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

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.