The X-Waiver Is No More: What This Means for Urgent Care

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Urgent message: In December 2022, Congress passed the Mainstreaming Addiction Treatment Act (W-Waiver), which would remove federal patient caps and allow any healthcare provider with a standard DEA controlled-medication license to prescribe buprenorphine.

Alan A. Ayers, MBA, MAcc is Senior Editor of The Journal of Urgent Care Medicine and President of Experity Consulting.

For over a decade, the question of whether or not to prescribe buprenorphine/naloxone (Suboxone) products in urgent care has resurfaced with regularity. With the announcement of this new legislation, I was asked by a couple of urgent care providers whether they should consider adding a medication-assisted treatment (MAT) program to their urgent care offerings. 

As a bit of background, U.S. opioid-related deaths have risen sharply in recent years from approximately 20,000 in 2010 to more than 80,000 in 2021.¹ Opioid-use disorder (OUD) is a chronic disease defined by frequent relapses. Patients who receive MAT have much fewer relapses and lower mortality.² Buprenorphine is a partial opioid agonist that exists in multiple formulations and routes of delivery (ie, buccal, transdermal, depot injection, oral tablet) and is variably combined with naloxone to reduce abuse potential.³

Data about the benefits of buprenorphine for MAT are unambiguously positive. For example, the number needed to treat (NNT) for buprenorphine/naloxone to achieve abstinence from opioids for 5 years is only three, making MAT with buprenorphine/naloxone the most medically effective therapy that exists in all of medicine.⁴

In the past, federal limitations on the number of buprenorphine/naloxone patients a provider could treat (panel) created a supply/demand imbalance, which meant that offering the service would almost guarantee patients would show up. In 2021, the revised regulation which expanded prescribing authority to nurse practitioners and physician assistants required 8 hours of training for a panel of 30 patients or 24 hours of training or a panel of100 patients. Certification and good standing with DEA regulations was indicated with an “X” added to the provider’s DEA number. Activists bemoaned that these time-consuming training and registration requirements created barriers which reduced access to what could be lifesaving medications for addicts.

The provision recently passed in the 2023 Consolidated Appropriations Act has entirely eliminated the X-Waiver requirement. In turn, any healthcare provider with a standard DEA controlled medication license can now prescribe buprenorphine, subject to state requirements, without any federal patient caps.

Prior to this announcement, my feedback to the urgent care operator considering offering this treatment would have been:

1. For an independent, physician-run, urgent care this could be a viable ancillary business— though not without challenges, including:

• Reimbursement including billing “behavioral health” insurance or Medicaid, prior authorization, and concurrent enrollment in counselling required by some insurances (but not covered under conventional “urgent care” contracts)
• Checking state-controlled substance registries to identify patients receiving potentially unsafe quantities and combinations of prescribed medications and abiding by other state laws, including adherence to treatment strictly according to ICD-10 diagnostic criteria for “opioid abuse disorder”
• Urine drug testing to assure buprenorphine is not being diverted or combined with other drugs of abuse
• First-dose observation when patients are beginning to experience opioid withdrawal.
• Willingness to work with a very complex patient population who are generally underinsured, underemployed, and have other behavioral health and social issues that complicate care.
• The fact that patients suffering from addiction and dependence often have tumultuous social situations (eg, unstable transportation, housing, employment) and comorbid mental health disorders that often complicate the plan of care. 

1. For a corporately owned, scaled, multisite operation, MAT could bring significant challenges in staffing, processes, oversight, and liability and thus would probably not be a good fit with the operating model.

In 2007, when running seven urgent care centers in Central Ohio—near the epicenter of the Appalachian Crisis of prescription abuse—I was involved with setting up an MAT program. It was born when one of the urgent care doctors began offering primary care one day a week at a local inpatient drug rehabilitation facility and quickly realized the potential benefits of offering buprenorphine to this population who were affected by OUD with tragic frequency.

So, I created an LLC, submitted applications for the doctors, and launched our “rehabilitation care” service. Once we were registered on the SAMHSA (Substance Abuse and Mental Health Services) website, patients showed up in the urgent care for treatment.

Although the doctors had argued with skeptical staff that the “addicts” who they’d be treating were grandmas, nurses, and lawyers whose paths to addiction were largely accidental (eg, after receiving a short course of oxycodone following surgery), demand from the beginning was overwhelming from other patients—the more commonly stereotype of an injection heroin user. It wasn’t long before we experienced confrontations in the waiting room and front desk with the above-mentioned patient population, so we moved the MAT clinic to a discreet urban location off a bus line away from the mothers waiting with their children who regularly came to our urgent care center.

Sixteen years later, that dedicated treatment clinic in Columbus, OH still exists.

Multiple venture capital (VC) and private equity (PE)-backed groups have since established chains of similarly positioned, discreet, storefronts that advertise heavily on the web and social media. Some vendors, like construction and supply companies, that have served urgent care in the past have even become involved in building up these MAT “chains.” So, there’s even competition in this marketplace now, including from nonprofit and county addiction and mental health agencies.

The addiction business, however, is not without risk. Robert Lesslie, MD of Rock Hill, SC sold his urgent care and occupational medicine centers to a national chain but continued to serve patients, including those suffering from chronic pain, in his private practice. Tragically, he and his family, as well as a repairman working in the clinic, were killed allegedly by a patient suffering from addiction who was cut-off from ongoing prescription opioids.⁵ This is an important consideration. When thinking about opening an MAT/buprenorphine service line, it’s important to also consider if you are prepared to deal with discharging or turning away patients for nonadherence, nonpayment, or disruptive and abusive behaviors.

So, when asked my opinion in light of this recent legislative change, I would give this advice:

• Remember that urgent care is episodic. Addiction and dependence are chronic conditions
• Patients suffering from addiction frequently have complex social and psychological needs, which often results in the need for intensive care coordination
• Individuals who inject drugs have multiple comorbidities and are at risk for serious health issues such as endocarditis, spinal epidural abscess, HIV, and viral hepatitis
• While the federal law may enable prescription solely for addiction, state Medicaid managed care programs can have more specific requirements that point to a “primary care” relationship being required for MAT.⁶

Therefore, despite strong evidence on the need for more access to buprenorphine/MAT and its clear benefit in mitigating rising mortality related to OUD, the decision to use UC as a space for an MAT service line should be pursued with caution. OUD is a chronic condition best managed with a longitudinal primary care type relationship. This certainly could include a physician-owned and operated urgent care that also provides primary care services. However, outside of this, I would ask urgent care operators if they are up to the challenges described above when considering whether an MAT program will work within their center.

References

1. National Institute on Drug Abuse. Drug overdose death rates. Available at: https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. Accessed March 15, 2023.
2. Ma J, Bao YP, Wang RJ, et al. Effects of medication-assisted treatment on mortality among opioids users: a systematic review and meta-analysis. Mol Psychiatry. 2019;24(12):1868-1883.
3. Shulman M, Wai JM, Nunes EV. Buprenorphine treatment for opioid use disorder: an overview. CNS Drugs. 2019;33(6):567-580.
4. Deyo-Svendsen M, Cabrera Svendsen M, Walker J, et al. Medication-assisted treatment for opioid use disorder in a rural family medicine practice. J Prim Care Community Health. 2020;11:2150132720931720.
5. Casiano L. Ex-NFL player Phillip Adams reportedly had medication taken away before South Carolina killings. Available at: https://www.foxnews.com/sports/nfl-phillip-adams-medication-south-carolina-killings. Accessed March 15, 2023.
6. Centers for Medicare and Medicaid Services. Health Official Letter. Mandatory Medicaid state coverage of medication-assisted treatment. Available at : https://www.medicaid.gov/federal-policy-guidance/downloads/sho20005.pdf. Accessed March 15, 2023.