The Drug Enforcement Agency (DEA) recently proposed new rule changes for telemedicine prescribing of controlled substances. This rule is more restrictive than the current Covid-19 flexibility, but less restrictive than pre-Covid requirements. The rule requires in person visits for Schedule II medications and Schedule III-V narcotic medications. There is a special exemption for Buprenorphine which is used to treat drug addiction.
The Federal Register has outlined some of the new record-keeping requirements that must be captured in the EPCS prescribing application, such as a valid DEA registration number, auto-renewal if applicable, the date the prescription was issued, the name and address of the patient, the drug name, strength, quantity, audio/visual technology used, and the location of the practitioners and patient.
These proposed changes may require EPCS applications to develop additional validations around telemedicine-controlled substance prescribing and to develop the capabilities to capture information related to in-person or remote patient encounters. In addition to the current EPCS requirements, these proposed regulations would add the following criteria:
- Prescriptions issued pursuant to a telemedicine encounter must include an additional note indicating that they were issued based on a remote encounter.
- Prescriptions issued via telemedicine must be restricted to only Schedules III-V and may not include narcotic medications.
- Prescriptions issued prior to an in-person evaluation must be limited to a 30-day supply.
- The electronic prescribing system must capture additional information for prescriptions issued pursuant to a telemedicine encounter. This would include the city and state where the patient is located during the remote encounter and referral information, including the name and NPI number of referring practitioner and copy of the referral communications.
- For medical practitioners conducting an in-person evaluation pursuant to a telemedicine prescription, the provider must record the NPI of the DEA-registered healthcare worker physically present with the patient, the address at which the prescribing practitioner is located during the telemedicine encounter, and the address at which the DEA-registered healthcare worker is physically present with the patient during the medical evaluation.
The DEA also released a Narrative Guidance document outlining how practitioners should exercise caution and diligence when prescribing controlled substances via telemedicine. This includes ensuring that the patient is truly in need of the medication, that they can receive it safely and legally, and that there are no signs of abuse or misuse.
The proposed rules on telemedicine prescribing for controlled substances have left many questions unanswered for the pharmacy community. These include concerns over liability, security, privacy, and accountability. Pharmacists also worry about how to monitor prescriptions written without having seen the patient in person, as well as potential issues with reimbursement from health insurers and prescription drug plans.
While the new rules have caused some concern among pharmacists, they could ultimately prove beneficial by improving access to care for patients who may not be able to receive it in person. With further research and clarification, these proposed rules could help open up new opportunities for both patients and practitioners alike. Drummond will continue to monitor the developments with this proposed rule and keep you informed about how they may impact the EPCS certification criteria.
References:
https://www.dea.gov/sites/default/files/2023-02/Controlled%20Substance%20Guidance.pdf
https://www.dea.gov/sites/default/files/2023-03/Telehealth_Practitioner_Narrative_312023.pdf