Key Drug Enforcement Administration (DEA) leaders said little last week during the roughly 11 hours of live presentations heard over two days of listening sessions regarding the future of telehealth and prescribing controlled substances.
What they did say, however, helps clarify what is top of mind for the DEA as the agency considers re-approaching how to regulate the prescription of controlled substances via telehealth. DEA leaders who participated in the listening sessions included Administrator Anne Milgram, Deputy Assistant Administrators Tom Prevoznik and Matthew Strait.
On their end, Milgram and Prevoznik were limited to only asking clarifying questions germane to presentations. Those questions largely focused on asking presenters to flesh out several ideas related to patient safety and prescription drug diversion prevention and tracking. Strait acted as host for the event but offered his own commentary on the DEA’s efforts as well.
During the several hours of presentations, these DEA leaders heard from 58 presenters curated from a list of over 180 requests to present. Milgram and Prevoznik did not ask questions of all the presenters.
In early August, the DEA published an informal notice that it would hold the listening sessions after stalling two previously announced, related proposed rules relating to telehealth and controlled substances released in February. The rules were roundly criticized. In response, the DEA announced in May it would delay the effective date of the rules to Nov. 11.
In short, the proposed rules would have re-established the requirement that a new patient establish a relationship with a provider through an in-person exam. The Ryan Haight Act, a 2008 adjustment to the Controlled Substances Act, mandates these visits before telehealth prescribing. This requirement was temporarily waived due to the federal public health emergency for COVID-19, which ended on May 11.
While the proposed rules provided a grace period for patients who started treatment during the PHE, many providers maintain that mandating in-person exams is counterproductive, especially in the context of the opioid epidemic and care shortages.
Apparent misunderstanding of the proposed rules
Commentary from opponents of the proposed rules inspired Strait to use his time at the mic as host and conductor for the sessions to add his two cents.
He said the proposed rules would not impact care where there has been an in-person exam to establish a patient relationship with a provider. He said this would apply even in instances of long-established patient relationships, so long as that patient has been seen in person.
“This is, I think, a fundamental assumption or perhaps a misunderstanding about our draft rule,” Strait said on the second day of the listening sessions. “It bears emphasis because we don’t want to lose in our translation the fact that this rule is not being applied broadly to all telemedicine encounters across the entire spectrum, whether that in-person relationship has been established or not.”
Strait made similar comments, clarifying the applicability and intent of the proposed rules once per day. The rule, he said, would apply to patient care situations where a care relationship and controlled substances were relevant but didn’t include an in-person exam.
“I just want to throw that out there — that in the instance of an existing patient that a doctor is treating, once that in-person treatment has been established, which could have been years back or relatively recently, the requirements of what we were proposing in our regulation would not exist because that in-person relationship has already been established,” Strait said.
Yet another opportunity to comment on the DEA rules
Federal rulemaking processes typically include comment periods where members of the public can give feedback on the regulations, typically in written format. That has already happened for these rules. It was also the impetus for the DEA’s change of course on the proposed rules.
The DEA received tens of thousands of largely negative comments during the comment period that ran through March.
During prepared remarks to kick off the listening session, Milgram acknowledged the comments and said they inspired the DEA to “reopen this conversation about telemedicine prescribing.”
During the listening sessions, Milgram said the DEA will hold another written comment period in the Fall of 2023 “before any telemedicine regulations are finalized.” She did not articulate when that would be.
“To those who applied to present today but were not selected, thank you for your interest in this issue, and we’re looking forward to receiving, reviewing and responding to your thoughts as well,” Milgram said.
Better data sharing to track potential diversion
Milgram and Prevoznik asked several participants about ideas around the better use of data regulators require pharmacies, prescribers and health insurance companies to collect and share with state and federal governments.
Many commenters critical of the proposed rule said the DEA’s existing regulations to become and remain a controlled substance prescriber already require strict record-keeping. They pushed back against some of the finer points of the proposed rule that would require additional information to be collected and shared when prescribing controlled substances via telehealth. In small part, many e-prescribing and other IT systems don’t allow for a destination that a prescription came from a telehealth visit at all.
Some commenters suggested, after questions from DEA leaders, that the government-backed and run health plans Medicare and Medicaid take up an additional role in controlled prescription oversight or share additional data with DEA for its oversight.
A focus on diversion prevention and patient safeguards
Milgram and Prevoznik asked multiple presenters about how they verify a patient’s identity and ensure compliance with the care provided.
Commenters frequently brought up the use of at-home, mail-in lab tests, or other texting services to track a patient’s progress and compliance with treatment involving controlled substances. That typically led to additional questions about the prevention of sample adulteration. Many commenters said they require certain elements of a sample collection to be conducted on an audio-visual call with a provider and encourage true samples even if a patient is off track with their treatment, especially in addiction treatment.
Several commenters also suggested that the DEA either get wider permissions to access state prescription drug monitoring program (PDMP) databases or that these databases consolidate into a national registry of controlled substance prescriptions.
DEA leaders asked questions about the practical implications of such a project. They also asked what additional information could be added to PDMPs to help providers and pharmacies better track prescriptions and prevent diversion.