The Role of Telemedicine in Meeting the Behavioral Health Needs of Oklahomans and Attendant Legal Issues
By Mary Holloway Richard and Mary R. Daniel
For decades, regulators and providers in the health care industry have actively sought to improve the health of the nation and to stretch both governmental and private health care dollars. Efforts to shift from inpatient-based care to an ambulatory model have been largely successful. Cost containment initiatives have gained significant momentum and have included, in addition to budgets cuts at state and federal levels, reimbursement controls by nongovernmental third-party payers and other incentives to ration services and products.1 There are also focused efforts to solve the troublesome issue of inequitable distribution of health care resources in Oklahoma and elsewhere in the nation by relying on prevention, physician extenders, practice models and increasingly advanced technology.2
TELEMEDICINE THEN AND NOW
One of the important ways in which the industry has responded to all of these concerns is through a marriage of the healing sciences and technology. “Telemedicine” has been de-fined as “…the 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.”3 The concept of telemedicine has been in existence for decades, but no commonly accepted definition exists, and efforts to describe or set the boundaries for the modality have created some confusion.4 The concept continues to spawn progeny such as teleradiology, telestroke, telehepatology, telerehabilitation, telenursing, teleaudiology, teledentistry, telehomecare, and, importantly for the purposes of this article, telemedicine for behavioral health. In some of these specialized practices in which electronic access is an integral part, the providers (in-state or out-of-state) contract to provide limited services such as study interpretations and monitoring. Behavioral health services include mental health evaluations, consultations between providers and therapeutic treatment.5 Whether the type of health services delivered remotely are largely interpretative or are direct patient care, providers are regulated by state professional boards. The processes of electronically transmitting behavioral health information from one site to another, and of examining, treating and communicating electronically with behavioral health patients raise numerous legal issues, including state regulation of providers, the nature of the physician-patient relationship, confidentiality, standard of care, provider credentialing, reimbursement, detention and involuntary commitment. This article focuses largely on recent developments in provider regulation and will provide a brief overview of several other legal issues in telemedicine behavioral health.6
TELEMEDICINE BEHAVIORAL HEALTH
All mental health procedures and services that can be delivered face-to-face can be delivered remotely through telemedicine.7 In fact, behavioral health has relied upon variations of remote servicing for a century through written consultations between psychiatrists about perplexing patients and family letters detailing patients’ histories for use in long-term treatment. Live videoconferencing was developed in the NASA-era of the 1960s followed by extensions of that medium in the next two decades, courtesy of federal grant monies. It was in the 1990s, when computer technology exploded and the cost of equipment fell, that email, websites, in-home monitoring technology and electronic records became realistic options for providers.8 The proliferation of behavioral health providers to include psychiatrists, licensed counselors, social workers and others has created additional opportunities to put such technology to use.
The regulatory governance of telemedicine of all types is spread out over several agencies — The Oklahoma State Board of Medical Licensure and Supervision (OSBMLS), the Oklahoma State Board of Osteopathic Examiners (OSBOE), and the Oklahoma Health Care Authority (OHCA). Oklahoma law does not prohibit the practice of telemedicine. In fact, the OSBMLS and the OSBOE recently have proposed new standards for telemedicine practice for medical doctors and osteopathic doctors, respectively. Oklahoma, unlike some states, has not chosen to offer a limited telemedicine license for doctors or other providers. For attorneys representing behavioral health and other providers engaged in such care outside Oklahoma it is important to consult the laws of the involved state. Most states have an exception for physician-to-physician consults across state lines in the interest of education and quality care.9 With regard to state oversight of telemedicine providers, we will focus on providers licensed in Oklahoma practicing remotely within Oklahoma and recent developments in state law.10
CURRENT RULES AND GUIDELINES GOVERNING MEDICAL AND OSTEOPATHIC PHYSICIANS
The OSBMLS rules define a physician-patient relationship as “a relationship established when a physician agrees by direct or indirect contact with a patient to diagnose or treat any condition, illness or disability presented by a patient to that physician, whether or not such a presenting complaint is considered a disease by the general medical community.”11 The use of the word “indirect” has been interpreted to allow a physician to see a patient using the Center for Medicare and Medicaid’s (CMS) interactive telecommunications system but prohibited the continuing use of telemedicine for the entire relationship. The OSBMLS re-quires “a medically appropriate, timely scheduled, actual face-to-face encounter with the patient, subject to any supervisory responsibilities established elsewhere in these rules.”12 While this requires a face-to-face follow-up, it does not mandate face-to-face interaction for the entire relationship.
The OSBOE has issued policy and guidelines addressing the use of telemedicine by osteopathic doctors. The guidelines are exhaustive, and while they are not actually regulations, they are useful to determine OSBOE’s scope of enforcement and philosophy. The OSBOE defines telemedicine as “the practice of medicine using electronic communications, information technology, or other means between a physician in one location and a patient in another location with or without an intervening health care professional. Current regulations authorize use of telemedicine to create and sustain an appropriate physician-patient relationship.”13 When treating patients in Oklahoma, the OSBOE requires Oklahoma licensure irrespective of the osteopath’s location, thereby giving the board authority over the osteopathic physician who practices telemedicine.14 The OSBOE defines “distant site” and “originating site.” The distant site is the “site where the physician providing the patient care is located at the time the service is provided via audio/video telecommunication.”15 The originating site is the “site where the patient receiving patient care is located at the time the service is being performed by a physician via audio/video telecommunications.”16 The OSBOE re-quires that a “licensed or certified health care professional (a ‘presenter’) must always be present at the originating site when direct patient care is involved in video conferencing/consultation.”17 It is important to note that this model of telemedicine contemplates the use of telemedicine between health care facilities. Other models of telemedicine are in use, such as where the physician interacts directly with the patient without a presenter.18 That direct interaction between the distant site physician and the originating site patient is currently being considered in Oklahoma.
PROPOSED RULES FOR MEDICAL DOCTORS
The OSBMLS, under its statutory authority, promulgated new telemedicine regulations on Jan. 16, 2014,19 making a discussion of those changes timely. The manner in which regulations are approved has changed significantly in Oklahoma because of amendments to the Oklahoma Administrative Procedures Act.20 After an agency approves regulations, the agency must send copies of the regulations to the Oklahoma Legislature (House and Senate) and the governor.21 The legislature may approve or reject any of these regulations.22 If the legislature approves the regulations promulgated by an agency, the governor must also approve the regulations.23 The legislature, both the house and the senate, approved the new OSBMLS rules (although the rules were not presented in a joint omnibus resolution), and the Governor approved the rules (along with a plethora of other agency rules) through an official declaration on June 19, 2014.24 The new rules are effective as of Sept. 12, 2014.25
The OSBMLS defines telemedicine as “the practice of health care delivery, diagnosis, consultation, treatment, including but not limited to, the treatment and prevention of conditions appropriate to treatment by telemedicine management, transfer of medical data, or exchange of medical education information by means of audio, video or data communications.”26 Like CMS, the OSBMLS does not consider the use of phones and fax machines as a “consultation,” but goes further to exclude “phone or Internet contact or prescribing and other forms of communication, such as web-based video” that do not meet the requirements of a new regulatory section on telemedicine.27 If a physician meets the requirements of this new telemedicine section, the physician does not need to have a face-to-face encounter with the patient thereby significantly facilitating the practice of telemedicine.28 The OSBMLS defines the originating site as “the location of the patient at the time the service being furnished via a telecommunications system oc-curs.”29 The distant site is defined as “the location of medical doctor providing care via telecommunications systems”30 While the OSBMLS did not change the definition of physician/patient relationship, it essentially expanded that notion by adding a reference to its new telemedicine regulations.
Oklahoma licensure is a requirement under the new Telemedicine regulations, and the OSBMLS sets forth additional requirements31 for telemedicine encounters, effectively eliminating the face-to-face requirement:
the distant site physician to perform an exam of a patient at a separate, remote originating site location. In order to accomplish this, and if the distant site physician deems it to be medically necessary, a licensed healthcare provider trained in the use of the equipment may be utilized at the originating site to “present” the patient, manage the cameras, and perform any physical activities to successfully complete the exam. A medical record must be kept and be accessible at both the distant and originating sites, preferably a shared Electronic Medical Record, that is full and complete and meets the standards as a valid medical record. There should be provisions for appropriate follow up care equivalent to that available to face-to-face patients. The information available to the distant site physician for the medical problem to be addressed must be equivalent in scope and quality to what would be obtained with an original or follow-up face-to-face encounter and must meet all applicable standards of care for that medical problem including the documentation of a history, a physical exam, the ordering of any diagnostic tests, making a diagnosis and initiating a treatment plan with appropriate discussion and informed consent.32
The OSBMLS also sets forth some technical requirements in compliance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996.33 The technology “must be sufficient to provide the same information to the provider as if the exam has been performed face-to-face” and the “audio and video equipment must permit interactive, real-time communications.”34
This new section not only contemplates the use of telemedicine between health care facilities, it also authorizes the use of telemedicine directly between a physician and patient. The distant site physician, in his or her medical judgment, can decide whether or not a presenter is required. With this model, the physician can decide whether or not a presenter is required, and, as long as the physician and patient use a HIPAA-compliant technology with interactive and real-time communication, the patient and physician can be located anywhere in Oklahoma. The patient could literally be at home, and the physician could be at his or her office, his or her home, or any number of secure locations. With the involvement of multiple sites, the physician still has to maintain a medical record accessible at both sites. If the patient is at home without a presenter, the physician will need to determine how to make the medical record accessible to the patient. This is distinguishable from facilities using telemedicine as both facilities keep and maintain medical records.
REIMBURSEMENT FOR TELEMEDICINE SERVICES: OKLAHOMA HEALTH CARE AUTHORITY REGULATIONS
The Oklahoma Health Care Authority (OHCA) has also promulgated telemedicine regulations35 under which a physician or practitioner may be reimbursed for telemedicine services that fulfil its requirements. The OHCA limits coverage to “consultations, office visits, individual psychotherapy, psychiatric diagnostic interview and examinations and testing, mental health assessments and pharmacologic management between originating sites located in rural areas connecting with distant sites in areas that are not easily accessible by the member at the distant site.”36 The purpose of the OHCA regulations is “to implement telemedicine policy that improves access to health care services by enabling the provision of medical specialty care in rural areas to meet the needs of members and providers alike, while complying with all applicable federal and state statutes and regulations.”37 The OHCA explicitly recognizes the need for specialized health care in rural Oklahoma.
TELEMEDICINE BEHAVIORAL HEALTH: GUIDANCE FOR PROVIDERS
Almost nowhere are services more needed, are providers more in demand, than in the areas of psychiatry, mental illness, and substance and alcohol abuse.38 And telemedicine behavioral health services, ranging from patient management, consultations with primary care physicians and subspecialty care, raise a variety of legal issues for the attorney representing distant and originating sites and practitioners practicing remotely including standard of care, informed consent, confidentiality and licensure. The established attributes of the physician-patient relationship apply even where the relationship is established and/or predominantly maintained remotely. For negligence claims arising from that relationship, Oklahoma law adopted the national standard of care39 and thus avoids issues presented historically by a perceived gap in practice standards between urban and rural areas and those arising from the nature of a relationship crafted, at least in important part, remotely. In a negligence action against a provider applying Oklahoma law, the provider’s practice location or physical location has little or no bearing upon the standard against which the provider’s performance is measured.
Obtaining robust informed consent40 at a distance places additional responsibilities upon the practitioner and, at a minimum, includes mention of the type of technology being used, the interactive nature of the modality, and the panoply of risks, benefits and options available to the patient for the particular diagnosis in the particular setting. For example, if psychotherapy services were to be delivered remotely, the patient at the originating site may expect to receive at a minimum information about the security of the room at the distant site (e.g., the identity of everyone present or the assurance that no one else is present, that the room is secure so that the conversation will not be overheard by others). The requisite elements of informed consent in this context — information delivered by a provider with an innate understanding of the care to be provided — are unchanged so that the explanation of treatment, alternatives, risks and benefits and the opportunity to ask questions occurs remotely, just as it has always been required in face-to-face encounters.
Privacy issues also present risks to the behavioral health provider interacting or providing services by telemedicine. Federal privacy protection regulations require procedural, administrative and technical safeguards, and so may require that attention be given to both the technical and physical space in establishing a secure environment — camera position and angle, lighting, audio, security of the transmission itself.41 It is also prudent under the federal regulations to establish a protocol for secure maintenance of the videoconferencing equipment when not in session and for storage of the electronic data.42
Attorneys for telemedicine behavioral health providers should be aware of requirements by accrediting bodies, regulators, third-party payers and other contracting entities to require quality and outcome metrics and data. Although in its nascent stages, evaluation of telemedicine behavioral health will likely require identifying activities for monitoring the facility, manpower, technical supports, interaction between patient and provider and impact of services.43 Provider-institution service agreements increasingly tie payment to outcome and performance standards as payers tie those metrics to reimbursement.44
CMS has approved reimbursement for telemedicine behavioral health services including a diagnostic interview, individual psychotherapy, pharmacological management, neurobehavioral status examinations and consultations.45 Some insurers have followed suit and reimburse according to the same Medicare billing codes associated with these services. Reimbursement, as always, is tied to specific documentation requirements.
The telemedicine encounter must also have the same scope and quality as a face-to-face encounter, and all standards of care must be met. What this means for the physician is that the physician can make the determination that, depending on the condition, a face-to-face encounter may be required. While face-to-face encounters may be important in certain specialties or to diagnose certain conditions, behavioral health seems to be an extraordinarily good fit for telemedicine. The OSBMLS provided significant support to telemedicine behavioral health in its “Telemedicine Policy (Mental Health)” by setting the parameters to include consultations, psychotherapy, psychiatric diagnostic interview examinations and testing, discharge planning and pharmacologic management.46 If these regulations are ap-proved, psychiatrists who are in short supply could be utilized in all of Oklahoma regardless of their location.
The benefits of telemedicine behavioral health include taking limited resources to rural areas, decreasing hospitalization, decreasing emergency department visits, improving compliance with therapies including psychotropic drugs. Out of the 77 counties in Oklahoma, 69, or nearly 90 percent are designated as a health professional shortage area for mental health by the Health Resource Services Administration. The professional boards and state government are making strides to protect consumers and give guidance to providers in the face of rapidly developing technology and consumer need and expectations.
1. Last accessed 9/12/14. “Mark Stanton prepared this 2002 study titled “Reducing Costs in the Health Care System: Learning From What has Been” for the federal Agency for Healthcare Research and Quality.
2. See http://247wallst.com/special-report/2012/10/19/states-with-the-fewest-and-most-doctors/2/ (Last accessed 4/21/14). According to the report by the American Association of Medical Colleges in 2011, Oklahoma was 8th out of the 10 states with the fewest doctors. The AAMC reported that the percentage of citizens without health insurance was 7th highest and the life expectancy was the 5th lowest, although the state was 23rd high in medical students per 100,000. The reports continues to describe Oklahoma as having “…one of the least healthy populations in the country. More than two-thirds of the residents are overweight or obese…. Also, the state had the third-largest percentage of residents who smoke. As of 2010, there were just 20.8 doctors in a residency program in the state per 100,000 people, compared to the national rate of 35.8 per 100,000. A New England Journal of Medicine article last year identified the state as having the least accessible health care. Tulsa World also notes that state medical universities have not increased their enrollment size yet, which could help increase the number of medical students who might eventually become practicing doctors in the state.”
3. http://goo.gl/ZQvYEl (Last accessed 9/16/14); http://goo.gl/Ry87bh (Last accessed 9/16/14). See also, http://goo.gl/U8Eh8m (Last accessed 9/12/14).
4. While the Centers for Medicare and Medicaid (CMS) characterize telemedicine by the use of interactive audio and video equipment excluding phones, faxes and emails, it has not defined the term. Rather, it defines an alternate term, interactive telecommunications system, as “multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.” http://goo.gl/3gS1Sm (Last accessed 9/12/14).
5. http://goo.gl/rETQGW (Last accessed 9/16/14) discussing remote provision of such services as medication management, involuntary commitment proceedings and patient-focused provider training in the future.
6. Although “telepsychiatry” is a well-accepted term, rather than limit this article conceptually to the practice of psychiatry at a time when all types of counselors are in short supply in Oklahoma, the authors have opted to use the term “Telemedicine-Behavioral Health.” “Behavioral Health” is the moniker selected by the American Health Lawyers Association in its pursuit of the legal issues arising from provision of these services.
7. The primary tools of behavioral health therapy and counseling are observation and discourse which are well adapted to this kind of technology in contrast to other medical practices requiring a physical examination of the patient.
8. See “Telepsychiatry: Overcoming Barriers to Implementation” 11 Current Psychiatry, No. 121 (Dec. 2012) Saeed, A., Block, R. and Diamond, J. See generally Telepsychiatry and eMental Health ed. Wootton, R., Yellowlees, P. and McLaren, P., Hodder Education Publishers (London) (2007).
9. 59 O.S. §492(D)(8) (excluding out of state consultants from the “practice of medicine.”) Most states have an exception for physician to physician consultation in the interest of education and quality care which is the most limited version of telemedicine. See http://www.fsmb.org/pdf/grpol_telemedicine_licensure.pdf (analysis of state laws on this subject by Federation of State Medical Boards).
10. The concept of “remoteness” may not be a matter of a significant number of miles, traveling to another city, state or region, but, rather a matter of making immediate access to services possible.
11. OAC 435:10-1-4 (emphasis added). See also 435:10-7-12 (establishing the physician-patient relationship.)
12. Id. (emphasis added).
13. http://goo.gl/cXnx0E (Last accessed 9/16/14).
14. Id. The OSBMLS effectively makes the same requirement without an explicit regulation.
18. In addition, physicians are currently engaged remotely in consultation with and providing education to other physicians regarding individual patients and case studies.
19. http://goo.gl/x9ZwXJ (Last accessed 9/16/14).
20. 75 O.S. §§250 – 323.
21. 75 O.S. §303.1(A).
22. 75 O.S. §308(B).
23. 75 O.S. §308(E)(2).
24. “Governor approves permanent rules,” Oklahoma Hospital Association, http://www.okoha.com/OHA/Hotline/2014/June_ 2014/Governor_approves_permanent_rules.aspx (Last accessed 9/22/14).
25. Proposed Rules, Oklahoma Medical Board, http://www.okmedicalboard.org/download/724/Telemedicine_Rules-Final_1014.pdf (Last accessed 9/22/14).
26. Proposed OAC 435:10-1-4, http://www.okmedicalboard.org/download/724/Telemedicine_Rules-Final_1014.pdf (Last accessed 4/21/14).
31. Proposed OAC 435:10-7-13(a), http://goo.gl/x9ZwXJ (Last accessed 9/16/14).
32. Proposed OAC 435:10-7-13(b)(1), http://goo.gl/x9ZwXJ (Last accessed 9/16/14).
33. 42 U.S.C.A. §§17901-17903; 45 C.F.R. §160; 45 C.F.R. §164.
34. Proposed OAC 435:10-7-13(b)(2-3), http://goo.gl/x9ZwXJ (Last accessed 9/16/14).
35. Proposed OAC 435:10-7-13(b)(2)-(3), http://goo.gl/x9ZwXJ (Last accessed 9/16/14).
36. OAC 317:30-3-27.
37. http://hokhca.org/providers.aspx?id=10014 (Last accessed 4/21/14).
38. OAC 317:30-3-27(a).
39. 76 O.S. §20.1.
40. See Scott v. Bradford, 606 P.2d 554, 556-7 (Okl. 1979).
41. Supra n. 31, 42 U.S.C.A. §1320 et seq.
43. Sources for methodologies and metrics for evaluating telemedicine-behavioral health are abundant and continuing to develop: http://goo.gl/F0xpA8 (Last accessed 9/12/14); http://goo.gl/BQdf1l (Last access 9/12/14).
44. See Joint Commission “Telemedicine Requirements-Hospital Accreditation Program Standard LD.04.03.09” http://goo.gl/B6nLqY (Last accessed 9/16/14).
45. http://goo.gl/mbkcWJ (Last accessed 9/16/14); http://goo.gl/0rDskT (Last accessed 9/16/14).
46. http://goo.gl/JQnjcE (Last accessed 9/16/14).
ABOUT THE AUTHORS
Mary Holloway Richard is an attorney with Phillips Murrah in Oklahoma City. Previously, she was legal counsel at INTEGRIS Health Inc. in Oklahoma City. She received her J.D. from the George Washington School of Law in 1980.
Mary R. Daniel is legal counsel at INTEGRIS Health Inc. in Oklahoma City. Ms. Daniel represents three hospitals, and ad-dresses issues in telemedicine and home health. She also serves as a special judge for the Prairie Band Potawatomi Nation in Mayetta, Kan. Ms. Daniel graduated from Dartmouth College and OCU School of Law. She is a member of the Ruth Bader Ginsburg Inn of Court, and is a full-fledged soccer mom.
Originally published in the Oklahoma Bar Journal - Oct. 4, 2014 - Vol. 85, No.26