By Ronald W. Chapman II, Safe Harbor Group
The Drug Enforcement Administration (DEA) has been working (some might say scrambling) to craft new regulations for prescribing controlled substances via telemedicine. If you’ve felt whiplash from all the rule extensions, in-person requirements, and new forms of telehealth expansions, trust us, you’re not alone.
At Safe Harbor Group, we’re here to ensure your medical practice stays on the right side of compliance (and well clear of the dreaded “Where do I send my fines?” scenario). Below is a forward-looking, pragmatic breakdown of the DEA’s latest proposed rules and what they could mean for doctors who plan to continue (or start) prescribing controlled substances via telemedicine.
The Big Picture: Why New Rules?
Context and Background
• COVID-19 Telehealth Flexibilities
At the height of the COVID-19 Public Health Emergency (PHE), the DEA granted temporary exceptions that allowed providers to prescribe controlled substances via telemedicine without an in-person medical evaluation. This was crucial in keeping patients safe at home and ensuring continuity of care.
• Where We Are Now
Multiple temporary extensions have punted the final cutoff date forward to December 31, 2025, to keep telemedicine prescribing afloat while the DEA finalizes long-term rules. The journey from indefinite audio-only prescribing to the new proposed regulations has been full of twists and turns.
• The Proposed “Special Registration”
One of the big new developments is a Special Registration for Telemedicine—effectively a special license that recognizes legitimate telemedicine but aims to prevent the diversion of controlled substances.
“If you feel like you need a Ph.D. in bureaucratic acronyms just to read these rules—hey, there’s a special registration for that, too.”
The Three Proposed Special Registrations
Under the DEA’s new rulemaking, you’d potentially see three distinct types of registrations tied to telemedicine:
1. Telemedicine Prescribing Registration (Schedules III–V)
• For practitioners who want to prescribe Schedules III–V medications (think non-narcotic controlled substances like certain anxiety, sleep, or ADHD meds—minus the heavy hitters in Schedule II).
• Ideal for routine telemedicine appointments where requiring an in-person exam is unreasonably burdensome.
2. Advanced Telemedicine Prescribing Registration (Schedules II–V)
• For specialized providers (psychiatrists, hospice/palliative care doctors, pediatricians, certain neurologists, and so forth) who need authority to prescribe Schedule II drugs (e.g., strong opioids, ADHD stimulants) without that prior in-person step.
• Why the special carve-out? Because the DEA recognized that certain specialties—hospice, mental health—frequently serve very vulnerable or mobility-limited patients.
3. Telemedicine Platform Registration (Schedules II–V)
• For covered online telemedicine platforms—the big digital “intermediaries” that connect patients with prescribers. Think direct-to-consumer telehealth companies.
• The DEA wants to ensure these “platforms” do more than just funnel patients to prescribers with minimal oversight. Hence the requirement that the platform itself register, maintain anti-diversion protocols, and stay fully transparent about its relationships with clinicians and pharmacies.
Burning Question: Do You Need All Three?
• Short Answer: No.
• If you’re a single MD prescribing only Schedules III–V in a standard telehealth context, you only need the Telemedicine Prescribing Registration.
• If you’re specialized and must prescribe Schedules II–V, you’d need the Advanced Telemedicine Prescribing Registration.
• The Telemedicine Platform Registration is specifically for companies (hospital systems excluded) that facilitate telehealth services and have a direct role in the “remote dispensing” of these meds.
The Other Registration Requirement: “State Telemedicine Registration”
Because 21 U.S.C. 831(h) essentially says you must be registered in the state where the patient is located, the DEA proposes an ancillary State Telemedicine Registration for each state in which you treat telemedicine patients.
Exemptions:
• Certain federal employees, like DoD or Public Health Service, or Department of Veterans Affairs (VA) providers acting within that scope may skip the extra paperwork.
• But for most private practitioners, expect a “State Telemedicine Registration” line item on your to-do list if you’re seeing out-of-state patients via telemedicine.
Key Changes and Requirements to Keep on Your Radar
1. Audio-Video for Most Patients
• DEA’s New Standard: Real-time, two-way audio-video telemedicine is required for prescribing controlled substances unless you’re continuing buprenorphine for Opioid Use Disorder (OUD) in established patients, in which case audio-only can be permissible.
• Rationale: The DEA believes seeing a patient’s face helps detect red flags of misuse and confirm identity.
2. Nationwide PDMP Checks
• Right now, the proposed rule says you must check PDMP data from:
• The state where you are located,
• The state where the patient is located,
• Any state with “reciprocity” with those states.
• After 3 years (if a national PDMP system is in place), you’ll have to do a 50-state, nationwide PDMP check for each telemedicine prescription.
• Are you sweaty yet? Because that’s a lot of clicks.
3. Photo ID Requirements
• You must capture or verify a photographic record of a patient’s ID for the initial telemedicine visit (and keep it on file for two years).
• Reassure patients that these images must be securely stored—HIPAA’s glare will burn you otherwise.
4. Monthly/Annual Data Reporting to DEA
• Pharmacies must submit monthly aggregated data on all “special registration prescriptions” for certain medications (Schedule II and certain III–V).
• Practitioners must also submit an annual count of new telemedicine patients, the number of prescriptions for Schedules II–V, etc. The DEA wants to ensure better real-time data on prescribing trends to detect potential abuses.
5. Schedule II Twist
• For advanced telemedicine prescribers (issuing Schedule II meds via telehealth), there may be an added requirement that either:
• You and the patient be located in the same state when prescribing Schedule II drugs, or
• The number of your telemedicine-only Schedule II prescriptions must be <50% of your total Schedule II prescribing in a given month.
• In simpler terms, the DEA is trying to keep Schedule II prescribing at least partly grounded in real-world patient contact.
How Will Doctors Implement This?
1. Check Your Practice’s Scope:
• If you only handle a handful of non-narcotic ADHD or anxiety meds (Schedules III–V) for out-of-state telemedicine, a Telemedicine Prescribing Registration might suffice.
• If you treat advanced pain, mental health, or palliative/hospice care, you may need the Advanced Telemedicine Prescribing Registration to prescribe Schedule II.
2. Prepare Your Credentialing Staff:
• They’ll need to fill out new forms (DEA Form 224S, and possibly 224S-M for modifications).
• Also plan for a new wave of “hey, we forgot to mention we’re registering in Alaska now,” so factor that into your compliance workflows.
3. Develop a PDMP Access Plan:
• Are you integrated with your state’s PDMP? Can you also access the PDMP in your patient’s state?
• If you’re prescribing in 10 states, do you have a workable solution to run these PDMP checks quickly?
4. Data Reporting Infrastructure:
• You (and your pharmacy partners) will need to electronically submit aggregated data about your telemedicine prescriptions.
• Make sure your EHR or practice management system can generate monthly and annual queries seamlessly.
5. Be Ready for Audits:
• Between photographic ID requirements, PDMP checks, new data submissions, and special registration forms, the compliance environment is robust. Keep tidy records and a swift audit response plan.
What if the DEA’s system for verifying nationwide PDMP data isn’t fully operational by the three-year mark? The rules say you’d be forced back into state-limited prescribing for Schedule II. Is that realistic given how widely telemedicine has expanded?
That’s a question we’d love the DEA to clarify further. We will keep our ear to the ground for an answer.
VA Telemedicine Update (in Brief)
• The DEA separately finalized rules specifically tailored to the Department of Veterans Affairs (VA) system, letting VA practitioners prescribe controlled substances via telemedicine so long as the patient was evaluated in person by any VA practitioner at some point.
• Contracted or community care network providers, though, are excluded from that final rule.
• The net effect: VA docs have a streamlined path for tele-prescribing. But if you’re outside the VA system, the new special registration rules described above apply.
Top 5 Questions Doctors Are Asking
1. Do I still need to see patients in person at all?
Under the special registration rules, you might not need in-person visits for certain Schedules if you meet all the telemedicine requirements. But watch the proposed constraints for Schedule II.
2. Will the “30-day supply limit” or “qualifying referral requirement” from the old proposed rules still happen?
• he DEA currently pivoted away from that specific approach. The new approach is to let doctors see patients entirely via telemedicine if they have the correct Special Registration plus PDMP checks, data reporting, etc.
3. What if I’m seeing patients in multiple states?
Yes, you’ll likely need multiple “State Telemedicine Registrations.” Or you might find some small niches/exemptions (like if you’re a federal employee). Factor registration fees and time costs into your practice plan.
4. Is my EPCS system enough, or do I need more?
You must use EPCS. Also confirm your system can handle advanced identity-checking, PDMP integration, and the monthly/annual data reporting. That’s more than just e-prescribing.
5. When do I actually have to comply?
The “Third Temporary Rule” extends your existing telemedicine flexibilities until December 31, 2025. After that, these proposed regs (once finalized) presumably take full effect—unless the DEA or Congress changes things again.
Final Thoughts (and Where Safe Harbor Group Can Help)
The DEA’s new proposals aim to preserve telemedicine’s flexibility while erecting guardrails against misuse of controlled substances. It’s a laudable goal, but the real question is how it’ll look in practice. The extensive new application steps, PDMP checks, and monthly/annual data reporting could create an administrative tangle—especially for smaller practices.
Safe Harbor Group can help you:
• Assess Your Telemedicine Readiness
We’ll map out whether a Telemedicine Prescribing Registration or Advanced Telemedicine Prescribing Registration is best for you.
• Streamline Your PDMP Integration
Implement a workable plan so you’re not double-checking random state websites at 2 a.m. on a weekend.
• Navigate Multi-State Licensing
Our compliance specialists can reduce the headache of registering in multiple states. We’ll tell you if you qualify for any special federal/VA exemptions.
• Train Your Staff
From capturing ID photos to gleaning how your new data reporting obligations work, we’ll create cheat sheets for your front-office or telehealth team.
Want More Guidance or Have Burning Questions?
Reach out to Safe Harbor Group’s Telehealth Compliance Team. Let’s ensure your practice is telemedicine-ready while keeping your sanity (and your license) intact.
Disclaimer:
This article summarizes proposed regulatory changes and does not constitute legal advice. Always consult with legal counsel or your compliance officer to address specific circumstances.
