Telemedicine – Still So Many Unknowns

In the July 14th issue of the New England Journal of Medicine, there was a review article titled “State of Telehealth.” In it, Drs. Dorsey and Topol describe the following three current telemedicine trends:

“The first is the transformation of the application of telehealth from increasing access to health care to providing convenience and eventually reducing cost. The second is the expansion of telehealth from addressing acute conditions to also addressing episodic and chronic conditions. The third is the migration of telehealth from hospitals and satellite clinics to the home and mobile devices.”

The article discusses many barriers to telemedicine, including legal barriers. I think an important barrier not mentioned is the restrictions on prescribing controlled substances. This is an area that not many people are thinking about, and those who are end up thinking about it differently! After discussions with a DEA representative, here is my understanding – NOT TO BE RELIED UPON AS LEGAL ADVICE – just one risk manager’s thoughts on prescribing controlled substances via telemedicine:

Step 1: You have to comply with state prescribing law applicable to all prescribing. In addition to being licensed in the patient’s state, states can require state controlled substance registration in the patient’s state (if different from prescriber’s state), registration with the Prescription Monitoring Program in the patient’s state, or other requirements, such as CME requirements.

Step 2: You have to comply with state law regarding prescribing via telemedicine.Some states specifically prohibit prescribing controlled substances via telemedicine, and some states allow it only under certain circumstances, such as for the treatment of psychiatric disorders.

Step 3: You also have to comply with federal law applicable to all prescribing. Some prescribers are surprised to learn that federal DEA registration is required in each state where controlled substances are prescribed. If the remote patient is out of state, services are deemed rendered in the patient’s state. Federal DEA registration covers multiple prescribing locations within one state, but it does not cover multiple states.

Step 4: You also have to comply with federal law regarding prescribing via the internet. Under the Controlled Substances Act (CSA), no controlled substance … may be delivered, distributed, or dispensed [defined to include prescribing] by means of the Internet without a valid prescription. “Valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—a practitioner who has conducted at least one in-person medical evaluation of the patient or a covering practitioner.

There is an exception to the federal one in-person visit requirement for “telemedicine.” BUT the exception for telemedicine is limited to telemedicine as defined by the CSA.The 7 definitions of the practice of telemedicine / 7 exceptions to the in-person visit requirement are:

1. Patient is remotely treated “while the patient is being treated by, and physically located in, a hospital or clinic [with a federal DEA registration] AND by a practitioner acting in the usual course of professional practice AND acting in accordance with applicable State law AND [has federal DEA registration] in State in which patient is located unless the practitioner [is with the VA or Indian Health Service]” OR
2. Patient’s remote treatment “is being conducted while the patient is being treated by, and in the physical presence of, a practitioner acting in the usual course of professional practice AND acting in accordance with applicable State law AND [has federal DEA registration] in State in which patient is located, unless the practitioner [is with the VA or Indian Health Service]” OR
3. Patient is remotely treated by provider with the Indian Health Service OR
4. Patient is remotely treated during a public health emergency OR
5. Patient’s remote treatment “is being conducted by a practitioner who has obtained from the Attorney General a special registration…” (No such registration currently exists, but it is on the DEA’s agenda and the American Telemedicine Association has provided input for this special registration.) OR
6. Patient is remotely treated during a medical emergency (defined) OR
7. Patient’s remote treatment “is being conducted under any other circumstances” as designated by the Attorney General and the Secretary.

Again, these are just my thoughts – and not legal advice. If you are insured through PRMS, feel free to call your risk manager to discuss this further and receive resources to assist you in navigating these uncharted waters.

Donna Vanderpool, MBA, JD
Vice President

As Vice President of Risk Management, Ms. Vanderpool is responsible for the development and implementation of PRMS’s risk management services for The Psychiatrists’ Program. Ms. Vanderpool has developed expertise in the areas of HIPAA and forensic practice, and has consulted, written and spoken nationally on these and other healthcare law and risk management topics. She most recently contributed to a chapter in Gun Violence and Mental Illness (APPI), authored chapters on telepsychiatry in Mental Health Practice in a Digital World (Springer) andPsychoanalysis Online 2(Karnac). She also has co-edited and contributed chapters to several other clinical textbooks. Prior to joining PRMS in 2000, Ms. Vanderpool practiced criminal defense law, taught business and legal courses, and spent eight years managing a general surgical practice. Ms. Vanderpool received a Bachelor’s degree in Business Administration and Management from James Madison University. She also earned a Master of Business Administration degree and Juris Doctor degree from George Mason University.Follow Donna on LinkedIn.