The X-Waiver and the Perfect Storm

The Perfect Storm

One of the consequences of the Covid pandemic that we have experienced for the past year is an increase in drug and opioid use and correspondingly an increase in overdose deaths. The reasons for this are several and easy to see. The economic lockdown and restrictions on gathering in groups limited social and family interactions. The loss of jobs and the general overall stress related to the pandemic increased tendencies towards depression. This made it even more difficult for individuals struggling with opioid addiction, and may have also caused some individuals to turn to drugs as a way to cope. At the same time the need for substance abuse treatment services was increasing, substance abuse treatment programs were reducing or suspending their operations in order to comply with Covid restrictions. The Covid pandemic created a kind of perfect opioid abuse storm that experts suggest may result in one of the highest number of deaths from opioid overdose than we have ever had.

Short-Lived Help

This perfect storm of opioid abuse did not go unnoticed by government officials. On January 14, 2021, in the last days of the Trump administration, HHS issued a rule eliminating the “X-waiver.” However the elimination of the waiver was short lived. The Biden administration reversed course and reinstated the X-waiver on January 27, 2021. How could eliminating the X-waiver help manage the perfect storm of opioid abuse? That, in fact, is what this article is about.

What’s the X-Waiver?

The X-waiver has to do with regulating the prescription of buprenorphine and other medication-assisted treatments. Buprenorphine reduces the physical dependency of opioids during withdrawal, reduces cravings for opioids, and perhaps most importantly, reduces the risk of overdose from opioids. It is best used in conjunction with a treatment and counseling program.

The X-waiver is part of a law passed in 2000 (The Drug Addiction Treatment Act). The X-waiver places restrictions on prescribing buprenorphine and other opiate replacement therapy drugs. The law requires physicians to complete an approved eight-hour course on medication-assisted treatment and submit an application for the X-waiver before being able to prescribe buprenorphine. The physician is then limited to treating up to 30 patients in the first year, 100 patients the subsequent year, and 275 patients the following year. Why is it called the “X-waiver?” Physicians who complete the eight-hour training requirement get a new DEA number that starts with an “X.”

Unintended Effects

While the stated intent of the lawmakers who drafted this legislation was to increase the use of medication-assisted therapy, the effect of the X-waiver requirement had exactly the opposite effect. The numbers speak for themselves. According to HHS, approximately 1,000,000 physicians have DEA licenses to prescribe opioids and similar drugs, while only 60,000 physicians have an X-waiver to prescribe buprenorphine.

While you ponder that statistic, here is another statistic that suggests how important it is to increase the availability of medication-assisted treatment for opioid addiction. Many years ago when France deregulated buprenorphine and allowed all physicians to prescribe it, opioid overdose deaths declined by 79 percent. What’s even more surprising is that statistic from France is from 1995, five years before the U.S. adopted the law that required the X-waiver. The U.S. had the opportunity when drafting the Drug Treatment Act of 2000 to deregulate medication-assisted treatment as France did, but chose to tightly regulate the prescription of buprenorphine instead.

What’s the Current Status of the X-Waiver?

The current administration reversed course to reinstate the X-waiver essentially because of a technicality. They say that because the X-waiver is required by law, the HHS had no authority to eliminate the waiver. The only way to eliminate the requirement for the waiver is to change the law, which the Biden administration and some legislators have indicated they want to do. But as of this date, April 19, 2021, the X-waiver is still required. Our hope is that Congress will soon pass legislation to eliminate the X-waiver and to increase the availability of buprenorphine and other medication-assisted therapy.