Healthcare Groups Urge DEA to Modify Virtual Prescribing Rules

Healthcare trade associations, mental healthcare organizations, and providers are noting their concerns about the Drug Enforcement Administration's proposed rules governing telehealth-based prescribing and requesting changes that extend prescribing flexibilities enacted during the COVID-19 pandemic.

Announced at the end of February, the DEA's proposed rules extend some virtual prescribing flexibilities enacted during the COVID-19 pandemic and limit others. For instance, while healthcare providers can continue to virtually prescribe a 30-day supply of Schedule III-V non-narcotic controlled medications and buprenorphine without a prior in-person evaluation, they would no longer be able to do the same for certain controlled substances, like Adderall, Oxycodone, Vicodin, and Ritalin, after the public health emergency ends.  

The healthcare industry is now reacting via comment letters submitted to the DEA, largely denouncing the move.

"We appreciate DEA's responsibility to write rules that provide effective controls against diversion and protect public health and safety but believe that the requirement that a patient see a clinician in-person is not an effective control against diversion and, instead, simply limits access to legitimate health care," said Kyle Zebley, executive director of ATA Action, the advocacy arm of the American Telemedicine Association, in its letter to the DEA.

ATA Action submitted two letters to the DEA with recommendations to adjust the proposed rules such that they prevent drug diversion while ensuring access for patients who require controlled substances for medical treatment.

The letters detail how the rules could harm patients, mainly by reducing access to care for marginalized groups who face various socioeconomic barriers.

"There is an ever-increasing number of patients who cannot or will not seek treatment for their conditions in person," Zebley said in the letter. "These are the patients who will fall through the cracks under this rule, creating a significant and avoidable public health crisis."

According to ATA Action, the proposed rules currently stand will also not be effective in curbing drug diversion.

"As access to legitimate healthcare is restricted, a consequence of these draft rules, illegal online drug sellers will fill the void," Zebley said.

Further, the 30-day limit on supplies of buprenorphine for opioid use disorder treatment and Schedule III-V non-narcotic substances is arbitrary and could do more harm than good, as patients who cannot continue with OUD treatment generally begin to misuse opioids again, the letter states.

ATA Action provided several recommendations to minimize the potential negative effects of the rules. If the in-person requirements cannot be eliminated, ATA Action suggests extending virtual prescriptions from 30-day supplies to 180-day supplies to give patients enough time to see a provider in person. They also suggest allowing short-term virtual prescriptions of Schedule II stimulants.

ATA Action provided additional recommendations to ease the registration process implemented by the DEA. Following the COVID-19 public health emergency (PHE), virtual prescribers must once again register with DEA in the state where the patient is and where the provider is located. This requirement was lifted during the PHE.

"These requirements are burdensome, unnecessary, and will be nearly impossible to comply with immediately," the letter states.

ATA Action recommends that, at minimum, the DEA extend the registration flexibility for 180 days post-PHE and require prescribers to register with DEA only once.

The American Hospital Association (AHA) and Alliance for Connected Care similarly weighed in on the proposed virtual prescribing rules.

The AHA noted in a letter that the proposed rules would "impose burdensome restrictions and additional administrative requirements on providers and patients, which we are concerned will adversely impact patient access to medically necessary treatment."

The association suggested that the DEA institute a special registration process to enable practitioners who register with the DEA to virtual prescribe controlled substances without an in-person evaluation.

The comment letter submitted by the Alliance for Connected Care also highlights the benefits that expanded telehealth prescribing provided patients during the COVID-19 PHE. Like the AHA, the group suggests that the DEA create a special telemedicine registration process, stating that the process "should be an opportunity for health care providers or provider organizations to subject themselves to a higher level of scrutiny by DEA, and in exchange have greater flexibility to prescribe without in-person referral requirements, prescribing time-limits, and the ability to prescribe a wider range of substances." 

In addition, the alliance sent a letter to the DEA on March 28 that includes numerous signatories, such as the American Psychiatric Association, Mental Health America, the Medical University of South Carolina, and Stanford Health Care.

This letter notes the importance of continuing access to controlled substances via telehealth and their concern that the proposed DEA rules will curb that access, negatively impacting patient care.

"Recognizing the ongoing national need for more behavioral health access, the undersigned organizations request that the DEA make modifications to the proposed rule to ensure more flexible prescribing limitations for providers when a controlled substance is offered by a highly trained clinician in conjunction with an ongoing mental health treatment plan," the letter states.

The DEA provided a 30-day comment period for the proposed rules, which ends on March 31. The agency will then consider the comments before drafting the final rule.