Buprenorphine relaxation of regulations

[whopper]

Back in March 2020 the DEA relaxed regulations for drug testing with Buprenorphine. It allowed for more telemedicine, less in person visits and less testing.

Well it's been over a year and I don't see any updates. I've looked at the SAMHSA websites and don't see any. If anything more relaxation occurred. Now I'm getting paranoid that they've made new regulations or restarted prior regulations that I'm not aware.

I'm going to give SAMHSA a call this coming Monday. Anyone know of any new updates more recent than 6 months? Are any regulations back up?

---

Members don't see this ad.

 

[PikminOC]

Back in March 2020 the DEA relaxed regulations for drug testing with Buprenorphine. It allowed for more telemedicine, less in person visits and less testing.

Well it's been over a year and I don't see any updates. I've looked at the SAMHSA websites and don't see any. If anything more relaxation occurred. Now I'm getting paranoid that they've made new regulations or restarted prior regulations that I'm not aware.

I'm going to give SAMHSA a call this coming Monday. Anyone know of any new updates more recent than 6 months? Are any regulations back up?

I thought they even waived taking the class to prescribe it. Not sure.

 

[dl2dp2]

No change on telemedicine. In fact the relevant agencies are looking to make this carve out permanent.

 

[littlefred]

Curious, what is the DEA regulation for drug testing when prescribing buprenorphine?

 

[reca]

I thought they even waived taking the class to prescribe it. Not sure.

They did, for like a week. You didn't need an x-wavier anymore. Then they nvm'ed it.

 

[hallowmann]

I thought they even waived taking the class to prescribe it. Not sure.

They did, for like a week. You didn't need an x-wavier anymore. Then they nvm'ed it.

You can request an X-number and indicate that you will be using the "Practice Guidelines" and submitting a Notification of Intent. Essentially this opens up prescribing for up to 30 patient at any one time. You cannot increase that to the 100/275 patient unless you actually complete THE training. Here's more info on it: Become a Buprenorphine Waivered Practitioner

 

[whopper]

I'll be more specific. I've had patients on Buprenorphine for years without any dirty drug tests, many have lowered to every small dosages such as 2 mg daily but despite my encouragement don't want to stop the medication.

So these patients I felt comfortable not testing them every single month. Maybe every few months.

So then with the COVID relaxation of guidelines it stated you didn't have to drug test even close to monthly, in fact you didn't have to test, unless you felt the need to do so. What I did was still test at least monthly for the first 6 months for new patients but then play it by ear.

Like all regulations, if you drop your guard, some might pop back up or new ones might start and if you don't keep up with it you might be out of compliance. So I've been somewhat hypervigilant wondering if the DEA/SAMSHA is going to drop the relaxed guidelines especially since the Omicron surge has recently died down but I hear nothing of it.

This is not a case of "no news is good news." It could be that the guidelines were restarted but I didn't know about it and it's not like the FDA/DEA or state medical authorities go out of their way to tell you they changed things around.

I work in an addiction clinic and the state I'm in changed some guidelines December 31st. Turned out despite this I was always in compliance. The new guidelines only affected doctors who were at the time of practice out of the state who were seeing patients in Missouri and operating with a Missouri license via telemedicine or telephone.

But for a week, a compliance officer in the organization I work in created a lot of histrionic buzz that turned out to be not true at all that we were out of compliance and there was going to be hell to pay. The guidelines that needed to be followed if you were out-of-state, she said because I wasn't doing them I was out of compliance. Also told NPs and a PA in that organization they were out of compliance too. A PA in the organization had a panic-attack and quit his job fearing he'd lose his license.

I had to damned get all the laws spend about 12 hours reviewing all of them, the new guidelines, get another compliance officer within the same organization and our organization's lawyer and it turned out we were always in compliance. It clearly said the new guidelines were only for doctors with a Missouri license but were outside the state while practicing with the patient in Missouri via telemedicine or phone. (Ouch the first compliance officer I mentioned was fired because this wasn't the first time she created a hysteria). The specific guideline stated that if the provider was not physically in the state that provider had to see the patient at least once in-person. Telemedicine wasn't good enough, but if the provider was in-state telemedicine only was fine.

I did contact SAMHSA as I said I would and after being put on hold for over an hour I just quit that attempt and I'm going to consider e-mailing them to make sure I'm following all the guidelines.

 

[theduderino]

as far as I know, there aren't concrete rules on how often to do drug tests when prescribing buprenorphine products. of course standard clinical practice involves increasing quantities of the script (weekly, biweekly, monthly etc) that coincides with quantity/quality of clinical stability but this isn't mandated by the DEA or SAMHSA.

 

[littlefred]

as far as I know, there aren't concrete rules on how often to do drug tests when prescribing buprenorphine products. of course standard clinical practice involves increasing quantities of the script (weekly, biweekly, monthly etc) that coincides with quantity/quality of clinical stability but this isn't mandated by the DEA or SAMHSA.

I have never seen DEA regulations on drug screening for prescribing scheduled drugs in an outpatient setting. I've seen some wording in that the physician can waive the testing with adequate documentation, but no frequency or anything like that is mentioned.

I have seen drug screen regulations on the code of federal regulations for OTPs (e.g. 8 UDS per year minimum).

A lot of clinics go by hearsay, I'm curious to see of this regulation you are referring to.
Maybe it's a Missouri state regulation?

 

[SeniorWrangler]

I think there was a Trump-era plan to significantly relax Buprenorphine regulations which has died in the Biden administration but I can't remember the details. What is a bigger deal for me is that the Ryan Haight Act was relaxed during the pandemic with promises that it would be fixed, and guess what? It never was, and now the rules are kicking back in, so all our Telehealth patients will have to be reviewed to make sure they've had at least one in person visit.

 

[littlefred]

I think there was a Trump-era plan to significantly relax Buprenorphine regulations which has died in the Biden administration but I can't remember the details. What is a bigger deal for me is that the Ryan Haight Act was relaxed during the pandemic with promises that it would be fixed, and guess what? It never was, and now the rules are kicking back in, so all our Telehealth patients will have to be reviewed to make sure they've had at least one in person visit.

Ryan Haight ain't coming back any time soon.

 

[whopper]

Ryan Haight Act is the federal law that says you can't do controlled substances without at least 1 in-person meeting. It was relaxed during COVID. Since then and this is what's ticking me off, I don't want to be in a situation where they take off the relaxation without me knowing.

 

[trophyhusband]

Ryan Haight ain't coming back any time soon.

I don't think they have the option to not bring it back. Once the public health emergency is over the waiver has to end (though I think they can give 90 days of leeway or something). CMS's Office of the Actuary has told health plans their current assumption is that the PHE will end at the end of June.

 

[whopper]

From my experience of reviewing several forensic cases and reading some actual text of the Haight Act, if the relaxations are dropped and some doctors aren't aware of it for some brief time, there very likely won't be any harmful consequences.

It happens a lot. E.g. a law is changed or even still in effect and the doc wasn't following it to the letter but no harm caused. Most of the time the law doesn't get involved. In cases where the doctor didn't know, was trying to do the right thing, usually the court is very lenient to the point where charges are almost always dropped. The Haight Act also has text stating that there will be penalties if the provider "knowingly" violated the law. So if they brought back the original regulations into full effect and a doctor found this out weeks to months later, in the interim they were unknowing.

 

[trophyhusband]

From my experience of reviewing several forensic cases and reading some actual text of the Haight Act, if the relaxations are dropped and some doctors aren't aware of it for some brief time, there very likely won't be any harmful consequences.

It happens a lot. E.g. a law is changed or even still in effect and the doc wasn't following it to the letter but no harm caused. Most of the time the law doesn't get involved. In cases where the doctor didn't know, was trying to do the right thing, usually the court is very lenient to the point where charges are almost always dropped. The Haight Act also has text stating that there will be penalties if the provider "knowingly" violated the law. So if they brought back the original regulations into full effect and a doctor found this out weeks to months later, in the interim they were unknowing.

I can see what you're getting at, but the doctor knows the law is waived because of the PHE and the ending of the PHE will be pretty widely known. So I don't know if saying I didn't know the waiver was going to end when the PHE ended is going to get you very far. I don't know that the DEA is going to go out checking on this right away or anything so it's probably fine.

Interested to see how quickly they start checking on these online pill mills though. We have a plan in place to start asking a lot of questions of anyone trying to join the wife's practice who are currently on controlled substances once the Haight Act is back in effect. We haven't run into any patients who are coming from one of these places yet but we want to be prepared just in case they start shutting down en masse.

 

[whopper]

It all depends. Sometimes regulations change in medicine without it being widely known. I would imagine, however, in the case of the Haight Act it will be very widely known as you mentioned because it's impact will be very consequential.

 

[SubzDoc]

I just heard at work there is a tentative target date of 7/15 (with the end of the current emergency declaration) to end the exemption and that there will be a 60 day notice coming soon. But I work for the VA, so that information is almost certainly wrong.

 

[milesed]

It looks like the date has been extended 90 more days to last until Oct 13th