There has been an emergence of interest in telemedicine and telehealth in light of the recent constraints related to providing in-office care to patients. This article serves as an introduction to the governing regulations of telemedicine and telehealth.
Part I below discusses the Texas telemedicine regulatory scheme and the significant changes made to the law in 2017. Part II examines the Illinois telemedicine regulatory scheme. And Part III addresses federal regulation of prescriptions and controlled substances, HIPAA, Medicare, and FDA regulation of devices and technology.
I. Texas Regulations
In 2017, the Texas legislature changed its definition of “telemedicine” to apply exclusively to physicians and those acting under the supervision of a physician under the physician’s license. This is in contrast to the changed definition of “telehealth” which covers a “health service, other than a telemedicine medical service, delivered by a health professional licensed, certified, or otherwise entitled to practice in this state….” The terms telemedicine and telehealth are mutually exclusive. However, the requirements for standard of care and practitioner or physician patient care are the same for both telemedicine and telehealth.
Prior to the 2017 revisions of the telemedicine governing rules, physicians providing services through telemedicine were required to meet face to face with their patients at some point in the course of care. After the 2017 revisions, the entire physician patient relationship could be conducted using telecommunications or information technology. In allowing telemedicine without an in person meeting, the Texas Medical Board (the “TMB”) is authorized to adopt rules “ensur[ing] that patients using telemedicine medical services receive appropriate, quality care….” This language allows the TMB to create rules requiring in person care between physicians and their patients, but to this point TMB has not done so.
Texas law and TMB rules require that physicians providing telemedicine health services comport with the same standard of care that would apply in person. The in person standard of care, is described by the Texas Supreme Court as: “A physician who undertakes a mode or form of treatment which a reasonable and prudent member of the medical profession would undertake under the same or similar circumstances shall not be subject to liability for harm caused thereby to the patient”.
Under Texas statute, the provider of telemedicine or telehealth services must establish a practitioner patient relationship. A valid practitioner patient relationship is established when the practitioner complies with the standard of care rules and:
(1) has a preexisting relationship with the patient;
(2) communicates with the patient pursuant to a call coverage agreement under TMB rules; or
(3) provides services using a permitted method.
Permitted methods include:
(1) “Synchronous audiovisual interaction.”
(2) “Asynchronous store and forward technology,” “as long as the practitioner uses clinical information” from “clinically relevant photographic or video images, including diagnostic images”, or “the patient’s medical records, such as relevant medical history, lab and pathology results, and prescriptive histories;” or
(3) “Another form of audiovisual telecommunication technology that allows the practitioner to comply with the standard of care….”
Additionally, the practitioner must provide the patient with guidance on follow up care and provide relevant information to the patient’s primary care physician within 72 hours of the services. More generally, a practitioner patient relationship can be established by explicit or implied contract, and “does not require the formalities of a contract”.
To provide telemedicine or telehealth services to Texas residents, the professional must be licensed in Texas, with limited exceptions. Moreover, the informed consent requirement – “ensure that the informed consent of the patient… is obtained before telemedicine medical services or telehealth services are provided” – for telemedicine services is generally the same as in person services, but telemedicine providers should still ensure that informed consent is explicitly given to the telemedicine care. Texas rules further require that the practitioner give notice of privacy practices, in accordance with federal privacy law, and obtain acknowledgement of such notice. Texas practitioners must also provide notice of the method by which patients can file a complaint with the TMB via the practitioner’s website, app, or bill. Lastly, the physician must keep adequate medical records of services as though they were in person.
Issuing prescriptions through telemedicine is generally subject to the same governing requirements as in person prescriptions. Texas law does prohibit prescriptions for abortion-inducing drugs through telemedicine. Texas rules also prohibits prescribing medication for chronic or acute pain unless otherwise allowed by federal or state law. This regulation has been amended for the duration of the shorter of either 60 days from January 2, 2021 or the duration of the COVID disaster declaration from the Texas governor. The amendment allows prescriptions for acute pain and refills on chronic pain medications.
Texas Medicaid covers costs so long as the physician is licensed, there is a valid practitioner patient relationship, the standard of care is abided, the patient gives informed consent for treatment, written notice of privacy practices, and guidance on follow up care. These requirements align with Texas law and regulation.
II. Illinois Regulations
Illinois telemedicine and telehealth law is significantly less developed than Texas law and regulation. Under Illinois law, telemedicine is a subset of, rather than mutually exclusive to, telehealth. Telehealth is defined as “[t]he 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.” Telemedicine is the performance of any of the activities requiring a physician’s license in Illinois, “including, but not limited to, rendering written or oral opinions concerning diagnosis or treatment of a patient in Illinois by a person in a different location than the patient as a result of the transmission of individual patient data by telephonic, electronic, or other means of communication.”
Illinois statute excludes certain health services from the definition of “telemedicine”, including:
(1) Periodic consultations between an Illinois licensed professional and non Illinois residents;
(2) “A second opinion provided to a person licensed” in Illinois;
(3) “Diagnosis or treatment services provided to a patient in Illinois following care or treatment originally provided to the patient in the state in which the provider is licensed to practice medicine;” and
(4) “Health care services provided to an existing patient while the person licensed” in Illinois “or patient is traveling”.
Licensing requirements and the standard of care under Illinois law are the same for in person care and telemedicine. Persons violating the telemedicine rules are subject to discipline by the Illinois Department of Financial and Professional Regulation (the “IDFPR”).
In 2015, Illinois joined the Interstate Medical Licensure Compact, holding membership currently with twenty-five other states, offering licensed physicians the ability to practice in other member states if meeting certain eligibility requirements. The Compact was ultimately designed to quicken the growth of telemedicine nationally.
Illinois Medicaid reimburses for telemedicine services, allowing physician, physician assistant, podiatrist, or advanced practice nurse provided care. Private insurers are not required to cover telehealth services, but if the plan does, the insurer is not allowed to discriminately treat either in person or telehealth care.
III. Federal Regulations
A. The CSA and Prescriptions
The Controlled Substances Act (the “CSA”), while generally prohibiting the distribution of controlled substances via the internet, specifically accepts prescriptions in the course of telemedicine. The “practice of telemedicine” is defined under the CSA as “the practice of medicine in accordance with applicable Federal and State laws by a practitioner… who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system….” The CSA further requires that the telemedicine provider fits within at least one of seven different contexts, including, for example: in a hospital, clinic, or with another practitioner in person, or in a public health emergency. If writing prescriptions while providing telemedicine, the provider must be aware of federal CSA regulation and ensure that the provider fits within the telemedicine definition.
The Health Insurance Portability and Accountability Act (“HIPAA”) requires that electronic protected health information (“ePHI”) be compliant with HIPAA privacy rules. The HIPAA Security Rule requires that (1) only authorized users should have access to ePHI, (2) a system of secure communication should be implemented to protect ePHI integrity, and (3) a system should monitor communications to prevent accidental or malicious breaches. The requirement of secure communications precludes a practitioner from using SMS, email, or unsecure video platforms such as Skype. “[A]ny system of communicating ePHI at distance must have mechanisms in place so communications can be monitored and remotely deleted if necessary. The system should also have automatic log off capabilities if the system is not used for a period of time.” Practitioners should consider using a telehealth platform that ensures HIPAA compliance.
Medicare Part B and Medicare Advantage cover some telemedicine and telehealth services. Such services must be provided via a multimedia communications system “that includes, at a minimum, audio and video equipment allowing two way, real time interactive communication between the patient and distant site physician or practitioner”. The Medicare coverage “does not include telephone calls,… facsimile machines and text messages”. The list of services that Medicare covers is updated regularly.
To qualify for coverage, the telemedicine or telehealth services must originate from an authorized originating site, which generally are in health shortage areas. The Health Resources & Services Administration maintains an analyzer to determine whether an originating site qualifies.
In 2019, the Centers for Medicare & Medicaid Services (CMS) distinguished certain services—which would be covered by Medicare—from those subject to the typical telemedicine and telehealth Medicare rules. These services include virtual check in, remote evaluation of prerecorded patient information, and interprofessional internet consultation.
D. FDA Regulation
Practitioners and providers should be aware that the U.S. Food & Drug Administration (FDA) has claimed jurisdiction over telemedicine and telehealth apps and software under the Federal Food, Drug, and Cosmetic Act. When choosing a telemedicine or telehealth app or communication platform to provide services to patients, providers should ensure that the platform is FDA compliant.
While Texas, Illinois, and federal law and regulation all are trending toward greater acceptance and integration of telemedicine and telehealth services—especially in light of the COVID 19 pandemic, practitioners and providers have a number of governing rules to be aware of.
Certain telemedicine and telehealth requirements are largely the same as in person services—namely, licensure requirements and the professional standard of care. But state and federal regulatory hurdles persist surrounding permissible technology, prescriptions, insurance and Medicare coverage, and HIPAA, security, and privacy precautions.
The Oracle Legal Group regularly advises employers regarding best practices for implementation of telemedicine and telehealth practices, and we encourage you to reach out to one of our attorneys to discuss how we can assist in achieving your business objectives.