What the latest DEA Proposed Rule Means for Telemedicine Prescribing of Controlled Substances
Late Friday (February 24, 2023), the US Drug Enforcement Agency (DEA) released a proposed rule to make permanent some of the flexibilities allowed during the Public Health Emergency (PHE) for telemedicine companies whose providers prescribe controlled substances.
Keep reading this timely post to find out:
What these proposed changes are;
How they will impact your telemedicine business; and
Where (and how) stakeholders can weigh in on the DEA’s proposal in the 30-day comment period.
Now let’s get to it.
How the New DEA Proposal for Tele-Prescribing Differs from the PHE Waivers and Flexibilities
Outside of the Public Health Emergency (PHE), which is set to expire on May 11, 2023, current DEA regulations based on the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) prohibit tele-prescribing controlled substances for a patient if the prescriber has not previously conducted an in-person medical evaluation of the patient.
The DEA waived the in-person visit requirement for the duration of the PHE, and without further DEA action, telemedicine companies will not be permitted to prescribe controlled substances based solely on virtual telehealth visits after the PHE expires on May 11, 2023.
The new proposed rule would make permanent some of the flexibilities allowed during the PHE by creating limited circumstances in which an in-person visit is not a prerequisite for providers to prescribe controlled substances, a shift many in the industry believe is key to ensuring access to and continuity of care.
Notably, this rulemaking does not propose to implement the “special registration” for telemedicine providers the DEA has been promising since the Ryan Haight Act passed in 2009. Instead, it would create a new regulatory category of the “practice of telemedicine.”
The DEA’s new approach could be a better option for providers because it would not require any affirmative registration process. However, many in the industry say they prefer a special registration that would allow much more flexibility and enable the agency to monitor and, if necessary, revoke registrations for bad actors. Look for many public comments to this effect.
It is unclear whether DEA intends to propose additional regulations implementing a special registration, though it appears the agency has shifted its strategy in favor of simply creating an additional category of telemedicine.
Proposed Requirements for Tele-prescribing in the Absence of an In-Person Visit
Writing a Prescription for a 30-Day Supply of Schedule III-V Non-Narcotic Controlled Substances
If finalized, the proposed rule would allow a practitioner to write prescriptions for a 30-day supply of schedule III-V non-narcotic controlled substances* based on a telemedicine encounter for patients they have never seen in-person, but only if the practitioner:
Is located in the US or one of its territories (including Puerto Rico) at the time of the encounter;
Conducts a telemedicine visit that constitutes a “bona fide medical evaluation” of the patient using two-way, live interactive audio/video communication, or “IAV”. If the visit is for diagnosis, evaluation, or treatment of a mental health disorder, the practitioner can use audio-only communication technology if the provider (a) is technically capable of using IAV visits and (b) has given the patient the option to conduct the visit via IAV;
Writes prescriptions in accordance with Federal and State law;
Possesses an active DEA dispensing registration in the State in which the practitioner is located (unless exempted);
Prior to prescribing, reviews recent prescription drug monitoring program (PDMP) data regarding controlled substance prescriptions issued to the patient in the last year. If this data isn’t available, the practitioner must limit the prescription to a 7-day supply;
Keeps detailed records regarding prescriptions written based on telemedicine encounters. Records can be kept in digital or paper form, and the proposed rule includes specific data points (e.g., the date the prescription was filled; drug name, strength, dosage form, quantity prescribed, and directions for use; the address at which the practitioner and patient are located at the time of the telemedicine encounter) that providers must document and maintain at the practitioner’s DEA-registered location; and
Includes a notation on each prescription or within each prescription order that was written based on a telemedicine encounter.
*A second proposed rule creates an exception for tele-prescribing certain narcotic medications such as buprenorphine for the treatment of opioid use disorder (OUD). We will publish a second post shortly on that proposed rule and link it here.
Writing a Prescription for More Than a 30-Day Supply of Any Controlled Substances
Under the proposed rule, practitioners may prescribe more than a 30-day supply of any controlled substance (not limited to schedules III-V) if:
The prescribing practitioner engages in IAV communication with another DEA-registered practitioner who is in the physical presence of the patient; or
The prescribing practitioner receives a “qualifying telemedicine referral (QTR)” (defined below) from another DEA-registered practitioner.
Patient Relationships Developed During the PHE and Transition Period
The proposed rule creates a 180-day transition period following the end of the PHE during which providers would not be subject to the requirements above.
During this transition period, a telehealth practitioner is not required to see a patient in person to prescribe more than a 30-day supply of controlled substances if (a) the practitioner developed a patient relationship prior to May 11, 2023, and (b) the practitioner prescribed a controlled substance during that time to the patient.
Once the Transition Period concludes, all practitioners will again be subject to the above requirements. Even practitioners with a current prescribing relationship with a patient will need to conduct an in-person medical evaluation of that patient to prescribe controlled substances beyond this 180-day transition period.
Qualifying Telemedicine Referral
Under the proposed rule, for purposes of issuing a prescription for more than a 30-day supply of a controlled substance, a valid QTR requires that:
The referring provider has conducted at least one in-person medical evaluation of the patient
The referring provider communicates the results of the evaluation to the prescribing practitioner prior to writing the prescription; and
Both practitioners document the referral and maintain those records.
What Would the New Proposed Rule Mean for Telehealth Providers?
Partnerships with brick and mortar will increase in value. “Virtual-first” models that incorporate brick-and-mortar relationships will thrive.
Payors and hospitals that have integrated telemedicine and IRL practitioners will have an advantage, as they’ll be able to coordinate the QTR piece of the puzzle
Provider burden will increase – they’ll need to develop processes for new recordkeeping requirements
Business models that do not currently incorporate an in-person option or partner with in-person partners will need to work quickly to establish an in-person option for patients in order to survive this change if finalized as proposed.
Telehealth Providers: Why and How to Provide Feedback on the Proposed Changes within 30 Days
DEA offered a notice-and-comment period of 30 days (shorter than the typical 60-day comment period) with the explicit purpose of moving quickly toward a final rule prior to the May 11, 2023 PHE expiration.
This is a telling strategy.
On one hand, DEA explicitly states that its primary concern is minimizing diversion and abusive patterns of tele-prescribing in the interest of public health and safety.
On the other hand, the proposed rule also makes clear that the DEA heard the concerns regarding continuity of patient care and access to medically necessary medications via telemedicine.
The agency seems willing to consider creative solutions to balance these two things.
That means that virtual care companies impacted by the DEA restrictions have a narrow but significant opportunity to weigh in on DEA’s proposal.
Specifically, the DEA is requesting comment on:
Whether the rule should limit the issuance of prescriptions for controlled substances to FDA-approved indications contained in the FDA-approved labeling for those medications.
The proposed recordkeeping obligations listed in proposed 21 CFR §1304.03(c)(i)-(k)
The 30-day maximum supply provisions (and whether 30 days is the appropriate limit)
Additional safeguards or flexibilities that should be considered
Other questions we’ve heard from stakeholders:
Is this strategy really going to prevent diversion? Or will this just hamper law-abiding (and enforcement-fearing) physicians from providing medically necessary clinical care for fear of DEA enforcement, patient abandonment, or other consequences? Will it cause patients to go through non-regulated channels to get the medicines they need?
Will there be enough time after the publication of the final rule for providers to adjust their workflows to comply with final regulations? Or do we need an additional grace period?
What happened to the special registration the agency is legally required to create!?
Will the requirement to put a telemedicine stamp on prescriptions make it harder for patients to get meds? Many are reporting that pharmacies are rejecting telemedicine-only prescriptions for fear of enforcement.
What happens to patients for whom there are few, if any, in-person physicians who can see them? What about specialists for whom it takes more than 30 days to get an appointment? Could this cause a crisis in which patients flood emergency rooms?
If providers need to get DEA registrations in every state in which they have patients, will DEA be able to handle the administrative task of processing this in time for providers to comply with the new rules? What about creating a national DEA registry?
To submit your feedback, click here for instructions.
Want Some Help Drafting Your Comments?
Clients, if you’d like help drafting these comments, please let your attorney know by Wednesday, March 8, so that we can meet the 30-day window.
If you’re not yet a client, we’ll update the blog with the final ruling and outline what it means for telemedicine businesses in general. (And if you want to know how these changes impact your business specifically, click here to find out if we’re a good fit to work together.)