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WASHINGTON — The Trump administration announced a major shift in addiction medicine policy Thursday, giving doctors dramatically more flexibility to prescribe a popular and effective drug used to treat opioid use disorder.

The change will allow almost all physicians to prescribe the addiction drug buprenorphine, regardless of whether they’ve obtained a government waiver. Previously, doctors had to undergo an eight-hour training and receive the license, known as the “X-waiver,” before they could prescribe buprenorphine. For years, addiction treatment advocates have argued that tight buprenorphine regulations prevent thousands of doctors from providing high-quality addiction care.

The announcement represents a sea change in addiction medicine during the final days of the Trump administration.

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Some drug policy officials have long resisted the deregulation of buprenorphine, citing its status as a controlled substance. But in a Thursday press briefing, assistant health secretary Brett Giroir told reporters that the rising level of drug overdoses in recent years, and especially in light of the Covid-19 pandemic, compelled the administration to act.

“Many people will say this has gone too far, but I believe more people will say this has not gone far enough,” Giroir said. “This is a measured, logical, appropriate, evidence-based, and patient-centered intervention that may save tens of thousands of lives.”

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The new policy will allow any physician with a Drug Enforcement Administration prescriber license to treat up to 30 in-state patients with buprenorphine. Hospital-based physicians will be exempted from the 30-patient cap, and doctors can still treat up to 275 patients with the drug if they undergo the training and receive a separate waiver. It does not impact nurse practitioners or physician assistants, who will still need to apply for separate waivers to earn buprenorphine prescribing privileges.

As of now, only 66,000 physicians and another 25,000 prescribers like NPs or PAs have an X-waiver, Giroir said.

Numerous researchers, doctors, addiction treatment advocates, and members of Congress have long advocated for eliminating the waiver and allowing physicians to prescribe buprenorphine as they would any other drug. One common argument: Doctors who prescribe potentially addictive opioids should be permitted to treat the addictions that sometimes develop.

A bill introduced in 2019 by Rep. Paul Tonko (D-N.Y.) that would have eliminated the X-waiver had 117 House co-sponsors, including 23 Republicans. Giroir cited the bipartisan support for buprenorphine deregulation, but acknowledged Congress hasn’t yet passed a bill. He said Covid-19 created an “urgent need” that meant waiting wasn’t an option.

“Nullifying this waiver requirement and making it easier for physicians to prescribe buprenorphine, even to a limited number of patients, will save countless lives,” Tonko said in a statement.

Health secretary Alex Azar implemented the new policy by issuing an update to practice guidelines for buprenorphine treatment. Since they are not codified in a new law or in a federal regulation, the new guidelines are easily reversible. The incoming Biden administration, however, is seen as sympathetic to the changes and unlikely to reverse them. “I doubt it seriously,” Giroir said.

The change represents one of the biggest addiction policy overhauls in President Trump’s four-year term. It is also likely the final major policy initiative put into effect by Giroir, Azar, and director of national drug policy Jim Carroll, all of whom will leave office on Jan. 20 upon President-elect Biden’s inauguration.

The move earned quick support from doctors. In a statement, the American Medical Association lauded the effort, citing estimates that though over 2 million Americans need treatment for opioid addiction, few receive quality care.

“The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder,” Patrice Harris, the organization’s former president, said in a statement. “Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it.”

  • Well for doctors making an 8 hours training is to much…,poor people! How can we ask them to loose their precious time for a course. This deregulation goes in favour for doctors not patient for sure. I working in a lab had to do abtraining to work with mice and for a doctor is to much a training like that. Ashamed, phisicians are too lazy and don’t care to be constantly updated and learn in order to give the best care. Shut up and take the training.

  • Nonsense. Any physician who wants to prescribe it has been able to since 2002. There has never been a barrier nor any onerous regulation. It’s a one page online form after an eight hour course. If doctors wanted to do it they would already be doing it.. They’re just eliminating the minimum basic training needed to begin prescribing. It will improve care the same way eliminating driver ed would improve the skill of drivers. And yes, the training course imparts about the same level of skill as driver ed does.

  • This is to benefit Big Pharma. Suboxone and other buprenorphine drugs are very expensive. Where as opiates are cheap. Buprenorphine is highly addictive and the withdrawal much worse than that from opiates. Buprenorphine is now commonly given to patients with severe, life disabling pain who can only function with opiates. It however, has a mild pain relief action. It is the Methadone of this generation, an addictive drug used to treat addiction.

  • Thank you Trump for getting to the root of the cause, trying to end addiction is a huge step in the right direction. I doubt the msm will be talking about this much

  • I retired from my medical practice in 2006. I also had a DEA waiver which allowed me to prescribe suboxone (30 patients at that time). Supposedly less addictive than methadone (but still addictive ), it avoided the stigma of methadone which had been an underused medication allowing addicts to function in society. Now the pharmaceutical industry is pushing its latest addictive drug . I have seen horrible reactions including strokes, brain damage and more when patients and physicians are not aware of proper prescribing practices for this very serious medication.

    • Absolutely true. I have seen status seizures and stroke with withdrawal from this addictive drug. It is another Methadone: an addictive drug to treat addiction. It is also expensive thereby profiting Big Pharma.

  • This drug is a life changer and a life saver. I’m surprised and heartened to see that it’ll soon be available to more people. It WORKS and needs to be an easier-to-obtain option for people struggling with addiction.

    • I absolutely agree. The physicians who specialize in su ozone also exploit patients financially enormously on Long Island. It is all cash pay as soon as you walk in the door for hundreds of dollars w no insurance coverage. In addition, visits several times a week are required. I was in over thousands of dollars. My primary care physician knows my medical history whereas this doctor did not and he should be the one prescribing the Suboxone if I ever need it again. The dose given to me from that other doctor was so high that I fell twice, hitting my head on a hard surface. The side effects were horrible. I have many friends who are addicted to opiates and need suboxone and if they can go to their Primary care physician for treatment they would. And so, now that aren’t able to and like so many others can lose their lives as a result of this. It’s all about money!! There needs to be more lobbying to change legislature!!

  • Physicians with poor training helped create the opioid crisis, and yet now we have policy to allow those with no training in opioid dependence treatment prescribe buprenorphine? Common on…it is an 8-hour CME (credits you need anyway to maintain your license). If you aren’t willing to take a simple course to learn how to use this type of medication, you have no business prescribing it

  • I have serious concerns about this also. The pharmacology of buprenorphine is extremely complex and the prescribing guidelines and formulation (with naloxone) are left over relics from a very dishonest drug company which resulted in a record fine with the Federal Trade Commission. The dosing guidelines are motivated by profit but cause this drug to be most often over prescribed with regard to dosage. Transiting to this medication from illicit drugs is not well understood by the current prescribers. Point is that existing prescribers are making numerous mistakes having taken this training which is obviously inadequate. Untrained physicians will be understandably mislead by the product monograph which is intentionally full of misinformation.

    • I live in a location where for a number of years there was only one doctor qualified to prescribe suboxone for the entire eastern half of the state. As he was approaching retirement, he was forced to offer a large bonus to any doctor willing to take the 8 hour course. So I say opening the door for addicts in dire need is a very welcome change for the better.

  • As a board-certified addiction specialist, I have serious concerns about this legislation. Patients presenting with opioid use disorder can be very complex and unstable, and poorly managed care can result in hospitalization or death. Existing regulations are not stringent, requiring only an 8-hour online course to ensure a basic understanding of how these medications are properly utilized. This is a low hurdle for those genuinely interested in managing patients with OUD. We must always consider the unintended consequences of our actions. I am reminded of the “pill mills” of the recent past, and pray that this shift in policy does not result in the “Suboxone mills” of the future.

    • But most doctors can prescribe opioids. When my son was alive, we struggled hard to find a doctor who could prescribe suboxone. Finally we did, and my son lived a relatively normal life for several years. Unfortunately, he was incarcerated and not allowed to continue his suboxone and passed away within days of being released.

    • Any doctor prescribing a controlled substance has a potential target on their back. The government is using the CSA against anyone they want, for money and jobs. Learn the truth on Doctorsofcourage.org. There is no such thing as a “pill mill”. Support your colleagues. Don’t attack them.

    • I agree. The comorbid presentations and psychosocial aspects that are tandem compel an integrated approach not a doc in the box.

    • Absolutely true. I have seen status seizures and stroke with withdrawal from this addictive drug. It is another Methadone: an addictive drug to treat addiction. It is also expensive thereby profiting Big Pharma.

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