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Understanding telehealth prescribing: Pros, cons and DEA rules

Telehealth prescribing, expanded during the COVID-19 pandemic, is under scrutiny as the DEA considers extending regulatory flexibilities beyond 2024 amid concerns of misuse.

Telehealth prescribing is top-of-mind among healthcare stakeholders as the industry waits with bated breath to see if the pandemic-era regulatory flexibilities will be extended beyond 2024.

Telehealth-based prescribing offers quick and convenient access to lifesaving medications. Regulatory flexibilities enacted during the COVID-19 pandemic significantly expanded access to telehealth prescribing for numerous therapies, including buprenorphine, methadone, Adderall, ketamine and Tramadol.

However, while many are eager to see the flexibilities extended, bad actors have shone a harsh light on the potential pitfalls of expanded telehealth prescribing.

The federal government has yet to weigh in, making telehealth prescribing regulations one of the most closely watched legislative issues as the end of 2024 draws near.

What is telehealth prescribing?

Telehealth generally refers to healthcare providers providing services such as medical evaluations, diagnoses and treatments virtually using various technologies. There are several telehealth types, including synchronous, asynchronous and audio-only telehealth. When these virtual appointments result in a prescription, it is termed telehealth prescribing.

These prescriptions are usually e-prescriptions, that is, electronic prescriptions, wherein the prescriber electronically sends a prescription directly to a pharmacy from the point of care. E-prescribing has become increasingly common in the 21st century. This is largely due to e-prescribing being included in the Medicare Modernization Act of 2003 and a 2006 Institute of Medicine report highlighting how e-prescribing helps reduce medication errors.

The scope of telehealth prescribing is broad, with healthcare providers allowed to prescribe various medications, such as antibiotics and nonsteroidal anti-inflammatory drugs, virtually. However, federal and state governments have placed limits on telehealth prescribing for controlled substances.

Evolution of DEA rules and where they stand now

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 is the landmark regulation governing telehealth prescribing. The act requires the healthcare practitioner providing a prescription for a controlled substance to have previously conducted at least one in-person medical evaluation of the patient.

During the COVID-19 pandemic, the DEA waived this requirement, allowing healthcare providers to issue prescriptions for controlled substances via telehealth without conducting a prior in-person evaluation. The DEA did specify that the prescription must be "issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice" and that the telehealth appointment be "conducted using an audio-visual, real-time, two-way interactive communication system."

The Ryan Haight Act requirement was lifted until the public health emergency (PHE) was declared over. In February 2023, the DEA released proposed updated rules for telehealth prescribing of controlled substances in preparation for the PHE's end in May of the same year.

Under the proposed regulations, healthcare practitioners would be allowed to prescribe a 30-day supply of Schedule III-V nonnarcotic controlled medications and a 30-day supply of buprenorphine for the treatment of opioid use disorder (OUD) without a prior in-person exam; however, this flexibility would not be extended to Schedule II controlled substances, such as Adderall, Oxycodone, Vicodin and Ritalin.

Following widespread and vehement pushback from the healthcare industry -- the DEA received a record 38,000 comments on its proposed rules -- the agency extended the in-person evaluation waiver through Nov. 11, 2023.

In September 2023, the DEA held listening sessions, inviting feedback from across the industry. Most speakers acknowledged the benefits of telehealth prescribing, noting that it significantly expands access to necessary medications. Some underscored the need for a special registration process for telemedicine, which would allow practitioners to affirm their adherence to patient safety processes.

Following the listening sessions and continued urging from the industry and even lawmakers, the DEA extended the telehealth prescribing flexibilities through Dec. 31, 2024.

Benefits of telehealth prescribing

Telehealth prescribing offers myriad benefits for healthcare consumers, including the overarching benefits of telehealth itself, such as convenient access and broader healthcare choices.

During the COVID-19 pandemic, telehealth prescribing was necessary across primary and specialty care as in-person care was severely restricted. Telehealth appointments and e-prescriptions enabled people to access care and medications without exposing themselves to the deadly coronavirus.

However, the most significant benefits of telehealth prescribing can be seen in behavioral healthcare.

Telehealth remains widely used in the mental healthcare arena, with mental health conditions ranking No. 1 on the list of top telehealth diagnoses nationally in June 2024, according to data from FAIR Health. Additionally, a 2022 survey revealed that telehealth use among psychiatrists and other mental health providers was well above that of other specialists.

The rise in telemental healthcare has prompted an increase in telehealth prescriptions for mental health conditions. According to Trilliant Health data released in 2023, stimulant prescribing via telehealth increased from 0.5% in 2017 to 1.4% in 2019 to 35.3% in 2020. In 2022, stimulant prescribing via telehealth rose to 38.4%.

Similarly, a data brief released by the Office of the National Coordinator for Health Information Technology in 2023 showed that 62% of prescribers used e-prescribing for controlled substances "often" in 2021 compared to 37% of prescribers in 2019.

Amid the rise in telehealth prescribing for mental healthcare, clinical evidence has also grown, showing that telehealth-initiated medication treatments can offer significant benefits for behavioral health patients, particularly those struggling with OUD.

For instance, a study published in 2022 showed that the increase in telehealth use during the pandemic was associated with an increase in the use of medications for OUD treatment and a reduction in the odds of medically treated overdoses. Not only that, but research published in 2024 revealed that telehealth-based referrals can be more effective than referrals made during an in-person emergency department visit in ensuring that OUD patients start and stay engaged in medication-assisted treatment.

Telehealth has also helped boost OUD treatment among vulnerable communities. Research published in 2023 showed that the proportion of Medicaid beneficiaries who started buprenorphine treatment through telehealth rose from 2.4% to 16.3% in Kentucky and from 1.3% to 15.2% in Ohio.

Further, a study published in March 2024 showed that virtual initiation and at-home doses of medications for OUD are likely cost-effective. Stanford University researchers conducted a model-based analysis of buprenorphine and methadone treatment for 100,000 OUD patients with and without regulatory flexibilities in place.

They found that if the treatment retention rate under the regulatory flexibilities remains unchanged or increases, thousands of dollars of healthcare expenditure could be saved.

Telehealth prescribing fraud, waste and abuse

As telehealth prescribing, particularly in the behavioral healthcare space, has soared, there have been instances of fraud, waste and abuse.

Telemental health companies Cerebral and Done Health have come under fire in recent years for overprescribing controlled substances, including medications for attention-deficit/hyperactivity disorder (ADHD). In 2022, CVS Health and Walmart announced they would no longer fill prescriptions for controlled substances provided by either company.

The decision followed months of turmoil at Cerebral, which received a grand jury subpoena related to a federal investigation into its potential violations of the Controlled Substances Act, faced a lawsuit from a former C-suite executive who claimed that the company planned to increase customer retention by prescribing stimulants to all its ADHD patients and was the subject of an expose by the Wall Street Journal.

Then, in June 2024, the U.S. Department of Justice arrested and charged Done Health Founder and CEO Ruthia He and Clinical President David Brody with conspiring to provide easy access to Adderall through a monthly subscription fee. He and Brody each face a maximum penalty of 20 years in prison if convicted.

Earlier this year, the U.S. Attorney's Office for the Central District of California sentenced a former physician to 37 months in federal prison for illegally prescribing medications during telehealth sessions. The office claimed that the physician issued prescriptions for controlled substances between December 2019 and August 2021 without getting the patient's entire medical history, conducting a physical examination, requiring medical testing or using diagnostic tools.

These incidents add to concerns about extending DEA flexibilities for telehealth prescribing, even among healthcare providers.

Though healthcare providers appeared largely in favor of the flexibilities at DEA listening sessions held in September 2023, there were a few dissenting voices.

John Wells, M.D., an associate professor of clinical psychiatry at Louisiana State University Health Sciences Center, told lawmakers that expanded telehealth 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.

Others noted that some limitations on telehealth prescribing are necessary. For instance, Sterling Ransone, M.D., a family physician in rural Virginia and immediate past president and board chair of the American Academy of Family Physicians, said that the DEA should allow prescribers to manage a known patient via telehealth for six months before requiring an in-person exam.

The healthcare industry is waiting with bated breath to see whether the DEA will extend telehealth prescribing flexibilities and, if so, for how long. Though stakeholders have pushed to make the flexibilities permanent, it is more likely that the DEA will once again temporarily extend them.

The Office of Management and Budget, part of the Executive Office of the President, received a final rule to review on Oct. 10, 2024, titled "Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications." It is unclear how long the extension would be.

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.

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