Telemedicine in the United States
What is Telemedicine?
Telemedicine is the practice of medicine using electronic information and communication technology between a doctor in one physical location and a patient in another. The “practice of medicine” can include diagnosing, treating, and even prescribing drugs to manage a patient’s care. Telemedicine is legal, within limits, in the US. Almost all states have some definition of telemedicine (sometimes known as “telehealth”) and recognize it for insurance reimbursement. However, some illicit pharmaceutical merchants, particularly those selling prescription drugs without requiring an in-person examination by a medical practitioner, may claim that they are merely engaged in the practice of telemedicine. It’s important to distinguish between legitimate telemedicine, in which an in-person examination may not be required, and practices that violate the law.
What are the types of telemedicine services: synchronous, asynchronous and remote monitoring.
The three distinct types of telemedicine services are synchronous, asynchronous, and remote monitoring. Synchronous refers to the delivery of health information in real-time. This allows for a live discussion with the patient or provider to deliver medical expertise. Asynchronous telemedicine refers to the “store-and-forward” technique, whereas a patient or physician collects medical history, images, and pathology reports and then sends it to a specialist physician for diagnostic and treatment expertise. Finally, remote patient monitoring involves continuous evaluation of a patient’s clinical status, whether through direct video monitoring of the patient or via review of tests and images collected remotely. Newer technologies, such as mobile applications on devices, allows for a wider breadth of telehealth possibilities.
In the US, telemedicine is regulated largely at the state level. This is because telemedicine involves the practice of medicine, which is regulated at the state level through state laws and medical boards. However, federal law can also come into play. With certain limited exceptions, a prescription for a controlled substance issued without at least one prior in-person medical evaluation is considered invalid under 21 U.S.C. § 829(e).
This means that, for now, it is almost certainly illegal for a website to issue a prescription for a federally scheduled controlled substance based solely on an online questionnaire, and without a prior in-person exam. Additionally, dispensing any prescription drug, even if it isn’t a controlled substance, without a prescription is illegal federally.
What’s key here is, even if a telemedicine merchant facilitates patients getting a real prescription, if it’s not prescribed in accordance with state law, the prescription is considered invalid and thus illegal federally and at the state level.
For example, if a telemedicine website prescribed and shipped prescription medicines to a patient in one state, and the doctors were not licensed to practice medicine in the state where the patient resides, the dispensed drugs might be considered misbranded under 21 U.S.C. § 353(b)(1) for not being dispensed pursuant to a valid prescription. Moreover, if the drugs are shipped into the US from a foreign pharmacy, those drugs are nearly always going to be considered “unapproved” and thus illegal.
Most states regard telemedicine as an extension of the traditional practice of medicine, and require doctors to apply the same standard of care for telemedicine patients that they would for patients they see in-person. For example, a doctor seeing a telemedicine patient for the first time is usually required to confirm the patient’s identity, obtain his/her medical history and other information necessary to make a diagnosis, and provide appropriate follow-up care — just like they would do in person.
Some questions that can help determine if a telemedicine website deserves a closer look include:
- Are its doctors licensed in the states where the website offers to provide services?
- Is the website offering to prescribe drugs solely via telemedicine?
- Is the website offering to prescribe controlled substances solely via telemedicine?