By Greg Freeman
EXECUTIVE SUMMARY
Proposed rule changes from the Drug Enforcement Administration (DEA) will make it harder to provide some telemedicine services. In-patient visits will be required for certain controlled substances.
- The proposed rules are in response to the end of the Public Health Emergency.
- Additional DEA licenses might be required.
- Documentation must be altered or created for compliance.
The Drug Enforcement Administration’s (DEA’s) proposed telemedicine rules in response to the end of the Public Health Emergency (PHE) could carry important implications for physicians and employers who use telemedicine to communicate with patients.
The PHE ended May 11. Now, the DEA is considering comments on proposed rules that would extend some of the flexibilities the DEA granted during COVID-19 PHE but are more restrictive in some ways than what was allowed during the pandemic. Concerns over the effect of the proposed rules prompted the DEA to announce on May 9 a temporary extension of its COVID-19 waivers for prescribing controlled substances through telemedicine. Those waivers are extended through November 11. Any practitioner-patient relationships created by that date can continue to operate under the more flexible prescribing rules through November 11, 2024.1
The first proposed rule (Docket No. DEA-407) would prohibit clinicians from prescribing Schedule II controlled substances and Schedule III-V narcotics other than buprenorphine without examining the patient in person first. The second proposed rule (Docket No. DEA-948) would expand the situations in which physicians may prescribe controlled substances through telehealth if the medications have been approved for treatment of opioid use disorder.2
If the rules are enacted as proposed, it will be important for clinicians to understand them and adjust their prescribing practices accordingly, says Paul F. Schmeltzer, JD, senior attorney with Clark Hill in Los Angeles. Simple neglect of the new rules, or a desire to help patients who benefitted from the PHE rules but are now negatively affected, could result in serious legal and regulatory consequences for the prescriber and employer.
“The concern here is if you’re a new patient and you are being prescribed a Schedule II through Schedule IV medication following the end of the COVID-19 PHE, you will have to have an in-person evaluation prior to obtaining a prescription for those medications via telemedicine,” Schmeltzer explains. “This is clearly impacting people in more rural environments in the United States. One of the benefits of telehealth even before the pandemic began was it provided greater access to healthcare and medications to people who live in more rural areas, where it might be an hour’s drive to a hospital or a medical provider. The relaxing of these restrictions allowed a lot of people to discover healthcare via telehealth.”
Could Jeopardize Access
The proposed rules would put telemedicine access in jeopardy for many people, Schmeltzer says, and could result in some patients discontinuing their care. Finalization of the rules also creates legal exposures for clinicians who have become accustomed to operating under the relaxed PHE rules.
To comply with the new rules, providers who use telemedicine may have to team up with local providers in other areas. If a provider works with patients in a dozen states through telemedicine, the provider would have to partner with primary care physicians or other profesionals in each of those dozen states who can conduct a physical examination on patients and then transfer that care to the telehealth clinician.
“The second thing is that with the rollback of the PHE, it’s going to require the providers who are in this telehealth space to have a DEA license in every state that they’re prescribing. During the PHE, that requirement was relaxed,” Schmeltzer explains. “As long as you were registered and in good standing with the DEA in one state, you could prescribe in others. However, with the rollback of the PHE, that’s going to necessitate a scramble for providers to become licensed with the DEA in every state that they’re prescribing in.”
Although the proposed rules could inconvenience patients and create compliance burdens for providers, Schmeltzer says he understands the logic behind requiring in-person visits for some drugs. The need for such visits were understood and generally accepted before the pandemic, but some providers argue that the PHE experience showed they could be relaxed without wide-ranging negative consequences.
In anticipation of rule finalization, Schmeltzer says risk managers should help clinicians understand the changes and begin formulating a response plan that may include making new contacts with local providers, obtaining DEA licenses in the necessary states, and deciding where to operate.
In addition, telehealth providers will need to alter or draft documentation to comply with the proposed rule changes. A document can be created for easy use by the clinicians that allows them to sign off on the transfer of care for that regimen to that telehealth provider.
“Now that the PHE is over, it’s a good time to revisit your compliance and your licensing to just make sure that all your providers and your staff who are prescribing these controlled substances are licensed properly with the DEA in each state they’re doing so,” Schmeltzer says. “Right now, there is a lot of hand-wringing about which way this is going to go, but I think we’re going to see these rules finalized.”
Schmeltzer says the rule changes could catch some providers by surprise. Larger telemedicine providers have followed the issue closely and have been involved in lobbying, but smaller providers may have less of an understanding of the potential consequences.
“I suspect that once the rules are finalized, the efforts at compliance will either fall by the wayside completely or lead to some misunderstandings and some shortcomings when it comes to the actual compliance by some of these smaller or mid-sized entities,” Schmeltzer says. “I have a lot of clients in the men’s health and women’s health space, and they prescribe medications like testosterone that are controlled substances. They have competitors in this space that have recently put out videos on social media trying to summarize for their own clientele what these proposed rule changes might mean, and they simply get it wrong. There’s certainly going to be opportunities for providers to misjudge and misunderstand how these rules might affect them.”
It is important to note that once the rules are finalized, providers will have 180 days to come into compliance. “This will be a lot administratively for smaller companies or smaller healthcare facilities that offer telehealth as part of their services to deal with,” Schmeltzer says. “It will either put them out of business or they’ll try to do things the wrong way and get into trouble with the DEA and shut down.”
REFERENCES
- United States Drug Enforcement Administration. DEA, SAMHSA extend COVID-19 telemedicine flexibilities for prescribing controlled medications for six months while considering comments from the public. May 9, 2023. https://www.dea.gov/press-rele....
- United States Drug Enforcement Administration. DEA announces proposed rules for permanent telemedicine flexibilities. Feb. 24, 2023. https://www.dea.gov/press-rele...
SOURCE
- Paul F. Schmeltzer, JD, Clark Hill, Los Angeles. Phone: (213) 417-5163. Email: [email protected].
The Drug Enforcement Administration’s proposed telemedicine rules in response to the end of the Public Health Emergency could carry important implications for physicians and employers who use telemedicine to communicate with patients. In-patient visits will be required for certain controlled substances.
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