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HHS Eliminates X-Waiver Requirement for DEA-Licensed Physicians

January 15, 2021

HHS on Thursday announced that it will publish new guidelines that will expand access to medication-assisted treatment for opioid use disorder by exempting physicians from certain certification requirements necessary for prescribing buprenorphine.

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder include an exemption from certain requirements under the Controlled Substances Act for physicians who are licensed under state law and possess DEA registration. Additional details of the exemption include:

  • It only applies to physicians who may only treat patients who are located in states where they are licensed to practice.
  • Physicians will be limited to treating no more than 30 patients with buprenorphine for OUD at a given time.
  • The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the Controlled Substances Act, and does not apply to the prescription, dispensation or use of methadone to treat OUD.
  • Physicians must place an “X” on prescriptions and clearly identify the prescription is being written for the treatment of OUD.

A working group will monitor implementation and results of the guidelines, including potential changes in medication diversion.

“The medical evidence is clear: Access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” Adm. Brett P. Giroir, MD, assistant secretary for health, said in an HHS news release. “Removing some of the certification requirements for an  X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment.”


Submitted byBCIDOC on January 21, 2021

I'm 65 years old and have been in the addiction field for 48 years. If you did the math I couldn't have been employed at the age of 17. After 17 years of injection drug use the very system that I will speak about is what helped me to become drug free, acquire a master degree and ultimately a Ph.D. I was able to work for hospitals in Baltimore City and county and ran what was doubted a National Model (Baltimore Substance Abuse Systems) and start a nonprofit behavioral health care clinic for the past 15 years. Treating addiction is about behavioral change. There are a flood of physicians now who offer suboxone without psychosocial support systems and regular drug screening to ensure adherence. In Baltimore, Maryland there is absolutely no shortage of the availability of suboxone and from what I have seen as a 30 year addiction practitioner with supervision of an addiction psychiatrist suboxone alone will not reverse addictive behavior. The streets are flooded with suboxone acquired from physicians and sold on the street so the patient can buy fentanyl, I say that because the pills are drying up and there is very little heroin on the street. I don't see any physician who may be responsible as the article indicated for the dependence/addiction that may have occurred during their care openly take responsibility for the addiction and treat it. What testing and support services will these physicians offer besides a "Written prescription." Lawyers don't defend themselves so why would we assume that the addicted person will heal their addiction with just suboxone? We're moving in the wrong direction here. That's just my opinion.

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