Drug Policy

Biden Restores a Barrier to Opioid Addiction Treatment

The new administration nixes a change that would have allowed more physicians to prescribe buprenorphine.

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Anonymous sources close to the White House say the Biden administration plans to reinstate special licensing requirements for physicians to prescribe buprenorphine, the most common medication used to treat opioid use disorder. Shortly before President Donald Trump left office, his administration updated federal guidelines to discontinue the "X-waiver," a regulation that required physicians to obtain eight hours of additional training before prescribing buprenorphine for addiction treatment. Although the Biden administration has made no official decision, the Department of Health and Human Services (HHS) recently removed the relaxed guidelines from its website.

During his campaign, President Joe Biden promised to undo regulations that prevent the optimal distribution of buprenorphine. Yet one of his first actions in office reverses a policy that would have allowed unprecedented access to opioid addiction treatment.

HHS officials cited concerns about whether the department had the authority to issue guidelines that bypassed regulations set by Congress. As recently as 2018, Congress explicitly outlined requirements that physicians and other health care providers must meet to treat opioid use disorder with buprenorphine. Although the Controlled Substances Act grants HHS broad authority, in conjunction with the Department of Justice, to reclassify any federally regulated drug, the rules imposed by Congress seem to cover all drugs in Schedules III through V. Oddly, the Justice Department might be able to avoid this obstacle by moving buprenorphine from Schedule III to the more restrictive Schedule II. Another possible option: The Biden administration could completely deschedule buprenorphine. The Trump Administration didn't attempt either approach to justify it's guidelines, but argued HHS has the authority to "eliminate the requirement that physicians with  a Drug Enforcement Administration (DEA) registration number apply for a separate waiver to prescribe buprenorphine for opioid use disorder treatment," which would effectively cover almost all practicing physicians in the U.S.

Legal issues aside, evidence from abroad suggests that physician licensing for buprenorphine prescribing might be preventing the U.S. from better addressing unprecedented levels of opioid-related deaths (mostly involving illicit fentanyl) amid the COVID-19 pandemic. Although the previous assistant HHS secretary, Elinore McCance-Katz, warns that loosening buprenorphine restrictions could lead to black-market diversion through overprescribing, France witnessed a 79 percent drop in opioid-related deaths within four years of eliminating its physician-licensing requirement for buprenorphine in 1995. During this period, the number of patients receiving medication-assisted treatment (MAT) with opioids like buprenorphine increased from fewer than 2,000 to more than 60,000. Evidence from the U.S. also suggests that buprenorphine distribution is followed by substantial reductions in opioid-related fatalities.

As of March 2020, 1.3 million Americans were receiving MAT for opioid addiction. Data from the National Survey on Drug Use and Health (NSDUH) indicate that 1.6 million Americans experienced opioid use disorder in 2019. That gap may help explain why 90 percent of illicit buprenorphine users report obtaining the drug to prevent opioid withdrawal. In addition to estimating the number of Americans who qualified for a diagnosis of opioid use disorder, the 2019 NSDUH found that more than 10 million Americans used illegal opioids or "misused" prescription analgesics that year. 

The idea behind MAT is to replace euphoric opioids such as heroin, fentanyl, and oxycodone with a milder opioid that relieves cravings and other withdrawal symptoms. Many public health officials would prefer that opioid users become completely abstinent and see MAT as, at best, a step toward that goal. Yet the Drug Enforcement Administration (DEA) has acknowledged the need for MAT medicines like buprenorphine and methadone to fight the worsening scourge of opioid-related deaths. The DEA even supported relaxing telemedicine restrictions to ensure access to buprenorphine during the pandemic. Since only 8 percent of illicit buprenorphine users report that they use the drug to get "high," the Biden administration should consider reposting the previous administration's guidelines, which would allow more doctors to help patients struggling with opioid addiction.

Buprenorphine is a Schedule III substance, which means it is deemed to have a lower "potential for abuse" than the opioids in Schedule II, which include morphine, oxycodone, and hydrocodone. Yet all physicians seeking to prescribe opioids for addiction treatment must acquire additional medical training and can treat no more than 100 patients in the first year and no more than 275 after that. Those restrictions are puzzling, because there is no patient cap or additional training requirement for prescribing Schedule II opioids, or even buprenorphine, for pain relief. Until recently, the DEA was much more likely to audit prescribers of buprenorphine than prescribers of oxycodone.

"Regardless of how it's done, it's important to end the X-waiver," says Kate Nicholson, a civil and disability rights lawyer who founded the National Pain Advocacy Center. "If HHS doesn't have the authority, an amendment can be easily added to pending opioid crisis legislation….There is a clear evidence basis that buprenorphine reduces the chance that those suffering from opioid use disorder die from an overdose, and the additional regulations surrounding the drug are simply a double standard steeped in stigma against drug users….We need to reassess whether the interventions we've put forward have led to more deaths and focus on appropriately prescribing all opioid medications."

CORRECTION: The original version of this article incorrectly attributed a prediction about future regulation to Kate Nicholson. 

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  1. It’s good to see that these decisions are being made by government bureaucrats, rather than being left to competent medical professionals who treat patients.

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      1. During his first week in office, Biden also abolished a Trump-era rule that imposed CXza some measure of accountability on the federal bureaucracy.……..MORE READ

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    3. Who could be more competent than the top men running our bureaucracy?

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    4. Well, the faggots at this establishment were jerking their cocks so hard at getting rid of Trump, they didn’t stop to think.

      And of course, Bidet’s assministration is worse.

      1. old joe only says what the hand up his backside tells him to.

        1. The new administration nixes a change that would have allowed more physicians to prescribe buprenorphine.The Trump Administration didn’t attempt either approach to justify it’s guidelines, but argued HHS has the authority to “eliminate the requirement QVtz that physicians with a Drug Enforcement Administration (DEA) registration number apply for a separate waiver to prescribe buprenorphine for opioid use disorder treatment,” which would effectively cover almost all practicing physicians in the U.S..……..MORE READ

  2. Yeah, well, even if that’s true, Biden will make it easier to access abortion care. So he’s still better than Drumpf on health / medical issues.

    #LibertariansForBiden

    1. Brainless whataboutism, exactly your speed.

  3. HHS officials cited concerns about whether the department had the authority to issue guidelines that bypassed regulations set by Congress.

    Odd, that’s never happened before.

    1. That’s because no case has come to their attention of executive action that increased liberty while Biden was president.

  4. 275 seems like a lot. How’s a doctor supposed to remember which patients they’re supposed to hate? If they put it in the chart they could get sued. Maybe there’s some kind of secret code.

  5. Physicians already have a DEA license to prescribe controlled substances. If the states want to impose additional requirements that is up to them.

    1. That’s worked out well in NY with the Covid vaccine.

      1. States all impose education requirements on docs. They each have their own number of CMEs you need for renewal, generally every two years, and often their own requirements like you need 2 hrs of Opiate prescribing, patient safety, child abuse, stuff like that. A lot of the ones that have medical marijuana have special requirements to get a certificate. All of that goes through state medical boards.

        It is not generally a big problem even if you don’t deal with those things. Like if you are a pathologist or diagnostic radiologist who doesn’t prescribe anything or see patients directly. A booklet or online with a quiz. You get credit hours you need anyway and it is free or low cost.

        This is the first I have heard of the feds getting involved. The last thing you want is for congress or the president to dictate medical practice at the ground level.

        What is happening with Covid is a different issue.

  6. Another option would be to reschedule it to 5, removing the federal requirement for prescribing by any kind of health care professional. This too could be done administratively, since it’s so hard to get Congress to do anything unless it’s packed into some omnibus bill, usually for spending.

  7. On yet another issue (treatment for opioid addicts), Trump’s policies were more libertarian, humane and beneficial for America than those announced/imposed by Biden in the past three weeks.

    Had Reason not spent the past four years trashing Trump, and the past year endorsing Biden and Jorgensen, this policy change probably wouldn’t have occurred.

  8. And the U.S. Constitution gave the federal government the authority to regulate healthcare WHERE???????

    Pass an Amendment or tell them to F-OFF! A Government that doesn’t heed “The People’s” Supreme Law over them isn’t The People’s Government.

  9. I happen to be under treatment with Suboxone not for opioid addiction but for pain relief for level 10 pain which occurs near constantly here. Given that my doctor is the head of the addictions treatment unit, as well, I suspect the additional requirements are already met. What bothers me is that the VA has a policy of not treating long-term high pain levels unless you are in the last six months of life. Yes, I’m terminal, but not in that last category. So, what do they recommend as a treatment in place of Suboxone? Just deal with it? Been there, done that, more than a dozen suicide attempts and six/seven successful attempts where I was resuscitated against my DNR order. If I do lose my patches, it’s either black market opioids here or make damn sure that I do my next suicide properly, without possibility of medical care.

    1. Don’t do it, Briny! Hang in there tight, don’t give up the fight! “Black market opioids” is a valid choice! I hate the DEA and the micro-managing self-righteous political power-grabbing bastards as much as pretty much anyone else, but… Don’t let the bastards win! Hang in there, buddy!

    2. If you’ve not heard of it yet, check out “kratom”…

      https://www.practicalpainmanagement.com/treatments/pharmacological/non-opioids/kratom-primer-miracle-medicine-herb-abuse

      If our lords and masters don’t take it away from us really soon now, it seems that it MIGHT work for SOME people…

      1. Kratom literally saves lives. I used it to get off oxy and dilaudid.

    3. Kratom is the real deal. Look into it. Good luck. I really hope your quality of life can be improved at some point. Regards.

  10. But no mean Tweets so it’s all cool, right Reason?

  11. “Biden Restores a Barrier to Opioid Addiction Treatment”
    More dead and imprisoned citizens, always a goo thing to the left.

  12. Everybody must get stoned……

  13. Good choice talking up Biden and talking down Trump.

    So far you got your border EOs, and the rest is authoritarian bullshit.

    Which explains everything.

  14. Single Mom With 4 Kids Lost Her Job but…READ MORE

  15. Muh norms is why Reason told us to vote for Biden

  16. Do u wanna know about the post..READ MORE

  17. If you look at Biden’s policies as ones that will cause the most white people to die, they make sense. Otherwise they look bizzare. Occams razor dictates, the junta running the US want white people to die.

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