Shedding Light on Telemedicine & Online Prescribing: The Need to Balance Access to Health Care and Quality of Care

I. WHAT IS TELEMEDICINE?

Telemedicine is the fastest growing alternative health care delivery option in the United States, demonstrating a growth of 53% between 2016-17 compared to urgent care centers (increase of 14%), retail clinics (increase of 7%), ambulatory surgical centers (“ASCs”) (increase of 6%), and emergency departments (decrease of 2%). ¹ According to a report by Global Market Insights, Inc. the U.S. telemedicine market is expected to reach $64 billion by 2025. ² In order to understand telemedicine's attractiveness as an option for delivering health care, it is important to first understand how telemedicine is defined.

The American Telemedicine Association (“ATA”) ³ defines “telemedicine” as “the remote delivery of health care services and clinical information using telecommunications technology.” ⁴ Further, the ATA explains that telemedicine “includes a wide array of clinical services using internet, wireless, satellite and telephone media.” ⁵ The organization recognizes that “telemedicine” and “telehealth” can generally be used interchangeably. ⁶ Other organizations have given distinct definitions for “telemedicine” and “telehealth”. ⁷ For the purpose of consistency throughout this article, the term “telemedicine” will be used.

In order to have a more comprehensive understanding of telemedicine, it is helpful to be familiar with the different types of services that can be delivered utilizing telemedicine. The ATA has identified several types of medical services that can be provided by telemedicine. ⁸ These include: primary care and specialist referral services, remote patient monitoring, consumer medical and health information, and medical education. ⁹ Telemedicine may be used in consultations between a primary care physician and specialists at a remote location in order to make a diagnosis for a patient. ¹⁰ “This may involve the use of live interactive video or the use of store and forward transmission of diagnostic images, vital signs and/or video clips along with patient data for later review.” ¹¹ Remote patient monitoring allows collection of the patient's medical data for interpretation by a home health agency or a remote diagnostic testing facility (“RDTF”). ¹² “Such applications might include a specific vital sign, such as blood glucose or heart ECG or a variety of indicators for homebound patients.” ¹³ The third category of services recognized by ATA is when consumer medical and health information involves the use of technology such as the internet or wireless devices in order to obtain “specialized health information”. ¹⁴ Additionally, this category of services includes consumers' use of online discussion groups. ¹⁵ Finally, telemedicine can be used for medical information by allowing for access to continuing medical education (“CME”) for medical professionals remotely. ¹⁶

II. DEFINING ONLINE PRESCRIBING

“Online prescribing” or “internet prescribing” can generally be defined as “a provider prescribing a drug to a patient based upon an interaction that has taken place online.” ¹⁷ This must be distinguished from “e-prescribing” which is “the act of a provider sending a prescription electronically to a pharmacy, such as through an EHR, and should not be confused with online or internet prescribing.” ¹⁸ This article will only focus on online or internet prescribing. For purposes of consistency, the term “online prescribing” will be used.

A variety of issues are raised with the use of online prescribing, primarily involving the patient-provider relationship. ¹⁹ There is concern that the use of online prescribing in the telemedicine context could be problematic if there is no requirement of a prior in-person patient-provider interaction resulting in prescription decisions being made based solely on an online patient-provider relationship. ²⁰ In a purely online relationship, some concerns are whether the patient's medical information and history are adequate and whether or not the patient is the person being represented as needing medical care. ²¹ These issues have led states to take different approaches to incorporating online prescribing into law which will be explored in a later section.

III. UNDERSTANDING THE DIRECT-TO-CONSUMER TELEMEDICINE OPTION

The concept of direct-to-consumer (“DTC”) began in the pharmaceutical industry and progressed to an approach to health care delivery. ²² The use of DTC is distinguished from other ways of providing telemedicine by the initiation of the encounter by the patient. ²³ “Direct to consumer telemedicine, specifically, can be carried out in one of three ways: (1) between a patient and a provider with whom they have an established relationship, (2) between a patient and another provider from a practice where the patient has an established relationship, or (3) from a provider with whom they have no pre-established relationship.” ²⁴ The last category of DTC has seen the greatest increase of the three in the past five years. ²⁵ Additionally, DTC has been recognized as the “most popular” method of using telemedicine. ²⁶

It is often the case that information from a DTC encounter is provided to the patient's primary care provider. ²⁷ Even within DTC telemedicine, there are multiple ways of providing care. ²⁸ This is explained as follows:

The types of DTC telemedicine are either synchronous, involving real-time two-way video conferencing or audio-only encounters, or asynchronous, where information is transferred between patient and provider over hours or days. Asynchronous telemedicine, also referred to as “store-and-forward” or “e-consults,” can be achieved via secure text messaging or email, and also involves the transfer of images, audio, or other multimedia files. Prescriptions may be provided whether the encounter is synchronous or asynchronous, depending on the information collected and the condition being treated. Both types of encounters are initiated with the creation of an online account, completion of a health history, and description of current symptoms. Asynchronous visits rely more on logic-based questioning and clinical decision support tools. Answers are typically reviewed by the physician through a secure portal, and a determination is made as to whether a prescription can be provided or there is not enough information. There are DTC companies, such as Lemonaid, which treat certain conditions through the use of a computer assisted algorithm only. A physician is not alerted unless certain criteria are met based on the computer-based screening. These companies are largely under regulated. ²⁹

It is important to have this context in considering the issues surrounding telemedicine and online prescribing, and relevant research studies will be discussed in the next section. Additionally, prescribing has become a common feature of DTC telemedicine, ³⁰ and has quickly grown in the telemedicine market. ³¹ More and more DTC use is being expanded into retailers as most recently seen with CVS ³² , Rite Aid, ³³ Amazon, ³⁴ and Wal-Greens ³⁵ which are now pursuing the DTC market.

IV. CURRENT RESEARCH ON TELEMEDICINE USE AND OVERPRESCRIBING

As individuals become more susceptible to antibiotic resistant infections, concerns have been raised that overprescribing of antibiotics could further fuel continued growth of antibiotic resistance. ³⁶ There is a specific concern that telemedicine could ultimately become a culprit in antibiotic resistance due to overprescribing. ³⁷ A number of recent research studies have demonstrated a correlation between the use of telemedicine for the delivery of health care services and overprescribing of antibiotics. ³⁸ Most recently, more light has been shed on the issue of overprescribing in DTC telemedicine involving children, as described in an April 2019 Pediatrics article. ³⁹ The study found that children who were seen at a DTC telemedicine provider were prescribed antibiotics for respiratory infections at a rate of 52% compared to 42% at urgent care and 31% at primary care physician (“PCP”) visits. ⁴⁰ Additionally, the study found evidence that diagnoses were frequently made without adhering to the proper prescribing criteria. ⁴¹

Other research has demonstrated evidence of overprescribing in telemedicine encounters involving adults. ⁴² One study documented telemedicine encounters between January 2013 and August 2016 where individuals had respiratory tract infections (“RTIs”) and sought treatment for care using a DTC telemedicine option in particular. ⁴³ The study was limited to the extent that only one format of DTC was utilized and the actual need for prescribing antibiotics was not evaluated. ⁴⁴ However, the research concluded that where antibiotics were prescribed for RTIs in this DTC context, the appointment times were shortened compared to those where antibiotics were not prescribed. ⁴⁵ The study ultimately suggested that the short length of telemedicine counters, which the telemedicine market depends upon for sustainability, increases the likelihood of overprescribing. ⁴⁶ The authors made recommendations for physicians to carefully examine symptoms and for patients not to be hesitant to ask questions in this context even if it means lengthening the visit. ⁴⁷ The article summarized, “because telemedicine encounters are short and physicians are often reimbursed by encounter volume, antibiotic stewardship efforts that lengthen visits even slightly may be difficult to implement.” ⁴⁸

A 2015 RAND study evaluated the rate of prescribing between telemedicine and regular face-to-face physician visits and found virtually no difference between occurrences of prescribing in the telemedicine context compared to face-to-face physician visits. ⁴⁹ The study examined DTC use involving Teledoc through the California Public Employees' Retirement System between April 2012 to October 2013 for individuals seeking medical care for acute respiratory illnesses (“ARIs”) for one or more visit. ⁵⁰ The study concluded that prescribing in both the telemedicine setting of Teledoc and physician offices was similar, though in both instances there was evidence of inappropriate prescribing. ⁵¹ Additionally, prescribing in the Teledoc context was shown to involve the use of broader spectrum antibiotics compared to those treated in the face-to-face context. ⁵²

Collectively, these research studies suggest problems with prescribing in the DTC telemedicine context, in particular with the potential for overprescribing and inappropriate prescribing. More research is needed to evaluate this trend and prescribing involving telemedicine outside of the DTC context. With the understanding of this research as background, the way in which online prescribing is regulated by law when telemedicine is utilized to deliver health care becomes critical. The following two sections will explore the current legal landscape for telemedicine and online prescribing.

V. FEDERAL LAW AND REGULATION OF ONLINE PRESCRIBING

VI. UNDERSTANDING STATE LAWS ON TELEMEDICINE

The current lack of a national telemedicine law or federal regulation has left the states with the ability to create their own ways of regulating the many legal issues involved with telemedicine. This begins with the very definition of telemedicine.

VII. BALANCING ACCESS TO CARE AND QUALITY OF CARE

The development of telemedicine and online prescribing laws has turned on defining what is sufficient to establish the patient-physician relationship. As technology and telemedicine continue to change the delivery of health care, the question is now whether the patient-physician relationship continues to require an in-person examination. Is the quality of the care provided diminished when an in-person evaluation does not occur? The use of telemedicine certainly eliminates the ability of a physician to touch a patient to potentially detect some symptoms which will be lost in the use of telemedicine. But can or should the in-person evaluation requirement be maintained in the traditional sense or does it need to be modified to allow telemedicine to flourish? How does this relate to the issue of prescribing specifically? Will too much be lost in the patient-physician relationship by eliminating or modifying the in-person evaluation requirement?

The American College of Physicians (“ACP”) has been weighing in on this very issue for some time, which it describes as attempting to strike a balance between health care access and quality. ⁹⁵ In January 2019, the ACP released the 7^th Edition of its Ethics Manual stating the following position regarding the patient-physician relationship involving telemedicine and the role of in-person encounters:

In the context of telemedicine, there must be a valid patient–physician relationship for a professionally responsible telemedicine service to take place. A telemedicine encounter itself can establish a patient–physician relationship through real-time, technically appropriate audiovisual technology. When there has been no direct previous contact or existing relationship with a patient before a telemedicine encounter, the physician must take appropriate steps to establish a relationship based on the standard of care required for an in-person visit, or consult with another physician who does have a relationship with the patient. The benefits of opportunities for increased access to care through telemedicine “must be balanced according to the nature of the particular encounter and the risks from the loss of the in-person encounter (such as the potential for misdiagnosis; inappropriate testing or prescribing; and the loss of personal interactions that include the therapeutic value of touch, communications with body language, and continuity of care).” ⁹⁶

Thus, the ACP promotes that it is ethically acceptable to establish a patient-physician relationship in the context of telemedicine without the traditional in-person evaluation if audiovisual technology is utilized. The ACP emphasizes the critical importance of medical professionals being mindful of the necessary balance between the access that telemedicine creates to medical care with the potential losses that can come from its use.

The ACP Manual further emphasizes that the responsibilities of the physician to the patient still exist even in the absence of an in-person encounter. ⁹⁷ The ACP Manual is particularly clear that prescribing is ethically prohibited when it is done only on the basis of an online questionnaire or telephone communication. ⁹⁸ The Manual does provide exceptions such as public health emergencies. ⁹⁹

However, the ACP does take a more critical position regarding the use of e-mail and telephone communications. ¹⁰⁰ As communication is a critical component of the patient-physician relationship, the ACP takes the view that communication via e-mail and telephone can be used as means to supplement the patient-physician relationship but should not serve as the basis of this relationship. ¹⁰¹

The ACP is not the only medical group which has taken positions regarding the ethics of physicians' responsibilities when telemedicine is utilized in the delivery of health care. In 2016, the American Medical Association (“AMA”) also weighed in on ethics of the practice of medicine when telemedicine is used. ¹⁰² Similarly, the AMA acknowledged that the use of telemedicine does not change a physician's responsibilities to a patient and that ultimately the same ethical obligations are required of the physician in this context:

Although physicians' fundamental ethical responsibilities do not change, the continuum of possible patient-physician interactions in telehealth/telemedicine give rise to differing levels of accountability for physicians. ¹⁰³

Additionally, the AMA guidance points out the responsibility the physician utilizing telemedicine has in making informed decisions in this context in light of a lack of in-person examination which certainly touches on the issue of prescribing. ¹⁰⁴ A specific set of guidance is included that goes to the physician's responsibilities in prescribing. ¹⁰⁵

VIII. CRAFTING INNOVATIVE LEGISLATIVE RESPONSES

IX. CONCLUSION

Technology is drastically changing the landscape of the delivery of health care through the use and practice of telemedicine. The law has not kept pace with the rapid movement of technology which will only continue to evolve. As online prescribing demonstrates, issues continue to emerge and the medical profession must consider the role that ethics plays in the delivery of health care when new technologies are involved. What is clear is that the ethical responsibilities of physicians cannot be ignored when it comes to drafting and implementing legislation addressing emerging issues in telemedicine. While it is critical to expand and improve access to health care for all, this cannot be done in a vacuum without considering quality and patient protection. Shedding light on online prescribing in telemedicine demands that policy decisions embrace the role of telemedicine in improving access to care while also ensuring that quality is not compromised by not overly limiting the requirements on physicians. As technology becomes an integral part of the delivery of health care, the law can be used as a valuable tool to ensure a necessary balance between regulating the telemedicine market and expanding quality access to health care.