This is an exclusive BHB+ story
The long-awaited special registration rule for telehealth prescribing dropped last week. The proposed rule has already raised some hackles with industry insiders, and the newly installed Trump administration has promptly withdrawn the proposal.
Withdrawing the proposal doesn’t mean the rule is dead. After review, the Trump administration may allow the rule to move forward. After all, his administration put COVID-era flexibilities in place.
The stakes are high for substance use disorder (SUD) treatment providers offering telehealth prescribing for medications for opioid use disorder (MOUD). I’ve chatted with several sources about the potential for the rule to benefit the SUD industry – and its potential to disrupt it.
Some interested parties have taken a strong stance almost right off the bat.
Kyle Zebley, senior vice president of public policy at the American Telemedicine Association (ATA) and executive director of ATA Action, told me via email on the day the rule was released that the rule was a “mixed bag.” A few days later, Zebley urged the Trump administration to withdraw the rule (he got his wish later that same day).
“This proposal would create untenable restrictions and significant barriers to care,” Zebley said in a statement. “It is essential that the [Drug Enforcement Administration] DEA, working with key stakeholders, take the time needed to establish a framework that ensures necessary access to care while safeguarding against diversion.”
The ATA has a point. The cumbersome rule makes it difficult for some providers to make life-saving drugs as accessible as possible. But from my conversations with providers, starting over from scratch would not benefit the industry, either.
The special registration rule wasn’t the only document released on the 15th. The DEA also released a final rule that allows SUD treatment providers to prescribe buprenorphine, one evidence-based OUD medication, for six months. This rule is likely permanent and provides a small amount of permanent assurance for patients and virtual providers, but leaves some details opaque.
In this exclusive BHB+ Update, I explore both the special registration rule and the buprenorphine prescribing final rule, specifically narrowing in on:
- What the special registration rule means for providers, big and small
- The special registration rule’s likely fate
- How the six-month buprenorphine prescribing final rule will impact the industry
Clarifying the rule
The proposed special registration rule would allow for controlled substances to be prescribed via telehealth but would require that providers maintain multiple DEA registration numbers. It also adds other requirements like recordkeeping and reporting in pursuit of a lower risk of drug diversion.
The rule’s main downside is its complexity. Telehealth SUD providers will have to register in every state they operate in, which Stephanie Strong, CEO of virtual SUD provider Boulder, said will be expensive.
Portland, Oregon-based Boulder offers telehealth outpatient care for opioid use disorder (OUD) and alcohol use disorder (AUD), including MOUD prescriptions. Most of the company’s patients are Medicaid beneficiaries.
It will also be cumbersome to navigate the legalese and ensure compliance. Telehealth OUD treatment provider Bicycle would likely have to hire someone full-time to confirm that the company conforms to all aspects of the complex rule, Dr. Brian Clear, the company’s chief medical officer, told me.
If passed, the rule would impact some providers more than others. Only larger companies like Bicycle are likely able to afford a full-time employee to steer it to compliance.
“I suspect it will disproportionately impact smaller and less resourced providers, and also low-income and more vulnerable patients,” Strong said. “The administrative costs, the complexity of maintaining some of these rules, the additional scrutiny from regulators, these are all deterrence, as we know, to the ability of providers to prescribe buprenorphine. But for providers like Boulder, that are specialized, well-resourced and able to influence policy at scale, it’s a huge opportunity for us to advocate not only for our patients and our staff, but for the community-based providers as well, and find ways that we can link arms with them.”
How the rule will be enforced is still unclear, according to Strong. The DEA itself may not yet know, she said.
The rule also gives the DEA more control, which Joelle Wilson, a shareholder at Polsinelli law firm, told me is not surprising given that the special registration process is based on the Controlled Substances Act.
“I don’t necessarily see any issues with the DEA controlling that process, as long as they’re given the appropriate authority to do so,” Wilson said.
Seasoned industry experts are not strangers to complex, evolving policies, Strong said. She, as well as several of the sources I’ve discussed the rule with, are overall pleased that progress toward a final rule is being made. I expect to see providers and other stakeholders lobby the DEA for a simpler special registration process, and I hope the agency will comply for the sake of patients and smaller SUD treatment providers.
The special registration rule’s future
A White House press release posted on Monday said that any rules sent to the Office of the Federal Register but not yet published will be withdrawn in order for the Trump administration to review the documents.
This is customary with a new administration, Strong said. She correctly predicted that the industry would push the Trump administration to pause the rule and change it to improve the balance between guardrails and expanding access.
Stakeholders overall are pushing to get a special registration rule passed, according to Wilson. Providers looking to ease the prescribing process will be left to argue the details.
“At Boulder, we’re going to continue to advocate for our patients and ensure that they all have unincorporated access to their medication treatment, whether that’s current patients or those that we will serve in the future,” Strong said. “ As we get more clarity on what the permanent policies look like, we’ll be reaching out to all of our partners, health plans, pharmacists, clinicians and patients to help make it as frictionless as possible for them in this next year of telemedicine.”
Overall, industry insiders seem optimistic that telehealth flexibilities will be finalized. Providers and patients have grown used to these flexibilities since COVID, and both sides of the political aisle have passed legislation seeking to tame the opioid crisis.
“There are bills right now that have bipartisan support and are expected to pass and make some of the telehealth flexibilities permanent,” Wilson said. “From my perspective, I think there’s an expectation that the telehealth flexibilities will be extended, and possibly within the next year, we may see some permanent change.”
There are no guarantees, however.
“That being said, everything’s up in the air,” Wilson continued.
The buprenorphine rule’s impact
While the special registration rule’s future is still tentative, the telehealth buprenorphine rule is already cemented. To change the rule at this point would take an act of Congress, or a very specific push from the Trump administration, Strong said. Neither of these are likely, and I anticipate that this rule will stay in place for the foreseeable future.
So the final rule is final. But how will it impact patients and the industry?
It guarantees a six-month runway to prescribe patients buprenorphine via telehealth, including only using audio. Allowing audio-only appointments is an exciting win for accessibility. People with OUD who are unhoused or unemployed may struggle to afford or access devices capable of audio-visual appointments, or the wifi necessary to conduct them.
The rule’s limiting factor is the six-month time frame. After the window is up, clinicians must either see the patient in person or meet a telemedicine exception outlined in the Controlled Substances Act.
One key exception that providers will likely rely on is the tele-presenter model in which patients can receive prescriptions through a virtual appointment if they are in the presence of another DEA-registered practitioner, according to Wilson. Another option, Wilson said, is the qualifying telemedicine referral, in which a primary care physician can conduct an examination and then refer to a specialist prescriber.
This time limit can be a real barrier to accessibility. If patients are required to have an in-person visit of any kind to receive their prescription, then “telemedicine is only telemedicine for the clinician,” Jessica Rigsby, vice president of legal and compliance at Ophelia, told me.
Some parts of the rule are still unclear. For example, the rule notes that for practitioners to take advantage of the final rule, they need to be licensed in the state where the patient is and the state where they themselves are located. The language here is confusing, Wilson said, but she interpreted the rule as only alluding to DEA licensure rather than state licensure.
Despite the six-month limitation and some confusion, the rule is still a “good step forward,” according to Wilson. From where I sit, the six-month rule is arbitrary. Why would the risk of drug diversion increase after six months? Arbitrary or not, it shows promise that the regulations are moving in the right direction.
“While I’m a firm believer that there needs to be safeguards in place to ensure that we’re not putting individuals, including patients, in harm’s way by overprescribing or not having the appropriate guardrail in place to diversion of these these drugs, I do think there’s something to be said for ensuring that people [who] need a drug are able to access it,” Wilson said. “ That’s compounded by the fact that we all know about the opioid crisis and that this treatment is life-saving for so many individuals. I definitely think it’s a step in the right direction. I think that the DEA definitely took into consideration some of the safeguards that need to be put in place, while still allowing access to care.”