Providers Make Impassioned Plea for Virtual Prescribing Flexibilities

September 15, 2023 - At the United States Drug Enforcement Agency's (DEA) listening sessions on September 12 and 13, healthcare stakeholders argued for permanently extending pandemic-era telehealth prescribing flexibilities for controlled substances.

During the COVID-19 pandemic, the DEA waived rules outlined in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 that required healthcare practitioners to conduct an in-person medical evaluation before allowing them to prescribe controlled substances through telehealth.

In February, the DEA released proposed rules stating that providers would only be allowed to virtually prescribe a 30-day supply of Schedule III-V non-narcotic controlled medications and a 30-day supply of buprenorphine for treating opioid use disorder (OUD) without a prior in-person examination. This flexibility was not extended to other controlled substances, like Adderall, Oxycodone, Vicodin, and Ritalin, in the proposed rule. The healthcare industry pushed back, voicing numerous concerns with the proposal.

After receiving nearly 38,000 comments on its proposed rule, the DEA issued a temporary rule extending the flexibility for the remote prescribing of controlled substances via telehealth through November. The agency then agreed to hold listening sessions to inform its virtual prescribing regulations.

The remarks primarily focused on the steps the DEA can take to ease medication access via telehealth, the urgent need to prevent drug misuse, and the benefits of a special registration process. At moments, the stakeholders grew emotional, with more than one commentator's voice wavering as they discussed patients who need convenient and quick access to life-saving healthcare.

Four key themes emerged from the comments made at the listening sessions.

TELEHEALTH PRESCRIBING EXPANDS MUCH-NEEDED ACCESS TO CARE

"I have fielded countless calls and messages from patients worried they won't be able to travel for an in-person visit, terrified they will lose access to the care that has been a literal lifeline" - Planned Parenthood of Michigan Director of Gender-Affirming Care Dr. Halley Crissman.

Several commentators described the recent rise in virtual prescribing and extolled the value of telehealth in enabling wider access to necessary controlled medications.

According to Helen Hughes, MD, medical director of the Office of Telemedicine at Johns Hopkins Medicine, telehealth has been particularly impactful in increasing access to mental healthcare. In 2022, 65 percent of outpatient psychiatry visits were conducted via telehealth at Johns Hopkins, and 40 percent of the provider-patient relationships in psychiatry were maintained exclusively via telehealth over the past three years with no in-person visits.

"The ability for these providers to prescribe controlled substances and use their medical judgment over telemedicine without a prior in-person visit allows patients to receive clinically appropriate essential care via a convenient patient-centered modality," she said.

This access is even more essential for certain medically vulnerable patient populations.

Joe Rotella, MD, chief medical officer of the American Academy of Hospice and Palliative Medicine, said the pain that terminally ill patients often experience represents "a true medical emergency," making virtual access to medications, including Schedule II controlled substances, necessary.

"For example, imagine an 86-year-old home-bound woman with moderate dementia and a flare of bone pain due to metastatic breast cancer who receives oral chemotherapy and accesses all of her cancer and palliative care from her home via telehealth," he said. "It's highly unlikely that a physician home visit would be available to her on an emergency basis transporting her to an emergency department or outpatient clinic for an in-person evaluation."

Robin Plumer, MD, an end-of-life physician in New Jersey, echoed this sentiment, noting how crucial telehealth-based prescribing has been to her practice, which largely cares for hospice patients in rural areas.

According to Plumer, requiring her to conduct an in-person visit before being able to virtually prescribe drugs to her patients in hospice care would result in her having to travel long distances. This would not only be more challenging for her but would also slow down the process of getting medications into patients' hands.

"Mandating in-person visits prior to prescribing controlled medications in this unique population would create a devastating burden to these patients, and it would delay their ability to obtain these medications in a timely fashion," she said. "At worst, many individuals would go without the medications necessary to mitigate their pain and ease their breathlessness, and instead, their last days would be devoid of comfort and dignity."

Further, virtual access to controlled substances is critical for individuals seeking gender-affirming care. Planned Parenthood of Michigan's Associate Medical Director and Director of Gender-Affirming Care Halley Crissman, MD, stated that requiring even one in-person visit to access testosterone could mean cutting off many patients from gender-affirming therapy.

"I have fielded countless calls and messages from patients worried they won't be able to travel for an in-person visit, terrified they will lose access to the care that has been a literal lifeline," she said.

She added that gender-affirming hormone care with testosterone is well suited to delivery via telehealth as it is non-narcotic, non-addictive, and not likely to be abused by patients. Not only that, but many LGBTQ+ patients rely on telehealth to access healthcare without facing harassment or discrimination.

"My clinical experience has made it clear that testosterone can be safely and effectively prescribed via telemedicine, and that this path is essential for patient access," Crissman said.

VIRTUAL PRESCRIBING COULD HAVE AN ADVERSE IMPACT

"We've experienced a nightmare with the proliferation of telehealth services in Northeast Tennessee and Southwest Virginia" - Catalyst Health Solutions Facility Director Jerome Cohan

Though commentators overwhelmingly favored making telehealth prescribing flexibilities permanent, a few healthcare stakeholders advised caution.

Jerome Cohan, APRN, facility director, and nurse practitioner at Catalyst Health Solutions, a group practice, highlighted the potential adverse consequences of widening access to telehealth-based prescribing without adequate controls.   

"We've experienced a nightmare with the proliferation of telehealth services in Northeast Tennessee and Southwest Virginia," he said. "From our clinical experience, poly-substance abuse has not been addressed with this approach, especially when it pertains to methamphetamine abuse, addiction, trafficking, et cetera, et cetera."

He added that many Catalyst Health Solutions patients who tried online prescription services returned to face-to-face visits with issues related to substance use disorders other than opioid misuse. Thus, Cohan advocated for face-to-face visits to mitigate poly-substance abuse so clinicians can thoroughly assess the patient in person.

John Wells, MD, associate professor of clinical psychiatry at Louisiana State University Health Sciences Center, similarly stated that telemedicine prescribing of controlled substances has made it easier for people to gain access to benzodiazepines, opiates, narcotics, and other stimulants from remote prescribers who are not a part of their community.

"During the pandemic, telemedicine exploded, as we all know, for a variety of reasons," Wells said. "But the community providers in FQHCs [federally qualified health centers] certainly expressed to me that they are worried about a free-for-all of remote providers. It takes away their business; it makes their clinic less resilient. And then, we are often left with mopping up prescribing that has not been so clean when provided by providers who are not embedded in these communities."

The answer isn't to get rid of telehealth prescribing, however. Telehealth prescribing has its benefits, so the DEA should instead focus on implementing reasonable controls in the prescription process, including in-person visits at certain junctures, he said.

BALANCING EXPANDED ACCESS AND PREVENTION OF MISUSE IS KEY

"Telemedicine can allow a physician to conduct pill counts, monitor toxicology screens, and ensure medication adherence or identify adverse behaviors requiring a change of therapy" - American Medical Association President Dr. Jesse M. Ehrenfeld

As the DEA develops virtual prescribing regulations, most healthcare stakeholders said that the agency needs to balance the benefits of broader access to care with the need to curb the misuse of controlled substances.

For instance, Sterling Ransone, MD, a family physician in rural Virginia and immediate past president and board chair of the American Academy of Family Physicians, believes that the DEA should allow prescribers to manage a known patient via telehealth for six months before requiring an in-person exam.

"Family physicians believe six months of telehealth-only prescribing of Schedule III through V medications achieves the appropriate balance of facilitating access to care and protecting patient safety," he said.

Ransone also urged the DEA to permanently allow telehealth prescribing of buprenorphine to treat OUD.

Some clinicians noted that the DEA should make better use of existing guardrails for drug diversion, such as Prescription Drug Monitoring Programs (PDMPs).

"The data that are available there are quite robust," said Stephen Martin, MD, medical director at Boulder Care, a telehealth addiction treatment provider. "People can tell what Steve Martin is prescribing in any given month to any given set of people in any given location. That's a lot of information to work with, and I do think that the tracking mechanisms that are available currently can let DEA evaluate not only the number of prescriptions but also the types of prescriptions and forms of buprenorphine that are prescribed."

Additionally, telehealth enables clinicians to implement protocols to prevent substance misuse much quicker than if the clinician had to rely on in-person care alone, Jesse M. Ehrenfeld, MD, president of the American Medical Association, stated.

"Telemedicine can allow a physician to conduct pill counts, monitor toxicology screens, and ensure medication adherence or identify adverse behaviors requiring a change of therapy for situations where an in-person evaluation would result in a delay in care that could lead to patient harm," he said.

Ehrenfeld further noted that safeguards already exist in the Controlled Substances Act and state licensure that governs medical and pharmacy practices. Thus, state medical boards can provide the necessary oversight to ensure that virtual prescribers of controlled substances adhere to high standards of quality and accuracy.

TELEHEALTH REGULATIONS MUST BE STREAMLINED

"The 30-day initiation would not be adequate given the current wait times, given the shortages — 70 percent of counties with no child psychiatrist, 55 percent with no psychiatrist" - American Psychiatric Association's Telepsychiatry Committee Chair Dr. Shabana Khan

The healthcare stakeholders providing comments to the DEA largely supported the creation of a special registration process for telemedicine.

The Ryan Haight Act called for establishing a special registration process allowing healthcare providers to use telehealth to prescribe controlled substances without a prior in-person examination.

According to Shabana Khan, MD, chair of the American Psychiatric Association's telepsychiatry committee and co-chair of the American Academy of Child and Adolescent Psychiatry's telepsychiatry committee, the telemedicine special registration process would allow practitioners to affirm their adherence to patient safety processes, such as having a plan in place if a patient needs to be assessed in person.

In addition, "the special registration could require reporting of the prescriber's employer to hold telemedicine employers accountable as necessary," she said. "Registration should also document the states in which the clinician is licensed, registered, and plans to practice telemedicine."

But, she stated that the special registration process should not require the prescriber's physical location in each state as this would be similar to the current process for state medical licensure, making it redundant.  

Johns Hopkins' Hughes also stated that the DEA should remove in-person requirements and instead develop a streamlined telemedicine special registration process allowing the agency to perform centralized record keeping, prescription tracking, and data monitoring.

In addition to the special registration process, providers urged the DEA to remove in-person care restrictions on the virtual prescribing of Schedule II controlled medications, including medications for treating common mental health conditions like attention-deficit hyperactivity disorder (ADHD).

Hughes added that if telehealth prescribing for Schedule II medications is restricted, the DEA should consider exempting Schedule II non-opioids.

"This would be particularly important…for pediatric populations where there is an even more significant mental health workforce shortage that can be addressed through telemedicine," she said.

The APA's Khan raised concerns regarding the DEA's plan to allow virtual prescribing of a 30-day supply of Schedule III-V non-narcotic controlled medications without an in-person exam.

"The 30-day initiation would not be adequate given the current wait times, given the shortages — 70 percent of counties with no child psychiatrist, 55 percent with no psychiatrist — [it] would not be adequate for evidence-based medicine," she said.

Then, there is the question of enforcement of new regulations and controls to prevent drug diversion. While AMA's Ehrenfeld agreed that a targeted enforcement policy is necessary, he noted several concerns. One major concern surrounds the DEA's proposal to maintain comprehensive prescribing records for investigation purposes.

"The DEA already receives a tremendous amount of data from manufacturers, distributors, pharmacies about controlled substances in the supply chain," he said. "These entities are required to provide DEA with suspicious order reports to help identify potential problem areas. State PDMPs contain personal health information regarding individual prescribers and patients that's clinical in nature and should not be shared or disclosed to law enforcement without probable cause."

Thus, the AMA does not believe that the agency needs more data to target illegal activity, he stated.

As the healthcare industry grapples with the move to a post-COVID-19 public health emergency landscape, the future of virtual prescribing of controlled substances is top-of-mind for stakeholders nationwide. The volume and candor of the comments show that DEA must carefully consider its next steps.

The agency said it will provide an additional written comment period.