Following up on its February 27 statement opposing the U.S. Drug Enforcement Administration's proposed permanent changes to the e-prescribing of controlled medications, the American Telemedicine Association and its ATA Action sent its final comments this week in two letters.

WHY IT MATTERS

In aiming to prevent drug diversion by telehealth, DEA misses the point of the gains made by telehealth during the pandemic, says ATA.

In two letters addressing the remote prescribing of controlled substances – expansion of "Induction of Buprenorphine via Telemedicine Encounter" and "Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation" – the ATA outlines several of its arguments, asks for more time to comply and provides suggestions to update the proposed rules in order to maintain mechanisms that prevent diversion and at the same time, ensure patients do not lose access to necessary treatments.

The primary concern is that in promulgating the in-person mandate – all patients must be seen by a doctor in person within 30 days or forfeit their prescription – in order to prescribe certain controlled substances, like buprenorphine, there will be a backlash of patient harm when the rule becomes effective on May 11 when the public health emergency ends.

"We are gravely concerned with the timeline to finalize and implement DEA’s proposed new process," ATA wrote.

"To ensure that patients do not lose access to necessary services via telehealth, we strongly urge DEA to extend the existing pandemic-era flexibilities for such period of time that the rule is finalized and implementable or at least through calendar year 2023."

Nationwide, those with mental health and substance use disorders as well as other vulnerable populations – such as those receiving palliative or hospice care – have relied on growing telehealth opportunities that boomed during the pandemic for a number of reasons:

• Provider shortages.
• In-person wait times.
• The nature of sensitive conditions and the need for privacy.
• SUDs disorder social barriers and stigmas.
• Nontrivial convenience issues – both rural and urban,

"We are concerned that in-person requirements will exacerbate existing inequities in the healthcare system, as it will only serve patients who have the ability to see an in-person provider and misses the point that telehealth provides to reach previously unreachable populations," ATA said.

ATA is also concerned that the "telehealth stamp" on legitimate prescriptions has already resulted in a rise of denials at the pharmacy counter.

"Clinically, a valid prescription is a valid prescription and the fact that one was issued via telemedicine makes it no less so. Unfortunately, such a stamp will likely result in confusion and frequent denials to dispense legitimate prescriptions," ATA said.

The organization pointed to the existing electronic prescribing of controlled substances used to determine the legitimacy of a prescription. 

EPCS ensures that only authorized providers who meet a series of criteria have the ability to safely transmit a controlled substance prescription electronically, but pharmacies need clarification on the stamp, and also lack guidance, so they err on the side of caution.

"A special registration process could have been an opportunity for pharmacists to easily identify legitimate telemedicine prescribers," ATA said.

If DEA does not exercise its power to waive the requirement, the organization recommends allowing group referrals, instead of a single specifically named clinician, and removing the requirement for a referring provider on the e-prescription.

"If this requirement is maintained, the proposed referral pathway will be nonfunctional – or at least executed in a non-compliant way – for most healthcare providers using standard e-prescribing platforms," said ATA.

DEA’s ability to identify providers operating legally and appropriately from those that are not could be managed under a special registration regime, required initially of DEA in the 2008 Ryan Haight Online Pharmacy Act.

That registry could also solve the confusion issue for pharmacies. 

THE LARGER TREND

Despite DEA's failure to establish a program ensuring that healthcare providers can successfully prescribe controlled substances via telehealth – similar to EPCS for in-person providers – the SUPPORT Act gave the agency a second mandate to do so by October 2019.

But that didn't happen either, with the agency citing administrative burden.

In 2022, Sen. Mark Warner, D-Va., urged the Biden Administration to allow doctors to prescribe controlled substances through telehealth with the end of the PHE looming.

"The DEA’s failure to address this issue means that a vast majority of healthcare providers that use telehealth to prescribe controlled substances to and otherwise treat their patients have been deterred in getting them the quality care they need," Warner wrote in May 2021.

While thousands of behavioral health specialists and other providers have voiced their concerns that permanent rules aimed to prevent drug diversion will result in patient harm and instead boost a black market for certain drugs, some healthcare providers have questioned the growth of prescription drugs during the COVID-19 PHE and its related waivers. 

But even those skeptics have said establishing systematic monitoring of controlled-substance prescribing through telehealth is achievable.

"We'd like to move towards appropriate prescriptions of controlled substances, and if we can find a way to meaningfully regulate that online, then great," Dr. Mimi Winsberg, CMO and the other cofounder of Brightside Health, told Healthcare IT News in October.

ON THE RECORD

"Telehealth enhances access and the requirement to see a provider in-person within 30 days is, best case, a barrier, and worst case impossible," said ATA in a comment letter. 

"Especially for vulnerable populations and those who may be distrustful of the healthcare system, the requirement to see a provider in person creates a risk that the patient will discontinue care."

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.

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