By info
•
15 Nov, 2020
Telemedicine is growing in popularity in the healthcare industry as physicians decide whether to use telemedicine to care for patients during the COVID-19 public health emergency. Before making any decision, you should consult with an attorney regarding the various legal implications since the laws surrounding telemedicine are constantly changing and vary from state to state. Telehealth v. Telemedicine Just as the laws surrounding telemedicine vary from state to state, so do the definitions of telehealth and telemedicine vary. Generally, telehealth refers to a broader scope of remote healthcare services, which includes both clinical and non-clinical services; whereas, telemedicine refers to remote clinical services. Thus, telemedicine is the subset of telehealth. Some states refer to telemedicine as telehealth; whereas, other states distinguish the two terms. For example, the Illinois Telehealth Act (225 ILCS 150/5) defines telehealth as “the evaluation, diagnosis, or interpretation of electronically transmitted patient-specific data between a remote location and a licensed health care professional that generates interaction or treatment recommendations.” On March 19, 2020, Illinois Governor Pritzker passed Executive Order 2020-09, which expands the definition of telehealth services “to include the provision of health care, psychiatry, mental health treatment, substance use disorder treatment, and related services to a patient, regardless of their location, through electronic or telephonic methods, such as telephone (landline or cellular), video technology commonly available on smart phones and other devices such as FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, and videoconferencing.” Distant Site v. Originating Site The terms distant site and originating site are also used frequently when discussing telemedicine. The distant site is the location of the physician at the time the service is provided; whereas, the originating site is the location of the patient. Main Categories of Telemedicine The three main categories of telemedicine include: (1) interactive medicine, (2) store and forward, and (3) remote patient monitoring. First, interactive medicine, also known as “live telemedicine”, allows patients and medical professionals to communicate in real-time through audio and video technology. Second, the store and forward category allows medical professionals to collect data from a patient, such as blood glucose levels, and forward the data to another licensed professional for assessment. Third, the remote patient monitoring method allows a medical professional to monitor a patient remotely using various medical devices to capture blood pressure, glucose levels, etc. Legal Implications As mentioned above, telemedicine laws vary from state to state, especially now as many states remove certain restrictions and barriers during the COVID-19 pandemic. Physicians must abide by the laws of that state where the patient is located. For instance, if an Illinois physician provides telemedicine services to a Michigan patient, the Michigan laws apply. Several legal issues must be considered before implementing a telemedicine program. 1. Physician-Patient Relationship Before providing telemedicine services, a physician-patient relationship must be established. A physician-patient relationship is established when a patient knowingly seeks a physician’s services and the physician knowingly accepts a patient. While some states require an in-person examination prior to providing telemedicine services, Illinois laws do not have such a requirement. As a best practice, when establishing the physician-patient relationship via telemedicine, the physician should verify the identity and location of the patient at the time of service to ensure compliance with the laws of the state where the patient is located. 2. Informed Consent Informed consent is the process in which a patient is made aware of the risks and benefits of undergoing a medical service, treatment, or procedure. A physician has a duty to disclose all reasonable information to a patient in order for the patient to make an informed decision about a particular medical service, treatment, or procedure. However, when it comes to specific requirements regarding informed consent for telemedicine services, some states require providers to give patients specialized, informed consent regarding the potential risks, benefits and limitations of telemedicine practice. When providing telemedicine services, it is important to have an attorney review the consent forms to ensure the appropriate language is included for virtual visits. While Illinois does not have specific requirements for informed consent via telemedicine, a best practice before the first telemedicine visit is to explain to patients how telemedicine works (i.e. when service is available, scheduling, privacy/security measures etc.), any limits on confidentiality, the possibility for technical failure, protocols for contact between virtual visits, prescribing policies, and coordinating care with other health professionals. 3. Licensure Telemedicine services must be provided by a health care professional who is licensed, registered, or otherwise authorized to engage in his or her health care profession in the state where the patient is located. The key factor in determining whether the physician may provide telemedicine services is the location of the patient. In addition, if services are conducted through an entity, the entity must be active and registered in the state where telemedicine services are provided. However, amid the COVID-19 pandemic, some states waived the licensure requirements and permit out-of-state physicians to provide telemedicine services. Licensing requirements vary from state to state so you must ensure that you comply with the laws of the state where the patient is located. 4. Teleprescribing Given the declaration of a public health emergency by the U.S. Department of Health and Human Services (HHS), DEA-registered practitioners may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met: The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice; The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and The practitioner is acting in accordance with applicable Federal and State laws. 5. Medical Malpractice Liability Before providing telemedicine services, a physician should check with his or her professional liability carrier regarding liability coverage for telemedicine services. By providing telemedicine services, the physician is subjecting himself/herself to the laws of the state where the patient is located and its jurisdiction. The physician should verify that he/she meets the other state’s requirements and that the insurance carrier provides coverage for the work in the other states. 6. Privacy The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) sets rules for how patient information must be protected. Since physicians are responsible for protecting patient information, they should ensure that patient information in telemedicine visits are safeguarded in the same manner that in-office visits are safeguarded. As of March 6, 2020, the HHS Office of Civil Rights announced that physicians and clinicians may use any audio or video communication technology that is “non-public facing” to care for patients for any reason (not just COVID-19 patients). Some examples of these non-public facing platforms include Apple FaceTime, Skype, Zoom and Google Hangout video. Facebook Live and TikTok are excluded from the permissible non-public facing platforms. Even though HHS relaxed the penalties for using non-public facing technology during the COVID-19 outbreak (which may not be fully compliant with HIPAA regulatory requirements), it is still important for physicians to enable application privacy and encryption settings when possible. With various technologies, there is a risk of a data breach, which may put sensitive patient information at risk of exposure. As a best practice, physicians should ensure the technology being used is fully secure and HIPAA-compliant. Furthermore, physicians should consider updating consent forms to ensure patients are notified of the privacy and security risks associated with telemedicine. Also, when allowing electronic personal health information to be stored by a third-party, physicians should ensure that a Business Associate Agreement (BAA) is signed by both parties. The BAA should discuss how the third-party will safeguard patient information and how often audits will be conducted to ensure the data’s security. 7. Non-Compete Provisions in Personal Service Agreements to Provide Telehealth Services for a Company as an Independent Contractor or as an Employee Contracts to provide Telehealth Services which contain non-compete provisions should be scrutinized carefully. Restrictive Covenants or “noncompete” language in contracts dictate where and when a former employee or contractor can work after a contract terminates, often for any reason or no reason. If you are entering into an agreement, consulting an attorney for advice is recommended to help limit personal legal exposure. The legal issues mentioned above are just a few examples of what needs to be considered when deciding whether to implement or be involved in a telemedicine program. Since each state has different requirements with telemedicine and the requirements are rapidly changing during the COVID-19 pandemic, please contact Malecki & Brooks Law Group, LLC to find out the specific requirements for a particular state. For assistance in telemedicine matter please contact Natalie Ficek or call us at 630-948-4807.