The recent growth of our law firm’s ketamine clinics and managed services organization (“MSO”) clients has been very significant. This is understandable given the strong momentum behind the state and local legalization and decriminalization of certain other psychedelics. Many companies that are exploring psychedelic drugs are entering the field of ketmaine. Unlike psilocybin (and definitely different from cannabis), ketamine alone is a Schedule III controlled substance, and its use to treat mental health disorders is “off the label”, all of which make it subject to state and federal health care laws. Strict supervision.
An interesting curveball related to off-label treatment of ketamine patients is the combination of telemedicine. Telemedicine is a quasi-emerging beast in the healthcare legal world, even though it has been around for some time. In any case, with the emergence of COVID-19 and the formulation of state and federal emergency orders, certain restrictions on the use of telemedicine have generally been relaxed. Even crazier is that due to the COVID federal emergency order, online prescriptions for controlled substances are also more relaxed. In turn, doctors who prescribe ketamine to patients are now increasingly using telemedicine to do so, which creates an incredibly tricky legal situation.
Given that I am based in California and licensed, I will use it as an example of the problems that arise when combining telemedicine with ketamine. In California, telemedicine is defined as:
“[T]Provide health care services and public health model through information and communication technology to facilitate patients to diagnose, consult, treat, educate, care management and self-management of patients’ health care at the starting location and at the time of health care. Providers are located in remote stations point. Telemedicine promotes patient self-management and nursing staff’s support for patients, including synchronous interaction and asynchronous storage and forwarding transmission. “
As long as medical practices are performed by California practitioners who comply with state and federal privacy laws, there is no law prohibiting the use of telemedicine technology in medical practices. Doctors should abide by the same standards of care and retain the same responsibilities in providing informed consent, ensuring the privacy of medical information, and any other duties related to practicing medicine, whether through telemedicine or face-to-face medical practice. -Personal visit.
Doctors who use telemedicine need to establish a doctor-patient relationship. If the same healthcare services provided by non-telemedicine require face-to-face meetings, the minimum requirement is to use face-to-face inspections. Informally, the California Medical Board also allows pre-examination through telemedicine, provided that the technology is sufficient to provide the same information as a face-to-face examination.
In addition, in California:
“[p]Prescribe, distribute or provide dangerous drugs. .. Failure to have proper prior inspections and medical instructions constitutes unprofessional behavior. “Nevertheless, “appropriate pre-checks do not require simultaneous interaction between the patient and the patient.” [physician] And it can be achieved through the use of telemedicine, including but not limited to self-screening tools or questionnaires, provided that [physician] Meet the appropriate standards of care. “
Especially with regard to California’s Internet prescriptions:
“The basic components of a correct prescription include performing and recording a physical exam, including obtaining a legal medical history, having a full dialogue to form a treatment opinion, determining the risks and benefits of a drug or treatment plan, and arranging follow-up appointments to evaluate before any drugs are prescribed for the first time. , To maintain adequate and accurate medical records.”
According to California law, ketamine is a “dangerous drug.” Although it is not necessary to check in person to comply with California telemedicine laws when prescribing controlled drugs, it is clear that “pre-checks” are still required before doctors can participate in telemedicine and prescribe controlled drugs, including ketamine.
In 2018, Congress passed the 2008 Ryan Haight Online Pharmacy Consumer Protection Act (“Ryan Haight Act”) because “teenagers and others are increasingly using prescription controlled substances for non-medical purposes. [had] Drug trafficking on the Internet has exacerbated this situation. “The Ryan Haight Act is designed to prevent illegal drug activity on the Internet. The regulation imposes a number of restrictions on the issuance and distribution of controlled substances, including instructions. With very limited exceptions, doctors cannot do so without conducting at least one face-to-face medical evaluation. In this case, controlled substances are prescribed via the Internet.
On April 6, 2009, the DEA issued a provisional final rule that included instructing the DEA to create a designated registration for telemedicine for prescriptions of controlled substances, and the subsequent law stipulated the one-year registration period set by the DEA.
On September 30, 2020, DEA issued the final rule entitled “Implementation of the 2008 Ruian Haite Online Pharmacy Consumer Protection Law”, and passed the interim final rule as the final rule (the “Final Rule”) Effective October 30, 2020. It is frustrating that so far, there is still no actual implementation of the regulations for the registration of telemedicine service providers.
On January 21, 2020, the public health emergency for COVID-19 (“Order”) announced that it temporarily allowed the expansion of the use of telemedicine to prescribe controlled drugs during the validity period of the order.Specifically, the Department of Health and Human Services (“HHS”) allows DEA registrants to prescribe controlled substances No The prior in-person medical evaluation provides:
“Practitioners act in accordance with the usual process of their professional practice, and the prescription is prescribed for legitimate medical purposes; telemedicine communications use audio-visual, real-time, two-way interactive communication systems; and the practitioner is in accordance with applicable federal and state laws Act.”
However, this exemption will expire at the end of the order (HHS last updated the order on April 15, 2021, but the expiration date has not yet been determined). On March 31, 2020, DEA released the “How to prescribe controlled substances to patients during the COVID-19 public health emergency“, to provide guidance to suppliers who prescribe controlled drugs through telemedicine until the end of the order.
Physician professional companies (PCs) and MSOs that provide services to them (especially in strict CPOM states) have begun to use this order to interpret it extremely loosely, so that ketamine can be prescribed to patients through telemedicine without prior physical examination and / Or only through asynchronous interaction. Given the vagueness of the order and its imminent nature, certain personal computers, MSOs, and telemedicine service providers are indeed pushing up pressure when it comes to online prescriptions for unstable controlled substances.
After the order ends, many of these companies may see DEA strictly enforce the Ryan Haite Act (unless and until the actual creation and implementation of telemedicine registrations). Any telemedicine company considering allowing doctors to participate in off-label prescription and treatment of ketamine needs to do their homework during the Internet prescription. with When canceling an order after COVID.