Heads Up! DEA Public Listening Sessions on
August 14, 2023
DEA Announces Public Listening Sessions on Telemedicine Prescribing
Health Highlights, Manatt Health
August 14, 2023
In response to the large number of public comments received to its recent proposed telemedicine rules,1 the Drug Enforcement Administration (DEA) is holding public listening sessions to consider a special registration for prescribing certain controlled substances via only a telemedicine encounter.
The Big Picture
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) generally requires DEA providers to see a patient in person prior to prescribing any controlled substances, unless a statutory exemption is met. Recognizing the critical need to continue care during the COVID-19 pandemic, providers were temporarily permitted to prescribe certain controlled substances without an in-person visit requirement through the end of the public health emergency (PHE).
In February 2023, DEA published two proposed rules that would end the PHE flexibilities and revert to DEA’s prior requirement that the patient have an in-person evaluation before being prescribed Schedule II medications (which include methadone) and Schedule III–V narcotic medications with limited exceptions. This policy would affect people who are newly prescribed one of these controlled substances after the PHE ends, but also those who began taking such medications during the PHE without an in-person visit. Under the proposed rules, without an in-person visit, a provider would only be permitted to prescribe a 30-day supply of buprenorphine as a medication for opioid use disorder, or of a Schedule III, IV or V nonnarcotic, controlled medication, via telemedicine. In order to extend the prescription beyond the initial 30-day supply, an in-person visit would be required. For a detailed summary of the proposed rules, see DEA Releases Proposed Rules Regarding Telemedicine Prescribing of Controlled Substances. The PHE officially ended on May 11, 2023, but the PHE flexibilities were extended through November 11, 2023, while DEA considered public comments to the proposed rules. The DEA received a combined total of 38,369 comments.
Public Listening Sessions Regarding Telemedicine and Controlled Substances
Due to the high volume of public comments received on the proposed rules, DEA is planning to hear oral presentations from stakeholders in two listening sessions on September 12, 2023, and September 13, 2023. Specifically, DEA is seeking feedback on the following questions during these sessions:
- If telemedicine prescribing of Schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of Schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
- Should telemedicine prescribing of Schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of Schedule II medications should be permitted in the absence of an in-person medical evaluation? If they were permitted, what safeguards with respect to telemedicine prescribing of Schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
- If practitioners are required to collect, maintain and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies and other third parties?
- If pharmacies are required to collect, maintain and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
The DEA noted in its announcement of the sessions that telemedicine flexibilities have the potential to expand access to controlled substances while also requiring new accountability frameworks to ensure patient safety and prevent diversion. The decision by the DEA to have these listening sessions appears to signal that DEA is willing to consider a special registration for telemedicine prescribing, for which stakeholders have been advocating for some time as one way to appropriately balance access to care and patient safety.
To present at the listening session, an attendance form (available on DEA’s website) must be submitted and include a summary of the presentation. The form must be submitted by August 21, 2023. DEA will choose presenters at its discretion, based on the person’s or organization’s ability to respond to the specific presented questions and to represent stakeholders on a particular issue.
1 88 Fed. Reg. 12875; 88 Fed. Reg. 12890
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Excerpt from the end of this article:
“But another study published last month revealed that the benefits of telehealth only apply to certain conditions. Researchers assessed visits at hospital-based outpatient clinics in Maryland between 2012 and 2021. They found that patients seeking care for behavioral health issues, metabolic disorders, dermatology, and musculoskeletal issues experienced benefits from telehealth, but others did not.”
After PHE’s End, Americans Signal Preference for In-Person Care
Only 6 percent of Americans prefer virtual care, while a majority believe the affordability, efficacy, and quality of in-person care are better.
By Anuja Vaidya, mHealth, 8/14
August 11, 2023 – Despite the boom in telehealth use during the COVID-19 pandemic, Americans and healthcare workers largely agree that in-person care is higher quality, more efficient, and more affordable than virtual care, a new survey shows.
Conducted by Morning Consult, the survey polled 1,006 healthcare workers from May 5 to May 18 and 2,202 United States adults from July 21 to July 23.
The loosening of regulations governing during the COVID-19 public health emergency (PHE) led to a massive spike in telehealth services.
But patient perceptions regarding telehealth may be changing. The survey shows that only 6 percent of US adults prefer virtual care versus 53 percent who prefer in-person care.
This preference for in-person care was evident across all age groups. Generation Z displayed the highest preference for virtual care, with 9 percent of survey respondents in this group saying they preferred virtual care. However, 49 percent of Gen Z patients preferred in-person care. Similarly, while only 8 percent of Millennials said they preferred virtual care, 43 percent preferred in-person care.
Generation X and Baby Boomers — the most likely to prefer in-person care — also doubled down, with 51 percent and 64 percent, respectively, stating a preference for in-person care in this survey. Only 6 percent of Gen X patients and 2 percent of Baby Boomers said they preferred virtual care.
On the other hand, hybrid care proved relatively popular across age groups. About 30 percent of Gen Z patients, 40 percent of Millennials, 37 percent of Gen X patients, and 31 percent of Baby Boomers said they preferred a hybrid healthcare model that includes both in-person and virtual care.
US adults appear to prefer in-person care as they believe the quality, efficiency, and affordability of these services are better compared to virtual care.
About 45 percent of survey respondents said that the affordability of in-person care was better, while only 17 percent said virtual care affordability was better. About 26 percent did not find a difference in the affordability of in-person and virtual care.
With regard to the quality of care, 74 percent of Americans said in-person care quality was better, 6 percent said virtual care quality was better, and 13 percent said there was no difference.
Americans also view the efficiency of in-person care as superior to virtual care. About 67 percent said in-person care efficiency was better, 11 percent said virtual care efficiency, and 13 percent said there was no difference between the two.
Healthcare worker perceptions in these areas hew closely to those of US adults. Of the healthcare workers surveyed, 44 percent said the affordability of in-person care was better, 77 percent said the quality of in-person care was better, and 72 percent said the efficiency of in-person care was better. Meanwhile, only 16 percent said the same about virtual care affordability, 6 percent about virtual care quality, and 8 percent about virtual care efficiency.
Similar to US adults, 26 percent of healthcare workers said there was no difference between in-person and virtual care affordability, and 13 percent said there was no difference between in-person and virtual care efficiency. Around 11 percent of healthcare workers found no difference between in-person and virtual care quality.
Researchers are still trying to gauge the overall efficacy and quality of virtual care as study results have been mixed.
One study published last September shows that virtual care methods perform on par or better than in-person care on most quality measures evaluated. The study evaluated data from 526,874 patients, with 409,732 receiving only in-person care and 117,142 participating in telehealth visits.
Researchers found that patients participating in telehealth performed better than those in the in-person-only group on four testing-based measures: patients with cardiovascular disease with lipid panels, patients with diabetes with hemoglobin A1c testing, patients with diabetes with nephropathy testing, and blood pressure control.
But another study published last month revealed that the benefits of telehealth only apply to certain conditions. Researchers assessed visits at hospital-based outpatient clinics in Maryland between 2012 and 2021. They found that patients seeking care for behavioral health issues, metabolic disorders, dermatology, and musculoskeletal issues experienced benefits from telehealth, but others did not.