Post-pandemic growth trajectory of telehealth and the complexity of prescribing controlled substances

In the first decade of the 21st century, deaths from prescription drug overdoses have seen an alarming increase in volume, driven by a tripling of deaths from opioid use. In the midst of this wave, Congress passed the Ryan Haight Online Pharmacy Consumer Protection Act in 2008 as part of an attempt to rein in the burgeoning online market for prescription drugs – especially those involving controlled substances – that had largely escaped previous enforcement action.

The extent to which the legislation has had a positive impact is up for debate. The number of deaths caused by prescription drug overdose continued to rise until 2018, when it began to modestly reverse the trend; however, the Covid 19 pandemic has seen the number of deaths increase again in several overdose categories.

In addition to the public health and mental health emergencies caused by the pandemic, Covid has also highlighted the increased use of telehealth and digital health platforms. In a world of lockdowns and quarantines, telehealth has been put to the test. By most accounts, it turned out surprisingly well. According to McKinsey, post-pandemic telehealth adoption has stabilized at a rate about 38 times higher than in the past.

Covid-era policy responses to the telehealth boom

However, with the rise of telehealth, public policies have not evolved at the same speed. One accommodation that was made during the pandemic – and which had a material impact on the growth of telehealth during Covid – came in the form of a Drug Enforcement Agency (DEA) waiver of certain provisions of the Ryan Haight Act. . Prescribing practitioners are generally required to conduct an in-person medical evaluation of the patient before administering controlled substances. Subject to the declaration of a public health emergency, the DEA waived its in-person medical exam requirement and set different criteria for controlled substances.

According to current guidelines, there are four requirements for writing a legal prescription for a controlled substance. First, the prescription must be issued for a legitimate medical purpose. Second, the prescription must be issued by a practitioner acting in the ordinary course of his professional practice. Third, practitioners must act in accordance with applicable federal and state laws. Fourth, new patients can now obtain a controlled substance prescription via telemedicine (i.e. without an in-person examination) if telemedicine communication was carried out using a two-way interactive, real-time, audio-visual communication system.

The DEA waiver is applicable for as long as the duration of the public health emergency. The Department of Health and Human Services (HHS) initially declared an emergency in January 2020, and it has renewed the declaration over time, with the last extension occurring on July 15, 2022. HHS will need to make another decision. in October 2022.

Even before the pandemic, telehealth was a hot topic and received significant coverage as an emerging healthcare modality; however, some segments of telehealth are more dependent on DEA waivers than others. For example, the number of remote ketamine clinics has exploded since the start of Covid due to a worsening national mental health crisis, combined with the growing popularity of telemedicine and the relaxation of government regulations.[1Ketamine, once used primarily as a recreational drug, has emerged as a promising anti-depressant when administered in a controlled, clinical setting.

The question remains on what will happen when the COVID-19 public health emergency does end. Will the DEA simply reinstate the in-person medical examination requirement? Will it make the waiver permanent? Or will it break new ground and develop an entirely new regulatory scheme? The answer will have a material impact on the delivery of telehealth services.

The Fate of the Waiver and Its Impact on Telehealth

At present, we view a return to the original regulations under the Ryan Haight Act as unlikely. The medical community has “reported positive appraisals of the shift to e-mental healthcare in terms of cost-effectiveness, acceptability, and convenience.”[2] In particular, the Centers for Disease Control and Prevention (CDC) recognizes “that with expanded access and improved reimbursement policies in place, as well as continued acceptability by patients and healthcare providers, telehealth could continue to serve as an important delivery modality for and after the pandemic.[3] Using telehealth appointments for chronic conditions, follow-up visits, and other non-emergency care can reduce unnecessary hospital visits, which in turn ensures triage and early treatment for those with severe sick.[4] The public shares this sentiment. According to a study published by the COVID-19 Healthcare Coalition, 73% of patients who received at least one telehealth visit during the pandemic expect to continue receiving healthcare services virtually once the pandemic is over.[5]

Considerable effort has gone into making the DEA waiver permanent after the pandemic is over. In March 2022, the American Psychiatric Association, along with 71 other organizations, sent a letter to the DEA and HHS calling for the permanent removal of the in-person evaluation requirement for prescribing controlled substances via telemedicine.[6] In April 2022, US Senators Rob Portman and Sheldon Whitehouse also sent a letter to the DEA and HHS “urging the agencies to use their authority under the Ryan Haight Act to ensure Americans can continue to access medications.” important…via telehealth once COVID-19 ends the public health emergency.[7] Senators Portman and Whitehouse first attempted to make the DEA waiver permanent in June 2020 when they introduced the Telehealth Response for Electronic Prescription Drug Treatment Services (TREATS) Act.[8] The TREATS Act would give telehealth providers the ability to prescribe controlled substances without the need for a prior in-person visit, thereby making the DEA waiver permanent.[9] If this federal law (or something similar) is not passed, a conflict between federal and state law is likely. In some states, lobbying efforts have resulted in permanent regulations allowing the prescription of controlled substances via telemedicine. For example, Florida lawmakers enacted revisions to the state’s telehealth law to now allow providers to waive a physical examination of a patient before using telehealth to deliver health services to the patient.[10] This revision also expanded the permitted use of telehealth to prescribe controlled substances.

Alternatively, a new regulatory regime for telehealth could be developed. It could take a moderate approach, acknowledging both the demonstrated need to provide telehealth and balancing it against the benefit of protecting patients with safety protocols. For example, the DEA could create a registration process for telemedicine providers. This would allow the agency to put in place oversight of telemedicine practitioners, rather than restrict the practice of telemedicine. In fact, in 2018, Congress directed the DEA to create this type of program under the Patient and Community SUPPORT Act, but the program has yet to be established.

Over the next few months, policymakers will determine the arc of the broader telehealth growth trajectory, and for some operators, like remote ketamine clinics, public policy decisions could be existential.

Kimberly Chew, Karen Luong and Natasha Sumner are attorneys in the Psychedelic and Emergent Therapies Practice Group at Husch Blackwell Law Firm in Kansas City, Missouri.

The authors would like to thank Husch Blackwell’s summer associates, Taylor Crossley and Colleen Pert, for their contributions to this article.

[1] See David Dodge, The Ketamine RemedyNew York Times (5 November 2021), https://www.nytimes.com/2021/11/04/well/ketamine-therapy-depression.html; See, for exampleTripSitter.Clinic, https://tripsitter.clinic/treatment (last visited July 15, 2022); See, for exampleBetter U, https://www.betterucare.com/ (last visited July 15, 2022).

[2] World Health Organization [WHO], Mental health and COVID-19: early evidence of the impact of the pandemicat 5, WHO/2019-nCoV/Sci_Brief/Mental_health/2022.1 (March 2, 2022), https://www.who.int/publications/i/item/WHO-2019-nCoV-Sci_Brief-Mental_health-2022.1.

[3] Lisa M. Koonin et al., Trends in Telehealth Use During the Emerging COVID-19 Pandemic — United States, January-March 2020Centers for Disease Control and Prevention, October 2020 (emphasis added).

[4] Praveen Kumar et al., Telemedicine in the Age of COVID-19: The New NormalCureus, Oct. 2020.

[5] See Libby Baney et al., The future of telehealth and the Ryan Haight law after the pandemic, Nat’l Ass’n of Bds. of Pharmacy (April 22, 2021), https://nabp.pharmacy/news/blog/the-future-of-telehealth-and-the-ryan-haight-act-post-pandemic/.

[6] Letter from the American Psychiatric Association et al. to Anne Milgram, Administrator, Drug Enforcement Administration [DEA] and Xavier Becerra, Secretary, Ministry of Health and Humanity. Serves. [HHS] (March 3, 2022).

[7] Press Release, Rob Portman, Portman, Whitehouse Urge DEA, HHS to Expand Americans’ Access to Telehealth After COVID-19 Public Health Emergency Ends (April 1, 2022), https://www.portman.senate.gov/newsroom/press-releases/portman-whitehouse-urge-dea-and-hhs-extend-americans-access-telehealth-once#:~:text =A%20the%20Ryan%20Haight%20Act%2C%20an%20in%2Dperson%20examination%20is,other%20needed%20medication%20via%20telehealth.

[8] Identifier.

[9] Identifier.

[10] Fla. Stat. § 456.47 (2022).

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Sharon D. Cole