Obtaining a DEA-X Waiver Exemption

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In contrast to methadone for maintenance treatment, buprenorphine enables ED physicians to begin OUD medication-assisted therapy immediately in the emergency department upon presentation. Two routes for its clinical deployment are via administration and prescription: 

Administration

Under emergency circumstances, an emergency physician reserves the right to exercise the nonrenewable, non-extendable “three-day rule,” an exemption to the federal mandate requiring a separate DEA-X Waiver to employ narcotic drugs in treating acute opioid withdrawal. In this event, DEA-X Waiver protocol legally allows a provider to administer up to 72 hours of buprenorphine treatment at his or her professional discretion. However, treatment is capped at one day’s limit at a time, thereby requiring multiple visits to continue care within the same ED. This averts the potential for abuse or adverse consequences during the detoxification process. Furthermore, the patient must be referred to longer-term care following treatment.

Prescription

Implementing buprenorphine maintenance therapy requires that physicians obtain a DEA-X Waiver. To do so, practitioners must first register for and then successfully complete a SAMHSA-approved eight-hour training course. Current statistics indicate that only 1% of all emergency medicine physicians have this waiver to prescribe buprenorphine, implying missed opportunities to successfully treat OUD immediately in the ER. 

Both mechanisms require a continuity of care that incorporates long-term management within primary care or specialty care environments. 

The History of the Waiver

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As numbers continue to rise in Opioid Use Disorder (OUD) related deaths, it is important to take a look back at what possible historical landmarks might have made an impact on the current opioid crisis in the United States. Various laws in the early 1900s , such as the Harrison Narcotics Tax Act, aimed to regulate the spread of opiates and cocaine in the United States1. This act, made effective in 1914, allowed physicians to prescribe only in ‘professional practice’. 2 Another major effort to regulate drug distribution and use occurred in 1920, in the court ruling of Jin Fuey Moy v. United States. It ruled that a physician could not provide opiates for patients to ‘satisfy a craving’. 

These almost more than a century old ruling affects how providers can prescribe partial agonists, such as buprenorphine, for treatment reasons, but has minimal restrictions when prescribed for pain relief purposes. It was not until the Narcotic Addict Treatment Act of 1974 that doctors were permitted to treat patients with OUD, after obtaining a specialized certification. Another change came about at the beginning of the 21st century when the Drug Addiction Treatment Act of 2000 (DATA2000) opened an easier path for providers to prescribe buprenorphine/naloxone. DATA2000 opened doors for physicians to obtain a ‘waiver’ in order treat OUD patients in any healthcare facility.

Joseph W. Frank, Sarah E. Wakeman & Adam J. Gordon (2018) No end to the crisis without an end to the waiver, Substance Abuse, 39:3, 263-265, DOI: 10.1080/08897077.2018.1543382)

A call to Arms

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Opiate overdose was the cause of death for nearly 48,000 Americans in 2017, and within the past two years this number has continued to  skyrocket. The treatment of addiction using both methadone and buprenorphine has proven to be useful in counteracting these staggering statistics, but unfortunately the rate of medical staff using these treatment methods is quite low. The main administrators of buprenorphine and methadone are those working in treatment clinics, however the increasing opioid use disorder (OUD) diagnosis have proven that more providers need to become trained in dealing with this current crisis.

 Under various laws that have been passed during the last twenty years, physicians, nurse practitioners, and physician assistants have been given the opportunity to assist in treating OUD patients through the use of buprenorphine, after obtaining an X waiver, which entails 8-24 hours of training through a federally approved facility. Although the X waiver had been put in place, a mere 5% of providers have trained to receive it. 80% of those who were diagnosed with OUD, however are not receiving the necessary treatment. It is crucial that all providers both encourage colleagues to become waivered, and to obtain waivers for themselves. 1 

 

NPs/PAs Becoming Waivered: How to Become a Buprenorphine Provider

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With the rising trend in deaths due to OUD, more licensed practitioners are needed to help in  fighting this health crisis. Currently there are around 270,000 nurse practitioners, 2 with only about 6% that have a waiver to prescribe OUD treatment medications. 1 It is key that this gap in our system be addressed, considering that opioid related deaths increased by close to 10% between 2016 and 2017. 3

The steps a nurse practitioner would fulfill in order to become certified in prescribing medications used to treat OUD, such as buprenorphine, would be to first obtain a license from the DEA (Drug Enforcement Administration). The application can be found on the U.S. Department of Justice website. The applicant would also need to complete no less than 24 hours of training by an approved DATA facility. The American Society of Addiction Medicine (ASAM), the American Association of Nurse Practitioners (AANP), the American Academy of Physician Assistants (AAPA), the American Psychiatric Nurses Association (APNA), and the Substance Abuse and Mental Health Administration (SAMSHA) all partner together to provide this training free of charge. 

The Providers’ Clinical Support System (PCSS), provides this 24 hour training nationwide.The training is broken down into an 8 hour and a 16 hour segment; all 24 hours of training involve patient contact. The training covers various topics, such as dispensation of FDA- approved medications, documentation of administered medication, pharmacology, OUD misuse, patient evaluations, reversal of opiate overdose, therapy, and rehabilitation. This form of treatment taught in the course is known as Medical Assisted Treatment (MAT), which is treatment that involves therapy in conjunction with medication for patients suffering with OUD. 5

DEA-X Waiver Protocol Following Training

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Application
Under the Drug Addiction Treatment Act of 2000 (DATA 2000), physicians who have completed the mandatory eight-hour training course are now eligible to obtain a DEA-X waiver to administer and/or prescribe buprenorphine medication-assisted therapy to treat opioid use disorder. DEA-X waiver protocol requires physicians to first notify the SAMHSA Center for Substance Abuse Treatment (CSAT) of their
intent via the Online Request for a New Waiver form. To verify waiver eligibility, physicians are to provide their DEA number, state medical license number, and training certificate details. Additional credentials and certifications will be assessed for qualification (i.e. the capacity to refer patients to counseling and/or alternative interventions). Physicians must also consent to the annual limit of thirty patients that may be treated with buprenorphine during the first year. Following application submission, official training certificates must be faxed to 301-576-5237, or emailed to csatbupinfo@dsgonline.com, to support the application under review.

Review
Processing may take up to 45 days following receipt. If approved, SAMHSA will send an email confirming the waiver and including the practitioner’s prescribing identification number. If no response is received after 45 days post-submission, please contact CSAT’s Buprenorphine Information Center at 866- BUP-CSAT (866-287-2728) or send an email to infobuprenorphine@samhsa.hhs.gov.

Exemptions
Special permission is granted to providers seeking to provide treatment immediately while an application is under review. For consideration, physicians must have a valid medical license, Drug Enforcement Administration (DEA) registration, or have completed the mandatory eight-hour training. Applicants
should check “New Notification, with the intent to immediately facilitate treatment of an individual (one) patient” on the notification form before contacting CSAT’s Buprenorphine Information Center at 866- BUP-CSAT (866-287-2728) to confirm receipt and to provide notification of the intent to begin treatment. Provisions limit immediate treatment to strictly one patient per form. If multiple forms are required, each must have a different submission date to be considered.

NPs and PAs join the fight

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In the early 2000s DATA 2000 was passed and gave physicians the opportunity to undergo 8 hours of training in order to become certified to administer buprenorphine to patients who were seeking treatment. This act also gave physicians the ability to provide medication outside of large hospitals, such as correction facilities, private offices, and other places where patients did not feel they had to be publicly shamed in order to get help. An unfortunate aspect of this opportunity was that physician assistants and nurse practitioners were not included in this new law. As a matter of fact, PAs, and NPs were prohibited from providing treatment even in cases where patients were presenting for help. 

 

In 2002, there were only a mere 1,119 physicians that were certified to prescribe buprenorphine. The number of opioid related deaths however continued to climb in the U.S., and the situation only became worse as not enough physicians were receiving training to prescribe and treat opioid addiction. In 2015, only about half of US counties had a physician who was certified to treat opioid addiction with buprenorphine. States with the highest rates of mortality were the ones who were found to have the least DATA 2000 certified physicians. 

 

To counteract this, President Obama signed CARA in 2016, which aimed to decriminalize first- time and non-violent drug offenses, and instead offered more treatment facilities to those who were suffering with addiction. It ensured that paramedics and police had access to naloxone, and also gave NPs and PAs the opportunity to undergo MAT training. This legislative move gave these mid-level providers the opportunity to treat OUD patients. Once these NPs and PAs acquired the necessary training and certification they could begin with treatment of up to 30 patients in the first year. The following year an appeal to Substance Abuse and Mental Health Services Administration (SAMHSA) can be made to increase this number to 100 patients.

 

In 2018 the SUPPORT Act gave NPs who had received MAT certified had the opportunity to prescribe buprenorphine to 100 in the first year. More specifics on regulations concerning the CARA, and NP practice is available in Section 3201 in the SUPPORT Act. CARA guidelines varies from state to state. In certain states, even if an NP were to be certified and eligible to prescribe buprenorphine, the supervising physician would also need to be waivered so that the order for the medication can be made. Because of the CARA Act, since 2018 around 6,843 NPs have now become certified to prescribe buprenorphine

 

Overview: The Waiver Process

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The Drug and Treatment Act of 2002 (DATA 2000) gives physicians the permission to prescribe buprenorphine and buprenorphine/naloxone for treatment purposes, once the physician has completed the required training and has received necessary certification by the Drug Enforcement Agency (DEA). Buprenorphine products can be prescribed by a certified, and qualified physician in any facility that medical practice is permitted.

Under DATA 2000 a DEA certified physician is someone who is licensed by the state to practice medicine, and has trained under DEA to administer narcotics. In the first year this physician is permitted to treat no more than 30 patients per year, and must be able to refer the patient to another facility for further treatment. 

 

The training from ASAM is excellent. It can be done for free by clicking on this link.

 

A DEA-X notification is then given to the physician after Substance Abuse and Mental Health Services Administration (SAMHSA) verifies that the background of the physician is correct and valid. When an order of buprenorphine is made two different numbers are entered into the order- the physician’s DEA registration number, and another ID number that shows the physician is DATA 2000 certified.

 

 Am I eligible to obtain a waiver?

 

Residents who want to be DATA 2000 certified

DATA 2000 does not exclude physicians who are still in residency training, so there are residents who are certified to administer buprenorphine.There are, however, certain states that have more strict guidelines than others, for example, some states do not permit residents to prescribe Schedule III medications even if it is for treatment purposes. 

 

Physicians working in Correctional Facilities

Providers who work with detained patients may obtain a waiver, to prescribe medication to those who those who need treatment. The rules pertaining to this however may vary by state. Methadone treatment has varying treatment regimens, and this is very likely the case for buprenorphine. Under DATA 2000 providers in these settings are also restricted to treating a certain amount of patients per year.

 

Government employed physicians

DEA training and the DATA 2000 waiver is also open to physicians that work for the government. Basic guidelines remain the same: physicians must obtain DEA training, and an identification number, he or she must be licensed to practice in the state, and must be able to pass a background check from SAMHSA. If the physician did not previously acquire any registration number, the state offers one free of cost. This is offered even for physicians who are not licensed to practice in that particular state, but are licenced to practice elsewhere in the United States, including Puerto Rico, the District of Columbia, and the Virgin Islands. In order to acquire this registration number the physician will need to fill out an application that contains the physicians address and the name and contact information of a reference. This newly acquired waiver from the DEA can only be used while working for the government, and cannot be used in other facilities such as private practices. Physicians who work under a contract cannot apply under this category.

 

DEA-X waiver the basics

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In 2002, the Drug and Treatment Act (DATA 2000), and the Comprehensive Addiction and Recovery Act of 2016 (CARA) allowed providers to acquire a waiver to permit the prescription of buprenorphine and buprenorphine/naloxone to patients suffering from withdrawal symptoms. This law is still valid as of today, and gives physicians the authorization to prescribe buprenorphine outside of a rehabilitation clinic.1

In order to obtain this waiver, physicians must first enroll and fulfill an 8 hour course in a DATA2000 accredited facility. Physician assistants and nurse practitioners can also participate in acquiring this waiver, and instead enroll in a 24 hour course. After the provider completes the training on opioid use disorder (OUD) treatment he or she must then contact the Drug Enforcement Agency (DEA) to request this waiver. After the waiver is acquired there are still restrictions on how many patients the physician can prescribe the medication to. In the first year the provider can only prescribe the medication to 30 patients and if all requirements are met, the number of patients can then increase to 100 patients, and in the following year 275 patients. Prescriptions can continue to be made as long as the provider has had DEA certification.

Overcoming the barriers in obtaining a DEA-X Waiver

By | Implementation

The field of behavioral economics has already been applied to address one facet of the opioid epidemic: most recently, the insights from the behavioral sciences have been used to reduce opioid prescribing in EDs. This is despite evidence that shows that emergency physicians are responsible for just a small percentage of the overall opioid prescriptions written nationally. For example, in 2012 less than 5% of all opioid pills prescribed originated from emergency room doctors. In a recent study, Dr. Doctor et al of the USC Price School of Public Policy found that when emergency physicians have learned in a letter from the medical examiner that one of their patients has suffered a fatal opioid overdose, they reduced the amount of opioids they prescribed by almost 10% over the next three months. Another study from the University of Pennsylvania sought to use new default options as a nudge in electronic health records (EHRs) in an effort to decrease the number of opioid pills that physicians prescribe. 

While efforts to reduce the risk of unnecessary exposure to opioid prescriptions are certainly a part of the solution, more can be done to leverage behavioral science to change provider behavior around prescribing life saving MAT. We sought to leverage the field of behavioral economics to support providers caring for patients struggling with OUD in an ED at an academic medical center by first understanding the pre-existing behavioral challenges related to prescribing MAT in EDs.

Barriers and Nudges

We uncovered three key behavioral barriers that impeded completion of the DEA X waiver process for our faculty and residents. Our team of behavioral economists worked to intuit the key psychological or situational factors behind each of these barriers and developed approaches that could be used to address them. These may be common themes and relevant approaches for stakeholders interested in making similar changes at their institutions as well. 

Barrier 1: Absent Social Norm

Behavioral economics defines social norms as the values, actions, and expectations of a culture or group. They offer, often implicit, guides to our behavior and, in particular, descriptive norms make people aware of what “most other people are doing”. These norms can reinforce and amplify an individual’s underlying motivations. The lack of consistent social norms around treating OUD and subsequently getting a waiver undercut the motivation of many attendings in our department to obtain a waiver. We targeted this barrier using six specific nudges including recruiting influential faculty members to be the first group of those waivered, creating a ‘Get Waivered’ Month, and holding a white coat pinning ceremony which was covered in a local news story and social media for those who had completed their waiver process as shown in figure 1.

Barrier 2: Hassle Bias in Obtaining a Waiver

Seemingly irrelevant details that make a task more effortful introduce hassle bias, and can make the difference between following through on an action and putting it off, sometimes indefinitely. Our group identified that many of the behaviors required to obtain their a DEA-X waiver introduced hassle bias including: accessing the online course and submission site after course completion and scheduling the in-person portion of the course. We targeted this barrier using three specific nudges including coordinating all schedules for interested participants, creating an easy to follow website, and presenting about the waivering process at resident and faculty conferences as shown on figure 1.

Barrier 3: Lack of Salience in Treating OUD

Salience refers to the fact that individuals are more likely to focus on items or information that are more prominent and ignore those that are less so. This creates a bias towards undertaking behaviors that are striking and perceptible. In the ED, the long-term benefits of proceeding with an action like starting a patient on MAT may be hidden and are therefore not always factored in at the time of decision making. Moreover, an emergency physician may be hard pressed in daily practice to remember stories of patients with OUD who have been treated successfully and are in recovery. Thus, because they are not regularly exposed to positive outcomes from OUD treatment, emergency physicians may come to develop an impression that patients cannot be treated effectively or recover. This worldview may alter their willingness to expend the effort to undergo extra training to obtain a DEA-X waiver. Making the benefits of our actions in treating patients with OUD more salient through vivid stories provides an opportunity to increase the motivation to follow through on obtaining a waiver. We targeted this barrier using three specific nudges around sharing in-person patient stories, including of physicians with OUD, who used MAT to enter into and stay in recovery as shown on figure 1.

DEA-X Waiver Protocol

By | Implementation

Our hospital created an evidence-based pathway to prescribe medication, as part of an addiction treatment protocol, for patients seeking to overcome their opioid addiction. In December of 2018, MGH Emergency Department initiated the ‘Get Waivered’ campaign leading to 95% of all MGH ED faculty on staff obtaining their DEA-X waiver, a federal requirement to prescribing buprenorphine. In contrast, nationwide only 1% of all emergency physicians nationwide have this waiver. A multidisciplinary team including physicians, addiction specialists, pharmacists, and others planned for over a year before implementing the dual pathway ED-initiated buprenorphine protocol on May 1, 2018. The primary aim is to give patients access to this medication when they present to the ED.

Option 1 in the pathway is the ‘Take Home’ protocol for patients not in opioid withdrawal but seeking treatment for their OUD. . Pre-packaged, pre-labeled bottles of ‘To-Go’ buprenorphine/naloxone are stocked in the ED. When an eligible patient is ready for discharge, MGH ED providers can prescribe two days’ worth of the medication in a small package with instructions on how to dose the medication. An ED pharmacist dispenses a ‘To-Go’ buprenorphine kit (six 8/2 mg sublingual films) and provides comprehensive counseling on home induction. Additionally, the pharmacist dispenses nasal naloxone and provides counseling on its administration for an opioid overdose. The patient is then discharged with guidance to follow up at a specialized addiction Clinic the next day for ongoing care. The patient can then self-administer buprenorphine when they begin withdrawing at home and have clear guidance on how to re-dose themselves as needed prior to follow up at the addiction Clinic. This allows patients to have the medication they need at the point of care instead of requiring them to follow up at the pharmacy to fill their prescription.

Option 2 in the pathway is the ‘ED Administration’ protocol. This option is available for patients in opioid withdrawal in the MGH ED and can take their first dose of buprenorphine while they are still in the hospital. Patients are observed for clinical improvement and discharged with instructions on how to follow up at the addiction Clinic. These patients also receive nasal naloxone with counseling from an ED pharmacist. The ‘To-Go’ buprenorphine and nasal naloxone are given to the patient free of charge (Hayes 2012).