Author: Andrea Flaute, Associate Member, University of Cincinnati Law Review
Telemedicine is a key innovation in the health care industry. Sharing patient information and physician services across long distances bridges a gap for patients across the world. Telemedicine’s benefits include access to services that would otherwise be unavailable; streamlined and efficient communication between patients and physicians; and the ever-important reduction of health care costs. The recent launch of “mHealth,” which provides health care services through mobile device applications, expands telemedicine even further. The ability to have real-time interactions with medical professionals, usually for nominal prices or free of charge, has alleviated many concerns regarding access to health care. However, in places like Ohio, these advances do not always align with current laws or industry standards.
Changing Definition of Telemedicine
The term “telemedicine” has a wide range of definitions that have continued to change over its relatively short-lived existence.[1] The development of the term coincides with the rapid development and widespread expansion of modern and mainstream technology. In its beginning stages, telemedicine was broadly defined as the use of telecommunications technologies to provide medical information and services.[2] It was considered a means of providing and supporting health care “when distance separates the participants.”[3] This was typically thought of as the sharing of photographs, x-ray images, patient records, etc., via telephone, facsimile, and computer.[4]
Today, the definition of telemedicine has drastically evolved. According to the Centers for Medicare and Medicaid Services (CMS), telemedicine is considered part of a larger set of telehealth services and is defined as two-way, real-time interactive communication between a patient and a physician or practitioner. [5] The Ohio Administrative Code (OAC) models this definition by defining telemedicine as “the direct delivery of services to a patient via synchronous, interactive, real-time electronic communication that comprises both audio and video elements.”[6] The larger umbrella of services, currently referred to as “telehealth” services by these entities, more closely resembles the archaic understanding of telemedicine and includes the use of such technologies as telephones, facsimile machines, electronic mail systems, and remote patient monitoring devices.[7] However, both CMS and the OAC specifically state that the use of telephone, facsimile, and electronic mail to aid in the delivery of services does not qualify as telemedicine, rather it is considered a type of telehealth service that has become the industry standard with electronic medical records.[8]
Telemedicine in Ohio
Most of Ohio’s telemedicine statutory construction is contained in § 5160-1-18 of the OAC and various other State Medical Board physician regulations. Section 5160-1-18 lays out the rules that providers must follow when treating Medicaid patients in order to have the health services paid for by Medicaid. The statute mirrors federal Medicare telemedicine reimbursement requirements but covers more services and patients.[9] To date, Ohio does not have any statute requiring private payers or self-funded insurance plans to cover the cost of telemedicine. However, legislation is currently pending which seeks to ensure telemedicine services are not excluded from coverage solely because the services are not provided through a face-to-face consultation.[10]
While the federal Medicare and Ohio Medicaid reimbursement plans allow for telemedicine, both place limitations on the geographic locations of the patient and physician at the time of care.[11] In general, each requires the patient site to have appropriate diagnostic equipment and to be a licensed medical facility.[12] Both plans also include requirements that the sites be located a minimum geographical distance apart and that communications be equipped with specific security measures to comply with HIPAA.[13] It is important to clarify that none of these restrictions are applicable to conversations between practitioners regarding a patient outside the presence, physical or virtual, of the patient.[14]
When considering the scope of telemedicine in practice it is important to consider physician regulations as these regulations tend to be more stringent and apply to the conduct of every physician, regardless of acceptance of Medicare or Medicaid patients. Specifically, it is important to analyze § 4731-11-09 of the OAC and § 4731.296 of the Ohio Revised Code (ORC). Section 4731-11-09 requires physicians to “personally physically examin[e]” a person before prescribing a controlled or dangerous substance.[15] Traditionally, this requirement was understood by most physicians to mean that a patient must be physically present in a physician’s office before a prescription is given.[16] However, recently the State Medical Board of Ohio released an Interpretive Guideline which “recognize[d] that with advances in medical technology it may be possible for the ‘personal’ and ‘physical’ examination required by Rule 4731-11-09 to occur when the provider and patient are located in remote locations.”[17] Despite this expansive interpretation, the Guideline continues to require minimum standards of care, including the establishment of a physician-patient relationship,[18] and the presence of appropriate diagnostic medical equipment.[19] ORC § 4731.296 is equally important to the practice of telemedicine in Ohio as it requires physicians located outside of the state to obtain a special telemedicine certificate if they wish to practice medicine, via telemedicine, on patients located within the state.[20] This certificate does not allow the physician to practice medicine in person in the state.[21]
The Emergence of mHealth
The most recent innovation in the health care industry implements telemedicine into a type of health care known as mHealth. The World Health Organization (WHO) defines mHealth as “[t]he use of mobile and wireless technologies to support the achievement of health objectives.”[22] In layman’s terms, mHealth allows patients to use an application (app) on a mobile cellular device to receive long-distance health care via real-time interactions with a physician.[23] This form of health care is attractive for many reasons: it is a cost-effective and efficient alternative to traditional face-to-face delivery of services and it provides access to health care that some patients may not otherwise be able to receive, improving overall quality of life for many.[24] Many health insurance companies are pushing for more widespread use due to the significant cost savings on the part of physicians and payers alike.[25]
Despite widespread benefits, concerns over the extent and quality of health services being provided and the inability for physicians to maintain the established provider-patient relationship have many state legislatures and medical boards resisting this technology-driven transition to mHealth.[26] The Ohio Academy of Family Physicians argues that telemedicine sacrifices quality and safety for improved access to care and convenience.[27] They further argue that health care becomes fragmented when “a physician you have never met, who has no historical knowledge of you and your health history, who has no access to your medical records, and who lacks the appropriate diagnostic equipment to examine you” takes on your care.[28]
The State Medical Board of Ohio agrees, stating that the type of care provided through apps fails to meet established standards of care required by all physicians.[29] A basic provider-patient relationship is formed when a patient knowingly seeks a physician’s services and the physician knowingly accepts the patient.[30] Once that relationship is formed, the physician has a duty to the patient that can only be terminated by the completion of the illness or very specific notices to the patient.[31] When physicians are located throughout the state or even across the country, follow-up care is nearly impossible, which creates fragmented care for the patient and requires the patient to see another physician, which negates the initial cost savings and increases liability for the physician.
A Proposed Future for Mobile Health in Ohio
The current push towards mHealth does not fit into the statutory scheme provided in Ohio. mHealth seeks to allow users to access a physician from wherever they are located. However, Ohio Medicaid requirements coupled with physician regulations, for the most part, do not allow this type of interaction. Patients need to be located at a medical facility before a two-way interactive communication can be initiated, particularly if the physician needs to perform an examination or diagnostic test in order to prescribe medication. To some extent telemedicine can occur in Ohio between a new patient and a physician, without risking loss of payment or malpractice, but that only involves the archaic notion of telemedicine: telephone, e-mail, and fax to share patient information.
However, there could be a bright future for telemedicine in Ohio that involves the modern mHealth and other mobile apps without risking liability or forfeiting minimum standards of care. Implementing mHealth and telemedicine into existing provider-patient relationships for a limited number of minor health issues—such as cold, fever, or earaches—accomplishes many of the goals of telemedicine while maintaining quality and security and minimizing risk. Patients still have the convenient and cost-effective option to see their primary-care physician via two-way interactive communication without relinquishing their option to seek follow up care. Additionally, physicians have the required background knowledge of the patient and prior medical history, reducing the risk of misdiagnosis and other forms of malpractice. The apps can also be used to connect patients without primary care physicians to physicians in their area. The provider-patient relationship can be created through the app, but a more permanent relationship can be maintained in person.
Conclusion
Before the future of mHealth in Ohio can expand, legislators and medical professionals need to create comprehensive legislation that cohesively addresses modern telemedicine. As part of their legislation, existing provider-patient relationships need to be given more freedom to use telemedicine for basic ailments. Telemedicine can change the way we think about and utilize health care, but only if it is done in a way that does not expose patients to faulty care and physicians to increased liability.
[1] The first reference to telemedicine in medical literature appeared in 1950. Institute of Medicine (US) Committee on Evaluating Clinical Applications of Telemedicine, Telemedicine: A Guide to Assessing Telecommunications in Health Care 36 (Marilyn J. Fields, ed. 1996).
[2] Douglas A. Perednia, MD and Ace Allen, MD, Telemedicine Technology and Clinical Applications, 273 JAMA 483 (1995).
[3] Telemedicine: A Guide to Assessing Telecommunications in Health Care, supra note 1.
[4] Teresa Smith Welsh, Telemedicine (June 20, 1999), http://ocean.st.usm.edu/~w146169/teleweb/telemed.htm
[5] Medicaid.gov, Telemedicine, Centers for Medicaid and Medicare Services, https://www.medicaid.gov/medicaid-chip-program-information/by-topics/delivery-systems/telemedicine.html; 42 C.F.R 410.78(a)(3)
[6] Ohio Admin. Code § 5160-1-18(A)(1)
[7] Medicaid.gov, Telemedicine, Centers for Medicaid and Medicare Services
[8] Id.; Ohio Admin. Code § 5160-1-18(A)(1)(a)
[9] Medicare.gov, Telehealth, Centers for Medicaid and Medicare Services https://www.medicare.gov/coverage/telehealth.html
[10] S.B. No. 32 Telemedicine Services-Insurance and Medicaid Coverage (proposed February 9, 2016), Ohio 131st General Assembly, available at https://www.legislature.ohio.gov/legislation/legislation-summary?id=GA131-SB-32
[11]Medicaid.gov, Telemedicine; Medicare.gov, Telehealth; Ohio Admin. Code § 5160-1-18; Medicaid Handbook Transmittal Letter (MHTL) No. 3334-15-01, Ohio Department of Medicaid http://www.ohioafp.org/wp-content/uploads/Medicaid_Coverage_of_Telemedicine_and_Related_Services.pdf
[12] Id.
[13] Id. HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. For a more detailed explanation, visit the Department of Health and Human Services website at http://www.hhs.gov/hipaa/for-professionals/index.html
[14] Ohio Admin. Code § 5160
[15] Ohio Admin. Code § 4731-11-09(A)-(B)
[16] Interpretive Guideline: Ohio Administrative Code Rule 4731-11-09, Prescribing to persons not seen by the physician, based on certain technological advances, State Medical Board of Ohio, http://med.ohio.gov/DNN/PDF-FOLDERS/Prescriber-Resources-Page/Telemedicine/Rule-4731-11-09-Interpretive-Guideline.pdf
[17] Id.
[18] Id. Minimum standards of care include, but are not limited to, having sufficient dialogue with the patient regarding treatment options and the risks and benefits of treatment; following up with the patient to assess the therapeutic outcome; maintaining a contemporaneous medical record that is readily available to the patient and other health care professionals; and including the electronic prescription information as part of the patient medical record.
[19] Id.
[20] Ohio Rev. Code § 4731.296(A)
[21] Id. at § 4731.296(C)
[22] Global Observatory for eHealth Series, World Health Organization, mHealth: New Horizons for Health Through Mobile Technologies 1 (2011) http://www.who.int/goe/publications/goe_mhealth_web.pdf
[23] Telehealth Policy Trends and Considerations, National Conference of State Legislatures, http://www.ncsl.org/documents/health/telehealth2015.pdf
[24] Id.
[25] Id.
[26] Id.
[27] Suellywn Stewart, MD, Op-Ed: Patients Should Use Telemedicine Only With Established Doctor, Ohio Academy of Family Physicians, http://www.ohioafp.org/news-publications/media/press-releases/op-ed-patients-telemedicine-established-doctor/
[28] Id.
[29] Id.
[30] Reynolds v. Decatur Memorial Hospital, 660 N.E. 2d 235 (1996)
[31] Id.
