Posts Tagged ‘new HHS guidelines’

Never mind….

You know that blog I posted a few weeks ago, about DHHS’s decision to allow any physician with a DEA license to prescribe buprenorphine products for their patients with opioid use disorder? That idea has been nixed. SAMHSA said HHS’s decision to announce the change of regulations to have been “premature.”

I have no idea what political machinations were behind all of this, but Medscape’s webpage said loosening the restrictions was an idea put forward by Trump’s administration, and Biden’s administration cancelled that plan.

Many addiction medicine specialists were wary about the idea of loosening restrictions, fearful of the consequences if any physician could prescribe buprenorphine without the mandatory training course. That eight-hour course teaches providers about opioid use disorder in general and specifically about how to prescribe buprenorphine products from an office-based practice to treat that disorder. They say prescribers need this education, since for decades it was illegal to treat opioid use disorder from an office setting. Consequently, most physicians don’t know much about treating addiction, and may mistakenly think it’s the same thing as treating pain.

On the other hand, eliminating the need to take this course could encourage more doctors to prescribe buprenorphine products to treat opioid use disorders, thus expanding access to treatment.

I’m not sure what I think.

 On the one hand, I’ve seen providers with no training or “X” number prescribing all sorts of buprenorphine products for years, and not always with the diligence I would hope for.

For example, several months ago I reviewed a new patient’s data from the North Carolina prescription monitoring program. I saw the local pain clinic had been prescribing an extended- release full opioid agonist, along with a short-acting full agonist for breakthrough pain for many months. Then I saw the Butrans patch (contains buprenorphine) was added to this regime of medication.

I asked the patient what happened when they started the Butrans patch.

“Oh I found out I was allergic to it. It made me very sick. I felt like I was back in withdrawal. I can’t take that medication.”

Of course, that was no allergic reaction. That was precipitated withdrawal, predictable to providers familiar to the pharmacology of buprenorphine. But now this patient is convinced that buprenorphine in any form will make her sick under any circumstance. She was started on methadone and has done very well, but it is a shame she had to be put through that nightmare.

However, another prescriber, this one who took the eight-hour course and who has a DEA “X” number, starts all patients at a dose of buprenorphine/naloxone 32/8mg per day (four of the 8/2mg tablets) and tapers down over a period of several months until the patient is off the medication completely. Apparently this prescriber wasn’t paying attention to instructions given at the 8-hour training course about how to do induction. Or how to do maintenance. Or that most patients need much longer than several months on the medication to remain in recovery, and few need any higher dose than 16 to 24mg per day.

Then there’s another prescriber in town, also with her DEA “X” number, who accepts methadone patients from our opioid treatment program and starts them on buprenorphine without asking for any data from us. We only find out about the patient’s medical misadventures when their counselor calls them, to find out why they’ve missed days of treatment with us. The patient says he told the prescriber what dose of methadone he was currently on, and but prescriber asked the patient to miss one or two days of methadone before she started a sublingual buprenorphine product.

If they patient was on a dose of 40mg or less for at least a week, everything will go well. But if the patient’s been dosing at 110mg per day, per example, and missed a few days…things usually don’t go well. The patient ends up in precipitated withdrawal, which is completely predictable. If we are lucky, we can get them back into treatment right away.

At our opioid treatment program, we switch patients all of the time, though much more slowly. My usual “recipe” for switching involves tapering by 5mg per week, down to 40mg, where they dose for at least a week. Then the patient misses two days and sees me on the third day. If they are in sufficient withdrawal, with a COWS greater than 12, I feel safe starting them on buprenorphine. I usually end up dosing them with between 4 to 8mg on that first day.

Anyway, my point is that most of these prescribers, who took the eight- hour course, don’t necessarily do things as I would hope they learned in the course. But perhaps it would be worse if buprenorphine prescribers took no course.

My opinion about this issue rockets from one side to the other faster than a tennis ball at Wimbledon.

I can’t decide what I think. I read opinions from leaders in the field that say untrained prescribers could lead to disasters, and I know they are correct. Then I read from other leaders in the field that increasing access will save lives and I know that’s right, too.

I have no conclusion for this blog post. I’m just acknowledging uncertainty.

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