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Nurse Practitioner and Physician Assistant Roles in Prescribing in Rural Areas

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The fight against opioid use disorder (OUD) in rural areas is vital to the hopeful end of this epidemic in the United States. Individuals are more likely to die from an overdose in a rural setting, as opposed to an urban setting.5 What is most striking however is that there are more people struggling with OUD in urban areas. This high mortality rate is likely due to insufficient transportation to and availability of treatment facilities. If nurse practitioners (NPs), and physician assistants (PAs) obtain federal waivers, more individuals may have access to treatment.The ability for mid level providers to be able to initiate buprenorphine treatment in primary care settings, could reduce the fears and stigmas associated with getting treatment for OUD.

 

In 2016, the Comprehensive Addiction and Recovery Act (CARA) allowed NPs and PAs to obtain DEA-X waiver to prescribe buprenorphine, a medication that is effective in treating OUD. Effectively between 2016 and 2019 the number of waivered PAs and NPs rose by more than 50% in rural U.S. This is especially important because over the past few years there has been a trend of physicians moving out of rural neighborhoods, and increased presence of mid level providers in practice.7 By encouraging NPs and PAs to receive a waiver this may help lighten the burden in counties where there are very few providers with DEA-X waiver.

In a 12 month study done in 2019, less than 35% of adults in the U.S. struggling with OUD were found to be receiving treatment.6 One reason the level of treatment is this low may be due to the stigma3 associated. If patients have the opportunity to see a primary care provider, with whom they already have established relationships, the patient might feel more comfortable with discussing treatment plans.

 

 Despite the growth seen of newly waivered providers, there are still a significant number of counties with no waivered NPs and PAs. The majority of these providers are found in the Eastern and Western coasts of the U.S.In March 2019, 52% of rural counties had 1 or more waivered NPs or PAs. It is easy to sign up, and the process can be completed within 8 minutes. To register for training in your area click here

 

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  1. Andrilla, C. H., Patterson, D. G., Moore, T. E., Coulthard, C., & Larson, E. H. (2018). Projected contributions of nurse practitioners and physicians assistant to Buprenorphine treatment services for opioid use disorder in rural areas. Medical Care Research and Review, 77(2), 208-216. doi:10.1177/1077558718793070
  2. Andrilla, C. H., Moore, T. E., Patterson, D. G., & Larson, E. H. (2018). Geographic Distribution of Providers With a DEA Waiver to Prescribe Buprenorphine for the Treatment of Opioid Use Disorder: A 5-Year Update. The Journal of Rural Health, 35(1), 108-112. doi:10.1111/jrh.12307
  3. Barnett, M. L., Lee, D., & Frank, R. G. (2019). In rural areas, buprenorphine waiver adoption since 2017 driven by nurse practitioners and physician assistants. Health Affairs, 38(12), 2048-2056.
  4. Jackson, H. J., & Lopez, C. M. (2018). Utilization of the nurse practitioner role to combat the opioid crisis. The Journal for Nurse Practitioners, 14(10). doi:10.1016/j.nurpra.2018.08.016
  5. Mack, K. A., Jones, C. M., & Ballesteros, M. F. (2017). Illicit drug use, illicit drug use disorders, and drug overdose deaths in Metropolitan AND nonmetropolitan areas — United States. MMWR. Surveillance Summaries, 66(19), 1-12. doi:10.15585/mmwr.ss6619a1
  6. U.S. News & World Report. (n.d.). What to Do When There Are No Primary Care Physicians Accepting Patients Near You. U.S. News & World Report. https://health.usnews.com/health-care/patient-advice/articles/2018-02-12/what-to-do-when-there-are-no-primary-care-physicians-accepting-patients-near-you. 

COVID-19 Effects on Individuals struggling with Opioid Use Disorder

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 In 2019 and 2020, COVID-19 ravaged worldwide and the World Health Organization (WHO) made various suggestions to decrease the spread of the disease. Many hospitals and clinics limited patient access, and some even closed down temporarily. COVID affected many both directly and indirectly, including those struggling with Opioid Use Disorder. Deaths due to opioid use surged nationwide during the COVID-19 pandemic. Patients who needed to have regular visits to manage their illness found their treatments to be disrupted. Social distancing mandates forced many struggling with addiction to become isolated, increasing the likelihood for substances to be abused. In fact, one study showed that there was a 25% increase in deaths between August 2018- August 2019 and August 2019 – August 2020. (CDC reported this number as underrepresented). According to the National Center for Health Statistics (NCHS), this was the greatest jump seen in 20 years. A similar trend occurred in China, as an increase in suicide attempts through drug overdoses during the 2003 Severe Acute Respiratory Syndrome (SARS) epidemic.

Figure 1- Month by month comparison between 2019 and 2020 for a 12-month ending count of OUD-related deaths in the U.S.

COVID spread quickly in prisons due to overcrowding, and to stifle the spread, many correction facilities released inmates with inadequate support systems. Altogether, major prisons in the U.S. reported having 11% fewer incarcerations during the pandemic in an effort to reduce crowding, and correctional facilities released many homeless individuals struggling with OUD. With an estimate of up to 65% of inmates struggling with some form of substance abuse, overdose is 40 times more likely to occur within weeks after release from prison. This is usually due to a lowered tolerance after abstinence from opioids in jail. 

 

Patients and providers found there were also hurdles to jump in the emergency room. When the pandemic first started in the United States, many OUD treatment facilities announced temporary closings. This, in turn, caused Emergency Physicians to have their hands tied. Those who were able to give patients a “bridge-dose” of buprenorphine did not have treatment facilities to refer patients to. Despite some offices changing to telemedicine after the government allowed it, many individuals did not have ease of access to telemedicine. These issues are not only localized to one area but were faced nationwide. 

The current administration has discussed some steps, which include: increasing funding and increasing ease of access for medication-assisted training (MAT). One key step providers can make to help reduce the number of people affected by OUD is to obtain a waiver. Having a waiver to prescribe medications such as buprenorphine can help patients start getting the help they need while waiting to go into treatment. This training is available to providers, nurses, and both nursing and medical students. To register for virtual training in your area, please visit <https://getwaivered.com/remote/>.  

 

 

 

 

  

 

Biden administration pulls back new guidelines on Prescribing Buprenorphine. (2021, February 05). Retrieved April 15, 2021, from https://www.aamc.org/advocacy-policy/washington-highlights/biden-administration-pulls-back-new-guidelines-prescribing-buprenorphine 

Mukherjee, T. I., & El-Bassel, N. (2020). The perfect storm: COVID-19, mass incarceration and the opioid epidemic. International Journal of Drug Policy, 83, 102819. doi:10.1016/j.drugpo.2020.102819

Overdose deaths accelerating during covid-19. (2020, December 18). Retrieved April 15, 2021, from https://www.cdc.gov/media/releases/2020/p1218-overdose-deaths-covid-19.html 

Products – DATA Briefs – Number 394 – December 2020. (2020, December 22). Retrieved April 18, 2021, from https://www.cdc.gov/nchs/products/databriefs/db394.htm 

Products – vital statistics rapid release – provisional drug overdose data. (2021, March 17). Retrieved April 15, 2021, from https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

Slavova, S., Rock, P., Bush, H. M., Quesinberry, D., & Walsh, S. L. (2020). Signal of INCREASED opioid overdose During COVID-19 from emergency medical services data. Drug and Alcohol Dependence, 214, 108176. doi:10.1016/j.drugalcdep.2020.1081761

The spike in drug overdose deaths during the covid-19 pandemic and policy options to move forward. (n.d.). Retrieved April 15, 2021, from https://www.commonwealthfund.org/blog/2021/spike-drug-overdose-deaths-during-covid-19-pandemic-and-policy-options-move-forward 

Wakeman, S., Green, T., & Rich, J. (2020, May 01). An overdose surge will compound the COVID-19 pandemic if urgent action is not taken. Retrieved April 15, 2021, from https://www.nature.com/articles/s41591-020-0898-0 

Walter, L. A., & Li, L. (2020). Opioid use disorder in the emergency department amid covid-19. Journal of Addiction Medicine, 14(6). doi:10.1097/adm.0000000000000717 

 

 

 

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.