Restrictions in DEA’s Telehealth Proposed Rules Put Vulnerable Patients at Risk

On February 24, 2023, the Drug Enforcement Administration (DEA) announced proposed rules for the remote prescription of controlled substances. These proposed rules would take effect when the COVID-19 Public Health Emergency ends on May 11, but providers have a 180-day grace period from that date to comply.

To submit comments to the DEA, visit www.regulations.gov by 11:59 p.m. Eastern Time on March 31, and reference Docket No. DEA-407.

Background

• DEA has been required to create a special registration process for telemedicine prescribers since the original Ryan Haight Act passed into law in 2008. These two rules, officially proposed on March 1, 2023, are DEA’s response to that requirement. However, the rules do not actually create a special registration process as DEA notes it believes that would only create more administrative burden for providers. 
• Right now, the two rules are separate, but DEA seeks comments on whether they should be combined. 
• Under the original Ryan Haight Act, telehealth prescribing of controlled substances is allowed after one in-person visit by that provider (this is still true). During the COVID-19 PHE, that in-person requirement was lifted, so any prescribing of controlled substances for a legitimate medical purpose was allowed via telehealth.

What the Telemedicine Proposed Rule Does

• If a provider sees a patient in person, they may subsequently do telehealth.
• If a provider does not see a patient in person, they may prescribe controlled substances via telehealth: 
  • For a maximum 30-day supply (for schedule III-V non narcotics and buprenorphine only); OR
  • If a DEA-licensed provider sees the patient in person and refers the patient to the telehealth provider to treat the same condition.
• All prescribers must follow all applicable state (licensing, practice, and Controlled Substance Acts) and federal laws related to licensing and DEA registration, including being appropriately licensed and registered with DEA in the state where the patient is located at the time when medication is prescribed. 
• Other interesting highlights: all prescriptions must be submitted electronically; all prescribers must have an NPI; all prescriptions must occur from direct telemedicine interaction with a patient; and all prescribers must be physically located in the U.S.

What the Buprenorphine Proposed Rule Does

• If a provider does not see a patient in person, they may prescribe buprenorphine via telehealth: 
  • For a maximum 30-day supply (for schedule III-V non narcotics and buprenorphine only); OR
  • If a DEA-licensed provider sees the patient in person and refers the patient to the telehealth provider to treat the same condition.
• Once a provider-patient relationship is established, buprenorphine can be prescribed via audio-only telehealth visit in locations where state law allows audio-only prescribing to patients.

What Does This Mean?

• This is significantly more restrictive than the pandemic era policy, but somewhat less restrictive than pre-pandemic policy. 
• Patients who have only established a relationship with their treating clinician via telehealth are the ones that will miss out; around the beginning of 2024, they will lose access to care unless they see a provider in person who is willing to refer to their treating telehealth provider. As we know, many patients don’t have primary care physicians or any clinician they see in person, so we would expect to see a large drop-off in patient access to care. This is inconsistent with our belief that telehealth should be held to the same standard as in person care and quality of care via telehealth should be the same or better than in-person. 

What We Are Doing

• Building on years of advocacy with DEA, HHS, the White House, and Congress, the ATA and ATA Action will make the voice of telehealth heard on this issue. We will submit formal comments to the rulemaking process during the 30-day comment period, as well as meet with the agencies and Congress to ensure that this rule does as little harm as possible to patient access.
• Please let us know your feedback on specific ways the rules could be changed with that goal in mind. To maximize our effectiveness, we need to provide tangible options for policymakers to consider tweaking the rules to do less damage.

We are collecting as much data and as many statistics as possible regarding the care patients are receiving now during the pandemic that stands to be impacted by the proposed rules. Please send any information you may have that could assist our advocacy efforts as soon as possible to Tom Mann (tmann@americantelemed.org).

For More Information 

ATA and ATA Action Call DEA’s Proposed Rule on Controlled Substances Overly Restrictive, Fear Consequences in Patient Care

ATA and ATA Action Press Release
February 25, 2023

DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends

Nathaniel M. Lacktman
Foley & Lardner
February 23, 2023

What the latest DEA Proposed Rule Means for Telemedicine Prescribing of Controlled Substances

Rebecca Gwilt
Nixon Gwilt Law
February 27, 2023

If you’d like more information on ATA Action, the ATA’s affiliated trade organization, please contact Tom Mann (tmann@ataaction.org).