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Legislators who want to see an extension of COVID-era telemedicine flexibilities slammed a draft proposed rule from the Drug Enforcement Administration (DEA) that would curb telemedicine prescribing of controlled substances.

Eleven senators, led by Sens. Sheldon Whitehouse (D-R.I.), Lisa Murkowski (R-Alaska), Mark Warner (D-Va.), and Marsha Blackburn (R-Tenn.), criticized the new restrictions of a draft rule that they learned about through , calling such restrictions "detrimental to patients and a barrier to accessing care," in to President Biden.

"We understand the DEA's responsibility to address the risks associated with prescription drug diversion and abuse and to ensure that prescriptions for controlled substances are issued for a legitimate medical purpose. However, it is vital that any new regulations do not erect barriers to necessary, life-saving care," the bipartisan group wrote, adding that the DEA needs to "strike a balance between regulatory oversight and accessibility."

Provisions of the draft proposed rule that included allowing no more than half of a providers' prescriptions to be given to patients using telemedicine; limiting providers' ability to prescribe Schedule II substances without first conducting an in-person visit; and requiring providers to check all 50 prescription drug monitoring programs (PDMPs) before prescribing a controlled substance to a patient who the provider hasn't seen in person.

On the same day that the senators sent their letter, the DEA submitted a rule titled, " to the White House's Office of Management and Budget (OMB). This temporary extension of the rules would allow telemedicine companies to keep prescribing controlled substances without an in-person visit, and would .

Given tensions between HHS and the DEA over telemedicine restrictions, it's unclear whether OMB will rubber-stamp it, reports noted.

In 2020, the Trump administration relaxed telemedicine rules in an effort to ensure continuous care during the COVID-19 pandemic. These rules have subsequently been extended twice. Some provisions have been enacted permanently, while others were slated to sunset at the end of this year.

In their letter, the senators underscored the critical role that telemedicine played in expanding access to care in rural and underserved areas. They noted that they were especially concerned that the restrictions in the draft rule could unintentionally disrupt access to treatment for patients with substance use disorder.

"The pandemic telemedicine flexibilities increased access to medications, like buprenorphine, for vulnerable Americans with opioid use disorder, improved addiction treatment retention, and reduced overdoses," they wrote.

Altogether, 36% of all mental health and substance use disorder outpatient visits are conducted via telemedicine, they added, citing a .

Clinicians Respond

Had a final rule -- originally slated to be released in September -- taken effect with the provisions reported, it would have disrupted care for patients who rely on remotely prescribed medications from providers with whom they lack an in-person relationship, said Helen Hughes, MD, MPH, medical director of the office of telemedicine at Johns Hopkins Medicine in Baltimore.

"These medications span a number of clinically important use cases, including ADHD, seizures, palliative care, and pain management. With the enhanced national focus on new DEA rules, we have already had pharmacies refuse to provide prescriptions if we cannot provide evidence of an in-person visit with the prescriber," Hughes told 木瓜直播.

The provisions of the draft proposed rule detailed in media leaks would also require "shifting large volumes of telemedicine visits to in-person; tracking the [percentages] of controlled substance prescriptions prescribed via in-person and telemedicine [visits] and alerting prescribers to change practice patterns once they reached an arbitrary 50% threshold; and creating a new technical ability to review all states PDMPs," she said.

Furthermore, the rule as described would have necessitated new pathways for sharing information with pharmacies regarding the types of visits through which prescriptions were provided, the logistics of which would have required a lead time of at least 6 to 12 months for systems to comply with legal requirements without compromising care, Hughes added.

To best manage this issue, Hughes hopes the DEA will collaborate with other agencies "to leverage existing data to prevent and prosecute inappropriate prescriptions, while allowing clinically appropriate prescribing to occur."

Chad Ellimoottil, MD, medical director of virtual care at the University of Michigan Medical Group in Ann Arbor, said the draft proposed rule "reportedly introduces several guardrails that, while intended to curb prescribing abuse, will inadvertently create barriers for both healthcare providers and patients."

"Requirements such as limiting 50% of ... prescriptions to in-person visits and requiring prescribers to check prescription drug monitoring programs across all 50 states present logistical challenges that are difficult for clinicians and health systems to operationalize, particularly for group practices. Most importantly, there is no clear evidence or pilot study to support the assumption that these guardrails will effectively address the risk of misuse," Ellimoottil told 木瓜直播.

"What we do know is that these proposed rules will reduce healthcare access for patients who rely on these medications for substance abuse treatment, particularly those in underserved or remote areas who depend on telehealth for care," he added.

Ellimoottil said an extension of current telemedicine flexibilities could allow agency officials to "work out a more practical and evidence-based solution, developed in collaboration with clinicians who are on the frontlines of patient care."

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