The Ryan Haight Act and the Changing Face of Telemedicine
Posted Aug 02 2013 12:26pm
The advent of telemedicine has made it possible to provide high quality medical care for underserved areas of Texas. Patients in rural areas now have the opportunity to receive care from the state’s best physicians when before travel costs would have made it impossible. Because of the new nature of telemedicine, state and federal laws and regulations have remained in flux. It is important for any telemedicine provider to be aware of these changes to ensure they remain compliant.
One of the most significant changes to telemedicine was the passage of the Ryan Haight Act in 2008. The Act places a number of restrictions on the practice of online pharmacies and the ability of practitioner's to prescribe medications through the internet. It was named after Ryan Haight, a teenager who died of a drug overdose in 2001 from controlled substances he bought from an online pharmacy. Mr. Haight was able to procure a prescription for Vicodin online without ever meeting a doctor.
The Act regulates anyone who delivers, distributes, or dispenses medication by means of the internet. The Drug Enforcement Agency treats a practitioner who prescribes medication following a telemedicine evaluation as covered under the Act. Generally a practitioner is in violation of the act if he or she does not perform at least one in-person assessment of the patient before prescribing medication.
The Act does exempt practitioners from this requirement as long as a practitioner meets the federal definition of practicing telemedicine. A physician practicing telemedicine may prescribe controlled substances without an in-person evaluation if: (1) The patient is treated by, and physically located in a hospital or clinic which has a valid DEA registration; and (2) the telemedicine practitioner is treating the patient in the usual course of professional practice, in accordance with state law, and with a valid DEA registration. 21 USC 802(54)(A). The most important thing to note for a practitioner is that the location where the patient is being treated must be a hospital or clinic that is itself registered with the DEA.
The requirement that the patient be in a hospital or clinic with a DEA registration is more stringent than Texas Medical Board requirements. Under Board rules, a physical, in-person evaluation is not necessarily required to prescribe medication and there is no requirement that the hospital or clinic have a DEA registration. A physician may treat a patient solely through telemedicine as long as the physician creates a physician-patient relationship, the patient is being treated at an “established medical” site, e.g., a clinic or hospital, and all additional requirements are met, including the use of a qualified presenter to examine the patient. Texas law also mandates that a telemedicine provider create and maintain detailed written protocols aimed at preventing fraud and abuse as well as separate policies covering the protection of patient privacy.
There are a number of other special types of telemedicine that under federal law allow a practitioner to prescribe medication without an in person visit, such as practicing telemedicine while working for the Veterans Administration, or receiving a special exemption from the Attorney General. The interaction between federal law and state law in this field is complicated and changing, and made all the more complicated by the piecemeal construction of the Controlled Substances Act.
If you are a physician who is thinking of beginning a telemedicine practice, it is important to seek the advice of experienced counsel to ensure your practice meets all federal and state law requirements. The applicable law can be complex and involve overlapping mandates on both the state and federal level. In Texas the rules regarding telemedicine continue to evolve as the Texas Medical Board frequently revisits this issue, often with an eye towards making more stringent regulation. The attorneys at the Leichter Law Firm have aided numerous physicians and other providers navigate both state and federal telemedicine law and implement best practices to help avoid the most common problems endemic to this field. In our experience, telemedicine is a complaint rich area where seeking the advice of a qualified attorney prior to being subjected to state or federal scrutiny makes all the difference.