During the COVID-19 Public Health Emergency (PHE), the Drug Enforcement Agency (DEA) granted waivers to allow providers to remotely prescribe controlled substances without an in-person visit. These waivers afforded countless individuals to continue (or initiate) services for Opioid Use Disorder (OUD), other behavioral health issues (ADHD, anxiety, etc.), and gender-affirming and gender-specific care.
With the PHE now confirmed to end on May 11, the DEA has proposed two rules that will be used to govern the remote prescribing of these substances in the future: one specific to the remote prescribing of Buprenorphine, used in Medication Assisted Treatment for Opioid Use Disorder, and a second that covers all other controlled prescription drugs.
Though each rule is slightly different, they share three over-arching qualities, discussed below.
The rules revert to requiring an in-person visit to prescribe controlled substances.
For patients that were in care with a prescribed medication before the end of the PHE, the prescriber would have 180 days to conduct an in-person visit with the patient (unless one was already conducted during treatment, which can satisfy the requirement). If an in-person visit is not conducted within 180 days after the PHE ends, no further prescription can be provided until an in-person visit is complete. Remote prescribers may refer a patient to a medical provider for an in-person visit to meet this requirement.
For all new patients who enter treatment after May 11, prescribers could only provide a 30-day prescription without refills for buprenorphine until an in-person visit is conducted. For other controlled substances, no prescribing is allowed without an in-person visit first, either with the prescriber or a medical provider who referred the patient to the prescriber.
Prescriptions would be stamped to be easily identified by pharmacists as being prescribed via telehealth.
In an effort to crack down on illicit online pharmacies and prevent the diversion of controlled substances into the black market, the DEA proposed that the first 30-day prescription without an in-person visit would be stamped as a “telemedicine prescription.” This process would not include schedule II substances or general prescription of narcotics. The DEA expresses concerns in the proposed rule that illicit utilization would pose “too great a risk to public health and safety.”
The concept of a “Special Registration” for prescribers of controlled substances would not move forward.
The 2008 Ryan Haight Act directed the DEA to establish a “special registration rule” that would permit prescribers to register as a means to allow for the remote prescribing of controlled substances. The proposed rule abandons this directive from Congress, with the DEA noting a concern around the administrative burden in adopting such a registration – even though such a registration could eliminate the need for many of the provisions contained in the proposed rule.
Industry Concerns Emerging over the Proposed Rules
At the recent annual American Telemedicine Association (ATA) conference, a roundtable of digital health providers was convened to hear about reactions and concerns regarding the proposed rule. In addition to industry leaders, DEA representatives were present to listen to the discussion. Several concerns were raised during the conversation, which has also been reflected in other press regarding the proposed rules.
Impact on Kids
The rules implicated many medications used in treating pediatric behavioral health issues. With a pediatric mental health crisis growing due to the pandemic and challenges around workforce and treatment access, there was significant concern about leaving high-risk youth without access to medication. Many noted that wait lists for pediatric psychiatric appointments are running in months in some areas would exceed the 30-day requirement and thus leave youth without access to their ADHD and other related medications.
Impact on OUD Treatment
The science around Medication Assisted Recovery (MAR) clarifies that a sudden suspension of buprenorphine treatment can be life-threatening, causing the return of opioid withdrawal symptoms and a resurgence of drug-seeking behavior. Since a patient’s tolerance threshold is lowered during treatment, returning to using the black market drug supply to manage symptoms dramatically increases the risk of accidental overdose. Many providers voiced significant concern about this, noting that an increase in overdose deaths simply because individuals could not get an in-person visit seems counter to the DEA’s rationale for effectively controlling access to these substances in the first place.
Impact on Clinical Workflow and Business Practices
Though there is a 180-day window to comply with the regulations with existing patients, no such window exists if a patient seeks treatment after the PHE expires on May 11, 2023. Many organizations felt that the lead time for a provider to adapt workflows, record keeping, and appointment schedules with patients to accommodate the rules would well exceed the 180-day window, with some calling for a six-month to a one-year window to come into compliance as a more reasonable event horizon to allow for time to adjust – especially since the time window between final rule publication and the end of the PHE could be a matter of only days or weeks.
Impact of SUD-specific Confidentiality Regulations
While the proposed rules speak to the ability for prescribers to refer someone to a separate provider for the in-person visit, some noted that the proposed rules don’t seem to contemplate the added hurdles substance use disorder treatment providers need to go through, given the privacy restrictions included in 42 CFR Part 2. This could particularly complicate efforts to comply with the regulations for higher-risk patients with barriers to accessing in-person care or other issues where garnering the proper consent to share information with a referral provider can be difficult.
Impact on Prescriptions
Many providers expressed concern that pharmacies are already refusing to fill prescriptions given during a telehealth visit, tied to high-profile cases involving the potential over-prescribing of controlled substances by some providers. Industry leaders expressed concerns that those incidences are not indicative of the industry as a whole and yet are hearing from patients who cannot easily fill the prescriptions they are given. Advocates noted that labeling prescriptions as being done via telehealth could further stigmatize patients and their providers, risking the continuity of care for those whose prescriptions are both clinically appropriate and necessary.
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What Action Telehealth Providers Should Take
If your organization provides behavioral health services or other health services via telehealth where scheduled drugs are prescribed, you should review the proposed rules, which can be accessed here and here. Foley and Lardner, LLP also released a more detailed summary, FAQ, and analysis of the proposed rules’ potential impacts, which you can find here.
Additionally – providers, advocates, and individuals who rely on services and prescriptions of controlled substances currently offered through telehealth should consider filing a comment. The comment period runs through March 31 – and by law, DEA must review the comments before determining any final rules. To date, over 2,000 public comments have been filed combined between the two proposed rules. You or your organization can comment on the rules pages linked above.
Looking ahead to a period of change
As these are only proposed rules, there is no line of sight at this juncture on what the final regulatory framework will be for the post-PHE prescribing of remote substances. Also of concern is the tight time window between posting the interim rules, the needed review period, and whether the federal government can publish a final rule before the May 11 ending of the PHE. Lastly, many providers have questioned whether the DEA may ultimately withhold final rule-making as it relates explicitly to prescribing Buprenorphine and instead move the existing waiver for that medication under the still-existing Opioid PHE, for which there is no current planned end date.
Regardless of potential scenarios, providers of telehealth-related behavioral health and other services will need to keep apprised of these developments and consider the implications of these regulations on current and future practice. Clarity on the regulatory framework will trigger a period of needed adaptation and learning, regardless of the final framework’s direction.
As we enter this transition period away from the COVID-19 PHE, our team at THS stands ready to assist and advise clients to ensure that critical health services can continue to reach those who need them most. Don’t hesitate to reach out if there is a way we can support you in your organization’s journey during this time.