Today is the last day to provide feedback on the DEA's proposed rule that could significantly limit telemedicine services—a lifeline for mental health care during the COVID-19 pandemic.

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While the proposal aims to preserve certain telemedicine flexibilities, it introduces new barriers, including the mandate for an in-person evaluation before prescribing controlled substances to new patients, potentially hindering patients' access to essential care.

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As a Public Benefit Corporation, Osmind has taken action by submitting an open letter to the DEA to voice our concerns and offer recommendations that prioritize public health and patient access to care. We call on you to join us in advocating for safe and reasonable access to crucial medications by submitting your comments before the deadline at 11:59 PM ET today.

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Read on to explore the insights we've shared with the DEA and learn how you can contribute to this vital conversation:

Submitted electronically on regulations.gov on March 31, 2023

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To: Scott A. Brinks, Diversion Control DivisionAnne Milgram, AdministratorDrug Enforcement AdministrationAttention: DEA Federal Register Representative/DPW 8701Morrissette DriveSpringfield, Virginia 22152

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Re: Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation (Docket No. DEA-407)

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Dear Mr. Brinks and Ms. Milgram,

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We write on behalf of Osmind to advocate for all the current and future practices and patients who rely on our services. Osmind is a Public Benefit Corporation that is the premier technology platform for breakthrough mental health treatment. We provide over 450 independent practices across the country a robust electronic health record, integrated telehealth platform, and e-prescribing system. We are scientists, technologists, psychiatrists, and other mission-driven professionals passionate about improving the lives of people with mental illness.

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As a Public Benefit Corporation, Osmind is committed to ensuring access to care for patients of all backgrounds across the country. We achieve this through rigorous research, advocacy, and modern technology that will most effectively help the medical community advance breakthrough therapies.

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We submit these comments in connection with the Drug Enforcement Administration (DEA)’s proposed rules regarding telemedicine prescribing of controlled substances when the practitioner and the patient have not had a prior in-person medical evaluation. The views and opinions expressed in this letter are those of Osmind and do not necessarily reflect the views and opinions of all the independent practitioners and patients that use the Osmind platform.

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During the COVID-19 Public Health Emergency (PHE), telehealth enabled the delivery of essential psychiatric services, including the prescribing of essential controlled medications. We agree that safeguards are needed as the PHE comes to an end to prevent substandard, illegal, and dangerous prescribing and diversion of controlled substances.

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However, some of the DEA’s proposed solutions to prevent these prescribing patterns may instead reduce access, increase costs, and create unnecessary friction for the DEA, clinicians, patients, and pharmacies without actually safeguarding against problematic prescribing.

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As a leader in the mental health electronic health record space, we are especially well positioned to provide a number of recommendations that we believe would better align with the goals of all stakeholders and still prioritize public health and safety:

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1) Require a clinician to have a single DEA Number tied to their primary practice location (which may be virtual/at home) rather than separate DEA numbers per state.

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In addition to the financial and logistical burden of obtaining and renewing DEA registrations in each state where a physician is licensed, having multiple DEA numbers per clinician makes it more difficult to detect anomalous prescribing patterns that may warrant a closer inspection. Clinicians have a single NPI number and citizens have a single Social Security Number.

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Given the DEA is a national organization, the need for separate DEA licenses per state is excessive and counterproductive. Furthermore, clinicians are required to maintain separate state licenses and are bound by the state medical boards’ rules around the prescription of controlled substances. If these are stricter than the DEA’s rules, these state rules would prevail.

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The DEA’s rules do not vary state-by-state. If the clinician is 100% virtual and utilizing the newly proposed telehealth referral process, they should not be required to publicly list their home address for this single DEA registration but rather be allowed to keep this information confidential with the DEA or be allowed to use a virtual mailbox for correspondence along with up-to-date email and professional phone numbers. There are reported instances of clinicians being stalked and harassed at their homes when they have been forced to share their home address publicly.

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2) Do not add a new requirement that clinicians be licensed and have DEA numbers in the state the patient is located and the state the clinician is located at the time of the appointment.  Keep the requirement that the clinician should be licensed in the state the patient is located at the time of the clinical encounter.

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Prior to the PHE, the expectation was that the clinician be licensed in the state the patient was located at the time of the appointment. Adding an additional requirement does not make sense given it is common practice for clinicians to travel for professional and personal reasons across state lines as well as internationally (for periods of less than 6 months) and continue to provide coverage for their patient panel.

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Technological advances in the past several decades in e-prescribing technology mean that a clinician can easily write a prescription from their phone, tablet or laptop regardless of their physical location. Requiring a clinician to find coverage every time they leave a state they are licensed to practice in is unrealistic, nearly impossible to enforce, and leads to discontinuity of care in the patient-doctor alliance.

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A covering clinician is less likely to have the full clinical picture and trust of the patient, so medical decisions could be negatively impacted. Alternatively, without coverage, a patient could experience a life-threatening interruption in receiving essential medications while a clinician is outside their primary state of practice.

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3) Do not require a “telemedicine stamp” on prescriptions given the logistical and technical chaos this requirement would introduce without proper planning and collaboration with technology platforms and pharmacies.

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Recently, some pharmacy chains have begun to scrutinize and decline prescriptions from telehealth companies due to fears around liability. Long before the PHE, it has been common practice for clinicians to “call in” (via the actual phone or via e-prescribing) prescription refills or new medications without seeing the patient via telehealth or in-person in between appointments. They have never been asked to designate that a prescription originated from this type of brief patient interaction, so adding this now is an additional and unnecessary burden.

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Instead, we would recommend working over the next year with EHR and e-prescribing platforms to develop standardized ways that clinicians could attest and document that they were compliant with whatever the final rules and expectations are at both the DEA and state levels around in-person visits and referrals. Introducing this requirement in May is premature and will lead to chaos and delays in prescriptions being filled or inability to enforce this expectation due to people simply not complying. Pharmacies may increase the practice of refusing telemedicine prescriptions to the detriment of patients who rely on these life-saving medications.

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4) Allow a telehealth referral to be to a Type II NPI (e.g. group NPI) rather than just to a single individual clinician, and if that group practice is unable to accommodate the referral, it should be at their discretion to refer the patient to another practice that can.

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We agree that the future of care, especially mental health care, is collaborative and support the concept of collaborative agreements and referral networks. However, the proposal as written specifies a referral for telehealth care specifically list an individual clinician. It is unrealistic to have that level of granularity for group practices, and so, this should be changed to allow for a referral to a group practice or health system.

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The proposal is inconsistent with the practice of all other types of referrals across the field of medicine, where referrals to group practices and health systems are the norm. Imagine if you were required to refer to a specific MRI technician rather than an MRI center, or if in the event of an emergency, were told to see a specific doctor at the emergency room rather than simply being told which emergency room to go to. The referral to a specific NPI (Type II or Type I) would be more reasonable.

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5) Collaborate with EHRs and other technology platforms to develop standards and workflows for what a telehealth referral should contain, rather than introducing this requirement without taking these necessary operational steps.

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Given how siloed much of healthcare technology is, when introducing a new concept such as a telehealth referral, collaboration with health tech companies to make this process unified, streamlined, HIPAA compliant, and transparent is crucial.

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We do not believe it is realistic to have this infrastructure in place by May 11, 2023. We would be happy to engage in discussions around how to incorporate this workflow into our EHR for practices that use our EHR and imagine other technology platforms would be as well.

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6) Given the introduction of a telehealth referral, eliminate the requirement that a telehealth-only clinician maintain a physical office address in the state where the patient is located for the sole purpose of “inspecting the records”. Instead, allow the clinician to register what cloud-based EHR and e-prescribing platform they are utilizing and keep contact information (e.g. email and phone) up-to-date should an inspection be warranted.

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While we fully understand the need to physically inspect practices that store and dispense medications on-site, a telehealth-only practice does not do this. If a clinician uses a cloud-based EHR and e-prescribing platform, which the majority of EHRs are at this point, they should be able to register what systems they use with the DEA just as they do for certain state-based PDMP programs in lieu of having physical addresses.

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Should an inspection of the records need to be performed, it could be virtual, which would also be much more cost-effective for the DEA. Asking a clinician to rent an actual office for the sole purpose of a virtual inspection of their records does not make sense in our modern era.

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If someone is using paper charting and/or paper prescription pads that are not scanned into an electronic system, it stands to reason that a physical office is necessary, but the vast majority of telehealth-only clinicians also use technology to replace the file cabinets filled with illegible charts of decades past.

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Osmind is grateful for the opportunity to provide comments on this proposed rule. Given our role as an electronic health record and technology platform, the above recommendations are focused on areas we believe the wide range of practices using our system would find reasonable, and are areas where our technological and clinical expertise could come to bear to help implement modern, reasonable safeguards.

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We also encourage you to consider the specific recommendations from care delivery companies and professional medical societies across the mental health space, especially those focused on substance use disorders, severe mental illness, and the care of children and adolescents, for recommendations around the specific requirements for in-person visits and certain enhanced restrictions around schedule II substances, as they are in the best position to speak to those needs.

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If you have any questions, please feel free to contact us.

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Respectfully,

Carlene MacMillan, MD, Chief Medical Office

Alison McInnes, MD, VP Scientific Affairs

Lucia Huang, CEO

Jimmy Qian, President, and the team at Osmind