Lawmakers and physicians are growing anxious for COVID-era telemedicine flexibility measures to be extended for a third time, as federal regulators signal a potential tightening of the rules ahead of a deadline at the end of the year.
Since 2020, the Department of Health and Human Services and the Drug Enforcement Administration (DEA) have allowed physicians to prescribe schedule II to V controlled substances without in-person medical evaluations. The loosened rules have been credited with improving access to care, particularly for patients seeking mental health care and dealing with substance use disorders.
Last year, the two agencies extended these flexibility measures through the end of 2024. With December fast approaching, a bipartisan group of lawmakers in both the House and Senate want another round of extensions secured.
The DEA submitted a rule titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” to the Office of Management and Budget earlier this month.
The rule is pending review and isn’t available to the public yet, but a Politico article on its details has already drawn protest. The outlet reported the proposed rule would require at least half of a prescriber’s prescriptions be given in person and would make prescribing Schedule II drugs like Adderall through telemedicine virtually impossible.
“We appreciated the DEA’s extension of the telemedicine flexibilities through the end of the year while developing this proposal, but are concerned that the new policies would significantly restrict access to necessary and life-saving treatments. These restrictions would be detrimental to patients and a barrier to accessing care,” a letter led by Sens. Sheldon Whitehouse (D-R.I.), Lisa Murkowski (R-Alaska), Mark Warner (D-Va.) and Marsha Blackburn (R-Tenn.) stated.
Despite the reports, telehealth supporters are hoping for — and expecting — a clean extension without the new restrictions.
“We don't know the length. We don't know if it's clean. But we assume it's one year, and we assume it's clean, and that means that we'll kind of live to fight another day. And the DEA might take yet another attempt at tackling this rule,” said Kyle Zebley, executive director of ATA Action, a political action committee and advocacy arm of the American Telemedicine Association.
Why doctors want flexibilities to stay
Physicians such as Holly Yang, former president of the American Academy of Hospice and Palliative Medicine, say going back to prepandemic standards would hurt patients.
“The flexibilities of the pandemic brought in; we forget how significant they are. Because it was very, very restrictive on who could get telehealth reimbursed prior to the pandemic, actually,” Yang said. “So, it's maybe one of the few silver linings of the pandemic — is the ability to really make health care more accessible.”
In her specialty — in which patients often have limited mobility, live with chronic pain or are at the end of their life and would much prefer to be at home — telemedicine has provided easier access for doctors, patients and their families.
“I'm not saying that telehealth is the only way we should deliver care,” added Yang. “I think it's important to see people in person. However, the ability to see people and prescribe for people with the COVID era, telehealth flexibilities have allowed us to be able to do that in a really meaningful way.”
According to Yang, having the option of telehealth visits means patients can see a provider more quickly, and those who live far from providers, such as in rural areas, can access more services.
Special registration pushback
The DEA is also reportedly proposing the creation of a special registration for the telemedicine process, something Congress first directed the agency to do about 16 years ago. This system would in theory require providers who wish to prescribe a controlled substance without an in-person visit register with the DEA.
But the agency’s proposal reportedly excludes entire classes of drugs and physicians.
“If the reporting is true, the proposed content of the rule seems misaligned with Congressional intent in authorizing such a Special Registration process. Such a rule may unnecessarily risk care for thousands of patients reliant on telemedicine for critical medications,” House lawmakers wrote in their letter to DEA Administrator Anne Milgram.
According to Zebley, interested parties like his organization were aware of the rumors of the proposed rule but felt the DEA has not had enough time to properly put together a rule on a special registration process.
“We didn't see how they could get a rule up and rightfully implemented prior to the end of this year, and so we had been asking for a clean extension of that flexibility, which the administration can do through existing authority past the end of the year,” he said
Regarding the 16-year delay in setting up the special registration process requested by Congress, Zebley described it as a "'60 Minutes' deep-dive story waiting to happen."
“I think there's a couple of different reasons for why it hasn't come about. One is changing political leadership, changing challenges, changing crises as you can imagine. Perhaps just one reason or another, it kept on getting knocked off of top priority for the DEA over the ensuing years,” said Zebley.
He also noted that the DEA is a law enforcement agency at the end of the day, so it may not be as concerned about health care access as they are about preventing illicit drug use: “I don't think there's any nefarious intent,” Zebley said.
Whatever the reason for the delay, House lawmakers have suggested it’s too late for a new rule this year, favoring a clean extension instead.
“Even if the reporting is inaccurate and DEA is prepared to propose a rule that would satisfy the needs of patients and providers, the clock is running out to ensure patients will not lose access to care,” they wrote.
“If DEA were able to propose regulations today, those regulations would still need time to go through public notice-and-comment period prior to being finalized. Furthermore, the provider community would likely need an additional on-ramp period to allow for the implementation of the rules.”
When reached by The Hill, the DEA declined to comment, as the rule is currently pending.
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