HHS Revises Buprenorphine Prescribing Requirements for Treating Opioid Addiction
by Leah King, PharmD, JD, Independent Pharmacy Consultant & Charlotte Chovanec, RN, BSN, MHA, Clinical Director
Although we don’t hear as much about it as we once did, the opioid crisis has continued to rage during the COVID-19 pandemic. Originally issued in October 2020, and updated in April 2021, the American Medical Association (AMA) published a brief that highlighted widespread reports of dramatic increases in opioid-related deaths. We discussed the issue in our blog, where we detailed the factors contributing to those increases, as well as the measures recommended by the AMA last October.
This increase in opioid-related deaths highlights the need for ongoing and accessible treatment options. Studies have shown that medication-based treatment enhances successful long-term recovery from opioid use disorder (OUD). One such prescribed treatment option is buprenorphine.
What is Buprenorphine?
Buprenorphine is a schedule III, controlled substance marketed in oral forms as Suboxone and Subutex, both of which are approved by the FDA to treat opioid addiction. Buprenorphine binds to opioid receptors in the brain, reducing pain and producing feelings of well-being. When taken as directed, it does not produce the state of euphoria observed with other opioids. As a result of its pharmacology, buprenorphine can prevent withdrawal symptoms and reduce cravings for opioids in those recovering from opioid addiction.
Treatment Programs & the DATA Waiver
Prior to the FDA’s approval of Suboxone and Subutex in 2002, drug treatment options for opioid use disorder were limited. Methadone and levo-acetylmethadol (LAAM) are only approved for use within opioid treatment programs (OTPs), more commonly known as methadone clinics. OTPs must be certified and accredited according to requirements set forth by federal law. There are approximately 1,500 federally certified OTPs across the United States, which equates to about 30 programs per state. The limited number of certified treatment programs dramatically limits access to prompt, life-saving opioid addiction treatment.
The Drug Addiction Treatment Act of 2000 (DATA) created what became known as the “DATA waiver” or the “X waiver”. DATA allows buprenorphine to be prescribed outside of federally certified OTPs by physicians, as long as the physician satisfies certain criteria, which are set forth in federal regulations. Waivered prescribers are required to participate in a training program and must agree not to exceed a specified maximum number of patients under treatment for opioid addiction. The Comprehensive Addiction Recovery Act of 2016 expanded the scope of the X waiver beyond physicians, allowing for other types of health care providers, such as physician assistants and nurse practitioners, to obtain waivers. On April 27, the Department of Health and Human Services (HHS), issued a press release that included new practice guidelines for buprenorphine prescribing, effective as of April 28, 2021. Under these guidelines, while physicians and other eligible providers are still required to apply to the Drug Enforcement Administration for a waiver, they will no longer be obligated to fulfill the training requirements (as long as they treat no more than 30 patients at a time). This adjustment to the guidelines allows for a larger pool of appropriately trained providers to treat patients with OUD, and serves as another tool in the arsenal against the ongoing opioid crisis.
Potential for Positive Impact
Treatment for chronic pain is an issue that touches many workers compensation claims and cost is always a consideration. Although the cost for buprenorphine may be somewhat higher than oxycodone/acetaminophen, studies suggest that buprenorphine can help reduce the frequency of opioid use in early stages of recovery (first 3-6 months) and also over the long-term (3-5 years) after receiving this treatment for the first time. As this is not an issue with a quick resolution, and it continues to impact workers compensation claimants undergoing treatment for various pain conditions, we’ll continue to report updates as they become available.
 Recovery Research Institute Study: Long-term Effects of Buprenorphine & Methadone on Opioid Use