X-Waiver Update: a Small but Promising Step in the Opioid Epidemic

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For the hundreds of thousands of Americans who fatally overdosed in the last 10 years, and for the millions of Americans subject to the physical and emotional burden that comes with Opioid Use Disorder (OUD), a major milestone was achieved last week in the battle against the opioid epidemic. 

Here at Med School Insiders, we seek to empower future generations of physicians with the understanding they need to shape the landscape of the medical establishment for the better. It is essential to read on if you are a future healthcare professional: not only will you be expected to delve into these current events at upcoming interviews, but one should understand how these events influence the future practice of medicine to take part in the change accordingly. 

With the recent update, the opportunity to serve those affected by the opioid crisis is more readily available than ever before. Maintaining this direction to resolve the opioid epidemic requires a collective effort. 

 

The News

A news release from January 14th, 2021 revealed that the U.S. Department of Health and Human Services will publish Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder in an effort to increase accessibility to medication-assisted treatment (MAT) for patients suffering from OUD. Specifically, physicians (not nurse practitioners or physician assistants) are now exempt from the “X”- waiver requirements that were previously needed to prescribe buprenorphine, an effective treatment for those with OUD. 

The specifications of the guidelines are attached below: 

  • The exemption only applies to physicians who may only treat patients who are located in the states in which they are authorized to practice medicine.
  • Physicians utilizing this exemption will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time (note: the 30 patient cap does not apply to hospital-based physicians, such as Emergency Department physicians).
  • The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD.
  • Physicians utilizing this exemption shall place an “X” on the prescription and clearly identify that the prescription is being written for opioid use disorders (along with the separate maintaining of charts for patients being treated for OUD).
  • An interagency working group will be established to monitor the implementation and results of these practice guidelines, as well as the impact on diversion.

 

Scale of the Issue and Historical Context

While the opioid epidemic was declared a national public health emergency on October 26th, 2017, progress in the battle against addiction has been slow. 

As of 2016, 2 million individuals in the US have been diagnosed with OUD and an estimated 130 people die on a daily basis from a drug overdose [A]. In the last year alone, there were 83,000 drug overdose deaths in the United States over a 12 month span ending in June 2020, marking the highest count of overdose deaths ever recorded in a 1 year duration and a 21% increase from the previous year, according to  CDC Provisional Data. Overdose deaths had already been increasing in the months preceding the COVID-19 pandemic, but the lockdown challenged those with OUD with reduced access to life-saving treatments, harm reduction, and recovery and support services. The economic challenges of the year also put in question the survival of addiction treatment centers, and the increased psychosocial stress from isolation, financial uncertainty, and fear added to the burden felt by those with OUD [B]

The scale of this epidemic is rooted in the 1990s, when pharmaceutical companies reassured the medical community that patients would not become addicted to opioid pain relievers, bringing healthcare providers to prescribe opioids at increased rates. The increased prescription of addictive opioid medications led to misuse of both prescription and non-prescriptive opioids, and the addictive nature of the medications only became clear far too late [C]. The second wave of the rise in opioid overdose deaths began in 2010 when there was a rapid increase in overdose deaths involving heroin. The third wave began in 2013, during which significant increases in overdose deaths involving synthetic opioids, particularly those involving illicitly prepared fentanyl (in addition to heroin, counterfeit pills, and cocaine) [D]

Opioid use disorder is a chronic disease characterized by a rewiring of the brain structurally and functionally as a result of excessive opioid use. The reward system of the brain is hijacked to such a degree that each domain of a patient’s life usually ends up compromised. In former clinical efforts, detoxification combined with psychosocial treatment remained futile, with relapse rates remaining at 90% or higher [E]. However, there is a medication founded on decades of evidence for its efficacy at treating OUD: buprenorphine. 

Buprenorphine is a long-acting agonist that blocks other opioids from binding to receptors, preventing the abuse of other substances. As a partial agonist, it has a small ceiling effect, low overdose risk, and significantly lowers the chance of mortality and adverse outcomes [E] by curtailing withdrawal symptoms, the main driver of continued opioid usage. While the utility of Buprenorphine is well established, government regulations have yielded a major shortage of providers who are eligible to prescribe the medication. For years, policy makers have been pointing to France, where deregulation enabled all medical doctors to prescribe Buprenorphine, resulting in a 79% decrease in opioid overdoses [F]

The regulations put in place years ago have failed to meet the scale of the opioid crisis.  As described by Hannah Knudsen, PhD, of the University of Kentucky College of Medicine in Lexington, even if all providers eligible to prescribe buprenorphine over the last 2 decades did so to their maximum capacity, there would still be many patients left untreated [G].

 

What Does the X-Waiver Update Mean? 

Under the Drug Addiction Treatment Act of 2000, physicians who wish to prescribe buprenorphine have been required to complete an eight-hour training program and apply to the Drug Enforcement Administration (DEA) to obtain a special permit known as the “x-waiver.” 

With hoops to jump through and increased DEA oversight, physicians have been reluctant to get the waiver. Research suggests that physicians don’t feel informed enough, or aren’t comfortable with, the idea of prescribing buprenorphine; they also don’t have the infrastructure or resources (e.g. knowledge on referral sites for counseling that isn’t available in primary care settings) to appropriately manage high volumes of patients with OUD [G]. Many physicians share several misconceptions that result in the continued underutilization of buprenorphine – five of which are described here – and with the permeating stigma surrounding those affected by OUD, the deficit in medical support has only grown with time.  

According to the Substance Abuse and Mental Health Services Administration, less than 7% of practitioners have obtained X-waivers and are eligible to prescribe this medication [H]. Nationally, only 1 out of 9 patients with OUD is able to obtain buprenorphine [I], and for those who lack access to such care, there is a black market where buprenorphine is illicitly purchased. You may be left thinking that if this medication is illicitly purchased and available in such a limited supply, there may be severe risk associated with it. However, Buprenorphine is safe, easy to use (can be self administered), and effective at preventing withdrawal symptoms and cravings [E]. Patients, in an effort to restore their lives and abstain from opioids, seek the medication in the black market to keep their withdrawal symptoms and cravings at bay. Health policy experts and physicians have been advocating for the elimination of the X-waiver, and the recent update is a step in the right direction.  

The X-waiver presents a significant barrier to treatment by limiting the number of physicians eligible to prescribe buprenorphine. However, from a decision announced on January 14th, 2021, the HHS has issued an exemption to the X-waiver certification requirement for physicians registered with the DEA who are willing to prescribe buprenorphine and other MAT. 

For the providers who may be reading this, you now have an increased opportunity to stand beside those with OUD and fight addiction. Treatment with buprenorphine allows opioid receptors to be stabilized so that patients can make changes in lifestyle, behavior, and psychiatric conditions to allow for ultimate recovery rather than a series of relapses. The mortality associated with relapse of opioids is too high for the efficacy of buprenorphine and the lack of providers prescribing this medication to continue to be overlooked [E].

 

Future Trends and Final Points

It has been said that all physicians confront addiction on a daily basis in their practice. For the patients suffering from obesity, diabetes, or heart disease, physicians provide medical support, battling a potential addiction to food. Similarly, patients challenged with cirrhosis and an addiction to alcohol are readily supported with the medical care they need. In recognition of the fact that addiction is not a moral failure but rather a medical disease, we provide such patients with the gold standard of care without hesitation. 

That said, this has not been the case for those suffering from OUD. The evidence indicates that Buprenorphine and other Medication Assisted Treatments have tremendous potential to restore the lives of those challenged with this disorder. The recent relaxation of the guidelines may increase accessibility to this drug and is indisputably a step in the right direction, but with the changes applicable only to physicians (each of whom are limited to 30 patients only), there is much progress to be made. For all the future healthcare professionals, the road being paved is set in the right direction, but the steps you take will ultimately influence the state of the opioid crisis. 

*NOTE: For providers seeking to understand the exact specifications as to how they can prescribe buprenorphine, the update is available here. Stay tuned with the news to see when this update will go into effect.

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