2023 update: The Biden administration enacted rules allowing prescribers to prescribe therapies for opioid addiction without the need for a DATA 2000 waiver. Because of that, some of this information is outdated, but is being left up for informational purposes. You can read more about the update here.
The Drug Addiction and Treatment Act of 2000 (abbreviated "DATA 2000") was passed to expand the conditions under which physicians could provide medication-assisted treatment (MAT) for opioid addiction.
Prior to the passage of this law opioid addition had to be managed within an opioid treatment program, so by reducing the regulatory burden the law allowed for more physicians to provide MAT.
Under the law, physicians (and more recently, with the passage of the Comprehensive Addiction and Recovery Act, nurse practitioners and physician's assistants) can apply for a waiver from registering under the Controlled Substance Act as an opioid treatment facility if they are prescribing medications in schedules III, IV, or V that are FDA-approved for the treatment of opioid addiction.
Because methadone is a Schedule II, that basically means buprenorphine products.
Here are the top things to know about DATA 2000 in the community pharmacy.
Physicians without a DATA 2000 waiver can still use buprenorphine for pain
DATA 2000 does not limit the ability of prescribers to write for buprenorphine off-label for pain and it will happen on occasion. As stated below, if they are prescribing buprenorphine for pain it is best practice to get a diagnosis code (i.e. ICD-10) so you have documentation that you followed-up and confirmed it was not being used for addiction. In fact, some states even require a diagnosis code on prescriptions for buprenorphine and methadone.
It is also a good idea to then look up the diagnosis code to be sure the one they gave you is not a code for addiction treatment.
You can search for qualified providers on the SAMSHA website
The Substance Abuse and Mental Health Services Administration (SAMSHA) provides a directory of practitioners that have a DATA 2000 waiver. I definitely recommend bookmarking this one because if you practice long enough you will get a prescription for buprenorphine without the DATA 2000 waiver written on it.
If that happens to you, here is the best way to handle it:
Check the SAMSHA directory and see if the provider is listed.
If yes, call the practitioner and take the DATA 2000 waiver over the phone (as long as your state allows Schedule III prescriptions to be taken verbally). Confirm the rest of the information on the prescription and enter is as a verbal prescription.
If no, call the practitioner and ask what they are using it for. If they say pain, get the ICD-10 code and the representative you spoke with and document that code on the face of the prescription. Google it to be sure it is not an ICD-10 code for addiction. If they say it is for addiction, the prescription cannot be filled.
The DATA 2000 waiver is always the DEA number with an "X" for the first letter
It's important to recognize the DATA 2000 waiver and, while most of us know what that looks like, I wanted to put it in the post for completeness.
It would look like "XM1234567" if the prescriber's DEA was "FM1234567"
Without a DATA 2000 waiver, a physician cannot prescribe burprenorphine at all for addiction
It has come up at least a few times in my career, but I have heard things like "it is only for a few days, why can't you just fill enough for them to get to psychiatry/addiction medicine?" The answer is no - I'm not saying that because of any personal belief about what prescribers should or should not be allowed to do but because currently that is the law.
If a physician writes buprenorphine for addiction without a DATA 2000 waiver it is not a valid prescription and you are not able to fill it.
DATA 2000 does not apply to methadone
Methadone still must be given for addiction within an opioid treatment center. This is an important point because we see methadone often enough for pain that we are already used to filling it so could miss this on the prescription. Prescribers might not fully understand the laws and attempt to prescribe it for addiction.
This is further compounded by the fact that prescribers can administer it under the following circumstances (link to legislation here):
"An exception to the registration requirement, known as the "three day rule" (Title 21, Code of Federal Regulations, Part 1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program, to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient’s referral for treatment, under the following conditions:
Not more than one day’s medication may be administered or given to a patient at one time
This treatment may not be carried out for more than 72 hours and;
This 72-hour period cannot be renewed or extended"
In short, do not fill methadone in the community pharmacy for addiction!
Keywords: methadone, buprenorphine, Suboxone, Subutex, DATA 2000 law.