We can win the fight against opioid use disorder (OUD).

Pandemic-era changes increased access to Medication for OUD (MOUD) through Telehealth.

The results are profound.

We can’t turn back now.
Tell Congress to protect access to Telehealth for OUD patients.

Tell Congress

Telehealth-based MOUD is safe, for now.

A temporary DEA rule that extended access to Telehealth-based treatment of opioid use disorder is in effect until November 2024.

In November the DEA will issue new guidance.

What did the temporary DEA rule do?

On May 10, the Drug Enforcement Administration (DEA) in conjunction with Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule, effective May 12, to allow the following:

  • All telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 public health emergency (PHE) will remain in place through November 2024
  • For any practitioner-patient telemedicine relationships all telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will continue to be permitted through November 2024

The COVID-19 Public Health Emergency came to an end on May 11th as planned.

Which DEA waivers are extended under this rule?

  • The March 16, 2020 announcement and update to the DEA’s COVID-19 FAQ that an in-person visit is not required for the prescription of controlled substances schedule II-V issued by the means of the internet within the U.S. during the COVID-19 PHE.
  • A March 25, 2020 “Dear Registrant” letter signed by William T. McDermott, DEA’s then-Assistant Administrator, Diversion Control Division. Which states that:
  • DEA-registered practitioners are not required to obtain additional registration(s) with DEA in the additional state(s) where the dispensing (including prescribing and administering) occurs. Thus, DEA-registered practitioners may prescribe clinically appropriate controlled substances to patients in states where they are not actively registered with DEA via telemedicine. The practitioner must continue to comply with all state laws and regulations in which they are practicing, if different
  • A March 31, 2020 “Dear Registrant” letter signed by Thomas W. Prevoznik DEA’s then-Deputy Assistant Administrator, Diversion Control Division. Which states that:
  • Practitioners can prescribe buprenorphine to new and existing patients with opioid use disorder (OUD) via telephone by otherwise authorized practitioners without requiring such practitioners to first conduct an examination of the patient in person or via telemedicine.

How does this impact you and your medical practitioner?

  • I have seen my medical practitioner in person: my practitioner may prescribe any of my prescriptions via telehealth
  • I have had an audio visual, two-way real-time telehealth visit with my medical practitioner and need a schedule II, III, IV, or V medication: prescriptions can be prescribed via telehealth until November 2024
  • I have NOT established a relationship via telehealth or in-person with my practitioner before November 2024 and need a schedule II-IV controlled substance: Prescriptions cannot be prescribed via telehealth after November 2024 unless the patient has had an in person visit with the medical practitioner. (This is subject to change depending on future rulemaking)
  • I am a practitioner; I have more than one license to practice medicine and only one active DEA registration: Double check the state requirements in which you are licensed, even though additional DEA registrations are not required under the extension, certain states may still have state-specific registry requirements when prescribing clinically appropriate controlled substances.

What does this mean for pharmacies?

  • Pharmacies should continue to dispense medications pursuant to a legitimate prescription, whether the prescriber issued the prescription based on a telehealth or in-person visit. Provider-patient relationships can be established via telehealth, and telehealth is a legitimate mode of clinical practice.
  • For the prescription of clinically appropriate controlled substances, pharmacists should continue filling legitimate prescriptions issued after a telehealth encounter in the same way they would following an in person visit through November 2024. Guidance or rules following November 2024, are pending.
  • Pharmacists should dispense medications based on state laws and not withhold the dispensing of a legitimate controlled substance prescription when the prescriber does not actively have a valid DEA registration in the state wherein the medication is being prescribed.

What will the DEA do next?

  • On March 1, 2023, DEA issued two proposed rules entitled “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation” and “Expansion of Induction of Buprenorphine via Telemedicine Encounter”. These rules received over 35,000 public comments during the 30-day comment period
  • The proposed rules are intended to govern telemedicine prescribing of clinically appropriate controlled substances post PHE. However, given widespread concern about the impact of the rules and the volume of comments, DEA has used this temporary extension rule to postpone issuing the final version of these rules.
  • The DEA said it plans to issue “one or more final rules … based on the two proposed rules published on March 1, 2023”. DEA anticipates such final rule(s) will “extend certain telemedicine flexibilities on a permanent basis” to permit “the practice of telemedicine under circumstances that are consistent with public health and safety, while maintaining effective controls against diversion.”
  • The DEA extended the deadline through November of 2024, with a pledge to develop a process to keep access to telehealth-based OUD treatment safe and accessible.

Background on New DEA Rule

As you may know, during the COVID public health emergency, Medication for Opioid Use Disorder (MOUD) treatment became accessible to patients through telemedicine under a temporary waiver of the Ryan Haight Act. Unfortunately, the Act’s restrictions become active again on May 11 unless some things change.

That is why the DEA has proposed new rules. While the DEA rule does create a permanent exception to the Ryan Haight Act that allows MOUD treatment via telemedicine to continue, the rule needs to be modified in order to protect patient health and safety.

What Does the Rule Do?
In its current draft, the new rule requires that by November 2024, patients already receiving treatment have to complete an in-person visit with a medical provider and get a referral back to telemedicine  if they want to stay in treatment.

This “in-person visit” requirement also applies to new patients, but new patients only have 30 days to complete an in-person visit and get a referral before their prescription runs out.

What’s the Medical Justification for an In-Person Visit?
There is no medical evidence that justifies this in-person requirement. It is medically unnecessary, it increases costs, inconveniences patients, and has no offsetting benefit. 

There is, however, ample peer-reviewed research that highlights the potential harm this rule could create, if enacted.

What Should Concern Lawmakers about the DEA's Proposed Rule?

Doctor-Patient Relationship Concerns:
For patients with opioid-use disorder who have established relationships with a telemedicine provider, how does it benefit their recovery to require a new provider’s approval to continue that relationship?

Impact on Quality & Outcomes of TeleOUD Treatment:
Ample research has shown that allowing access to buprenorphine via telemedicine, during the pandemic, reduced the rate of opioid-related overdoses, ER visits and deaths, and did not increase the rate of buprenorphine misuse. How will making the process more difficult improve patient outcomes?

Access to Specialists in Addiction Medicine: Addiction medicine is a high-demand specialty. Telemedicine democratizes access to these specialists, so what is the value of making a general practitioner with little or no expertise in addiction medicine a gatekeeper to this form of specialty care?

Cost of Care: The DEA’s proposed rule ignores the cost to patients of having an additional in-person exam, the cost of transportation, childcare, time off of wor, and how those impact a person in recovery. Would the in-person requirement disproportionately impact access to care for lower-income patients who already struggle to afford care?

No Accounting for Emergencies:
If a patient or provider misses a scheduled in-person appointment for any reason and the appointment can’t be rescheduled within the 30 day window, the proposed rules don’t permit exceptions for any reason.  Understanding that people with OUD have a high likelihood of relapse, overdose and death if their medication runs out, is this reasonable?

Lack of Benefit of In-Person Visit:
There is no evidence to support the DEA’s assumption that in-person care is more thorough than telemedicine. There is evidence that telemedicine care is more effective than in-person for most patients with OUD. The new rules mandate a less effective form of care, from a generally less specialized provider, with no evidence of benefit to offset the expense and potential harm. Why?

No Evidence of Diversion:
The data is clear that buprenorphine-involved deaths did not increase despite wider access to telemedicine OUD care during the pandemic, according to research published in JAMA in January of 2023. Can DEA support their assumption in the rule that telemedicine increases risk of diversion or misuse of buprenorphine?

Increased Risks to Patient Health: There is ample research showing that patients who stop buprenorphine for OUD after just 30 days return to opioid use. One example is this 2009 study that showed 87 percent of OUD patients who tapered off of buprenorphine over a 28-day period returned to other opioid use within just three months.  

Rationale for 30-Day Prescriptions:
The medical rationale to only permit certain patients who meet the in-person requirement to continue treatment beyond 30 days does not exist. If treatment beyond 30 days is recommended for everyone, why should this arbitrary 30-day limit be imposed?

Risks of a 30-day Prescription: A 2011 study found 93 percent of OUD patients who completed a 4-week course of buprenorphine treatment returned to active opioid use. Should the DEA provide a medical rationale for putting a patient’s health at risk by limiting their prescription to 30 days without an in-person visit?