We at Array Behavioral Care applaud the Drug Enforcement Agency (DEA) for its work in recognizing the importance of telehealth and the value it has been able to provide patients before COVID-19, during the pandemic, and for years to come. As a telemental health organization that provides telepsychiatry services across the care continuum from hospitals to homes, we have seen the positive impacts that the relaxed pandemic telehealth regulations have had for patients across the country.
As you and our colleagues at DEA are aware from our prior interactions on this topic, members of our practice have been conducting telepsychiatry since 1999, and our 50-state experience before and during the pandemic, has proven to us that safe and effective prescribing of certain controlled substances via telemedicine is both possible and essential.
Our perspective is that of a virtual psychiatry and therapy practice, and our comments reflect that emphasis.
While we appreciate the DEA’s work on rules to control against diversion and to protect public health, we are concerned with the timeline to finalize and implement the proposed rules. To ensure practitioners and organizations fully understand the new process and can make any necessary operational changes, we urge the DEA to extend the PHE flexibilities at least until the rule is finalized and implementable.
With that being said, here is a summary of our recommended changes:
1. 1306.31(4)(2)
While we appreciate that the DEA believes that prescribing schedule III-V controlled substances can occur after an initial evaluation and assessment via audio/video visual means, we do question why it is limited to 30 days. The challenge that may happen for patients and prescribers is that it may take more than 30 days, (e.g., for certain behavioral health conditions) to ensure that a medication is working and some adjustments in the dosage and medication may be needed. Under this rule, the limitation of prescribing to 30 days may put prescribers at risk from a standard of care and not provide proper treatment for the patient, in which they have a duty of care for those patients as they have established a proper physician-patient relationship (via telemedicine).
Furthermore, and possibly more importantly, not all patients may have an immediate local in-person provider or PCP to see within those 30 days. This can be due to a lack of schedule availability or unwillingness to take on new patients by that in-person provider. As a result, this “initial prescription” may not be helpful to the patient in the long-term if the treatment cannot continue due to this requirement. It also adds undue burden on already overstretched primary care providers.
Additionally, if a patient does not have an in-person provider, the proposed 30-day timeframe to comply with an in- person visit may inadvertently create situations for more waste and abuse. There is risk of increased unnecessary medical costs for these patients trying to comply with the new rules only to end up going back to the telehealth prescriber to continue a prescription already written based on the initial telehealth visit.
The example we present is a patient that seeks out a psychiatrist for mental health treatment via telehealth and receives a 30-day initial prescription for a schedule IV anti-anxiety medication after the evaluation and assessment. According to the proposed rule, to continue to prescribe, the patient must go back to their PCP solely to have an “in-person visit” to complete a telemedicine referral form. It can be assumed then that the PCP will submit a bill for those services to the patient or insurance payer, or possibly in some cases, may decline to do this because no immediate reason for the medical visit is necessary. As a result, this may cause financial waste and time taken away from the PCP to care for any patients that may have more immediate needs.
We recommend extending the time period for an initial schedule III-V prescription to 90 days.
2. 1306.31(a)(3)(i)
Per the Controlled Substances Act (CSA), practitioners prescribing controlled substances to patients via telemedicine must hold a DEA registration in the state where the patient is located. There has been no requirement that the practitioner must also hold a DEA registration in the state where they are physically located. However, under proposed 1306.31(a)(3)(i), practitioners would need to maintain a DEA registration both in the state where the patient is located and where the practitioner is located. This requirement would be burdensome and wasteful to telemedicine practitioners who do not practice or prescribe in the state where they reside.
We recommend removing the requirement that practitioners maintain a DEA in their home state, unless they are prescribing in that state, but maintaining the requirement that a DEA registration be required in the patient’s state. Maintaining a DEA registration in the state where the patient is located is a standard practice within the telemedicine industry. However, requiring practitioners who do not prescribe to any patients in their home state to maintain a DEA registration would be a significant shift from the previously maintained requirement.
3. 1306.31(4)(c)(1)
We acknowledge that schedule II substances may create a risk to public health and safety if not monitored and dispensed in a medically appropriate manner. But we do want to point out that there are several safeguards already in place within the other aspects of the proposed rule (e.g., qualified telemedicine referral) and through other mechanisms to monitor and enforce that prescribing is done in a safe manner.
First, we believe that the ones most affected by this strict in-person requirement will be those patient populations that include minors under the age of 18, and those in areas where there is a shortage of mental health providers who have the expertise and ability to treat these patients.
From a clinical perspective, patients who may require schedule IIN prescriptions to treat conditions such as ADHD can be safely treated via telehealth. It has been accepted within the medical community and through state medical practice acts or legislative statutes that an audio/visual synchronous visit can be just as effective and meets the standard of care as it would have been if performed in-person. This is because the symptoms of these conditions (e.g., ADHD) are neurological and cannot always be visibly seen through a physical examination. Furthermore, professional standards of care have already been established to ensure appropriate safeguards are in place. National organizations like the American Psychiatric Association (APA), American Academy of Child and Adolescent Psychiatry (AACAP), and the American Telemedicine Association (ATA) have published guidelines that detail the best practices a mental health provider should take to appropriately diagnose and prescribe via telemedicine (i.e., verify the identity of the patient, collect collateral, obtain parental consent for minors, etc.)
Additionally, other safeguards already in place that would allow for these telehealth visits to occur safely include: 1) all 50 states require providers as part of their licensure obligations to review PDMP databases for any potential overprescribing or diversion; 2) pharmacists also have the ability to provide oversight and discretion when these prescriptions are dispensed and picked up to ensure that the prescription was medically appropriate and also validate the individual picking up the prescription; and 3) healthcare providers are subject to civil and criminal sanctions and disciplinary actions from their state licensing boards, state regulatory and law enforcements agencies, and the DEA.
Therefore, while we would recommend and strongly encourage that prescribing of Schedule II controlled substances could occur via telehealth, if the DEA strongly believes that there should be additional guardrails in place, we recommend that schedule IIN substances (i.e., Adderall, Dexedrine, Desoxyn, Ritalin) should be exempted from this initial in-person requirement, and that they should be treated in the same way as Schedules III-V under these new regulations.
4. 1300.04(o)
Given the length of the public health emergency period, there are many patients who have been seen only via telehealth for almost 3 years due to the accommodations that the DEA has allowed. If there was any indication that overprescribing, drug diversion, or other misuse was occurring during this time, there would have been much more evidence and reports of potential overdoses, lack of medication adherence, and patient harm. There is lack of evidence that this has occurred in the medical community and industry.
Additionally, all 50 states have allowed through the state Medical Practice Acts or other legislative statutes, that a valid patient-physician relationship can be established via telehealth. To require that any established telemedicine relationships must now have at least one in-person visit by a provider is an unnecessary cost for the patient and/or the insurance companies, and does not justify such a requirement, especially for a patient who has been seen via telehealth over such an extended period.
We recommend the in-person exam requirement for provider-patient relationships that were established during the PHE be removed or have other guardrails in place. For example, if the initial visit has occurred within the last 90 days prior when these new rules become in effect, then an in-person visit may be warranted, but not one if the patient has been seen during the duration of the PHE.
5. 1300.04(k)
Within the definition of a “qualifying telemedicine referral,” it outlines that the “referral must note the name and National Provider Identifier (NPI) of the practitioner to whom the patient is being referred.”
Requiring the name of a specific practitioner and their individual NPI number on a referral is far too burdensome on both the referring provider and the patient. For referring providers, it would require them to have an identified telehealth provider that they can refer patients. Particularly for behavioral health providers, in many parts of the country, there are little to no local resources available and thus, referring providers are unlikely to know specifically which providers they can refer patients to and are far less likely to know if those practitioners are accepting new patients. In some cases, it is left to the patient to contact their insurance carrier or search on the internet for a specialty provider. Furthermore, it would require pre-referral preparedness such as identifying a provider they want to be referred to, obtain that provider’s NPI number, and confirm they have availability to be seen. This is completely impractical.
Instead, we strongly recommend removing the requirement that the referral must list a specific practitioner and instead allow the patient to be referred generally to a telemedicine practitioner.
6. Maintaining addresses in states where practitioners do not reside or have a physical office location
Although not specifically addressed in the proposed rule, we wanted to address one other consideration while you are evaluating the regulations around telehealth prescribing. In your rationale as to why practitioners do not need addresses in each state where they see patients via telemedicine for the purposes of storing medical records, you explain:
“If DEA instead were to require records to be maintained in the State(s) where telemedicine patients are located, practitioners could theoretically have to maintain telemedicine records in over 50 different locations (if they had a nationwide practice), including in states in which they may not retain a physical office location. This would be burdensome for both the practitioner and DEA investigators…This process would become impracticable if investigators had to obtain records from 50 different locations across the county, resulting in significant administrative waste (p.21).”
While we appreciate the recognition that the majority of practitioners now maintain electronic records, the burden still applies when practitioners need to apply for a DEA registration in a state where they are prescribing to patients via telemedicine, but they do not reside or have a physical office location in that state.
While we agree with the Controlled Substance Act (CSA) requirement of having a DEA registration in the state where the patient is located, for telemedicine practitioners, the DEA application for that registration is onerous given the physical address requirement. These telehealth practitioners do not have a physical office in the states where they are treating patients via telemedicine, yet the physical address requirement still stands. Just as you justify above regarding the storing of medical records, for practitioners who have a nationwide practice, they need to maintain a physical address in all 50 states to apply for a DEA registration. This is burdensome on both the practitioners and the DEA investigators, and we wanted to bring this issue to your attention and recommend revising the application regarding the physical address location for practitioners practicing via telemedicine.
Similarly, we would also like to request that the DEA reviews certain definition and categories to help clarify some terms that need to reflect current telehealth practices and standards.
“Administering”, “Dispensing”, “Maintaining” – These terms should not be interchangeable nor should be collectively grouped together as it relates to telehealth and reasons why an applicant may need a certain physical address vs practice address. In telehealth practice, it is practically non-existent that any clinicians will maintain any controlled substances or physical records at a physical location. Medical records are stored in an EMR, and controlled substance prescriptions are sent electronically to a pharmacy for the patient to pick up. Therefore, putting a physical address on a DEA application provides great confusion to the applicant since many of them are not in the same state where services are delivered, but still hold a valid state medical license where the patient will be sitting, and there is no limitation on those applications where that clinician needs to practice within the state.
To reduce diversion concerns, we propose that the DEA make a distinction between the authority to write a prescription and the authority to administer, dispense, or maintain controlled substances in how DEA registrations are issued. Practitioners who only conduct telemedicine do not need the authority to store, dispense, or maintain controlled substances, and we believe such a distinction could reduce diversion risk while also reducing DEA’s investigative burdens of certain site inspections.
On behalf of Array Behavioral Care, we appreciate the opportunity to provide comments and recommendations and we would be happy to offer any additional consultation.
James Varrell, MD, Executive Chief Medical Officer
Geoffrey Boyce, Chief Executive Officer
Leroy Arenivar, MD, Medical Director
Shane Rau, MD, Medical Director
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