Mindbloom Comment on DEA Proposed Telemedicine Regulation

Dear Administrator Milgram,

On behalf of Mindbloom, I am submitting the following comments to the proposed rule entitled “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation.” Mindbloom works with licensed psychiatric clinicians who treat depression and anxiety, including by prescribing controlled medications through telemedicine. We thank the Drug Enforcement Administration (DEA) for committing to establishing telemedicine prescribing regulations prior to the end of the COVID-19 Public Health Emergency (PHE), and for providing the opportunity to comment on the proposed rule. The proposed rule, as drafted, takes a nuanced approach to controlled medication prescribing, and does allow for some telemedicine prescribing to continue. However, Mindbloom is concerned that the proposed rule will cause millions of Americans to lose access to critical, clinically-appropriate treatments for mental and behavioral health.

The United States is experiencing a persistent and growing mental health crisis. According to a Substance Abuse and Mental Health Services Administration (SAMHSA) survey released in January 2023, almost 25% of adults suffered from a mental illness in the last year¹—up from 17.7% in 2008. This crisis is growing worse, in part, because many Americans do not have access to care: 160 million Americans live in mental health provider shortage areas,² and half of counties in the United States do not have any mental health providers.³ Moreover, 99 million Americans live in primary care shortage areas,⁴ and more than 100 million Americans do not have a primary care provider.⁵

At the start of the COVID-19 pandemic, the DEA helped address this provider shortage by waiving the requirement that practitioners examine a patient in person before prescribing a controlled medication, thereby allowing qualified practitioners to prescribe based on a live audio/video telemedicine examination.⁶ This waiver significantly expanded access to mental and behavioral health care—especially for people in rural areas, and for people who cannot access in-person care due to illness, cost, stigma, and other barriers.

Numerous studies have shown that during this three-year waiver, mental and behavioral health treatments that include controlled medications were delivered effectively and safely through telemedicine, without evidence of increased diversion.⁷ Telemedicine prescribing has been a lifeline for Americans struggling with mental illness and addiction—for many, telemedicine is not a choice, but is the only means through which they can receive care.

The medical community has consistently supported maintaining access to controlled medications through telemedicine. For example, in March 2022, the American Medical Association (AMA), American Psychiatric Association (APA), and 70+ other health care organizations sent a letter asking the DEA to implement a Special Registration for telemedicine prescribing, noting concerns that the in-person exam requirement would result in “many patients, especially new patients seen for the first time by a clinician during the pandemic, [being] left without access to care.”⁸ In September 2022, more than 350 health care organizations sent a letter asking Congress to extend the in-person exam waiver after the PHE ends.⁹ And in November 2022, more than 100 health care organizations reiterated their request for the DEA to permanently preserve access to telemedicine prescribing.¹⁰

Given the urgent demand for accessible, low-cost mental and behavioral health care, the three-year expansion of access to effective care through telemedicine without evidence of increased diversion, and the support of the medical community, Mindbloom and practitioners across the country were hopeful that the DEA would issue a regulation that preserves this pathway to critical care. Unfortunately, the proposed rule would cause millions of Americans to lose access to care, and would exacerbate the ongoing mental health crisis.

First, requiring an in-person examination to continue treatment with Schedule III-V non-narcotic medications and buprenorphine will prevent patients from receiving life-saving care. As described above, there is a massive shortage of mental health providers and primary care providers across the U.S. 160 million Americans lack sufficient mental health providers in their area, and millions more are unable to obtain in-person care due to illness, cost, stigma, and other challenges. For them, an in-person exam requirement is a complete barrier to treatment, and they simply will not receive the care that they desperately need.

The proposed regulation also does not provide a rationale for why an in-person examination should be required to continue treatment that a patient initiated through telemedicine. For example, the proposed rule does not identify any evidence that the waiver of the in-person exam requirement has led to increased diversion over the past three years, or that requiring in-person exams will reduce diversion. Nor does the commentary explain how an in-person exam is medically necessary to continue treatment. To the contrary, the proposed rule acknowledges that mental health care can largely be provided based on audio-only examinations, although visual information may be helpful in the context of prescribing certain medications. Mindbloom agrees with this assessment and believes that medically-necessary information has been and will continue to be conveyed through live audio/video telemedicine, which for many mental health cases is equivalent to in-person care.

In sum, Mindbloom is concerned that the proposed in-person examination requirement will prevent millions of Americans from accessing critical mental and behavioral health care. The rule does not determine who receives care and who does not based on medical necessity—instead, it determines who receives care based on the luck of geography, mobility, and wealth. Mindbloom respectfully asks that the DEA remove the requirement that patients receive any in-person examination to begin or continue treatment for mental or behavioral health with Schedule III-V non-narcotics or buprenorphine, and allow practitioners to prescribe these medications based on a live audio/video telemedicine examination.

Second, if in-person examination is required to continue treatment with Schedule III-V non-narcotic medications and buprenorphine, then the initial supply that can be prescribed through telemedicine should be longer than 30 days. The proposed rule does not identify a medical basis for a 30-day limit, and many controlled medications require more than 30 days of treatment to be effective. Moreover, wait times for mental health appointments currently average more than 35 days, meaning it is not realistic to expect patients to find in-person care within this 30-day timeframe.

If the DEA chooses to limit the supply of a Schedule III-V non-narcotics and buprenorphine that can be prescribed through telemedicine, Mindbloom respectfully asks the DEA to allow for a six-month supply of medication to ensure that patients have enough time to find an in-person practitioner.

Third, Mindbloom believes that practitioners should only be required to obtain a single DEA registration to prescribe controlled medications—as has been the case for the past three years.¹¹ The proposed rule would require practitioners to obtain registration not only in each state where their patients reside, but also in each state in which they are located when they see patients through telemedicine. This would be a significant burden for practitioners: DEA currently requires practitioners to have a practice location in order to obtain registration, and it would be prohibitively expensive for practitioners to obtain office space in each state where they might relocate or treat patients (in addition to paying each registration fee).

Practitioners already are required to meet state requirements for licensure and controlled substance registrations in each state where they treat patients, and maintaining a single registered address with the DEA—along with prescription drug monitoring program (PDMP) requirements and other checks—should allow DEA to monitor practitioners effectively and efficiently. The proposed requirement for multiple registrations will prevent practitioners from treating patients in multiple states, thereby diminishing the already-insufficient supply of mental and behavioral health practitioners and further restricting access to care.

Finally, the DEA sought comment on whether telemedicine prescriptions should be limited to only on-label uses. Mindbloom respectfully submits that they should not. The decision of whether to prescribe an FDA-approved medication for an on-label or off-label use is left to the discretion of qualified medical providers, and the regulation of such decision-making is the purview of state boards of medicine and nursing, not the federal government. Additionally, over 20% of prescriptions are for off-label uses—for example, the use of beta blockers like propranolol for performance anxiety, or modafinil for depression. Restricting telemedicine prescribing to only on-label uses would improperly regulate the practice of medicine and would prevent patients from accessing clinically-necessary care.

We thank the DEA for the opportunity to comment on the proposed rule, and would be happy to work with the Administration to find solutions that ensure Americans have access to clinically-appropriate mental and behavioral health care.

Sincerely,

Leonardo Vando, M.D.
Medical Director
Mindbloom