In response to this national emergency, health authorities have enacted several initiatives to make effective treatment and recovery support more available for people struggling with opioid addiction.
Health authorities have enacted one such initiative: the removal of DATA Waiver (also known as X-waiver) in the 2023 Omnibus Bill Updates for Behavioral Health.
If you’re unsure of how the removal of the x-waiver program might impact your practice, your patients, and the community as a whole—keep reading and we’ll explain everything you need to know.
Why Have X-Waivers Been Ceased?
The best place to start with the Omnibus Bill changes is to look at why the legislation was enacted.
For over a decade now, despite the fact that medications have been by far the most effective way to treat opioid use disorder (OUD), people in need have struggled to get access to this life-saving treatment.
A combination of factors, such as a lack of understanding about medication-assisted therapy (MAT) among physicians and patients, stigma about addiction, and complex prescribing restrictions and procedures, has meant that only around 20% of people with OUD receive MAT.
One of the biggest prescribing barriers was the requirement for physicians to apply for a DATA waiver from the DEA before prescribing. Not only did this result in MAT being perceived as a high-risk and unconventional treatment—it placed a cap on the number of patients each physician could prescribe to.
As we’ll detail more in the following section, the 2023 updates for behavioral health in the Omnibus Bill were implemented for two reasons. First, to increase both understanding and acceptance of MAT amongst physicians and the wider community. And second, remove the practical barriers doctors face in getting this life-saving treatment to patients.
What Changed in the 2023 Omnibus Bill?
According to the Substance Abuse and Mental Health Services Administration (SAMHSA),
“Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill) removes the federal requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe medications, like partial opioid agonists, for the treatment of opioid use disorder (OUD).”
SAMHSA further explains,
“All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe partial opioid agonists for Opioid Use Disorder in their practice if permitted by applicable state law and SAMHSA encourages them to do so.”
“SAMHSA and DEA are actively working on implementation of a separate provision of the Omnibus related to training requirements for DEA registration that becomes effective in June 2023.”
To sum up:
- Doctors (and some other prescribing professionals) no longer need an x-waiver to prescribe partial opioid agonists.
- All professionals applying for registration to prescribe schedule II-V medications (whether renewing or a new application) are required to demonstrate a certain level of knowledge and training in prescribing MAT for OUD.
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Rationale for Only Including Certain Medications
The FDA has approved three medications to treat opioid dependence. Each has been proven to be safe and effective in the treatment of OUD and no one is “better” or “worse” than the other. However, there are some distinct advantages of partial opioid agonists that we’ll list below (for a full overview, please see How Partial Opioid Agonists Are Saving Overdose Victims):
Advantages of partial opioid agonists
- Low abuse potential
- Reduces opioid withdrawal symptoms and cravings
- Increases safety in the event of an overdose
- Does not require detox before starting treatment
- Long-acting, with some patients only requiring one dose every second day
Practical Implications of the Omnibus Bill
For patients, prescribers, and the community as a whole, there are several important practical implications of the behavioral health changes in the 2023 Omnibus Bill.
People struggling with OUD can now receive MAT from a wide range of prescribers, including family physicians and ER doctors.
Previously, to receive MAT, a person had to find a prescriber with an x-waiver who still had capacity in their DEA-stipulated patient limit to treat them. This often led to lengthy delays in treatment. And some patients simply were simply unable to access MAT due to lack of availability in their area and access barriers.
Physicians (and Nurse Practitioners with appropriate prescribing rights) no longer need to seek permission from the DEA to prescribe partial opioid agonists.
Prescribers may still choose to refer a patient to an addictions specialist, but there is no need to wait for availability before starting treatment. Taking this action can dramatically improve safety, especially in the critical window after an overdose when the risk of death is greatly increased.
Community-based substance misuse and OUD recovery programs can now more easily facilitate access to MAT for vulnerable and underserved populations.
Historically, community-based organizations faced several barriers to delivering MAT, many of which centered around finding physicians with appropriate prescribing rights. Now, agencies can employ a wider range of prescribers, making their programs more financially and practically viable.
For examples of innovative agencies implementing the Omnibus Bill changes, see How Texas is Using Substance Use Treatment Telehealth.
The benefits of the 2023 Omnibus Bill updates for behavioral health extend beyond just the practical implications.
Of course, the expanded access to MAT is a welcome change for everyone. But we can not understate the cultural shift the legislation represents.
For many years, despite clear evidence that MAT is the most effective treatment for OUD, it remained stigmatized and misunderstood by some prescribers and segments of the community.
Now, the Omnibus Bill sends a clear signal to everyone that MAT can and should be offered to everyone struggling with OUD. Prescribers should consider it a core element of standard practice—not a high-risk, niche treatment that can only be delivered by specialists.
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