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Document ID Nos. DEA-2023-0029-0001; DEA-2023-0028-0001
Public Interest Comment1 on the DEA Proposed Rules on (1) Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation and (2) Expansion of Induction of Buprenorphine via Telemedicine Encounter
Introduction & Background
In response to the COVID-19 pandemic, DEA made several significant changes to long-standing policy to accommodate social distancing while supporting patient care for treatment of opioid use disorder (OUD) with buprenorphine. Most relevant to these particular regulatory proceedings was DEA’s action to invoke the public health emergency (PHE) to waive the Ryan Haight Act requirement for an initial, in-person visit before a patient could begin treatment with buprenorphine. This cleared the way for patients and prescribers to meet via telehealth.3 DEA at first required audio-video connections and later provided additional flexibility to permit audio-only connections. These steps were important and undoubtedly saved lives.
In prior work, Laura E. Stanley and I found that DEA possessed sufficient legal authority to make its pandemic flexibilities permanent,4 so it is encouraging to see DEA moving forward to make telehealth a more realistic option for patients. While we worked on this legal question, public health researchers leapt into action and produced an impressive amount of research exploring the changes in the field. I am part of an interdisciplinary team at The George Washington University and New York University that produced two narrative reviews, one on pandemic flexibilities for methadone take-home supplies5 and another on buprenorphine initiation via telehealth.6 This comment shares the results of the buprenorphine initiation narrative review with DEA and offers recommendations to DEA based on its findings.
DEA should be commended for supporting patient treatment in the pandemic, despite what may have been some apprehension on DEA’s part about potential risks that their flexibility might exacerbate. We now have much more information about how those pandemic flexibilities worked in practice, and the evidence very strongly suggests that any risks of telehealth are outweighed by its tremendous benefits. With the end of the pandemic PHE expected in May 2023, DEA should also be commended for using lessons from the pandemic to make telehealth a permanent option for patients. While this progress is encouraging, DEA’s proposed rules impose an arbitrary limitation on telehealth that DEA should reconsider prior to finalizing.
In-Person Visit Requirements in 1306.31(c)(2) & 1306.34(b)(4)
In DEA’s proposed rule “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation,” DEA would restrict initial prescriptions via telehealth for non-narcotic controlled substances on Schedules IIIV.
This proposal retreats from some of DEA’s pandemic flexibility, which applied to narcotic and non-narcotic controlled substances on Schedules II-V. See proposed § 1306.31(c)(1)(i). The agency also proposes that prescribers may only prescribe a supply of medication beyond 30 days if the patient undergoes an in-person evaluation. See proposed § 1306.31(c)(2). In DEA’s proposed rule “Expansion of Induction of Buprenorphine via Telemedicine Encounter,” DEA proposes to extend this same approach to buprenorphine, which would otherwise be left out because it is classified as a narcotic. See proposed § 1306.34(b)(4).
Stated more simply, these proposed requirements allow a prescriber to use telehealth to give a new patient a prescription buprenorphine to treat opioid use disorder, but only for up to 30 days unless the patient has an in-person medical evaluation. This is a new kind of policy for DEA, and as such it deserves careful consideration before adoption. No matter how well-intentioned, the introduction of a new limit on access to healthcare services sparks the potential for significant, unintended consequences for patients, prescribers, pharmacies, payers, and more.
Unfortunately, DEA does not delve into potential consequences or explain its reasoning for this 30-day limit; instead it asserts that this limit is proposed “in order to balance benefits and risks to individual and public safety” without explaining how DEA would describe, assess, or weigh the relevant benefits and risks. See 88 Fed. Reg. 12,875, 12,882 (Mar. 1, 2023).
In rulemaking, DEA bears the burden of explaining that its actions are not arbitrary under 5 U.S.C. § 706(2). As the Supreme Court explained in Motor Vehicle Manufacturers Association v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 (1983):
“Normally, an agency rule would be arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise. The reviewing court should not attempt itself to make up for such deficiencies; we may not supply a reasoned basis for the agency’s action that the agency itself has not given.” State Farm, 463 U.S. at 43.
DEA’s final rule, therefore, must do more to explain the agency’s basis for its novel telehealth limit in general, and for buprenorphine in particular. DEA could include this kind of explanation in the alternatives section of its regulatory impact analysis as required by EO 12,866. The results of our narrative review of 41 studies related to the pandemic flexibilities for telehealth and buprenorphine (see Appendix A) suggests, however, that DEA will find it challenging to argue that a limit based on any particular number of days is non-arbitrary. Our review found overwhelmingly positive results on the benefits of telehealth for buprenorphine initiation, and—despite worries and concerns—few to no materialized downsides. These results call into question—at a fundamental level—the need for DEA to impose an in-person visit requirement at all, especially one which is based on a number of days. While other commenters might suggest a “compromise” number of days, this comment calls upon DEA to consider its obligation to avoid arbitrary decision-making in the first instance. A “compromise” number of days that is no better explained or grounded in reason remains arbitrary.
Recommendation 1: In its final rules, DEA should abandon a time-based limitation on telehealth unless it can articulate a well-reasoned rationale.
Another concern about the telehealth limitation described above is that it appears to override flexibility provided by SAMHSA in its recent proposed rule relevant to opioid treatment programs.
In that proposal, SAMHSA did not place an in-person visit requirement on telehealth for buprenorphine initiation that takes place in opioid treatment programs. See 87 Fed. Reg. 77,330 (Dec. 16, 2022). DEA’s proposal appears to override the SAMHSA proposal by imposing a time-based limit on all prescribers—including those in opioid treatment programs—that SAMHSA did not. DEA and SAMHSA should resolve this policy conflict prior to finalizing these proposed rules so that both agencies can provide the public with a clear explanation of how the rules intersect.
Recommendation 2: DEA and SAMHSA should deconflict their rules and explain to the public how they intersect.
Leveraging Recent Research
Our narrative review on the pandemic flexibilities for buprenorphine initiative via telehealth is under review with a peer-reviewed journal. It summarizes 41 studies that help shed light on telehealth’s role in getting patients started on buprenorphine in the pandemic. Nothing we saw suggests that telehealth should always replace in-person care for every patient. Instead, the results show that telehealth has an important role to play, especially for those who might not otherwise be able to get it. The great risk of regulations that limit telehealth is that a set of patients will simply
not have access to life-saving treatment with buprenorphine.
As DEA finalizes its proposed rule, this comment encourages the agency to consider ways to bolster its analysis with the findings of the studies that we summarize in our review. To facilitate this review, this comment includes a preprint version of our narrative review, which contains citations to the relevant studies.
A Role for the Opioid PHE
With the end of the pandemic PHE coming up very soon, DEA should consider shifting the legal basis for its pandemic telehealth flexibilities for buprenorphine from the pandemic PHE to the opioid PHE. We discuss this option in an article published in 2021:
“DEA relied on the COVID-19 public health emergency as the basis for its action to permit telemedicine. As discussed above, under 21 U.S.C. § 802(54)(D), DEA has the authority to allow the ‘practice of telemedicine’ when it is being ‘conducted during a public health emergency declared by the Secretary under section 247d of title 42.’ Both the opioid crisis and the COVID-19 public health emergencies were declared under section 247d. Just as DEA used its authority to allow for the initial evaluation to be conducted via telemedicine during the COVID-19 public health
emergency, it has the discretion as a matter of law to use that authority to extend that policy under the opioid-specific public health emergency.”7
Relying on the opioid PHE would leave the highly net beneficial pandemic policies in place while giving DEA more time to complete its analysis of this important agency decision. DEA could use some extra time to consult with stakeholders on the implications of its novel telehealth policy proposal, assess the extent to which buprenorphine should be treated differently from other controlled substances in light of its unique safety profile, likelihood of diversion relative to other medications, etc., all while leaving the pandemic flexibilities in place and therefore helping to ensure continuity of care for patients.
Recommendation 4: DEA should consider using the opioid PHE to provide ongoing flexibility for buprenorphine prescribed via telehealth while working on a long-term solution.
In its proposed rules, DEA takes significant steps towards supporting the use of telehealth for patients receiving treatment for opioid use disorder with buprenorphine. In the four recommendations above, which are summarized below, this comment encourages DEA to reconsider its proposed in-person visit requirements, leverage recent research to bolster its rationale, and consider how the opioid public health emergency could help alleviate some of the time pressure to resolve these important issues.
1. This comment reflects the views of the author, and does not represent an official position of the GW Regulatory
Studies Center or the George Washington University. The Center’s policy on research integrity is available at
2. Bridget C.E. Dooling is a Research Professor at the George Washington University Regulatory Studies Center.
What is the proposed rule for buprenorphine? ›
For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe: a 30-day supply of Schedule III-V non-narcotic controlled medications; a 30-day supply of buprenorphine for the treatment of opioid use disorder.What is the DEA proposal for telehealth? ›
The Drug Enforcement Administration is proposing limiting telehealth prescriptions for buprenorphine to an initial 30-day supply until the patient can be seen in person by a physician.Can buprenorphine be prescribed by telemedicine? ›
On May 15, 2018, DEA issued a statement “Use of Telemedicine While Providing Medication Assisted Treatment”, to clarify how practitioners can use telemedicine as a tool to expand buprenorphine treatment for opioid use disorder under current DEA regulations. 1 21 U.S.C.Is Ryan Haight Act telemedicine for testosterone? ›
During the pandemic, telehealth providers were permitted to prescribe gender-affirming prescriptions for testosterone due to the suspension of the Ryan Haight Act, which typically requires patients to make an in-person visit in order to receive a prescription for controlled substances.What is the 3 day rule for buprenorphine? ›
During the three-day period, the provider is expected to arrange for the patient's referral for treatment in a maintenance or detoxification program. The goal of the three-day rule is to allow health care providers some flexibility to address emergency situations when a patient is experiencing acute withdrawal.What is the DEA 72 hour rule for buprenorphine? ›
The U.S. Drug Enforcement Agency (DEA) provides physicians with emergency access to these medications for up to 72 hours in such cases to enable detainees to receive the medications without interruption while the jail establishes a longer-term plan for the remainder of incarceration.What are FDA approved uses for buprenorphine? ›
INDICATIONS AND USAGE
SUBUTEX is indicated for the treatment of opioid dependence and is preferred for induction. SUBUTEX should be used as part of a complete treatment plan to include counseling and psychosocial support.
All patients receiving buprenorphine, including those receiving new formulations of the drug, will be counted toward the 275-patient limit.Can GPs prescribe buprenorphine? ›
Most GPs will not prescribe methadone/buprenorphine without DHI. Please check with DHI for an up to date list of GP surgeries who are registered with the Primary Care Team.Can opioids be prescribed through telemedicine? ›
Answer: Yes. While a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in-person medical evaluation (21 U.S.C. 829(e)), the Controlled Substances Act contains certain exceptions to this requirement.
Can I get Adderall through telemedicine? ›
Finding a telemedicine provider doesn't immediately allow you to get Adderall online. As mentioned above, this medication is a controlled substance, so you must meet with a doctor to get the prescription. With telemedicine, you never have to leave the comfort of your own home.Can Teladoc prescribe erectile dysfunction? ›
Teladoc doctors do not issue prescriptions for substances controlled by the DEA, non-therapeutic and/or certain other drugs that may be harmful because of their potential for abuse. Also, non-therapeutic drugs such as Viagra and Cialis are not prescribed by Teladoc doctors.What's the difference between telemedicine and telehealth? ›
While telemedicine refers specifically to remote clinical services, telehealth can refer to remote non-clinical services, such as provider training, administrative meetings, and continuing medical education, in addition to clinical services.What are the four domains of telehealth? ›
Today, telehealth encompasses four distinct applications. These are commonly known as live video, store-and-forward, remote patient monitoring, and mobile health.What are the benefits of telehealth in substance abuse? ›
Increased privacy. Patients can get care from their home without going to a public place like a clinic. Reduced stigma. Patients have access to providers who understand substance use disorder and are not judgmental.What is the maximum buprenorphine per day? ›
During this phase, the dose of buprenorphine is gradually increased according to the patient's physical and psychological needs but should not exceed a maximum of 24 mg in one day. Most patients respond to doses between 8 to 12 mg per day.Is buprenorphine a Schedule 2 or 3? ›
Buprenorphine is a schedule III narcotic analgesic. It was first marketed in the United States in 1985 as a schedule V narcotic analgesic.What are the guidelines for buprenorphine doses? ›
Generally, buprenorphine initiation should occur at least 6–12 hours after the last use of heroin or other short-acting opioids, or 24–72 hours after their last use of long-acting opioids such as methadone. →Induction of buprenorphine should start with a dose of 2–4 mg. Dosages may be increased in increments of 2–4 mg.Did the DEA remove the waiver requirement to prescribe buprenorphine? ›
The signing of the Consolidated Appropriations Act of 2023 on Dec. 29, 2022 did away with waivers and limits entirely. Clinicians who are interested in prescribing buprenorphine for opioid use disorder are encouraged to educate themselves to ensure they are able to meet accepted and prevailing standards of care.Are there 3 phases to treatment of addiction with buprenorphine? ›
Dosing. Maintenance treatment of opioid addiction with buprenorphine can be divided into the following three phases: 1) induction, 2) stabilization, and 3) maintenance.
How many buprenorphine can you take in 24 hrs? ›
Target dose: 16 mg sublingually once a day; range 4 to 24 mg/day. Maximum dose: 24 mg/day; higher doses have not shown a clinical advantage.Is Suboxone being discontinued? ›
Suboxone (buprenorphine and naloxone), used to treat opioid dependence, will no longer be available in tablet form starting in March, because of the risk of children becoming poisoned after swallowing the drug.What drug types are buprenorphine? ›
Official answer. Buprenorphine is a partial opioid agonist used to treat opioid use disorder and severe pain. It is available in a number of dosage forms under the brand names Sublocade, Probuphine, Belbuca, Butrans, Buprenex, and Subutex (discontinued).Why is buprenorphine safer? ›
Its partial agonist effects imbue buprenorphine with several clinically desirable pharmacological properties: lower abuse potential, lower level of physical dependence (less withdrawal discomfort), a ceiling effect at higher doses, and greater safety in overdose compared with opioid full agonists.How many times as potent is buprenorphine considered to be than morphine? ›
Buprenorphine is approximately 25–100 times more potent than morphine. The slow dissociation from μ-receptor also accounts for its prolonged therapeutic effect to treat opioid dependence as well as pain.How much is buprenorphine equivalent to? ›
buprenorphine is equivalent to 75 milligrams of oral morphine and that one patch delivers the dispensed micrograms per hour over a 24 hour day. Example: 5 ug/hr buprenorphine patch X 24 hrs = 120 ug/day buprenorphine = 0.12 mg/day = 9 mg/day oral MME.What is the highest mg of buprenorphine? ›
Daily buprenorphine doses typically range from 8mg to a maximum of 24 to 32mg (5, 17), in order to provide for patient-specific needs, to minimize withdrawal symptoms, and provide an adequate maintenance dose.Can buprenorphine be taken home? ›
When should I take buprenorphine/naloxone at home? Take this medicine only when you're in moderate to severe withdrawal. This is the point when you feel like you want to use opioids to prevent more withdrawal symptoms. It's important that you feel really sick before you take your first dose of buprenorphine/naloxone.Can you prescribe buprenorphine for pain? ›
Clinicians can only prescribe buprenorphine for addiction after receiving certified training and a Drug Enforcement Administration (DEA) waiver. However, any DEA-licensed clinician can prescribe buprenorphine for pain.Can buprenorphine be prescribed without naloxone? ›
There are different brand names including Subzolv tablets and Bunavail film preparations. Buprenorphine alone is available as SL tablet (Subutex) without the naloxone that is often used in pregnancy to decrease risk of withdrawal symptoms.
Can a virtual doctor prescribe hydrocodone? ›
By law, online doctors cannot prescribe DEA-controlled/scheduled pain medications. However, there are other effective medications that are less risky than opioids and available to assist with pain and pain management. Our doctors can prescribe effective medications that are less addictive than narcotic pain pills.What is the opioid legislation for 2023? ›
For fiscal year 2023, the bill provides $1.6 billion for states and Tribes. Naloxone Access and Education Act: Reauthorizes grants that provide funding for states and Tribal entities to promote education, dispensing, and distribution of the life-saving opioid overdose reversal drugs.Can telemedicine doctors prescribe Xanax? ›
There are a few exceptions that an online medical team will not be able to prescribe. These include controlled substances like benzodiazepines and stimulants like Adderall. Why is this? The FDA classifies benzodiazepines as a controlled substance, meaning that getting a prescription requires an in-person visit.Will any online doctors prescribe Adderall? ›
Most online doctors are unable to prescribe Adderall. Adderall is classified as a controlled substance by the Food and Drug Administration, and not all online doctors can prescribe controlled substances. For this reason, it is generally recommended to meet with a doctor in person to get an Adderall prescription.Can you get prescribed Adderall from an online doctor? ›
You may consult a doctor online in your state, who will assess your health and prescribe Adderall. It is known to be the best choice for people with ADHD.What medication is closest to Adderall? ›
Popular Adderall alternatives include lisdexamfetamine (Vyvanse), methylphenidate (Ritalin and Concerta), clonidine (Kapvay), atomoxetine (Strattera) and guanfacine (Intuniv). Currently, all of these medications require a prescription from a licensed healthcare provider.What is the new cure for erectile dysfunction? ›
Stem cell therapy is a new treatment option that offers the potential to reverse the underlying causes of ED and reduce patient reliance on the transitory effects of PDE5-I medications. It has been studied in several animal models in subjects who poorly respond to PDE5-Is (cavernous nerve injury and DM).Can telemedicine prescribe Viagra? ›
Yes. You need a prescription for both Viagra and generic sildenafil. You can get a prescription either in person or online. With an ever-growing number of telehealth companies providing remote services, it's easier than ever to skip an in-person doctor's visit and request a prescription online.Will my doctor prescribe Viagra over the phone? ›
Viagra is only available with a prescription from a healthcare provider. This means that you can't get Viagra without talking to a doctor (or other prescriber) first. But this doesn't have to be in person. There are many virtual care providers who can make a diagnosis of ED and prescribe Viagra online.What is the FDA advisory for buprenorphine? ›
ISSUE: The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.
What are the prescribing guidelines for buprenorphine for pain? ›
BUP TDS is available in 5, 7.5, 10, 15, and 20 mcg/hour patches; the BUP TDS prescribing information recommends the 5mcg/hr patch as the starting dose for patients on less than 30mg oral morphine equivalents per day while the 10mcg patch is the recommended starting dose for patients on 30-80 mg of daily morphine ...What are the limits of buprenorphine? ›
✹Dosing recommendations are based on data from trials before 2002 at doses equivalent to 6-24 mg/day. ✹The recommended daily dose for maintenance is 16/4 mg. ✹The maintenance dose “is generally in the range of 4/1 mg buprenorphine/naloxone to 24/6 mg buprenorphine/naloxone per day depending on the individual patient.Is buprenorphine used for mental health? ›
Buprenorphine is an opioid medication typically prescribed for treating opioid use disorder. However, literature supports its utility for treatment-resistant depression (1).What is a treatment gap for buprenorphine? ›
A buprenorphine treatment gap indicator was the key predictor used in our analyses. A treatment gap was defined as a month in which a patient went without buprenorphine for more than 15 consecutive days.Is buprenorphine classified as an opioid? ›
Buprenorphine is a long-acting (24-72 hours) opioid that produces less respiratory depression at high doses than other narcotic drugs.What narcotic schedule is buprenorphine classified in? ›
Schedule III/IIIN Controlled Substances (3/3N)
Examples of Schedule III narcotics include: products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®), and buprenorphine (Suboxone®).
It can help sustain recovery and prevent or reduce opioid overdose. Common side effects of buprenorphine include headache, nausea, vomiting, constipation, pain, increased sweating, and insomnia.What is the most common barrier to prescribing buprenorphine? ›
Among waivered NPs/PAs, key buprenorphine prescribing barriers were insurance prior authorization and detoxification access.Can I prescribe buprenorphine for chronic pain? ›
Clinicians can only prescribe buprenorphine for addiction after receiving certified training and a Drug Enforcement Administration (DEA) waiver. However, any DEA-licensed clinician can prescribe buprenorphine for pain.How long should buprenorphine be taken? ›
Depending on why you're taking buprenorphine, you may only need to take it for a short time. For example, if you're in pain after an injury or operation, you may only need to take buprenorphine for a few days or weeks. You may need to take it for longer if you have a long-term condition.