Array and Other Leading Telepsychiatry Organizations Band Together to Recommend Rules and Proposed Safeguards to the DEA for the Virtual Prescribing of Controlled Substances

DEA Registration

Special Registration

• Allows qualified providers to prescribe Schedule II (any duration) and Schedule III-V (>30 days) medications via telehealth after 1) an in-person visit, or 2) qualified referral from in-person provider (other limited circumstances allowed²)
• Primarily impacts incidental telemedicine prescribers (i.e., providers who see patients in both in-person and virtually)

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• Allows qualified providers to prescribe Schedule IIN non-narcotic, III, IV, and V medications via telemedicine without an in-person visit or referral
• Primarily impacts large provider groups that see patients predominantly or exclusively via telemedicine without an in-person evaluation.
• Exemptions from certain requirements for a) providers at not-for-profit organizations or hospitals (for-profit and not-for-profit) and b) buprenorphine prescriptions

Focus of this document

• Require providers to evaluate the patient at least once every 90 days to continue to prescribe controlled substances

• Regular cadence of care is necessary to appropriately titrate medication

• Require providers to have the capability and to offer synchronous audio/video visits and communicate with patients via a HIPAA compliant platform

• Critical to maintain high quality care

• For controlled substance prescriptions, prohibit telemedicine practitioners from requiring, recommending, referring, or suggesting a patient utilize a specific registered pharmacy, unless the patient initiates the request for a suggestion or recommendation of a pharmacy

• Critical to maintain quality care and avoid misaligned incentives

• Limit the authority for qualified providers to the prescription of medications for standard of care
• The authority to store and dispense these medications on site would not be granted via Special Registration

• Physical locations for storing and dispensing medications are out of scope of the Special Registration

• Exclude ketamine from the list of medications that can be prescribed under the Special Registration (can still be prescribed under the DEA Registration)
• If the FDA approves labeling for a ketamine drug for patients to self-administer at their domicile or finds it to be safe for a patient to administer without medical supervision, the DEA will review this prohibition and seek amendment to this regulation

• Ketamine is approved for treatment resistant depression
• In-person observation is the standard of care after prescription to allow provider to intervene if necessary

• Limit Schedule II to Schedule IIN non-narcotic medications
• Limit to treatment of mental health conditions
• Require prescribers to satisfy one of the following:
  • Physician
  • Certified advanced practice Nurse Practitioner with a Board Certification in Psychiatric-Mental Health from ANCC
  • Physician Assistant with certificate of added qualification of Psychiatry from NCCPA
  • Completed 8 hours of approved State licensing medical board or its equivalent continuing medical education credits related to ADHD

• Schedule IIN non-narcotic drugs are critical to treating legitimate mental health needs, while broader Schedule II have a history of abuse

• Limit controlled substance prescriptions to 500 per provider per month (recommended)
• Limit number of patients on a controlled substance to 275 per provider (alternate limit)
• For either limit recommendation, in specific circumstances where a practitioner exceeds the limit(s), consideration will be given to the reason documented in the patient’s medical record
• While roughly equivalent, we recommend a limit on controlled substance prescriptions rather than patients:
  • Prescription volume is easier to track
  • Patients may be prescribed more than one controlled substance
  • Provider coverage (for doctors on vacation or leave) would complicate per provider patient count

• Limits potential for abuse, consistent with pre-existing DEA regulations

• For each provider, report the following non-PHI data to the DEA on a quarterly basis:
  • Prescriber DEA registration number
  • Healthcare Entity the prescription was affiliated with
  • Name of drug(s) prescribed
  • Number of prescriptions for each drug
  • Date of prescription(s)
• Providers may delegate reporting authority to others and the delegate will be provided to the DEA
  • For example, if a medical practice employs multiple medical practitioners that are required to report, the practitioners may delegate to the medical practice entity to report on their behalf
  • Alternatively, medical practitioners may delegate the reporting to an administrative person or may contract with a third party for reporting
• This data can be stored and reported in common spreadsheet formats, in the format of a Certified Electronic Health Record (CEHR), or in other formats approved by the DEA
• Reports can be submitted to the DEA electronically via online reporting, electronic file upload, or other means as approved by the DEA

• Allows DEA to access previously hard to get data
• Creates accountability to minimize risk of diversion
• Protects patients’ privacy by removing PHI
• DEA to propose the format and mechanism for the sharing of these reports within 6 months of the Special Registration process being created, and to allow sufficient time for public comment
• DEA may also consider pharmacy prescription data as not all prescriptions written are filled by patients