Developments in Telemedicine & Telehealth. Thomas H. Hawk, III 1

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1 Developments in Telemedicine & Telehealth Thomas H. Hawk, III 1 An 1879 article in the medical journal The Lancet discussed using the telephone to reduce unnecessary office visits. 2 The British medical journal noted that: The Yankees are rapidly finding out the benefits of the telephone The journal goes on to describe a situation where a new mother, worried that her baby daughter has the croup, phones the family doctor in the middle of the night. Seeking to avoid having to leave his house in the middle of the night, the doctor commented: Lift the child to the telephone, and let me hear it cough.. Upon hearing the cough, he declares that is not the croup and advised the mother to go back to bed. 3 Thus began the use of developing technologies to deliver health care remotely. Fast forward to today: rapid technological innovation over the past several years has created significant opportunities in medicine and health care to expand the use of the remote treatment of and care delivery to patients by physicians and other providers via telemedicine. Although precise definitions vary, telemedicine generally means the practice of medicine using electronic communications, information technology or other means between a [provider] in one location and a patient in another location with or without an intervening health care provider. 4 More broadly, the related term telehealth generally means the remote delivery of a broader set of health care services using information technology, including remote patient monitoring, prescription writing and patient education. 5 For example, one state Medicaid program defines telehealth as the use of telecommunication technologies for clinical care (telemedicine), patient teachings and home health, health professional education (distance learning), administrative and program planning, and other diverse aspects of a health care delivery system. 6 What began several decades ago primarily as a way to expand access to rural and other underserved areas, has developed into growing platform for health care providers to diagnose, treat and, increasingly, monitor patients in all areas of the country. Telemedicine also has the potential to assist providers in the treatment of patients with highly contagious infectious 1 The author would like to gratefully acknowledge the contributions of Kerrie Howze, Ramsey Prather, Isabella Edmundson and Linda Lin to the drafting of this article Notes, Short Comments, and Answers to Correspondents, The Lancet, vol. 114, no. 2935, Nov. 29, 1879, at See Fed n of State Med. Bd s Model Policy for the Appropriate use of Telemedicine Technologies in the Practice of Medicine ( Model Policy ), 3, at 4 (Apr. 2014), 5 For definitions of telemedicine and telehealth, see Am. Telemedicine Assn. What is Telemedicine?, (last visited Jan. 6, 2015). 6 Ga. Dep t of Cmty. Health, Georgia Medicaid Telemedicine Handbook (Oct. 2014), at 2, available at (last visited Jan. 9, 2015). DMSLIBRARY01:

2 diseases such as Ebola and to also deliver care to remote areas of the world with virtually no access to physicians and nurses. Telemedicine technologies may also provide remote school systems with a virtual school nurse and prison systems with better access to care. And, moreover, with the advent of increasingly sophisticated smartphones, some experts are predicting that telemedicine and telehealth are on the verge of causing disruptive innovation in how Americans use and receive health care, particularly in the treatment and monitoring of patients with chronic conditions. Though technology may be on the precipice of disruptive innovation, it is an understatement to say that the law is in a similar posture. Although it is changing, the laws and both private and public health payers typically assume (and therefore favor) face-to-face patient treatment by health care providers. This paper examines recent developments in laws regulating the remote diagnosis and treatment of patients by discussing the Federation of State Medical Boards Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine, as well as the telemedicine rules and regulations in the following cross section of states: California, Florida, Georgia, New York and Texas. With respect to the state summaries, this paper provides a discussion of (i) licensure requirements, (ii) special requirements for the establishment/maintenance of a physician patient relationship in the telemedicine context, (iii) restrictions on services provided via telemedicine (including particularly prescriptions), and (iv) Medicaid reimbursement and any state laws mandating private payer reimbursement of certain telemedicine services (sometimes called parity laws). It also discusses briefly developments in Medicare reimbursement for the remote treatment and monitoring of patients. A. FSMB s Model Policy In April 2014, the Federation of State Medical Boards ( FSMB ) released its Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (the Model Policy ). The Model Policy provides guidance that state boards of medicine can use in whole or in part in drafting their own rules and/or regulations regarding the use of telemedicine in health care delivery. Although the Model Policy is advisory and state boards are free to use, modify or disregard it entirely, it represents the collective effort of the representatives of the nation s state medical licensing boards. Given that, its provisions are illustrative of how policy makers believe rules and regulations in this area will develop in the coming years. The Model Policy contains several key premises that could serve as building blocks as states (or the federal government) further develop telemedicine and telehealth policy. 1. Standard of Care / Scope of Practice Parity The Model Policy calls for a consistent standard of care and scope of practice notwithstanding the delivery tool or business method in enabling Physician-to-Patient communications. 7 There should be parity of ethical and professional standards applied to all aspects of a physician s practice. 8 In other words, physicians and extenders utilizing 7 8 Model Policy 1, at 3. 5, at 8. 2

3 telemedicine or telehealth for patient treatment must meet the same standard of care no more and no less as if the patient was treated in a face-to-face interaction. Of course, because of the different care delivery modalities, different or additional steps may be needed to ensure physicians have all appropriate information to make clinical decisions. Some of the different steps are discussed in more detail in the Model Policy. Further, the reference to scope of practice makes it clear that whatever existing rules the state may have in place regarding the use, supervision and treatment authority of extenders such as nurse practitioners, physician assistants or others apply equally in the telemedicine and telehealth care delivery context. Finally, note also the Model Policy s inclusion of the reference to both professional standards and ethical standards in its reference to parity. The ethical rules regarding appropriate physician remunerative relationships apply equally in the telemedicine context (as do the federal fraud and abuse rules). The Model Policy notes A physician s professional discretion as to the diagnosis, scope of care, or treatment should not be limited or influenced by non-clinical considerations of telemedicine technologies, and physician remuneration or treatment recommendations should not be materially based on the delivery of patient desired outcomes (i.e., a prescription or referral) or the utilization of telemedicine technologies. Therefore, for example under the Model Policy it would not be appropriate for a physician associated with an online pharmacy and writing prescriptions to be filled by the online pharmacy to be paid on a per prescription basis Licensure Requirement The Model Policy would require that a physician be licensed by or under the jurisdiction of the medical board where the patient is located. 10 This is largely consistent with how most states currently approach licensure for out-of-state physicians providing care to in-state patients. The language in the Model Policy is flexible enough to permit both of the most common approaches to telemedicine licensing today: (i) a full licensure requirement, which is the approach taken by the majority of states, and (ii) a special license or permit which may enable an out-of-state physician to provide care to an in-state patient via telemedicine, subject to certain restrictions. Interestingly, in the licensure section of the Model Policy and in several other places discussed herein, the drafters plainly state that treatment and prescriptions provided via online service sites (and, presumably, also through smartphone applications ) constitute the practice of medicine and require licensure in the state of the patient. This could be the drafters intent to signal to the online pharmacies and other websites purporting to provide medical and health advice that some of the services provided through those sites fall over the line and constitute the practice of medicine, which could be an important demarcation as additional health related modalities and monitoring abilities are developed on smartphones and similar devices There may be other legal issues with this structure as well. Model Policy 4, at 5. 3

4 3. Physician-Patient Relationship Requirements The drafters put great emphasis on the centrality of the physician-patient relationship to the delivery of health care. The physician-patient relationship is fundamental to the provision of acceptable medical care. 11 Physicians utilizing telemedicine must take appropriate steps to establish a physician-patient relationship, if a relationship does not pre-date the telemedicine encounter. This includes a documented medical evaluation and review of clinical history as required by the presentation of the patient to establish appropriate diagnoses and identify conditions and contra-indications for the proposed treatment. 12 The Model Policy does not indicate that a face to face interaction is required to establish a physician-patient relationship. Here again, the drafters make a point to state that [t]reatment, including issuing a prescription solely based on an online questionnaire, does not constitute an acceptable standard of care. 13 This seems to indicate that online pharmacies selling various types of prescriptions virtually on demand by web users are not acting consistently with what the Model Policy considers to be an appropriate standard of care. 4. Informed Consent The area of patient informed consent for treatment via telemedicine contains several different and additional requirements than those applicable to informed consent in a face-to-face encounter. In addition to information normally required to be disclosed in the context of obtaining a patient s informed consent, patients treated via telemedicine must be provided information about the technology, its limitations and any limitations about the care provided. In particular: Identification of the patient, the physician and the physician s credentials. This means that a physician cannot remain anonymous (e.g. in an online pharmacy) and his or her name and background must be provided to the patient. Types of transmissions permitted using the technologies in use (e.g. prescription refills, appointment scheduling, patient education, monitoring, etc.) The patient agrees that the physician determines whether or not the condition being diagnosed and/or treated is appropriate for a telemedicine encounter. The patient must be provided details on computer and other technical security measures , at 4. 4, at 5. 4

5 The patient may be requested to provide a hold harmless for information lost due to technical failures. A requirement for express patient consent to forward patient identifiable information to a third party. This last requirement is very broadly worded. It is not clear if the drafters meant to include within the scope such routine data transmissions as bill submission (which occur in the face-to-face context too). 5. Follow Up Requirements / Continuity of Care The Model Policy requires that patients being treated via telemedicine be able to seek with relative ease follow-up care or information from the physician who conducted the patient visit. Physicians providing care solely through telemedicine must make documentation of the encounters readily available to the patient using technology easily available to the patient. 14 As discussed below, although the Model Policy does not require this, some jurisdictions include a requirement or suggestion for a follow-up or periodic face-to-face visit for physician-patient relationships conducted primarily via telemedicine modalities Referrals for Emergency Services The Model Policy requires that physicians providing services via telemedicine have an emergency plan that must be provided to the patient when the care being provided via telemedicine indicates that a referral to an acute care facility or ER is or may be necessary for the safety of the patient. Practically, this provision likely will require only physicians in certain specialties, such as psychiatry, to provide a written plan to patients, though it likely would be prudent for all physicians providing services to have developed a written emergency plan Records Requirements; Security Medical records and patient encounter documentation are important points of emphasis in the Model Policy. Medical records requirements applicable to the face-to-face physician-patient relationship context apply equally to the telemedicine context. In addition, the medical records for telemedicine visits should reflect the additional informed consent requirements to the extent applicable. Of course, the federal privacy rules will apply to all patient records (as will applicable state medical record and privacy rules), 17 but in the telemedicine context providers must pay particular attention to compliance with the HIPAA Security Rule standards as well. 18 All transmissions of patient data (e.g., prescription data, laboratory results) during the telemedicine encounter and thereafter must be secure within existing technology, which the , at 6. See, e.g., GA COMP. R. & Regs (a)(8). Model Policy 4, at C.F.R. Part 160,164 (2014). 45 C.F.R. Part 160, 162, 164 (2003). See also 68 Fed. Reg (Feb. 20, 2003). 5

6 Model Policy defines as password protected, encrypted electronic prescriptions, or other reliable authentication techniques. 19 Although this is fairly well known among telemedicine providers, it should be noted that many common technologies allowing simultaneous visual and audio communication (e.g. Skype or Facetime) are not secure modalities. Also, many common services are not secure. Therefore, patient data should not be transmitted using such technologies unless additional steps are taken to make sure the data is secure. 8. Web Based Services As noted previously, the drafters of the Model Policy took note of several common commercial practices available over the internet and sought to delineate what they viewed as acceptable practices consistent with the appropriate standard of care. The Model Policy includes more detailed guidance and requirements for online sites providing medical services than any state rules or regulations to date. The Model Policy requires that online services used by physicians must disclose: (i) specific services provided, (ii) contact information for the physicians providing professional services, (iii) licensure and qualification of physicians, (iv) fees for services and how payment is made, (v) financial interests, other than fees charged, in any information, products or services provided by a physician, (vi) appropriate uses and limitations of the site, including for emergencies, (vii) uses and response times for electronic communication (e.g. s, texts, etc.), (viii) to whom patient information may be disclosed and for what purpose, (ix) rights of patients with respect to patient health information and (v) information collected and any passive tracking mechanisms utilized. The Model Policy also requires that the sites provide patients a mechanism to register complaints about the physician with the appropriate state medical board, as well as a mechanism to access and amend patient provided health information and provide feedback on the site services and quality. In what seems to be a pretty clearly implied criticism of the practices of certain web-based pharmacies, the drafters of the Model Policy note that [t]he maintenance of preferred relationships with any pharmacy is prohibited. Physicians shall not transmit prescriptions to a specific pharmacy, or recommend a pharmacy, in exchange for any type of consideration or benefit from that pharmacy. 20 Further, the drafters also emphasize that physicians are discouraged from providing professional medical services when either the patient or the physician is unknown to the other party. A physician is discouraged from rendering medical advice and/or care using telemedicine technologies without (1) fully verifying and authenticating the location and, to the extent possible, identifying the requesting patient; (2) disclosing and validating the provider s identity and applicable credential(s); and (3) obtaining appropriate consents from requesting patients. An appropriate physician-patient relationship has not been established when the identity of the physician may be unknown to the patient. Where appropriate, a patient must be Model Policy 4 at 7. Model Policy 4 at 7. 6

7 able to select an identified physician for telemedicine services and not be assigned to a physician at random. 21 These requirements will be important to monitor as new web-based or smartphone applications purport to deliver what constitute professional medical services using telemedicine technologies. The final Model Policy, officially promulgated in April 2014, is relatively recent. However, state medical boards, such as Florida (discussed in more detail below) have used and considered drafts of the Model Policy when promulgating rules and regulations on telemedicine. Further, as other states implement or revise telemedicine regulations, the Model Policy can serve as a guide for regulators. Note that around the same time as the issuance of the Model Policy, the American Medical Association s Council on Medical Service issued its report on the Coverage of and Payment for Telemedicine ( AMA Report ). The AMA Report contains recommendations about the provision of telemedicine services that is largely consistent with the Model Policy. The AMA also contains several additional practice recommendations for physicians providing telemedicine services, such as verifying that professional liability policies cover the provision of telemedicine services, including when physicians provide such services across state lines. 22 B. California 1. Licensure Physicians using telemedicine to provide care to patients located in California must be licensed in California. 23 California provides a licensure exemption for physicians when in actual consultation with a California licensed practitioner. 24 However, this consultation exemption does not permit a physician who is not licensed in California to open an office, appoint a place to meet patients, receive calls from patients located within California, give orders, or have ultimate authority over the care or primary diagnosis of a patient who is located within California Establishing A Physician-Patient Relationship California allows the use of telemedicine to establish the physician-patient relationship. 26 A health care provider who is initiating the use of telemedicine must obtain informed verbal or written consent from the patient prior to the delivery of health care services via telemedicine , at 4 (emphasis added). 22 American Medical Association Council on Medical Service, Coverage of and Payment for Telemedicine, CMS Report 7-a-14 (2014). 23 Med. Bd. of Cal., Practicing Medicine Through Telehealth Technology, (last visited Jan. 6, 2015) See CAL. BUS. & PROF. CODE See Cal. Health & Safety Code (b)-(c). ( It is the intent of the Legislature to recognize the practice of telehealth as a legitimate means by which an individual may receive health care services from a health 7

8 3. Internet Prescribing California prohibits prescribing, dispensing, or furnishing dangerous drugs or devices (as defined in California Business & Professions Code 4022) without an appropriate prior examination. 28 There is, however, no express requirement that the appropriate examination take place in person Private Payer Reimbursement California has a telemedicine parity law that requires comparable coverage and reimbursement for telemedicine-provided and in-person health care services, subject to the terms and conditions of the contract between the enrollee/subscriber and the health care service plan, and between the plan and its participating providers Medi-Cal Reimbursement California s Medicaid program (Medi-Cal) covers health care services provided via real time interactive communication, as well as ophthalmology and dermatology services provided via asynchronous store and forward technology. 31 Medi-Cal does not reimburse for telephone calls, electronic mail messages or facsimile transmissions. 32 Medi-Cal does not specify a patient setting or patient location as a condition of payment for services provided via telemedicine. 33 Additionally, the health care provider is not required to document a barrier to an in-person visit. 34 Medi-Cal requires, however: For real time interactive communications: 35 care provider without in-person contact with the health care provider. [] No health care service plan shall require that in-person contact occur between a health care provider and a patient before payment is made for the covered services appropriately provided through telehealth ) CAL. BUS. & PROF. CODE (b). 2242(a), (a), 4067(a); see also Med. Bd. of Cal., Internet Prescribing - Information for Physicians, (last visited Jan. 6, 2015) See Internet Prescribing, supra note 28. CAL. HEALTH & SAFETY CODE Cal Dep t of Health Care Servs, MEDI-CAL PROVIDER MANUAL, MEDICINE TELEHEALTH, at 1, 5 (Dec. 2013), available at For a broad overview of the type of services covered by Medi-Cal, see Cal. Dep t of Health Care Servs., Telehealth Frequently Asked Questions, (last visited Jan. 1, 2015). Note that on September 27, 2014, A.B. 1174, Leg. (Cal. 2014), was signed into law, providing that, to the extent that federal financial participation is available, face-to-face contact between a health care provider and a patient shall not be required under the Medi-Cal for teledentistry by store and forward MEDICINE: TELEHEALTH, supra note 31, at 1, 6. at 1. 8

9 1. the use of interactive audio, video or data communication; 2. the audio-video telemedicine system used must, at a minimum, have the capability of meeting the procedural definition of the code provided through telemedicine; 3. both the health care provider who has ultimate responsibility for care of the patient and the provider performing services via telemedicine must be licensed in California and enrolled as a Medi-Cal provider; 4. the health care provider at the originating site must obtain informed oral consent from the patient prior to the provision of health care services via telemedicine and document the consent in the patient s medical record; and 5. all medical information transmitted during the delivery of health care via telemedicine must become a part of the patient s medical record. For store and forward technology: images must be specific to the patient s condition and adequate for meeting the procedural definition of the national code that is billed; 2. service must be performed by a physician who has completed training in an Accreditation Council for Graduate Medical Education-approved ophthalmology or dermatology residency; 3. patient must be notified of the right to receive interactive communication with the distant health care practitioner, upon request. If requested, communication may occur either at the time of consultation or within 30 days of the patient s notification of the results of the consultation; and 4. the health care provider who is initiating the use of telemedicine must obtain informed verbal or written consent from the patient prior to the delivery of health care services via store and forward. C. Florida In March 2014, the Florida Boards of Medicine and Osteopathic Medicine enacted new rules setting forth standards for telemedicine practice. The Boards had in place for over a decade rules setting forth the standards for telemedicine prescribing practices, which were enacted to prevent the practice of internet prescribing without the benefit of a face-to-face examination (the Prescribing Practices Rules ); however, these new rules are the first to address broader telemedicine practice in Florida. To develop the new regulations, the Florida Board of Medicine s Surgical Care/Quality Assurance Committee created the Joint Boards of Medicine and Osteopathic Medicine Telemedicine Subcommittee in August of 2013 for the purpose of evaluating the current Prescribing Practices Rules and considering whether revisions to that rule or the adoption of new standards may be necessary to address the broadening scope of telemedicine. In this endeavor, the Subcommittee looked to what requirements had been enacted in other states, as well as at 1 2. at

10 considered resources available from the American Telemedicine Association, Center for Telehealth & E-Health Law ( C-Tel ) and FSMB, among others. 37 Initially, the Subcommittee considered amending the Prescribing Practices Rules, but ultimately the Boards enacted separate rules titled Standards for Telemedicine Practice -- 64B (Board of Medicine) and 64B (Board of Osteopathic Medicine) (the Telemedicine Standards Rules ). Thus, for a time both the Prescribing Practices Rules and broader Telemedicine Standards Rules remained in effect in separate sections, and, thus, for a period of time there were two definitions of telemedicine in the Board rules one for prescribing practices, defined to include prescribing legend drugs to patients through internet, telephone and facsimile modes of communication, and one for broader telemedicine practice, defined to include the practice of medicine by a licensed Florida physician where patient care, treatment or services are provided through the use of medical information exchanged from one site to another via electronic communications, but excluding the provision of health care services only through an audio only telephone, messages, text messages, facsimile transmission, U.S. Mail or other parcel service, or any combination thereof. 38 The Boards eventually repealed the Prescribing Practices Rules and merged certain language (not including the more narrow definition of telemedicine) from the Prescribing Practices Rules into the Telemedicine Standards Rules, which caused some confusion regarding the use of telemedicine to establish the physician-patient relationship, as discussed more fully below. 1. Licensure and Standard of Care. Any physician wishing to practice telemedicine must be licensed in Florida pursuant to the definition of telemedicine as the practice of medicine by a licensed Florida physician or physician assistant where patient care, treatment, or services are provided through the use of medical information exchanged from one site to another via electronic communications. 39 This full licensure requirement is consistent with the Board s historical position on the issue that physicians who perform a professional service that contributes to the diagnosis and treatment of a Florida patient must be licensed by the Board to practice in Florida The materials for these Subcommittee meetings is available on the Florida Board of Medicine s website at (last visited Jan. 9, 2015). 38 FLA. ADMIN. CODE r. 64B (1); FLA. ADMIN. CODE r. 64B (1). The Florida legislature considered several pieces of telemedicine legislation in 2014, one of which was the Florida Telemedicine Act, S.B See S.B. 1646, 2014 Legislative Session, available at (last visited Jan ). The Act died on the last day of the session in May 2014, but would have added new sections under the health professions and occupations chapter (chapter 456) title XXXII (regulation of professions and occupations) of the Florida Statutes. With respect to licensure, the Act generally would have required Florida licensure for out-of-state physicians providing services to Florida patients via telemedicine, but would have exempted an out-of-state physician from the full licensure requirement if, among other things, the out-of-state physician held an unrestricted active license to practice allopathic or osteopathic medicine in the state of the distant site whose licensure requirements met or exceeded the requirements for Florida licensure See FLA. STAT. ANN (defining practice of medicine as the diagnosis, treatment, operation or prescription for any human disease, pain, injury, deformity, or other physical or mental condition and defining physician as a person who is licensed to practice medicine in this state ); see also FLA. STAT. ANN (unlicensed practice of a profession). 10

11 The rule expressly provides that the standard of care under Florida law remains the same regardless of whether the Florida licensed physician or physician assistant provides services in person or via telemedicine, and specifies that those Florida licensed physicians and physician assistants choosing to provide services via telemedicine are responsible for the quality of equipment and technology used to do so, and for their safe use. 41 The rule expressly does not prohibit certain consultations, specifically those between physicians or the transmission and review of digital images, pathology specimens, test results, or other medical data by physicians related to the care of Florida patients, or those for patient care in consultation with another physician who has an ongoing treatment relationship with the patient, and who has agreed to supervise the patient s treatment, including the use of any prescribed medications, [or] on-call or cross-coverage situations in which the physician has access to patient records. 42 The former is a new provision included in the March 2014 enactment, which could be construed to permit out-of-state physicians who are not licensed in Florida to provide consultations to Florida licensed physicians, while the latter was merged into the new rule from the Prescribing Practices Rule. The rule also contains exceptions for certain emergency medical services Establishing A Physician-Patient Relationship The Prescribing Practices Rules had been understood to require a face-to-face examination to establish the physician-patient relationship by stating that prescribing medications based solely on an electronic medical questionnaire would constitute the failure to practice medicine with the appropriate standard of care, and specifying that physicians may not provide treatment recommendations, including issuing a prescription, via electronic or other means unless there was a documented patient evaluation that included a history and physical examination to establish the diagnosis for which any legend drug was prescribed. 44 The new Telemedicine Standards Rules, however, expressly permit establishment of a physician-patient relationship via telemedicine. 45 Shortly after enactment, the Boards began considering whether to merge certain language from the Prescribing Practice Rules into the new Telemedicine Standards Rules and to repeal the Prescribing Practices Rules. Ultimately the Boards merged the language regarding unacceptable practice and standards to be met before providing treatment recommendations, as well as a provision specifying that certain consultation, on-call and cross-coverage arrangements would not be prohibited. 46 Merging the language from the Prescribing Practices Rules that had historically been understood to require an in-person examination of the patient into the new Telemedicine Standards Rules created some confusion in light of the language permitting a FLA. ADMIN. CODE r. 64B (2), (3); FLA. ADMIN. CODE r. 64B (2), (3) FLA. ADMIN. CODE r. 64B (9)(a), (d); FLA. ADMIN. CODE r. 64B (9) (a), (d). FLA. ADMIN. CODE r. 64B (9)(b), (c); FLA. ADMIN. CODE r. 64B (9)(b), (c). FLA. ADMIN. CODE r. 64B-9.014(1), (2); FLA. ADMIN. CODE r. 64B (1), (2). FLA. ADMIN. CODE r. 64B (8); FLA. ADMIN. CODE r. 64B (8). FLA. ADMIN. CODE r. 64B (5), (6), (9)(d); FLA. ADMIN. CODE r. 64B (5), (6), (9)(d). 11

12 physician-patient relationship to be established via telemedicine. To date, the Boards have not amended the language to clarify this point, but in response to comments the Board of Medicine s Rules/Legislative Committee has responded that a physical examination may be conducted via telemedicine, provided that the standard of care is met Controlled Substances. Controlled substances may not be prescribed via telemedicine. 48 As originally enacted, the Telemedicine Standards Rules contained blanket statements to that effect without further elaboration. Shortly after enactment, however, the Boards amended the Rules to address confusion among physicians that the Rules prohibited the ordering of controlled substances through the use of telemedicine for their hospitalized patients, stemming from the lack of clear definition of prescribing under Florida law. 49 Thus, as amended, the Rules expressly state that physicians are not precluded from ordering controlled substances through the use of telemedicine for patients hospitalized in a facility licensed under Chapter 395 of the Florida Statutes Private Payer Reimbursement Florida law does not currently require private payers to cover telemedicine services. In 2014, the legislature considered, but ultimately did not pass legislation which would have required certain health benefit plans issued in the state to cover services provided via telemedicine to the same extent such services would be covered if provided in a face to face encounter Medicaid Reimbursement Telemedicine services are available to Florida Medicaid fee-for-service beneficiaries and those enrolled in Managed Medical Assistance (MMA) Program. These services include behavioral health, dental and physician services. Under the Florida Medicaid State Plan, telemedicine is the practice of health care delivery by a practitioner who is located at a site 47 Florida Board of Medicine Rules/Legislative Committee Meeting, Oct. 9, 2014, (last visited Jan ). Note that the meeting minutes suggest that the ability to conduct a physical via telemedicine may be limited by whether the patient is in the presence of another licensed practitioner who conducts the physical examination while the telemedicine physician observes FLA. ADMIN. CODE r. 64B (4). Florida Board of Medicine, Emergency Rule Related to Telemedicine, April 30, 2014, (last visited Jan. 9, 2015); Florida Board of Osteopathic Medicine, (last visited Jan. 9, 2015) Note that this would not include certain behavioral and community mental health settings. See Florida Senate Bill 70 (2014). 12

13 other than the site where the patient is located for the purposes of evaluation, diagnosis, or recommendation of treatment. 52 With respect to physician services, Agency for Health Care Administration s ( AHCA ) Practitioner Services Coverage and Limitations Handbook states that telemedicine is the use of medical information exchanged from one site to another via electronic communications to improve a patient s health. 53 The Handbook defines electronic communications to mean the use of interactive telecommunications equipment that includes, at a minimum, audio and video equipment permitting two-way, real time, interactive communication between the patient, and the physician at the distant site. 54 A physician, advanced registered nurse practitioner ( ARNP ) or physician assistant ( PA ) may initiate a consultation from the spoke site, which is the location of the Medicaid recipient at the time the service occurs, but the spoke site does not receive reimbursement unless the provider at the spoke site performs a separately identifiable service for the recipient on the same day as the telemedicine service. 55 Telephone conversations, video cell phone conversations, messages, facsimile transmission, telecommunication with a recipient at a location other than the spoke and store and forward consultations transmitted after the recipient or physician is no longer available are not reimbursable telemedicine services, and the Medicaid program also does not reimburse for the costs or fees of any of the equipment necessary to provide telemedicine services. 56 Consultation codes through are the only reimbursable codes with the addition of the GT modifier, and telemedicine services are limited to the hospital inpatient, hospital outpatient and physician office settings. 57 Documentation requirements for physician services provided via telemedicine include: (1) a brief explanation of why the services were not provided face-to-face; (2) documentation of the telemedicine service provided, including the results of the assessment; and (3) a signed statement from the recipient indicating their choice to receive services through telemedicine, which may be for a set period of treatment or a one-time visit. 58 D. Georgia 1. Licensure and Establishment of the Physician-Patient Relationship. Georgia requires that any physician providing telemedicine services, whether located within or outside of the state, be fully licensed by the Georgia Composite Medical Board (the 52 Florida Medicaid State Plan, Attachment 3.1-B, page 11, available at (last visited Jan. 9, 2015). 53 Florida Agency for Health Care Administration, Practitioner Services Coverage and Limitations Handbook, April 2014, 2-120, available at (last visited Jan. 9, 2015) Note that the referring practitioner must be present during the consultation. 13

14 Board ). 59 By statute, any person physically located in another state or foreign country who through the use of any means, including electronic, radiographic, or other means of telecommunication, through which medical information or data are transmitted, performs an act that is part of a patient care service located in [Georgia], including but not limited to the initiation of imaging procedures or the preparation of pathological material for examination, and that would affect the diagnosis or treatment of the patient is engaged in the practice of medicine in [Georgia], and, as such, shall be required to have a license to practice medicine in [Georgia] and shall be subject to regulation by the [B]oard. 60 Any such out of state or foreign practitioner shall not have ultimate authority over the care or primary diagnosis of a patient located in Georgia. 61 The statutory licensure requirement does not apply to any physician located in another state or country who (1) provides consultation services at the request of a Georgia licensed physician on an occasional basis; (2) provides consultation services in the case of an emergency without compensation, remuneration or other expectation thereof, or provides consultation services to a medical school located in Georgia and approved by the Board; or (3) acts as an invited guest of any medical school approved by the Board or a state medical society for the sole purpose of engaging in professional education through lectures, clinics or demonstrations, provided that the physician is licensed to practice medicine in the state or foreign country in which he or she is located. 62 In 2014, the Board enacted a new regulation under its disciplinary chapter setting forth the minimum standards of practice while providing treatment or consultation by electronic or other such means. 63 Among other requirements, the regulation specifies that all treatment and/or consultations must be done by Georgia licensed practitioners, and that such practitioners will be held to the same standard of care as licensees employing more traditional in-person medical care. 64 In fact, the rule contains an in-person requirement to establish the physician-patient relationship via telemedicine, in that it requires a Georgia licensed physician or practitioner (i.e., physician assistant ( PA ) or advanced practice registered nurse ( APRN )) to have either personally seen and examined the patient and [be] provid[ing] ongoing intermittent care by electronic or other such means, or be providing medical care by electronic or other such means at the request of a physician, [PA] or [APRN] licensed in Georgia who has personally seen and examined the patient, unless certain exceptions are met. 65 One such exception would permit treatment via telemedicine by a practitioner who has not either personally seen the patient or does not have a referral from another practitioner who 59 O.C.G.A (a); GA. COMP. R. & REGS O.C.G.A (a) (b). 63 GA. COMP. R. & REGS at (a)(1) and (f). Note that the rule is not intended to interfere with care and treatment by telephonic communication in an established physician-patient relationship, call coverage for established physicianpatient relationships or telephone and internet consultations between physicians, NPs, PAs or other health care providers or child protection agencies (b) (a)(3)(a)-(b). 14

15 has personally seen the patient if the telemedicine practitioner is able to examine the patient using technology and peripherals that are equal or superior to an examination done personally by a provider within that provider s standard of care. 66 Practically, this exception could come into play when a practitioner s standard of practice would not typically require a hands on examination, such as in the case of certain psychiatric examinations, though it also specifically recognizes the advancement of technology that could be used by a practitioner remotely to inform his or her clinical decisionmaking just as efficiently if not more so than would be the case during an in-person examination. For example, a telemedicine practitioner could conduct a standard history and physical using devices that would allow the telemedicine practitioner to listen to the patient s heartbeat and visually examine other parts of the body, such as the inside of the patient s mouth or ear. But whether the examination by peripheral devices rises to the level of being equal or superior to an in-person examination likely will require a case-by-case determination depending on the patient and the applicable standard of practice. And, even if the telemedicine practitioner is able to provide equal or superior care via telemedicine, the rule imposes a duty on the telemedicine practitioner to make diligent efforts to have the patient seen and examined in person by a Georgia licensed physician, [PA] or [APRN] at least annually, which suggests a belief by the Board that telemedicine should not necessarily be a permanent treatment option. 67 Notably, the rule expressly states that it does not authorize the prescription of controlled substances for the treatment of pain by electronic or other such means. This provision generally is intended to prevent virtual pain clinics, or the prescribing of pain medications without any sort of physical evaluation. A separate rule under the disciplinary chapter of the Board s regulations sets forth the minimum standards for prescribing controlled substances for the treatment of pain and chronic pain, which, among other things, includes a requirement that a physical examination of the patient have been conducted Patient History. Included among the minimum standards of practice for telemedicine set forth in the Board s rule is a requirement that a history of the patient be available to the physician, PA or APRN providing treatment or consultation via telemedicine. 69 Presumably, this provision is intended to work in conjunction with the provision under the definition of unprofessional conduct, which states that it is unprofessional conduct to provid[e] treatment via electronic or other means unless a history and physical examination has been performed by a Georgia licensee, exclusive of situations involving call coverage for another physician or an attending physician obtaining consultations or recommendations from other physicians. 70 To satisfy this requirement, the telemedicine practitioner likely would be able to request the patient s history from the referring physician in many instances, or may even be able to perform a history and physical himself or herself during the initial telemedicine visit using peripheral devices (a)(3)(d) (a)(8) (a)(2) (6). 15

16 3. Recordkeeping Requirements. Practitioners providing treatment via telemedicine must comply with all applicable requirements under Georgia law relating to the maintenance of patient records and confidentiality of patient information, regardless of where the telemedicine practitioner may be located and regardless of where or how the records of any patient located in Georgia are maintained. 71 By regulation, the telemedicine practitioner must maintain patient records and must document the evaluation and treatment and the identity of the practitioners providing services via telemedicine. If there is a referring practitioner, the telemedicine practitioner must provide the referring practitioner with a copy of the patient s record. 72 Also included in the Board s rule setting forth the minimum standards of telemedicine practice are a number of other requirements intended to protect Georgia patients, such as the requirement that the patient be given the name, credentials and emergency contact information for the Georgia licensed physician, [PA] or [APRN] providing treatment, and be provided with clear, appropriate, accurate instructions on follow-up in the event of needed emergent care related to treatment. 73 Though some criticized these provisions in comments submitted to the Board during the rulemaking process, the Board included these provisions in the rule to ensure that patients understand who is providing their treatment and that they know what to do in the event of an emergent situation following the provision of care via telemedicine. 4. Private Payer Reimbursement In 2005, the Georgia legislature enacted the Georgia Telemedicine Act (the Act ) to mitigate geographic discrimination in the delivery of health care by recognizing the application of and payment for covered medical care provided by means of telemedicine. Thus, the Act requires that every health benefit policy issued, amended or renewed on or after July 1, 2005, shall include payment for services that are covered under such health benefit policy and are appropriately provided through telemedicine in accordance with [O.C.G.A ] and generally accepted health care practices and standards prevailing in the applicable professional community at the time the services were provided. In other words, the Act prohibits payers from discriminating against services provided via telemedicine rather than more traditional inperson means provided that the services can be appropriately delivered via telemedicine. This statute also applies to health benefit policies offered by Medicaid care management organizations. 5. Medicaid Reimbursement The Georgia Medicaid fee-for-service program generally covers consultation, diagnostic and treatment services provided to eligible members via telemedicine when the service is medically necessary, the procedure is individualized, specific, consistent with the symptoms or confirmed diagnosis of an illness or injury under treatment, and not in excess of the members O.C.G.A (d). GA. COMP. R. & REGS (a)(4) (a)(6) and (7). 16

17 needs. 74 As a condition of payment, the telemedicine service must be provided by an interactive telecommunications system, which, at a minimum, requires that the originating site s system have the capability of allowing the distant site provider to visually examine the patient, including body orifices (e.g., ear canals, nose, throat), and that the distant site provider be able to hear heart tones and lung sounds clearly using a stethoscope (if medically necessary and within the provider s current scope of practice). 75 With respect to reimbursement, the Georgia Medicaid program generally does not distinguish between services provided on site versus those provided via telemedicine. The physician or practitioner providing the professional services at the distant site will be reimbursed the current fee schedule amount under their applicable category of service, provided that the service is within the practitioner s scope of practice under Georgia law. Note that Georgia Medicaid does not reimburse separately for store and forward. For example, if an MRI is taken then providers may be appropriately reimbursed for the professional and technical components, but no separate reimbursement will be made for the store and forward service itself. E. New York 1. Licensure Physicians using telemedicine to provide care to patients located in New York must be licensed in New York. 76 New York provides a licensure exemption for physicians who are licensed in a bordering state and who resides near a border of New York. 77 However, physicians practicing under this exemption must limit their practice in New York to the vicinity of the border and must not maintain an office or place to meet patients or receive calls within New York. 78 New York also provides a licensure exemption for physicians who are licensed in another state or country and are meeting a physician licensed in New York for purposes of consultation Establishing A Physician-Patient Relationship New York appears to allow the use of telemedicine to establish the physician-patient relationship. A Statement on Telemedicine issued by the New York State Department of Health (DOH) s Board for Professional Medical Conduct states that: Georgia Medicaid Telemedicine Handbook, October 2014, supra note at See N.Y. Dep t of Health, Statements on Telemedicine, (last visited Jan. 6, 2015); see also 2014 N.Y. LAWS ch. 550 (defining health care provider as a person licensed in New York, a hospital, a home care services agency, or a hospice) N.Y. EDUC. LAW 6526(2). 6526(3). Statements on Telemedicine, supra note 75 (emphasis added). 17

18 A critical issue in telemedicine is determining the definition of a physician-patient relationship.... Health information sites accessed for general information only, without personal interaction, through electronic media are no different from accessing a reference text in a library, and do not constitute a professional relationship. The fact that most types of telemedicine practice are not reimbursed is irrelevant.... [T]he following statement... is a clear and practical guiding principal: If a patient receives professional advice or treatment, even gratuitously, there is prima facie evidence that a physician-patient relationship exists. 3. Internet Prescribing Section 80.63(d)(1) of the New York Controlled Substances Regulations prohibits the prescription of any controlled substance, with some exceptions, prior to an examination of the patient by the practitioner. 81 The DOH has said that section requires a practitioner to physically examine a patient prior to initially prescribing a controlled substance Private Payer Reimbursement On December 29, 2014, New York adopted Senate Bill No. 7852, which requires comparable coverage and reimbursement for in-person health care services and services provided via telemedicine and telehealth. 83 S defines covered telehealth and telemedicine services broadly to include the delivery of health care by store and forward technology, telephones, and remote patient monitoring devices. 84 S mandates parity for telemedicine services (defined as clinical services delivered by means of real time two-way electronic audio visual communications) that meet the requirements of Medicare, other than originating site requirements. 85 S mandates parity for telehealth services that are consistent with New York Public Health Law 3614(3-c), which governs home telehealth services Medicaid Reimbursement New York Medicaid currently 87 covers health care services and consultations provided via real time interactive audio and video technologies. 88 Telemedicine provided via store and forward technology is not covered N.Y. COMP. CODES R. & REGS (d). 82 N.Y. State Dep t of Health, PRACTITIONER UPDATE at 1 (Summer 2007), N.Y. LAWS ch S. 7852, which took effect on January 1, 2015, provides that: Subject to the approval of the director of the budget, the commissioner [of social services] shall not exclude from the payment of medical assistance funds the provision of medical care through telemedicine services. 18

19 New York Medicaid currently reimburses for medically necessary services provided via telemedicine to patients located at: 90 (i) Hospitals established under Article 28 of the New York Public Health Law; (ii) Diagnostic and Treatment Centers established under Article 28 of the New York Public Health Law; (iii) Federally Qualified Health Centers ( FQHCs ) that have opted into New York Medicaid Ambulatory Patient Groups; and (iv) Non-FQHC School Based Health Centers. Practitioners who may deliver covered telemedicine services include: 91 (i) Physician specialists (including psychiatrists); (ii) Certified Diabetes Educators ( CDEs ); and (iii) Certified Asthma Educators ( CAEs ). The physician specialist performing services via telemedicine must be licensed in New York, enrolled in New York State Medicaid and be credentialed and privileged at both the originating and the distant sites. 92 The CDE or CAE performing services via telemedicine must be enrolled in New York State Medicaid as either a billing provider or a non-billing provider. 93 F. Texas 1. Licensure. Texas requires out of state providers delivering telemedicine services to Texas residents to obtain an out-of-state telemedicine license. 94 This limited license authorizes an out-of-state provider to (1) interpret diagnostic testing and report results to a physician fully licensed and located in Texas or (2) perform follow-up for patients who received the majority of their care in another state. 95 If an out of state provider delivering telemedicine services wants to be able to provide services without those restrictions, he or she would need to obtain a full Texas medical license... provided that such services meet the requirements of federal law, rules and regulations for the provision of medical assistance pursuant to this title, and for telehealth services, N.Y. LAWS ch The Act expands New York s Medicaid s coverage of telemedicine services, for example, by expanding the types of providers who may deliver reimbursable health care services via telemedicine. 88 N.Y. State Dep t of Health, Expanded Coverage of Telemedicine, 2011 DOH Medicaid Updates vol. 27, no. 13 (Sept. 2011), available at TEX. ADMIN. CODE (a) (c). 19

20 2. Establishing a Physician-Patient Relationship. In Texas the requirement for establishing a physician-patient relationship differs depending on the type of telemedicine that the provider practices. Texas law permits two types of telemedicine: (1) telemedicine medical services provided at an established medical site, and (2) telemedicine medical services provided at sites other than an established medical site. 96 With respect to established medical sites, telemedicine medical services may be used for all patient visits, including initial evaluations to establish a proper physician-patient relationship between a distant site provider and a patient. 97 An established medical site is a location where a patient will present to seek medical care where there is a patient site presenter and sufficient technology and medical equipment to allow for an adequate physical evaluation, as appropriate for the patient s presenting complaint. It requires a defined physician-patient relationship. 98 A patient s private home is not considered an established medical site. 99 For new conditions treated at an established medical site, a patient site presenter must be reasonably available onsite at the established medical site to assist with the provision of care. 100 However, it is at the discretion of the remote physician if a patient site presenter is necessary for follow-up evaluation or treatment of a previously diagnosed condition. 101 A patient site presenter is the individual at the patient site location who introduces the patient to the remote physician for examination and to whom the remote physician may delegate tasks and activities. 102 A patient site presenter must be licensed or certified in Texas to perform health care services or a qualified mental health professional-community services. 103 With respect to medical services provided at sites other than an established medical site, a remote provider must either: (1) see the patient one time in a face-to-face visit before providing telemedicine medical care, or (2) see the patient without an initial face-face to visit, provided the patient has received an in-person evaluation by another physician who has referred the patient for additional care and the referral is documented in the medical record. 104 A face-to-face visit is an evaluation performed on a patient where the provider and patient are both at the same physical location or where the patient is at an established medical site. 105 Patient site presenters are not required for pre-existing conditions previously diagnosed by a physician through a face-to-face visit. 106 Additionally, a remote provider may treat an established patient s new symptoms ; id (a) (2) (b) (7) (7)(A) (a)(1) (2) (3) (b). 20