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.
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.”
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.”
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That’s wonderful, as they are on their way out the door. Glad they could find it in their hearts to help addicts further. Their plight is and should be one of the top concerns of the U.S. Govt’. However, what is that going to do for the Chronic Intractable Pain folks who have lost all access to their medications? AFTER THE VERY Harmful 2016 CDC Guidelines were made law of the land and a “standard” on how to treat anyone with Rare Incurable Disease. The one size fits all attitude of our Govt’ was a sure, to be a dangerous , noneffective way to handle the most vulnerable population in the U.S. We were/are left at the curbsides to our own devices after decades on Compliant/Effective Rx Opiate therapy. Thousands already died due to medical breakdown & suicide. Their families broken up lost homes, jobs and QOL due to being “Medical Refugees.” None, of which, was their own doing.
My experience is a bit different. Several of my patients were on methadone previously and experienced tolerance and dose escalation to a level that left them dysfunctional. I almost never see a patient even ask for more than 24 mg/day of buprenorphine, only one takes 32mg/day which is still in the approved range.
The effectiveness of buprenorphine for treating OUD is exaggerated. Due to the complex pharmacology of this substance, i.e. as a partial opioid agonist with a ceiling effect, it really isn’t suitable for maintaining many opioid addicts. This includes many users of heroin and especially addicts who are heavy users with higher tolerances. Diversion is rampant due to over-prescribing. Anectodally, a number of addicts prescribed buprenorphine sell it and/or use it as a last resort comfort med when their opioid of choice isn’t available to them. For those who are opioid-naive a 2 mg dose could be toxic.
This is not to say it isn’t effective for anyone. It is more effective for those who haven’t been using very much or for very long. But it still has it’s own withdrawal syndrome which is lengthened due to the long half-life of the drug. Furthermore, it simply is not supplied in dosage forms conducive to tapering from the medication.
Methadone is the better choice for many addicts. But it is quite strictly regulated, unable to be prescribed for OUD outside of specialized clinics and more heavily stigmatized.
What is really needed are more options besides buprenorphine or methadone for maintenance therapy, or at least during medically supervised tapers at detox centers.
Gary, I couldn’t agree more ! Addicts need MUCH more than 30 or 90 day programs in order to be successful. Much o their issues are laid on the laps of their families. They need dual Diagnosis Programs in order to be successful. They must be moved away from their familiar surroundings to regain any sense of a normal life. Suboxone is another cure all solution drummed up by Dr. Kolodny in a way to line his and others’ pockets. People will only have the shade pulled down on them for so long. Getting well means no more pills to replace other drugs. I can see the part of detoxification but after that , who is it benefitting?
For Gary & Carol Benack.
Your comments on Buprenorphine (bup.) took me by surprise. I was addicted to opiates for 12 years. By the time I went to rehab, I was taking 8 to 12 percodan as one dose, at least 2 to 3 times a day. I was found near death many times. I had initially begun taking opiates to relieve back pain, which was the result of an injury.
I went to an excellent rehab center in Grapevine, Texas, to be medically withdrawn from opiates. The Dr. used suboxone to facilitate withdrawal. Before I had completed my 30 day treatment, the staff took me off the Bup, at a gradual pace. I was finally free of opiates.
However, I was still dealing with chronic pain, and after trying several other options (Chiropractor, Physical therapy, anti-inflammatories, and homeopathic remedies) I was miserable. I had come to HATE Opioids. My life on opiates was in tatters. Once I was freed of opiates, I had NO desire to start taking them again, but I was in chronic pain. Finally, a Dr. Zrecommend I try the buprenorphone as part of my plan to deal with the pain. I started on 16 mg a day. My pain was still there, but manageable. I’ve had a great., full life since then. I worked full time, teaching elementary school, for a decade, volunteered, raised (ing) my 2 grandkids as a single parent, & cared for my elderly mother for seven of those years. I do Zoom meetings with others who are living a full life while on bup. Most of them are heroine addicts. It’s not a perfect solution, but it beats the HELL out of chasing a high, being numb to life, shaming your loved ones and hating yourself!
As far as withdrawals, they are mild in comparison to the opioids that take one’s life completely over.
Interested physicians must keep in mind that there are clinical issues with treating those with Opioid Use Disorders (OUDs) that have legal ramifications. Care must be taken to follow the administrative requirements noted in the new guidelines. Because they will be treating people with OUDs with a controlled substance, their records must be able to survive a DEA audit. Note that the guidelines require that charts for patients being treated for an OUD must be maintained separately from charts for patients who are not being treated for an OUD to ensure confidentiality pursuant to 42 CFR Part 2. I hope that these new providers have EHRs that would allow for this.