JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY Volume 26, Number 3, 2016 ª Mary Ann Liebert, Inc. Pp. 198–203 DOI: 10.1089/cap.2015.0018 Telemental Health for Children and Adolescents: An Overview of Legal, Regulatory, and Risk Management Issues Gregory M. Kramer, JD, PhD,1 and David D. Luxton, PhD1,2 Abstract Objective: The use of technology to provide telemental healthcare continues to increase; however, little has been written about the legal and regulatory issues involved in providing this form of care to children and adolescents. Methods: This article reviews existing laws and regulations to summarize the risk management issues relevant to providing telemental healthcare to children and adolescents. Results: There are several legal and regulatory areas in which telemental health clinicians need to have awareness. These areas include: 1) Licensure, 2) malpractice liability, 3) credentialing and privileging, 4) informed consent, 5) security and privacy, and 6) emergency management. Conclusions: Although legal and regulatory challenges remain in providing telemental healthcare to children and adolescents, it is possible to overcome these challenges with knowledge of the issues and appropriate risk management strategies. We provide general knowledge of these key legal and regulatory issues, along with some risk management recommendations. Introduction T he use of telecommunications technologies to deliver mental healthcare in the public and private sectors continues to expand, as technological advances make it easier to provide services beyond traditional in-person clinic settings. In particular, governmental agencies such as the United States Department of Veteran Affairs and the Department of Defense have active programs that are using technologies to improve access to mental healthcare. Providing mental healthcare from a distance using technology is sufficiently advanced to have its own name: Telemental health (TMH). Often defined as a subset of the broader and more commonly used terms ‘‘telehealth’’ and ‘‘telemedicine,’’ TMH generally refers to methods of using technologies to connect patients at one location with providers of psychiatric, psychological, or other behavioral health services at a distant location. Research continues to demonstrate the benefits and effectiveness of delivering mental healthcare using technology such as videoteleconferencing (VTC) (Richardson et al. 2009; Grady et al. 2011; Backhaus et al. 2012; Hilty et al. 2013), including TMH services specifically for children and adolescents (Nelson and Bui 2010). Despite the many technological and empirical advances, many clinicians have legitimate concerns about how to practice TMH safely, given the current legal and regulatory environment that is largely based on providing healthcare in the traditional in-person setting. The good news is that with the increasing use of TMH throughout the world, few absolute barriers to providing safe and effective TMH services remain, and many obstacles specific to TMH have been reduced (Brooks et al. 2013). This article provides a general overview of some of the key TMH legal and regulatory issues that currently exist in TMH, with a special focus on some particular issues relevant to providing services to children and adolescents. This article does not provide any legal opinion; advice of counsel is always encouraged for specific legal questions relevant to an individual situation. This article focuses specifically on TMH delivered via videoconferencing technology. There are additional considerations for TMH conducted with other technologies such as web sites, e-mail, mobile applications, and social media, which we do not address here. Our overall aim is to provide introductory knowledge of the key TMH legal and regulatory issues along with some common risk management strategies, which will enable all mental health professionals to be more knowledgeable and comfortable with TMH. Licensure Licensure is one of the primary TMH legal issues pertinent to services for adults as well as for children and adolescents, given that TMH provides the opportunity to provide care across state lines in distant or neighboring states. Via ‘‘police powers’’ granted to states 1 National Center for Telehealth and Technology (T2), Joint Base Lewis-McChord, Tacoma, Washington. University of Washington School of Medicine, Seattle, Washington. The views expressed are those of the authors and do not reflect the official policy or position of the Department of Defense, the Department of the Army, or the United States government. 2 198 TMH LEGAL AND REGULATORY ISSUES under the Tenth Amendment of the United States Constitution, the individual states have historically had control over establishing and enforcing licensure requirements for healthcare professionals located within their jurisdiction (United States Department of Health and Human Services 2010). The perceived financial and administrative burden of obtaining multiple licenses to see patients in distant states, along with the promise of TMH to increase access to care if more licensure mobility were possible, have increased debate on the limits of the current state-based licensure system (Miller et al. 2005; Gupta and Soa 2010; Ameringer 2011). A variety of ‘‘solutions’’ have been proposed, including allowing states to create interstate licensure compacts with each other whereby states can mutually recognize the licenses of other participating states (in general or for specific purposes), creating a special telemedicine license, and creating a national license (Gupta and Soa 2010; Ameringer 2011). The debate is vigorous enough that national health organizations representing different healthcare disciplines such as the Federation of State Medical Boards (FSMB), the Association of State and Provincial Psychology Boards, The National Council of State Boards of Nursing, and the American Telemedicine Association (ATA) (see www.fixlicensure.org, dedicated to reforming the state-based medical licensing system in favor of a national license portability system) have all undertaken efforts to address licensure portability for healthcare professionals in different ways (see individual web sites of each organization to see efforts to date). It is of note that the American Medical Association continues to support a state-based licensure system and, ‘‘opposes efforts to change such to federal licensure of telemedicine.’’ (American Medical Association Policy Statement H480.969 2012; American Medical Association Resolution 920 2013). However, the FSMB recently approved policy to study the creation of an ‘‘interstate compact’’ licensure system ‘‘to increase efficiency in the licensing of physicians who practice in multiple states.’’ (Federation of State Medical Boards 2014). For some federal employees (e.g., employees of the Veterans Administration [VA], Indian Health Service (IHS) Department of Defense [DoD]), cross-state licensure is less of an issue because statute or case law interpretation allows certain categories of federal employees to provide healthcare services anywhere under federal duty as long as they are licensed in one state. In what was seen as positive precedent in the telemedicine licensure area, the DoD recently expanded the categories of DoD telemedicine providers granted portability of licensure to include not only members of the armed forces, but also civilian employees of the DoD, personal services contractors, and select others when performing their federal duties (Title 10, United States Code, Section 1094[d], as amended by Section 713 of the National Defense Authorization Act for Fiscal Year 2012). At the state level, and as it pertains to most TMH practitioners, the ability to practice across state lines without obtaining multiple licenses remains an issue. A recent legal case highlights the dangers of not paying attention to the issue. In Hageseth v. Superior Court (2007) a psychiatrist was convicted of practicing medicine without a license and sentenced to 9 months in a county jail, after a patient to whom he prescribed fluoxetine died by suicide. The psychiatrist convicted in this case was licensed in Colorado, but had prescribed the medication to a California resident after administering him an online questionnaire, and without conducting an in-person examination (Hageseth v. Superior Court 2007). There were other relevant issues in this case related to whether it is an appropriate standard of care to prescribe online without physically examining a patient, which we discuss in the next section; however, this case highlights that states can take the licensure issue seriously. 199 Some attention to state law regarding where any individual practices and sees patients is recommended, given the constantly changing legal environment, as many states are developing, reviewing, and modifying telemedicine licensure requirements and other aspects relevant to TMH practice. There is great variability in terms of the licensure and practice issues that these laws address, as some simply define telemedicine, some stipulate informed consent and information management procedures, and some define acceptable services one could provide in a state without a full license. Some laws are general to all healthcare providers, whereas others are specialty specific, leaving lack of clarity regarding what applies to what professions when the law is silent. For medical professionals, the FSMB has a handy Board-by Board ‘‘Telemedicine Overview’’ that is an excellent resource (Federation of State Medical Boards 2013). For psychologists, the American Psychological Association has a 50 state review of laws (American Psychological Association 2013). The ATA has a State Telemedicine Legislation Tracker to keep people up to date with current tends (American Telemedicine Association 2014). Although there may be some exceptions for certain states and certain circumstances, for now, the safest risk management approach for most is to obtain licenses in each state where one wishes to see patients (more specifically, the state where the patient is located when receiving services). Given the flurry of legislative activity, this could change in the future for some. Malpractice Liability Issues Given that TMH is a new method of care delivery to many, it is natural that questions would arise over appropriate standards of care to help avoid malpractice liability. One thing to consider is that TMH ‘‘is not a clinical service itself, but rather a mode of service used to connect patients or providers located in one location with providers in a distant location’’ (Kramer et al. 2013). As a result, in general, best practices, standards, and guidelines for in-person care also apply for TMH care, although additional guidelines, regulations, and best practice information that are TMH specific is emerging. Of particular note, the ATA TMH Special Interest Group has published three guidelines: one on evidence-based practice, one on practice guidelines for videoconferencing-based TMH, and, most recently, another on guidelines for video-based online mental health services (Yellowlees et al. 2010; Grady et al. 2011; Turvey et al. 2013). The ATA is also currently developing guidelines for children and adolescents, although published guidelines that focus on children and adolescents already exist (Myers and Cain 2008). Because few cases of TMH malpractice have been adjudicated, the full range of issues and what constitutes appropriate standard of care for TMH services is emerging. Most of the early ‘‘telemalpractice’’ cases, such as Hageseth, have focused on the issue of prescribing medication via technology (telephone, Internet) without conducting an appropriate initial examination of the individual (Natoli 2009). Another case that recently received attention is State of Oklahoma ex rel. the Oklahoma Board of Medical Licensure and Supervision v. Thomas Edward Trow, M.D. (2013). In this case, an Oklahoma licensed physician was found guilty of unprofessional conduct, and as a result had his license suspended for 9 months and was placed on 2 years of probation. Although much news coverage of the case focused on the use of Skype (which is not a method of providing services approved by the Oklahoma Health Care Authority, the agency that operates Oklahoma’s Medicaid program), the major issues the Board identified were related to Dr. Trow’s not 200 following the standard of care in prescribing controlled substances, and his failure to perform adequate initial examinations (Heartland Telehealth Resource Center 2013). According to the record, Dr. Trow would send his nurse to travel to the patients and have her present them to him via Skype, or in some cases, he would just talk to patients over the phone as a result of a nurse-only visit, without actually seeing them via Skype. Both this and the Hageseth case highlight that physicians providing TMH need to follow appropriate standards of care when prescribing medications, particularly when prescribing controlled substances. In particular, TMH prescribers need to become aware of the Ryan Haight Online Pharmacy Consumer Protection Act (Public Law No. 110-425, H.R. 6353 2008) that regulates Internet prescribing, and the Drug Enforcement Administration Final Rule that implements this statute and defines telemedicine (21 Code of Federal Regulations Parts 1300, 1301, 1304, 1306 2009). TMH physicians who wish to prescribe medication via technology should become familiar with medical practice laws within their own state, as well as the state where the patient is located, to know what will satisfy requirements for establishing a physician–patient relationship, and what is sufficient for meeting the initial examination requirement (see, e.g., Natoli 2011 for a discussion of these key issues related to telemedicine and prescribing). Although some states may have or create exceptions for telemedicine prescribing, currently most states do require physicians to have an initial inperson encounter prior to prescribing via technology. With regard to malpractice liability insurance, because TMH is a newer form of care, many malpractice insurance carriers are silent on the issue of telepractice. It is recommended that physicians look at their current coverage to see if it mentions any form of telepractice, and also to see whether it includes coverage for care provided to a patient physically located out of state (note that some policies may cover practice in any state where the clinician is licensed). Even if a particular policy is silent, it might be wise to consider contacting the insurance carrier to try to get answers to the extent that the particular policy might or might not cover TMH. According to one informal survey of professional liability insurance companies, most telepsychiatry questions were handled on a case-by-case basis with no common approach (Hyler and Gangure 2004). It is hoped that more insurance carriers will soon include telemedicine clauses in their policies; but even if they do not, physicians need to be assertive in trying to get answers, and it is recommended to document any oral conversations with malpractice insurance carriers when trying to get answers. Credentialing and Privileging As any healthcare professional with privileges at multiple hospitals may know, hospitals often use different local administrative processes to verify credentials (e.g., diploma, license) and grant privileges to practice an appropriate medical specialty. The credentialing and privileging (C + P) process is relevant to TMH because clinicians need to have privileges at each site where they see patients, including the remote hospital or clinic where the patient is physically located when receiving the service. TMH conceptually allows clinicians to see patients located at many different sites from the convenience of their home hospital, clinic, or office; but the process of initially obtaining and maintaining privileges every few years at more than one site has traditionally been burdensome for some clinicians. To ease that burden somewhat, the agency that issues C + P standards for certifying hospitals – the Centers for Medicare and KRAMER AND LUXTON Medicaid Services (CMS) – recently released a new regulation on telemedicine C + P in 2011 (42 Code of Federal Regulations, Part 482 and 485 2011) meant to streamline the process. The new regulation allows a local hospital to rely upon the C + P decision of a distant site hospital under certain conditions (see 42 Code of Federal Regulations, Part 482 and 485 for a list of the conditions). This new ‘‘privileging by proxy’’ rule applies to telemedicine and likely TMH, as it broadly defines telemedicine to include ‘‘overall delivery of healthcare’’ (42 Code of Federal Regulations, Part 482 and 485 2011). As a result of and consistent with the new rule, The Joint Commission (TJC) issued similar telemedicine standards ( Joint Commission Perspectives 2012). Although it remains unclear how effectively hospitals will implement this new regulation to improve the C + P process, this is one area in which the regulatory environment has opened up the possibility for processes more supportive of TMH advancement. Risk Management Strategies Although we have highlighted some potential areas of concern for TMH clinicians, we also emphasize that TMH is safe and effective with some basic risk management strategies. We highlight a few areas in which TMH clinicians can take informed steps to engage in ‘‘best practices’’ that help to mitigate risks. Although the evolving legal and regulatory arena for TMH still leaves many open questions, attention to informed consent, data security and privacy, and emergency management procedures can help to reduce risks and assure competent and ethical TMH practice. Informed consent Informed consent is an important consideration in TMH care and is a standard of care as in traditional in-person care. Several states have specific legal requirements for what constitutes valid informed consent, and it is recommended that TMH clinicians review any applicable informed consent regulations in their state to see what specific consent elements are required (see American Psychological Association Practice Organization 2010 for a review of the issue). Recent TMH guidelines from the ATA have highlighted the importance of obtaining informed consent with patients in real time (Turvey et al. 2013). Those guidelines also provide some recommended elements for TMH informed consent (in the absence of specific law or regulation), that include the following: Confidentiality and limits to confidentiality when using electronic communications, emergency plan, process for documentation and storage of information, potential for technical failure and procedures for coordination of care with other professionals, protocol for contact between sessions, and conditions under which TMH services are terminated and a referral for face-to-face care made (Turvey et al. 2013). An additional issue to consider when providing TMH to children and adolescents is age of consent. Age of consent laws vary from state to state; therefore, TMH professionals should familiarize themselves with the age of consent requirements for any state where patients are receiving services, as most state law considers care as occurring in the state where the patient is physically located. Failure to know the specific age of consent laws when providing TMH services to other states can expose the TMH clinician to potential liability for not obtaining appropriate informed consent. Knowing and considering age of local consent laws is also relevant to emergency management when working with children and adolescents, as it may help determine appropriate parents or guardians to involve in safety planning. TMH LEGAL AND REGULATORY ISSUES Emergency management Safety planning ahead of initiating TMH services is an important risk management strategy. TMH professionals should consider and establish a plan for addressing technical, medical, and clinical emergencies. Fortunately, industry guidelines (Yellowlees et al. 2010; Turvey et al. 2013) and other resources (Luxton et al. 2012b, 2104) provide useful recommendations for establishing a safety plan. Because this topic is of sufficient importance, we recommend reviewing these and other resources to gain additional information on this issue beyond the scope of what we can mention here. However, given the importance of this topic, here are several considerations physicians need to consider, including some specific to working with children and adolescents. 1. Know the local civil commitment laws and Tarasoff type duty to warn/protect requirements where patients are located, because procedures for hospitalization and Tarasoff warnings vary by jurisdiction (Tarasoff v. Regents of the University of California 1974, 1976; Walcott et al. 2001; Herbert 2002; Godleski et al. 2008; Turvey et al. 2013). 2. Know the specific emergency procedures (if they exist) for any site (e.g., clinic, school) where treatment of children or adolescents take place. If none exist, establish emergency procedures, including who will do what at each site to ensure coordination; ensure there is a backup/secondary method for contact in emergencies. Specifics to consider when planning emergency procedures, as presented in the ATA Practice Guidelines for Video-Based Online Mental Health Services (2013) include: Identifying local emergency resources and contact information; identifying location of nearest hospital emergency department capable of managing psychiatric emergencies; having patient’s family/support contact information; and collection of contact information for other local professional associations, such as the city, county or state, provincial or other regional professional association(s), in case a local referral is needed to follow up with a local professional. Regardless of what emergency procedures are in place, it is a good practice to discuss with the patient all technical, clinical, and emergency procedures at the initial encounter as part of informed consent. Also, depending upon age of consent issues, it may be necessary to communicate to and even include the parent or guardian in all emergency procedures. 3. Become familiar with transportation issues and what access, means, and geographical restraints caused by long travel distances, the child or adolescent may have if needing urgent response for a clinical or medical emergency. Having a local support person (staff, parent or guardian) involved in the emergency plan can help consideration of these issues ahead of time. 4. Finally, as with civil commitment and duty to warn laws, it is also recommended to know the local requirements, procedures, and phone numbers for mandated reporting to Child and Protective Services, as state requirements for mandated reporting may vary as to types of professionals who must report, what is required to report, procedures and timeframes for reporting, and to whom to report. Security and privacy Given the diversity in technologies available for TMH (e.g., VTC, Internet, mobile phone apps), assuring patient privacy and 201 data security that are compliant with the Health Insurance Portability & Accountability Act of 1996 (HIPAA) needs to be a priority for TMH professionals. New HIPAA rules enacted in 2013 make the fines and consequences for HIPAA noncompliance greater than they have been in the past (78 FR 5565 2013). It is important to consider that HIPAA compliance is a set of processes that one can employ, and not simply technical requirements that are to be met. For example, just because a software company may claim its product meets HIPAA’s 128 bit encryption standard, there are other considerations that can make the product HIPAA compliant or not, such as whether the company enters into business associate agreements with providers or healthcare organizations they do business with and whether they allow patient health information audits if a security breach does occur. For this and other reasons, choice of technology is important. There continues to be debate on whether the use of commercially available products, such as Skype, is HIPAA compliant (Mahue and McMenamin 2013). The first step in risk management is knowledge of the appropriate rules and, fortunately, the American Medical Association has written a summary of the new HIPAA rules (http://www.ama-assn.org/ resources/doc/washington/hipaa-omnibus-final-rule-summary.pdf). It is also important for physicians to know any relevant state privacy laws in the state where they reside, as state laws that have more stringent privacy and security requirements might preempt HIPAA (Hyler and Gangure 2004; Genomics Law Report 2011). In addition, there are a several guidelines and other TMH resources specific to HIPAA compliance, appropriate technology to use, and methods to safeguard data security and patient privacy (Yellowlees at al. 2010; Luxton et al. 2012a; Kramer et al., 2012; Turvey et al. 2013). Ultimately, in addition to privacy and data security concerns, TMH clinicians should use technology that allows them to feel comfortable enough in interacting with the patient to make accurate clinical decisions. Additional Considerations: Children and Adolescents in Nontraditional Settings TMH provides the opportunity to reach out to children and adolescents in a variety of settings, including nontraditional clinic settings, like a home, foster home, group home, or residential care facility. Some of these settings may not have clinical staff available on site or may not have staff who are available full time, therefore raising additional considerations for providing care in these environments. Recommendations for safe provision of in-home care exist (Gros et al. 2011; Shore 2011; Luxton et al. 2012b; Turvey et al. 2013) and data provide initial indication that TMH care can safely occur in environments such as a home (Luxton et al. 2010). At least one federal agency – the VA – already has established inhome TMH programs. When providing care to a child or adolescent who may reside in a clinically unsupervised setting, such as a foster or group home, it is essential to have contact information of someone (a foster parent, guardian, group home staff) who can assist in an emergency, and who may have to initiate a 9-1-1 call from the child or adolescent’s home residence, and/or assist with transporting the child or adolescent in a medical or clinical emergency. These care collaborators can also provide technical assistance in the case of equipment malfunction, particularly in the case of children who are too young to understand how to independently resolve the technical issue. It is preferable to include those with appropriate legal interest in the child or adolescent (e.g., foster parent, case worker, court staff, 202 group home staff) in safety planning. In particular, this person could help assess and maintain a safe physical environment for the child or adolescent receiving home-based care. This might include assessing or restricting access to weapons or otherwise ensuring that the physical environment is safe (e.g., open windows or other hazards), private (e.g., reducing distractions that could occur from other children in the home intervening in the treatment), and otherwise conducive to treatment. Assessing for risk is also important when treating children from a distance who may become easily distracted by a TMH session or by other factors at their local site, such as other children in the home. An initial assessment of the technology available in the home is recommended to ensure that the patient’s equipment (personal computer, videocamera) are reliable and adequate to establish and maintain a private and secure connection (Luxton et al. 2012b). Of course, the legal rights of the child and adolescent are paramount, and may vary depending on circumstance (e.g., age, foster status); therefore, it is important to ensure that whoever has a legal right to be included in treatment with or without consent in an in-person environment is also afforded the same right in a TMH environment. Conclusions TMH options will continue to expand the opportunities to provide children, adolescents, and their families with quality care. TMH legal and regulatory issues persist, although solutions are emerging. Knowledge of the key issues can help any clinician considering or using TMH make informed decisions and engage in ‘‘best practice.’’ TMH practice consistent with published guidelines and risk management strategies mentioned in this article can increase comfort level and mitigate risk. Disclosures No competing financial interests exist. References 21 Code of Federal Regulations (CFR) Parts 1300, 1301, 1304, 1306. 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Kramer, JD, PhD National Center for Telehealth and Technology (T2) 9933 West Hayes Street Joint Base Lewis-McChord, WA 98431 E-mail: gregory.m.kramer7.civ@mail.mil Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.