Health and Human Services Seeks to Expand Buprenorphine Services

Last week, the U.S. government’s Department of Health and Human Services announced new guidelines intended to expand access to treatment for patients with opioid use disorder. [1]

 My reading of this announcement is that HSS is exempting prescribers from obtaining a waiver to prescribe buprenorphine products from office-based practices. It appears to mean that physicians no long must take the eight-hour training course that is necessary to get a DEA “X” number waiver. Physicians only need a valid DEA license that covers prescribing Schedule III controlled substances. Physician extenders such as nurse practitioners and physician assistants must still go through the extra training already in place, however.

Non-waivered physicians can start prescribing buprenorphine products to up to thirty patients at any one time. The thirty-patient cap doesn’t apply to hospital-based physicians like those working in emergency departments.

This change applies only to buprenorphine products and does NOT apply to the prescribing of methadone for opioid use disorder. That medication must be prescribed from an opioid treatment program, as it has been.

HHS says that physicians can only prescribe buprenorphine products to patients residing in states where the physician is licensed and must keep separate charts for these patients. I think both things are already required. If they want to prescribe for more than thirty patients at a time, they will need to get the usual DEA “X” number. Prescribers must also put an “X” on the prescription to indicate it is being prescribed for opioid use disorder and not for pain.

HSS also says an interagency group will be formed to monitor implementation of these services.

For the past twenty-one years, we’ve tried to convince medical providers that instead of viewing opioid use disorder as a crime, we need to treat it as the chronic medical problem that science shows that it is. Trying to reverse a near-century of bad policy (the time from passage of the Harrison Act until the DATA 2000 Act) has not been easy.

Then our present epidemic of opioid use disorder with its corresponding epidemic of death started at the end of the 20th century and it grew like cancer into this century.

This has been a tough year for more than just COVID deaths. A record number of people – around 83,000 – died from opioid overdoses over the twelve months ending in June of 2020 in the U.S.

 We know prescribing buprenorphine products (or methadone, by the way) to patients with opioid use disorder is life -saving. Mortality is reduced at least three-fold by the most conservative estimates. I challenge anyone to name any other medical intervention that has such an impact and reduction of mortality. Yet medical providers haven’t been enthusiastic about providing this treatment. Old ways of thinking have been hard to challenge.

The new guidelines intend to loosen restrictions on prescribing buprenorphine products. People in the government fear that the eight-hour course to get a special DEA number is keeping physicians from prescribing buprenorphine products. Many patients with opioid use disorder have a hard time finding prescribers with the waiver to treat, and the Department of Human Services wants to make it easier for these patients.

Both the American Medical Association and the American College of Emergency Physicians praised the change in policy.

Not surprisingly, I have some thoughts about this change in HSS policy.

Weirdly, my first thought was, “Wow, someone is going to have to tell all the CVS pharmacists because they are going to lose their minds about this.” Readers of my blog may recall the comical insistence of CVS pharmacies that providers to include a “NADEAN” number in a specific format before they will fill any buprenorphine product.

Overall, I agree that dropping training requirements may make providers more willing to prescribe buprenorphine products. Providers may not be as educated about buprenorphine before starting to use it, but other than causing precipitated withdrawal, it’s hard to kill anyone with it.

We experts may not like to admit it, but just providing the medication saves lives. Even with no psychosocial counseling and very little provider interaction, lives are saved if patients just take the medication. Ideally, the medication should be provided in concert with counseling, but some patients aren’t interested in counseling, for whatever reasons.

There may be diversion if physicians with little experience miss evidence the patient is selling medication. I hate to see diversion, even as I recognize the benefits of buprenorphine when used off the black market. I also know that every day a person with opioid use disorder takes buprenorphine instead of fentanyl, the risk of overdose is decreased. And that’s worth a lot.

Will dropping the eight-hour training requirement prompt more physicians to prescribe buprenorphine? Perhaps, but as I said above, it’s hard to convince doctors that this is a disease that can and should be treated, and not criminalized.

Here’s the biggest value I see with these new guidelines: hospital-based physicians can prescribe buprenorphine without needed the “X” DEA number.

For years, I’ve wished our local emergency department physicians would start buprenorphine when they see patients with opioid use disorder. They have not, partly because they say they don’t have the required “X” number, and partly because they say they don’t have anywhere to refer patients newly started on buprenorphine products.

This new guideline will eliminate the first problem, and the second problem has already been solved. Our opioid treatment program does intakes five days per week, Monday through Friday. Even if the patient is seen on a Friday night, the emergency department physician could write two days of medications to last until we can evaluate and admit the patient on Monday.

And there are three or four office-based providers of buprenorphine in the community now, as well as another good opioid treatment program. Surely we can all get together to make a plan to admit a patient to treatment very quickly.

I plan to keep pushing for this, because the studies show the reduction in the risk of overdose and death. At some point, it will be malpractice NOT to provide life-saving treatment to people with opioid use disorder.

Hopefully we will continue to make progress. That’s why I started this blog in 2010. I wanted a platform to tell people about the mountain of evidence to support the treatment of opioid use disorder with medications and get patients and providers interested.

Change takes time.

And change also takes patience and perseverance.

  1. https://www.hhs.gov/about/news/2021/01/14/hhs-expands-access-to-treatment-for-opioid-use-disorder.html?mc_cid=d21a328f2d&mc_eid=9c7edff92d

13 responses to this post.

  1. Posted by Stuart Gitlow MD on January 19, 2021 at 1:19 am

    Great review, but wanted to clarify one point. You wrote: “HHS says that physicians can only prescribe buprenorphine products to patients residing in states where the physician is licensed ….” Actually, the word “residing” is not in the HHS materials. What the Federal Register entry actually says is “located” where the physician is licensed, leaving it open to interpretation as to whether this has anything to do with residence. For instance, a patient in Wyoming comes to see a doctor in his Colorado office. The patient is now located, but does not reside, where the physician is licensed. I interpreted the regulation as being meant to avoid the potential use of telemedicine for long distance treatment, but you raise another interpretation which is that this is a residence and state-rights issue.

    Reply

    • Thanks Stuart. I didn’t catch that difference. I too thought they were trying to avoid having telemedicine overtake the field.

      Reply

    • Stuart –
      Great information but this is why they all need to be tried for conspiracy and so many patients died of endocarditis and for 20 almost year’s people just didn’t believe their patients who injected buprenorphine and that we were crazy,
      I am so happy you let people know the truth.

      Reply

  2. Posted by Matthew McClure on January 19, 2021 at 2:20 am

    I don’t know the actual # but thousands of physicians with a waiver have never written a prescription for a buprenorphine product. Will easing the waiver restriction help? I am skeptical.
    Lifting the cap completely would have the most immediate impact in my view. Let those of us that are interested treat as many as we are comfortable with.
    After all, Paul Pain Doc down the road has 500 people on opiates and they didn’t need any special disposition.

    Reply

  3. Posted by Mark Wulff on January 19, 2021 at 6:41 am

    I live down under and I understand that the US and Australian health systems are vastly different but I think it is really sad the decision hasn’t come sooner.

    Thousands of people have died needlessly because of lack of access to buprenorphine.

    As you all would be very aware, France made that decision in 1995.

    Within four years, overdose deaths had declined by 79 percent.

    I understand there are more details to that percentage but that basically is the statistic.

    I also know that there are other contributing factors as to why buprenorphine isn’t widely available – we have doctor surgeries and pharmacies here in Australia that don’t want to provide MAT because they don’t want ‘THAT TYPE’ on their premises – sadly stigma is alive and well.

    That judgment is based on complete ignorance about all aspects of addiction and a complete lack of compassion for suffering human beings.

    Add to the mix the ignorance about buprenorphine and it is a roadblock to preventing so much human misery and suffering.

    You still hear that is only ‘swapping one addiction for another’ and then you have organizations like NA that discriminate against people on MAT.

    Opposition to buprenorphine is tantamount to passing a death sentence.

    It might not be ‘Medical Malpractice’ to not provide life-saving treatment to people with opioid use disorder at this point in time but history will show that it is certainly ‘Human Malpractice’.

    When did the world become so hard hearted?

    Reply

  4. Posted by Michael Lindgren on January 19, 2021 at 11:08 am

    I just want so say that I love your blog. Its super informative and its not that common to se a doctor as involved in its patients as you are.
    You’re an advocate for all of us suffering from the horrific downsides of opioids.

    I’m following you from Sweden and we have a Healthcare system that is top notch and suoer modern in so many ways. Surgery doesn’t cost anything at all, we have cheap or free medicine, we don’t have to have health insurance because every single person in this country has the right to be provided the same treatment.. The list goes on and on. Except! opioid use disorder treatment. Its quite hard to get into this program here, but its starting to loosen up and be more widely practiced among doctors.

    It’s great to hear these news from the US and I’m happy for all the people in the United States that will benefit and be able to continue to live their lifes because of this lifesaving treatment.

    Keep blogging! Its inspiring and interesting to read all your posts. Thank you so much for all your effort and help!

    / Michael

    Reply

  5. Posted by Bradwell McAlister on January 22, 2021 at 12:18 am

    I understand the benefit of increased availability of buprenorphine but having physicians prescribe a medication they don’t understand for a condition they don’t understand to a patient they don’t really know just because it probably won’t kill them doesn’t seem to be a good idea. Addiction treatment is not a prescription. If a PCP wants to treat addiction in his community, eight hours of information on buprenorphine and it’s use in addiction is a ridiculously low expectation. Learning about diversion clues, drug screening, DEA monitoring, using the PDMP, these topics are the bare minimum needed to prescribe buprenorphine. When the DEA shows up at your office for a buprenorphine patient audit, you will be glad to have studied the regulations so you are prepared. I have been through a few of these, having prescribed buprenorphine for more than 10 years.

    Reply

  6. Posted by Matthew McClure on January 29, 2021 at 3:26 pm

    “I have been through a few of these,” That could be a whole column describing what that was like. The only contact I have had was to get my waiver, increase to 100 and then a couple of years ago I was able to get an emergency increase to 275 when a colleague left abruptly. Never had anyone come to the office and I have been doing this for 8 years.

    Reply

  7. Posted by Matthew McClure on January 29, 2021 at 3:28 pm

    According to HHS the rule modification has been rescinded and will undergo further review.

    Reply

  8. Posted by Trudy Duffy on February 5, 2021 at 4:16 am

    Thank you. I always appreciate your insight.

    Reply

  9. Get ready to reprint this next week when. X waiver is gone 03/6/2021

    Reply

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