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The Ongoing Evolution of the Definition of Telemedicine

James T. O'Reilly

University of Cincinnati College of Medicine

Mary Ellen Keegan

General Electric Aircraft

The introduction of telemedicine has invited new scrutiny of the definitions of the practice of medicine and healthcare. Telemedicine is the use of technology to dialogue with patients, and to undertake activity constituting the “practice of medicine” when the healthcare provider and patient are not in the same physical location.

There is no single definition of telemedicine; indeed, a 2007 World Health Organization study had found 107 definitions in peer-reviewed publications. This is a broadly changing field, in which the definitions are changing alongside the rapid evolution of technology. The American Telemedicine Association uses a definition that is as broad as the information network at the physician’s disposal, including email, telephone, and fax: “[T]he use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status. Telemedicine includes a growing variety of applications and services using two-way video, email, smart phones, wireless tools and other forms of telecommunications technology.”

The legal definition of telemedicine in the United States varies based on the location of the act and the governmental agencies that have authority to regulate the act. The definitions are crucial for legal counsel in advising physicians because they describe, specifically and by implication, what a physician can and cannot do across state lines without having a license to practice medicine in the jurisdiction where the patient is located. For example, CMS defines telemedicine to include two-way, real-time interactive communication between the patient and distant-site physician, but not communication via telephone, email, or fax.

Many state laws follow CMS’s lead in this definition of telemedicine for the purposes of state Medicaid participation, but other state law definitions of telemedicine include telephone calls, emails, or faxes. The definition of telemedicine can even vary within a given state, depending on the regulatory authority or purpose of the particular law in question, such as medical licensure, pharmaceuticals, private health insurance, or rural utilities services. To further complicate the issue, telemedicine laws and regulations do not always explicitly refer to “telemedicine” and may use other words, such as “telehealth,” “practicing medicine across state lines,” or “practicing medicine by electronic means,” to name a few.

Licensure of the Physician

Any physician or medical group interested in a telemedicine practice should be aware of their “duty of care” under state healthcare practitioner licensing statutes or regulations, which may create heightened licensing or practice requirements for each jurisdiction that the physician seeks to reach through telemedicine. Physicians should be aware of not only any additional permits or licenses that may be required by a given state, but also the additional practice requirements that may be imposed on any physician who uses telemedicine within the state or reaches into the state through telemedicine. Physicians should also be aware of any additional licensing or practice requirements on those healthcare practitioners whom they supervise in relation to a telemedicine activity.

States have developed their medical licensing laws independently of one another, and the lack of state consistency in regulating the practice of medicine presents a significant barrier to any multi-state telemedicine program. One of the initial questions when thinking about a telemedicine practice is whether a license to practice medicine is required in each state. Some states explicitly address telemedicine in their state medical licensing laws and define the practice of telemedicine to include telemedicine that reaches into their state. Some states indirectly address telemedicine by including the act of diagnosing or recommending treatment through any “electronic” means in the practice of medicine in their state. Other states use broader language such as “by any means or instrumentality” to implicitly subject out-of-state telemedicine physicians to their medical licensing laws. Still other states do not address telemedicine, directly or indirectly, in their state physician licensing statutes or regulations. Even for those states that do not directly or indirectly address telemedicine in their medical licensing laws or define the location of the practice of medicine, it is generally assumed that any act of diagnosing or recommending treatment constitutes the practice of medicine in the state where the patient is located for the purpose of medical licensing and falls within the state’s interest in protecting public health. The Federation of State Medical Boards has the best current charts of legal obligations on its website.

All state physician licensing boards explicitly require a license granted by the board to practice medicine in their state. In the absence of licensure exceptions for telemedicine, each state medical board would likely require a physician to obtain a license to practice medicine in their state before allowing the physician to provide telemedicine services to a patient physically located in their state. Physicians should reconsider their medical licensing law coverages even when they only seek to provide telemedicine services within their licensed state. This is because many states have special telemedicine licensing or permitting requirements for currently licensed physicians seeking to commence telemedicine activities within the state.

It is important to review the statutes and administrative codes for each state where your client may want to practice electronically. Obtaining valid licenses to practice medicine can be expensive, time consuming, and burdensome. The healthcare provider will be subject to multiple state medical boards, statutes, and regulations whenever they participate in out-of-state licensing processes or exceptions.

Other Exceptions

Another alternative to obtaining licenses in multiple states is the common exception for out-of-state doctors. Some states follow Alaska, where medical licensing boards offer a consultation exception for those physicians who are licensed in another state.

Telemedicine activities often are intertwined with technologies providing pharmaceutical prescribing and dispensing. Many state and federal regulations and enforcement efforts have been aimed at telepharmacies, and each year more laws are passed. The regulations relate to informed consent, medical records, credentialing and regulating telemedicine licenses, standard of care, transmitting orders for medicines, and contractual arrangements. The federal government has enacted requirements concerning the reimbursement to the distant site practitioner if the services are provided to a Medicare patient at an acceptable site.

Minimum requirements will apply for physicians who use physician practice websites, Internet advertising, or email for patient communications. Physicians who use email for patient communications must have periodically evaluated policies for email management, processing, responses, privacy, archiving, and hours of operation. Physician-practice websites must include numerous disclosures, such as website ownership, in-office contact information, licensure and qualifications of affiliated physicians and healthcare professionals, complaint and feedback processes, and disclosure of any financial interest the physicians may have in any products or services discussed or advertised on the website.

Breach of Standards of Care

Existing state malpractice case law, tort law, and civil procedure govern telemedicine malpractice issues not directly addressed by a specific telemedicine statute or case. The standard of care to which the physician’s actions is compared to determine negligence is not always clear, even in traditional medical encounters. Some courts prefer using a local or community standard of care, while others use a national standard of care.

In addition to pre-existing standards of care, based on the type of physician or disorder being treated, states and private organizations have taken proactive steps to create standards of care specific to telemedicine encounters. For example, some states have created telemedicine-specific informed consent standards, privacy standards, and general telemedicine standards of care. This may create an additional, heightened standard of care to which the physician’s actions might be compared in a telemedicine malpractice case. Controlled substances prescribing rules apply under Drug Enforcement Administration (DEA) requirements. Finally, professional healthcare and technology organizations and the U.S. Food and Drug Administration (FDA) have published standards and guidelines for various aspects of telemedicine that are good reference material to review on the standard of care for telemedicine.

Of course, traditional rules on joint and several liability will apply to telemedicine encounters in which more than one physician is involved and is found to be responsible for an indivisible injury to a patient during a single encounter. However, it would be better for the physicians involved in the telemedicine encounter to communicate their respective responsibilities at the outset rather than waiting for something to go unattended and result in a jury’s determination of who was responsible. In addition to negligence, once the relationship is established, physicians can be held liable for patient abandonment if the physician unilaterally severs the relationship with the patient without reasonable notice or without providing adequate alternative medical care at a time when there is a necessity of continuing medical attention. Telemedicine encounters are often one-time encounters for a specific purpose. Failed communication between the consulting and referring physicians in the ongoing care of the patient could result in an unintentional patient abandonment case, in which both physicians assumed that the other was responsible for the ongoing care of the patient.

Again, communication at the outset could prevent these unnecessary risks that arise in telemedicine. Thus, counsel should identify the range of risks presented by the particular telemedicine activity and preempt these issues by developing processes to ensure continuity of care, coordination of care, creation and termination of the physician-patient relationship, and ultimate responsibility over the patient among multiple healthcare providers and facilities.

Telemedicine is challenging the tradition of independent state control over medical malpractice. States have significant variances in statutory and common law authority governing the elements of medical malpractice, including standards of care, statutes of limitations, informed consent requirements, arbitration requirements, burden of proof, joint and comparative liability, immunity, and damage caps. The Federation of State Medical Boards has a useful compilation.

Insurance and Reimbursement

Another issue to consider is whether the physician’s malpractice insurance covers multi-state telemedicine encounters. Insurance policies vary from state to state, and some policies may only cover malpractice claims in the state in which the physician is licensed to practice, even though the physician may qualify for an exception to practice medicine in the state without a license. Malpractice insurance policies should be examined to determine if multi-state telemedicine encounters are directly addressed, or if additional coverage is necessary. Counsel should first identify the possible states where the specific telemedicine is practiced, and then review the similarities and differences in medical malpractice law for the identified states. These variances allow for increased attention to potential telemedicine claims and the need for heightened risk management.

The intensity of regulatory control for telemedicine practices within a state and throughout different states is increasing daily.

CMS reimbursement issues are also evolving rapidly. Besides considering licensure requirements for each state in which the physician is involved, there are ethical guidelines applicable to the physician’s activities. There are many new areas of regulation, conflicts, and legal principles about which attorneys must become knowledgeable and advise their clients. These issues go beyond conventional employment counseling and require counsel to be continuing learners.

This article is an excerpt from James T. O’Reilly and Mary Ellen Keegan’s book, Healthcare Employment Practice: Policy, Law and Procedure (read now on PLUS), available from PLI Press. The book explores how the healthcare system actually operates, and suggests how lawyers, human resource professionals and hospital management teams can improve their outcomes through astute planning and careful drafting of agreements.

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Disclaimer: The viewpoints expressed by the authors are their own and do not necessarily reflect the opinions, viewpoints and official policies of Practising Law Institute.

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