DEA Announces Proposed Rule Restricting Telehealth Prescriptions

Sarasota, FL (WorkersCompensation.com) –The federal government, the Drug Enforcement Administration or DEA, regulates the classification of drugs and uses certain criteria determinates to classify a drug into a category. A new drug rule proposal by the DEA at the end of February has healthcare in an uproar with its impact to telehealth, and a lack of details could result in a lot of red tape unless the rule is clarified. 

The FDA sorts or classifies drugs based on their medical use, whether they are legal, and based on their potential for overuse and abuse. Those classifications or categories are known as “Schedules”. 

Schedule I drugs have no acceptable medical use, have a high potential for abuse, and are unsafe to use even under medical supervision. Some examples would include illegal drugs such as heroin, lysergic acid diethylamide, also known as LSD, marijuana or cannabis, ecstasy, methaqualone, and peyote.

Schedule II drugs have acceptable medical uses, however these drugs have a high potential for abuse and can cause severe psychological or physical dependence if over used. Additionally, they are considered dangerous, and can include illegal drugs as well. Illegal examples include cocaine and methamphetamine. Examples of legal drugs includes hydrocodone, methadone, hydromorphone or Dilaudid, meperidine or Demerol, oxycodone also known as OxyContin, fentanyl, Dexedrine, Adderall, and Ritalin.

Schedule III drugs have a valid medical use, and have a lower threshold for potential abuse, but have a moderate or low physical dependence or high psychological dependence if abused. Examples of Schedule III drugs includes ketamine, Tylenol with codeine, anabolic steroids, and testosterone. 

Schedule IV drugs also have valid medical uses. Additionally, Schedule IV drugs have a lower potential for abuse than Schedule III drugs, and have a lower probability of limited physical or psychological dependence as well. Some examples of Schedule IV drugs include Xanax, Darvocet, Valium, and Tramadol. 

Schedule V drugs have valid medical uses, and have the lowest potential for abuse, and lowest potential to cause physical or psychological dependence. Some examples include cough medicine with less than 200 milligrams of codeine per 100 milliliters, or common nerve medication Lyrica. Most drugs in this class are prescribed for antidiarrheal, antitussive, and analgesic purposes.

In a recent press release, the DEA announced new proposed rules that would affect prescribing medications via telehealth, and would take effect on May 11th when the Public Health Emergency ends. Developed with input from the U.S. Department of Veterans Affairs as well as the U.S. Department of Health and Human Services, the new rules would require an in-person visit for prescriptions for certain medications. 

According to the DEA proposed rule guide, unless a patient has seen a medical provider, they can not receive a prescription for a Schedule II drug. Additionally, if a patient has not seen a provider but needs a Schedule III, IV, or V medication, or they need buprenorphine for medication for an opioid use disorder they can get a 30-day supply via a telehealth visit and must see a provider in person to get a refill. For cases where the patient has seen the provider in person or for referrals, all schedules of medications can be prescribed via telehealth. 

What is interesting is that in the FDA guide as well as the announcement, there is no time requirement mentioned. The only requirement is that a patient has seen a provider in person, however that could be 10 days ago or a year ago. Depending on if and how the adjustments are made to the proposals, the lack of detail could ultimately result in a lot of red tape, especially if litigation arises down the road. 

The proposed changes are open for 30 days for public comment. The American Telemedicine Association (ATA) released a response to the proposed rules. ATA Senior Vice Present Kyle Zebley believes the rules are stricter than necessary stating, “The proposed rules from the DEA are significantly more restrictive than is warranted. Our concern lies with the potential public health crisis this could cause for individuals needing access to clinically appropriate prescriptions of controlled substances for a wide variety of medical circumstances, including for mental health and substance use disorders. The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our healthcare system without access to needed medications.  We recognize that the administration is doing their best to balance protections for patients with patient access to care. However, requiring every patient who has initiated treatment via telemedicine during the pandemic to now visit a provider in-person clearly falls on the side of being overly restrictive. As the ATA, ATA Action, provider groups, and patient advocates have long stated, mandatory in-person visits are clinically unnecessary barriers to appropriate care.”

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