatening.’ These concerns have been heightened by raids and criminal investigations of waivered physicians by the DEA and state attorneys general. Recently, to its credit, the DEA has conducted outreach to physicians in an effort to mitigate these fears, and the AMA has assisted DEA in this effort as part of a much larger effort by the AMA to remove stigma from OUD treatment. Removing the DEA requirements would help allay physicians’ concerns and, in our view, increase the number of physicians treating patients with OUD.”); 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://bit.ly/3lNlDTU (“Buprenorphine training requirements, X-waiver applications, and DEA audits discourage prescribing buprenorphine.”).
The federal barriers give medical providers the impression that buprenorphine is complex. In fact, buprenorphine is safer and easier to manage than many common medications like insulin and blood thinners.
3
Sarah E. Wakeman, MD and Michael L. Bennett, MD, Primary Care and the Opioid-Overdose Crisis – Buprenorphine Myths and Realities, 379 New England J. of Med. 1-4 (2018), https://bit.ly/3sleD2U (“The first myth is that buprenorphine is more dangerous than other interventions physicians master during training. In fact, PCPs regularly prescribe more complicated and risky treatments. Titrating insulin, starting anticoagulants, and prescribing full-agonist opioids for pain are often more challenging and potentially harmful than prescribing buprenorphine. Yet this perception has been cemented by federal policy. The Drug Addiction Treatment Act of 2000 requires that physicians complete 8 hours of training (sacrificing a full day of work) and apply for a DEA waiver to begin prescribing buprenorphine. After passing these hurdles, physicians are authorized to treat only a limited number of patients. These requirements make buprenorphine treatment intimidating.”).


According to the National Academy of Sciences, Engineering and Medicine, “[t]hese policies are not supported by evidence, nor are such strict regulations imposed on access to life-saving medications for other chronic diseases.”
4
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
Instead they’re a result of outdated policies that criminalized substance use disorder and restricted medical providers from treating people with the condition.

As a result of these barriers, only about 1 in 10 medical providers have obtained federal approval to prescribe buprenorphine for opioid use disorder.
5
In February 2022, there were more than 116,600 medical providers who had federal approval to prescribe buprenorphine for opioid use disorder. This compares to 1,022,006 active physicans and more than 430,000 nurse practitioners and physician assistants. See U.S. Dep't Health and Human Svcs., Substance Abuse and Mental Health Svcs. Admin, Justifications of Estimates for Appropriations Committees, Fiscal Year 2023, p. 226 ("As of April 28, 2021, there were a total of 97,880 practitioners certified to prescribe buprenorphine. That number increased to a total of over 116,600 by February 1, 2022."); Kaiser Family Foundation, Professionally Active Physicians (Mar. 2020), https://bit.ly/31eSW8R (listing total physicians in U.S. at 1,022,006); Letter from American Assoc. of Nurse Practitioners (“AANP”) and American Academy of Physician Assistants (“AAPA”) to the Hon. Alex Azar (Jan. 15, 2021), https://bit.ly/2OUmdmO (“The American Association of Nurse Practitioners (AANP) and American Academy of PAs (AAPA), collectively, represent the interests of the more than 430,000 NPs and PAs practicing in the United States.”).
It’s no surprise that overdose deaths have reached historic highs and continue to accelerate.

For these reasons, the U.S. Commission on Combating Synthetic Opioid Trafficking has called on Congress to remove the patient limits, registration requirements, and other barriers that discourage healthcare providers from prescribing this lifesaving medication.
6
U.S. Commission on Combating Synthetic Opioid Trafficking, Final Report, at 49-50 (Feb. 2022), https://bit.ly/3ycCKVt ("In further regulatory changes, to increase the number of providers who can prescribe medications, Congress should remove unnecessary barriers to prescribing buprenorphine, including through elimination of the cap on the number of patients a waivered provider can treat and potential elimination of the requirement that a prescriber obtain an X waiver.")