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In the end, the Drug Enforcement Administration (DEA) has signaled its consideration of a separate Particular Registration for telemedicine prescribing for sufferers with out requiring an in-person examination.
On August 4, 2023, DEA filed a pre-publication Discover of Assembly (printed within the Federal Register on August seventh) to announce its intention to conduct public listening classes this fall. These classes shall be designed to obtain public enter on the suitable method to ascertain a Particular Registration for practitioners to prescribe managed substances through telemedicine. That is notable as a result of in its proposed rule printed earlier this 12 months, DEA had said that the proposed rule “fulfille[d] DEA’s obligation” to publish a Particular Registration. Various commenters, together with Foley, disagreed that the proposed rule met the earlier Congressional mandate. In consequence, this present discover might symbolize a retreat from that place and is encouraging for events who’ve lengthy sought implementation of a Particular Registration.
“DEA is open to contemplating—for some managed substances—implementation of a separate Particular Registration for telemedicine prescribing for sufferers with out requiring the affected person to ever have had an in-person medical analysis in any respect.”
As described within the quote above from the Discover, DEA is “open to contemplating” a revision to its prior coverage. Particularly, DEA is searching for public enter on the next questions:
- If telemedicine prescribing of schedule III-V drugs have been permitted within the absence of an in-person medical analysis, what framework, together with safeguards and knowledge, with respect to telemedicine prescribing of schedule III-V drugs can be really useful to assist DEA guarantee affected person security and forestall diversion of managed substances?
- Ought to telemedicine prescribing of schedule II drugs by no means be permitted within the absence of an in-person medical analysis? Are there any circumstances during which telemedicine prescribing of schedule II drugs ought to be permitted within the absence of an in-person medical analysis? If it have been permitted, what safeguards with respect to telemedicine prescribing of schedule II drugs particularly can be really useful to assist DEA guarantee affected person security and forestall diversion of managed substances?
- If practitioners are required to gather, keep, and/or report telemedicine prescription knowledge to DEA, what items of knowledge ought to be included or excluded? What knowledge is already reported to federal and state authorities, insurance coverage corporations, and different third events?
- If pharmacies are required to gather, keep, and/or report telemedicine prescription knowledge to DEA, what items of knowledge ought to be included or excluded? What knowledge is already reported to federal and state authorities, insurance coverage corporations, and different third events?
This discover comes after years of public remark and advocacy from institutional stakeholders and sufferers alike calling for elevated entry to digital care and distant prescribing. As Foley has beforehand reported, DEA has been underneath a statutory mandate to promulgate guidelines implementing a Particular Registration for digital practitioners to allow distant prescribing of managed substances with out an in-person examination and, up till now, has failed to take action. Certainly, DEA obtained 38,369 public feedback in response to proposed guidelines printed by the DEA earlier this 12 months (a lot of which particularly requested the particular registration method). Based on this discover, these have been among the many highest variety of public feedback obtained on a proposed rule in DEA’s historical past.
Whereas it nonetheless stays unclear when such a registration would turn out to be obtainable, or to which managed substances and practitioners it will apply, this discover displays a broader development by DEA of recognizing telemedicine as a elementary facet of well being care innovation and entry.
The general public listening classes shall be held on Tuesday, September 12, 2023, and Wednesday, September 13, 2023, from 9 a.m. to five:30 p.m. on the DEA Headquarters, 700 Military Navy Drive, Arlington, VA 22202 and shall be live-streamed on-line. events are inspired to attend and should submit a request to make an oral presentation throughout the listening session. Events eager about attending in-person or making a presentation should register and submit a request on the DEA’s web site no later than August 21, 2023.
Need to Be taught Extra?
Foley is right here that will help you tackle the short- and long-term impacts within the wake of regulatory adjustments. For extra data on telemedicine, telehealth, digital care, distant affected person monitoring, digital well being, and different well being improvements, together with the group, publications, and consultant expertise, go to Foley’s Telemedicine & Digital Well being Trade Staff or our Well being Care Apply Group.
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