February 16, 2024

Remote Prescribing of Controlled Substances via Telehealth: Stakeholders Urge DEA to Address Geographic Red Flag for Pharmacists

At a Glance

  • A group of telehealth leaders have written a letter to the DEA requesting that the geography “red flag” be explicitly addressed in the upcoming telehealth rulemaking.
  • Current processes prevent many pharmacists from filling prescriptions for controlled substances when the prescriber and patient are not in the same geographic area — which is an increasing concern as telehealth retains its popularity after the pandemic.

Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for treatment of behavioral health conditions, including substance use disorder (SUD) and attention deficit hyperactivity disorder (ADHD), that was previously only available after an in-person visit. Some of the standard of care treatments for conditions like these are controlled substances, meaning medications that are tightly regulated by the Drug Enforcement Administration (DEA) due to their potential for diversion and abuse. Prior to the pandemic, in most cases, an in-person visit was required before a provider could prescribe a controlled substance via telehealth. During the pandemic and through the end of 2024, that restriction has been waived, opening up a new channel of access to care for patients in need.

DEA Telemedicine Rulemaking

The DEA is currently writing new proposed rules around the requirements for providers prescribing controlled substances via telemedicine without a prior in-person visit. In March 2023, DEA proposed its initial framework for the post-pandemic rules and more than 38,000 stakeholders commented, many raising concerns regarding the restrictiveness of the proposed rules. In response, DEA held two days of stakeholder listening sessions in September 2023 to get feedback on what guardrails are appropriate and whether a “special registration” process for providers would be a feasible solution. DEA is now expected to release updated proposed rules early this year to give time for another round of comments, final rule and implementation before the current flexibilities expire in December.

However, the previous proposed rules and the idea of the special registration process focus on the prescriber. Stakeholders in the pharmacy community (as well as others) who want to continue patient access via telehealth have stressed the need for DEA to address the pharmacy or dispensing piece of the puzzle. If a special registration process is created for prescribers, will pharmacists know on the face of the prescription that the prescriber has obtained the appropriate registration? Must the dispenser be responsible for knowing? Will the dispenser know if a prescription was issued pursuant to a telehealth visit, or would the pharmacist  guess that is the case when the prescriber is far away from the patient? If the prescription is issued via a telemedicine visit, what signs will indicate to the pharmacist that it was an appropriately registered prescriber, and will this give the pharmacist confidence to dispense?

Clarity for Pharmacists

The problem is that currently, without answers to those questions, telehealth providers and their patients are increasingly seeing pharmacists decline to fill their legitimate prescriptions. Out of an abundance of caution and an effort to avoid the mistakes of the opioid epidemic, pharmacists see a prescription for a controlled substance that resulted from a telehealth visit or from a prescriber location that is far away from the patient and automatically deny the prescription. This is also the message that they are receiving from the DEA, multi-district litigation opioid settlements and — likely — their own in-house leadership.

In recent months, Faegre Drinker convened multiple roundtable sessions with members of the telehealth and pharmacy community to get to the bottom of this problem and collectively brainstorm potential solutions. While the problem is multi-factorial and will require a range of solutions, the discussion led to one targeted solution that DEA could enact with immediate impact: explicitly state that geography is not a “red flag” when it comes to telehealth prescribing.

DEA Red Flags

The concept of a “red flag” is designed to signal to pharmacists that a prescription may be illegitimate in some way and the pharmacist should view it with suspicion. They are referenced in legal orders, public informal DEA materials and DEA press releases, but no formal DEA guidance exists on them. Stakeholders cite this lack of guidance for  collective confusion among prescribers and pharmacists, a wide variance in pharmacy dispensing policies, and the reluctance of many pharmacists to dispense controlled substances.

In a 2012 legal order, DEA stated that “a pharmacist or pharmacy may not dispense a prescription in the face of a red flag (i.e., a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid.”

DEA has been clear that a pharmacist should not move forward with dispensing a medication unless “red flags” are resolved.

Geography or distance — a certain mileage away or across state lines between the prescriber and the patient — has been explicitly referenced as a red flag. Thus, this red flag is directly contributing to patients being unable to access their medication that was legitimately prescribed by their provider via telemedicine as very often the purpose of telemedicine is to digitally bridge such distances.

Stakeholder Statement to Government

In response, telehealth community stakeholders joined together to write a letter to the DEA requesting that the geography red flag be explicitly addressed in the upcoming telehealth rulemaking.

DEA has the difficult task of writing rules to ensure that patients can still access necessary care via telehealth while preventing abuse and diversion. Historically, only the latter (diversion control) was a part of DEA’s mission, although DEA in recent years has acknowledged at a minimum the importance of access to buprenorphine, a schedule III controlled substance for the treatment of opioid use disorder. The easiest way to prevent diversion may be to put strict limits on how often medications can be prescribed; however, that solution is not tenable for the millions of patients that need specific medications to treat their conditions.

DEA is working to strike the balance in the rules for prescribing. However, stakeholders say those efforts will be moot if pharmacists are not given clarity about the rules for them and feel unable to dispense controlled substance prescriptions issued as a result of a telemedicine visit. Proponents of access to care via telehealth want to ensure that doesn’t happen.

You can read the full letter telehealth leaders sent to the DEA — DEA Should Address Geographic “Red Flag” in Telemedicine Prescribing of Controlled Substances Rulemaking — online. This letter was publicized with an initial group of signers and will be updated as additional organizations sign it.

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