So Long X-Waver: What Will Change?

Eric Morse, M.D., D.F.A.P.A. 

As an addiction psychiatrist who has been treating Opioid Use Disorder (OUD) for over 20 years in both Opioid Treatment Programs (OTP), commonly known as methadone clinics like the Morse Clinics and Officed Based Opioid Treatment (OBOT) commonly known as Suboxone practices like Carolina Performance, I recently had to say good-bye to my X DEA number or X-waiver that I was assigned to in 2002.   The DEA even emailed me an updated DEA certificate with the same date of issue and expiration that removed my X-waiver as if it never existed.  Under the DATA 2000 Act, MDs and DOs who wanted an X-waiver were required to take an 8-hour training course either in person or online and then submit proof of that training to be issued a DEA registration that replaced the first letter of their DEA number with an X. This number was required to prescribe buprenorphine for OUD to be filled at an outpatient pharmacy. Under the CARA Act, PAs and NPs had to attend a 24- hour training to receive the X-waiver. The Data 2000 Act placed various limits on the number of patients who could be seen. With passage of the Mainstreaming Addiction Treatment Act in December 2022, any medical provider with a DEA number can now prescribe buprenorphine for OUD and now there are no limits on patient numbers. In the OTP, where we use stock bottles of buprenorphine and never needed an X-waiver, we never had limits. 

Now that any medical provider can prescribe buprenorphine, will they?

Sadly, probably not, but they should.  Stigma abounds, especially, in the medical community.  I did not learn how effective and easy using medications for OUD (MOUD including naltrexone, buprenorphine, and methadone) was until I started my Addiction Psychiatry fellowship at the University of Maryland.  Less than 10% of prescribers got their X-waivers and less than 40% of X-waivered prescribers ever wrote for buprenorphine.  Since COVID, any prescriber could prescribe buprenorphine without an X-waiver if you submitted an intent to train – very few prescribers did. 

Which “never X-waivered prescribers” will most likely start prescribing buprenorphine now

Buprenorphine prescribing is becoming the standard of care in emergency medicine when OUD is diagnosed. “But I do not have an X-waiver’’ is no longer an excuse! The same is true for nursing homes, jails, prisons, hospitals and substance use rehabs.  On April 5, 2022 the US Department of Justice published a statement that people who suffer with an OUD have the ADA right to remain on their MOUD.  I have filed my share of ADA complaints on behalf of my patients on since then.

Should all psychiatrists prescribe buprenorphine?

Yes, just like any other psychiatric medicine that treats a mental disorder.  You read, learn, and prescribe as you see the need for it.  You can at the very least, prescribe a few days’ worth of the medication and refer the patient to an OBOT or OTP.  Not doing so, will put your patient at a much higher risk of overdosing. We are in an epidemic.  If you are not part of the solution, you are part of the problem.

Where can I learn more about prescribing buprenorphine? 

In addition to the AAAP, ASAM and APA websites, you can read TIP 63 or the Quick Start Guide on the website. Alternatively, call or email me and I can help you. Help is also available thorough the NC Star program, directed by Robyn Jordan, MD, an NCPA member.

What should I do before prescribing buprenorphine?

Besides taking a thorough history and documenting like any other patient, I suggest doing a urine drug test.  I buy instant drug test cups online for $3 a cup if you buy more than 25 of them. If you plan on seeing a patient more than once for buprenorphine, you may want to work with a send out lab to do confirmatory testing when a patient contests a result or says they are using something that is not in the test cup (like certain Benzos or Fentanyl).

What is a standard dose of buprenorphine?

The national average is about 12 mg a day.  The usual dose range is 8 – 24 mg a day, but 16 mg is the usual starting dose.  Most patients have tried it off the streets and can tell you what they need.  If that number is between 2-24 mg a day, most buprenorphine prescribers will start there. Most buprenorphine prescribers will usually see people weekly until they pass their drug test, then add a week up to 4 weeks.

Wait, if every prescriber starts prescribing buprenorphine, won’t that put Dr. Eric Morse out of business?

Yep, probably.  Please put me out of business!

Might there be unintended consequences of removing the X-waiver?

I worry that medical schools and residency programs that were insisting that their graduates do the X-waiver training, will stop training on MOUD especially if the funding for it stops.  Will SAMHSA maintain the buprenorphine medical provider locator?  I also worry that lower quality prescribers, especially online services (go Ryan Haight Act, go!), that were previously limited to 275 patients per prescriber will far exceed that number and the DEA and Medical Boards will not be able to track  the buprenorphine prescriptions as easily.  I am a big believer in lowering barriers and improving access to care so long as there is still some quality to the care.



How to Contact Eric Morse, MD:

DEA Q&As - Elimination of X-Waiver & Limitations on OUD Patients

Question: In light of the elimination of the DATA-Waiver (X-waiver) requirement, do I need to take any action to get an updated DEA registration certificate? 

Answer: No action is needed on the part of registrants, as a result of the statutory repeal of 21 U.S.C. 823(h)(2).  On December 29, 2022, with the signing of the CAA[i], Congress eliminated the DATA-Waiver requirement.  Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, § 1262(a)(1), 136 Stat. 4459, 5681 (2022) removed the federal requirement for practitioners to apply for a special waiver prior to prescribing buprenorphine for the treatment of Opioid Use Disorder (OUD).  It also removed the requirement for the assignment of an identification number (i.e., X-waiver number) associated with being a DATA-waived provider, for inclusion with the registration issued to the practitioner.  21 U.S.C. 823(h)(2)(D)(ii). EO-DEA260, DEA-DC-067, March 22, 2023.

[i]  Pub. L. No. 117-328, 136 Stat. 4459 (2022).

Question: Are there any limitations on the number of patients with OUD that a practitioner may treat with buprenorphine after the passage of the Consolidated Appropriations Act of 2023 (CAA)?

Answer:  After enactment of the CAA,[ii] there are no longer limitations, under federal law, on the number of patients with OUD that a practitioner may treat with buprenorphine.  On December 29, 2022, President Biden signed into law the CAA which expanded patient access to medications for OUD.  Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, § 1262(a)(1), 136 Stat. 4459, 5681 (2022) amended the Controlled Substances Act by repealing the “DATA-Waiver” requirement codified in 21 U.S.C. 823(g)(2), which had previously imposed limits or patient caps on the number of OUD patients a prescriber may treat with buprenorphine.  These limits were previously outlined at 21 U.S.C. 823(g)(2)(B)(iii), and allowed qualified practitioners to treat up to 30, 100, or 275 patients at one time.   EO-DEA263, DEA-DC-066, March 21, 2023.

[ii]  Pub. L. No. 117-328, 136 Stat. 4459 (2022).