What is Telehealth and How Has it Evolved
The History of Telehealth
Telehealth is defined as "[T]he use of electronic information and telecommunications technologies to support long-distance clinical healthcare, patient and professional health-related education, public health, and health administration."15 As technology progressed, the utilization of telehealth evolved. In the 1940s, aside from giving medical advice over the phone, the first real iteration of telehealth was conceived by radiologists who electronically transferred scans to one another, in two towns 24 miles apart.16 Then in the 1960s the National Aeronautics and Space Administration (NASA) needed a way to monitor the health of astronauts during missions to the moon and developed the Integrated Medical and Behavioral Laboratories and Measurement Systems (IMBLMS) system to allow a seamless transfer of health data from space.17 In the 21st Century, the Veterans Association (VA) has been using telehealth systems to provide healthcare to veterans who have a difficult time making it to their physicians.18 Additionally, with the advent of the internet and mobile applications, companies like MDLive and Teladoc began providing remote consultations for patients via videoconferences or phone call.19 Still, significant hurdles hindered the widespread use of telehealth for the greater public.20
The Evolution of Telehealth
The original motivation for institutionalizing telehealth was to provide healthcare access to rural communities that were faced with shortages of local healthcare professionals.21 It has been estimated that nearly 80 million people live in “shortage areas” where physicians, medical staff, and healthcare specialists are scarce, inevitably leading to a less healthy population.22 Telehealth provides an opportunity to bridge this health gap by delivering premier healthcare to rural communities remotely. But even the greatest advocates and believers of telehealth could not have imagined the shifting parameters that have allowed its proliferation.23 As the pandemic forced individuals to stay at home, industries got creative and turned to companies like Zoom to continue their work virtually.24 The healthcare industry was no different. This shift was just the push that telehealth needed to exhibit its beneficial use and dismantle the preconceived notions that both stigmatized and stymied its concept as inferior care.25 Additionally, many of the regulations, restrictions, and limitations on telehealth were paused allowing patients to seek medical care from physicians across the nation.26 Research has shown that telehealth use has increased 38-fold from the pre-COVID-19 baseline.27 Furthermore, venture capital investment in the first half of 2021 totaled $14.7 billion, which is nearly twice the investment in all of 2019.28 Many speculate that the pandemic has been telehealth’s tipping point, and that we are on the precipice of a new medical frontier.29 Although the propagation of telehealth is an exciting and positive development, there are still numerous issues to address to ensure that the technology is regulated properly.
State Licensure Laws: Pre-Pandemic, Pandemic, Post-Pandemic
State medical boards are delegated with the authority to regulate medical practices in their state, and therefore, are the issuers of physician licenses.30 Such licenses limit a physician’s practice to provide treatment to residents that are in that state.31 This is because “states have a compelling interest in the practice of professions within their boundaries, and that as part of their power to protect the public health, safety and other valid interests they have broad power to establish standards for licensing practitioners and regulating the practice of professions.”32 In essence, licensure regulations are “consumer protection” laws implemented to protect residents of a particular state.33 Aside for ensuring quality control of their physicians and protecting their constituents, by relinquishing their licensure powers, states would suffer economic loss from licensing fees and revenues while saturating the market for their physicians by allowing out-of-state physicians to practice telehealth on their patients.34 Theoretically, it is possible for physicians to obtain licenses from other states, in addition to the states in which they are already licensed, however, such a process is costly and time-consuming.35 Even in states that have implemented exceptions and compacts for out-of-state physicians, telehealth expansion had been stagnant, as providers understood the impractical components and financial risks.36 Finally, if a physician practices without a license, states can pursue civil and criminal liability suits.37
Secretary of Health and Human Services Alex Azar declared a public health emergency after confirming cases of COVID-19 on January 31, 2020.38 As the country grappled with and prepared for many possible scenarios, numerous decisions regarding healthcare were made.39 Among other things, stay-at-home orders were implemented, and as a result citizens were unable to access the medical care they needed.40 Physicians, state medical boards, and legislators realized that the use of telehealth would limit the risk of exposure and spread of the virus, and therefore governors implemented broad waivers of the in-state licensures requirements allowing individuals to receive telehealth care across the country, irrespective of their location.41
At the federal level, several agencies regulate different aspects of telehealth. The Office for Civil Rights (OCR), which is responsible for the protection of personal health information and the enforcement of the Health Insurance Portability and Accountability Act (HIPAA), only permitted certain secure video platforms to be used for telehealth prior to COVID-19, however, once the pandemic hit, it permitted “every communication technology,” including platforms like FaceTime and Zoom.42 In addition to loosening privacy regulations, the Centers for Medicare and Medicaid Services (CMS) waived many of its own limitations to allow providers to practice remote care across state lines and to bill and collect for telehealth services commensurate with in-person visits. 43 These waivers increased the weekly use of telehealth services from 13,000 beneficiaries before the pandemic to 1.7 million during the pandemic.44 Lastly, the Drug Enforcement Administration (DEA) waived the prohibition of prescribing controlled substances via telehealth, even without an in-person visit.45
The federal waivers did not supersede state guidelines, and therefore, states had to lift their own regulations as well. Nearly all states waived their licensure regulations and allowed providers with equivalent licenses to practice in their state.46 Additionally, many states waived in-person prescribing requirements.47 Many states also waived written informed consent requirements, allowing it to be accomplished verbally.48
In July 2020, CMS Administrator Seema Verma wrote:
With these transformative changes unleashed over the last several months, it's hard to imagine merely reverting to the way things were before. As the country re-opens, CMS is reviewing the flexibilities the administration has introduced and their early impact on Medicare beneficiaries to inform whether these changes should be made a permanent part of the Medicare program.49
Additionally, 30 U.S. legislators sent a bipartisan letter to Senate Majority Leader McConnell (R-KY) and Senate Minority Leader Chuck Schumer (D-NY), in June 2020, asking Congress to permanently adopt some of the temporary telehealth provisions set forth at the beginning of the pandemic.50 President Biden has been extremely supportive of the telehealth push, and on March 14, 2022, signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the Omnibus Bill), extending many of the aforementioned waivers.51 It is unclear what will happen once the extension ends, however, clear guidelines will need to be conveyed especially in light of new abortion laws in which patients and physicians will have to determine whether the issue of telehealth and state licensure laws will play a role in the prescription of abortion pills via telehealth.
Establishing a Physician-Patient Relationship, the Standard of Care, and Prescribing Practices in the Realm of Telehealth
For a physician to provide treatment to a patient, the physician must first establish a physician-patient relationship.52 One challenge with telehealth is determining when the physician-patient relationship takes effect.53 In general, in order for such a relationship to be established, there must be a two-way communication, the physician must agree to treat the patient, and the patient must agree to be treated by the physician.54
In New York, a mere telephone call from a physician to a patient can be enough to establish a physician-patient relationship.55 Similarly, in Arkansas, the physician-patient relationship can be formed through any audio-video interaction.56 However, in states like Georgia and Texas, even though a physician-patient relationship can be performed via telehealth, an in-person follow-up visit is required.57 Rural states including Idaho, Nebraska, North Dakota, West Virginia, and Wyoming have all allowed the formation of a physician-patient relationship to be established via two-way video conference.58 However, Florida is silent “with respect to the modality required to establish the physician-patient relationship.”59 The American Medical Association (AMA) has suggested that in order to establish a physician-patient relationship, a face-to-face meeting should occur prior to the rendering of telehealth services.60 The concern for allowing the physician-patient relationship to be formed via telehealth is that it will be difficult to confirm and authenticate the patient and physician and it will be difficult to obtain necessary consent.61
Standard of Care
Another question to address is the standard of care to which physicians should be held to when rendering treatment via telehealth. In general, the standard of care takes into consideration the circumstances and the physician’s specialty.62 In malpractice cases, it is medical experts who explain what the standard of care should have been.63 When it comes to telehealth, some states view it as a tool to practice medicine, while others view it as its own form of medicine.64 For example, California, Florida, and Kentucky all view the telehealth standard of care as “a tool in medicine practice, not a form of medicine,” and therefore, the standard of care should be the same as the regular practice of medicine during an in person visit.65 However, in Hawaii, the standard of care for telehealth providers is that of a “non-in-person consultation,” which is ultimately a lower standard of care, taking into account some of the limitations of performing an exam remotely.66 While many states have not addressed the standard of care for telehealth services, it is clear that a uniform model among the states will not be established.
Historically, state regulations required face-to-face encounters between patients and physicians in order to prescribe medication. However, in Teladoc, Inc. v. Texas Medical Board, a Texas court found that requiring in-person visits in order to prescribe patients would violate the Sherman Antitrust Act 67 because it would effectively prohibit telehealth services.68 In response, many states have loosened their requirements and now allow physicians to prescribe drugs to patients via telehealth.69
Federally, the Ryan Haight Act requires the dispensation of controlled substances pursuant to a valid prescription obtained through an in-person evaluation.70 If the telehealth visit occurs at a particular facility, for example a hospital or a clinic, the physician can prescribe remotely.71 There is also an exception to the general requirement for an in-person evaluation: prescribing of controlled substances is allowed if the telehealth provider registers with the DEA and receives training before prescribing remotely..72 However, the DEA has yet to establish such a registration process and therefore, the mechanism has not been implemented.73 During the COVID-19 pandemic, the Ryan Haight restrictions were paused, and physicians have been able to prescribe controlled substances via telehealth.74 On October 13, the public health emergency is set to end, and it is unclear whether there will be another extension or permanent implementation of these waivers.
Four Proposed Solutions and Why None Will be Implemented
As policymakers consider legislation to facilitate the use of telehealth, physicians and academics agree that licensure reforms will be essential in enabling the increased use of this technology.75 While states may be motivated to maintain the status quo and preserve their control, some argue that the expansion of large national and regional health systems has expanded the scope of healthcare markets beyond state lines.76 Furthermore, the absurdity of having individuals cross state borders to attend primary care visits from their cars, in order to be in the same state as their physician, has already been discussed.77 It has also been argued that state licensing boards are focused on protecting their physicians from competition and collecting licensing fees, rather than working to ensure the safety of their patient population.78 This was seen when the Federal Trade Commission sued the North Carolina State Board of Dental Examiners in 2014 for violating antitrust laws when the board arbitrarily prohibited non-dentists from providing teeth-whitening services.79 In response to many of the aforementioned concerns, numerous proposals have been suggested.
The first proposal is to keep the current in-state licensure system while making it easier for physicians to get licensed out of state. In 2017, under the Interstate Medical Licensure Compact, 29 states agreed that physicians can complete a single application to expedite the approval of licensure from other states in the compact. 80 For $700, individual physicians can join the compact and obtain a license from each participating state for a small fee.81 However, as of now, only 0.4 percent of all eligible physicians have joined the compact.82 It is possible that if the fees are lowered and the remaining states join the compact that more doctors would join. This proposal is unlikely to become reality because there seems to be little incentive for physicians to join the compact as many states are not part of the compact, and the fees and administrative burdens remain high. Similarly, there is no incentive for states to relinquish their control over the competition and agree to such a proposal as they want to maintain their long-history of state-based disciplinary authority and limit competition from out-of-state providers.
A second proposal would be to implement a system of reciprocity where states would allow their own state licensed physicians to practice in each other’s state.83 This would be similar to the bar reciprocity that lawyers use to practice in other states. In 2013, Rep. Devin Nunes (R-CA) proposed the Tele-Med Act that would have allowed Medicare providers to provide telehealth services to Medicare beneficiaries and permanently implemented reciprocity.84 Again, this proposal seems unlikely to come into practice for the same reasons mentioned above; states are not going to be willing to relinquish their long history of control over the healthcare industry, competition from out of state providers, and the profits that are generated from licensure boards.
A third approach would be to implement a federal license to practice medicine. Sen. Tom Udall (D-NM) proposed a bill on January 31, 2012, that would create a dual licensure process; in addition to receiving a state license, physicians can apply for a national license as well. In another form, this system would just abolish the concept of state licensing and create a single federal licensure system, as physicians would have no reason to receive licenses from the states. However, “such a policy may be impractical, since it overlooks more than a century of experience with state-based licensure systems” and dismisses the role that boards play in disciplinary activity.85 For the rejections seen in the first two proposals, states will never agree to such a model because they won’t want to relinquish control of their disciplinary authority. Additionally, physicians will be nervous to allow such a system where competition will be much more fierce if patients in their area can see physicians on an opposite coast.
The Practice of Medicine is Based on The Physician's Location
A fourth, and most novel proposal, would be to license the practice of medicine based on where the physician is located rather than where the patient is. This model was recently introduced on April 15, 2020, by Sen. Ted Cruz (R-Texas) and Sen. Marsha Blackburn (R-Tenn.) in the Equal Access to Care Act86 as a way to increase access during the COVID-19 crisis. This model is sheltered from the criticisms of the first three proposals because states would maintain their control over the physicians and physicians will not have to worry about out-of-state doctors competing for their patients. However, this law is extremely unlikely to be enacted because it challenges long-standing systems of regulating medical practice. One of the main purposes of requiring patients to be in the same state as the physician is to grant the states with the power to protect their patients. Currently, the bill has been temporarily authorized until the end of the emergency declaration.
Although the aforementioned proposals are unique and somewhat helpful, they are unrealistic. Therefore, a new framework is needed.
A Novel Solution: Distinguishing Telehealth Based on an Initial in-Person Consultation
In order to alleviate the concerns regarding the future of telehealth, it is clear that a new regulatory framework will be necessary. Taking into account the needs of patients, physicians, and states is complex and will be difficult to balance. This article proposes a solution that can appease all parties while ensuring the safety and efficacy of this exciting breakthrough in healthcare.
The Initial In-Person Requirement
The proposed solution will adapt some elements of the AMA’s telehealth policy recommendations and convert them into policy.87 Under this legislation, patients and physicians will have to conduct an initial in-person check-up prior to the rendering of future telehealth services. Once the initial consultation is complete, under this proposal, the patient can access unfettered telehealth services across state lines. This is because the initial consultation will create a physician-patient relationship according to state standards, and by doing so, the future telehealth visits can be considered a continuation of that initial visit.
From the states’ perspective, this will relieve concerns about patient identification, physician identification, and consent, because each has already been confirmed at the initial visit. Additionally, requiring an initial in-person visit effectively allows the states to maintain their licensure requirements. States will preserve their regulatory control over the industry as well as the economic incentives appropriated from their licensing fees. Under these circumstances, states should have no problem considering the telehealth visits as a continuation of the initial in-person visit. In practice, this simply means that the states will waive the in-state licensure requirement after the initial in-person visit.
For physicians, requiring an in-person initial consultation will assuage their fears of online-only physicians competing for their patients and saturating their market. Medically speaking, physicians will also be more comfortable providing future recommendations and diagnosis via telehealth once they have examined the patient in person.88 Studies show that “physicians remain conservative in their view of telehealth’s effectiveness compared with in-person care.”89 Additionally, under this approach, it makes sense that physicians will be able to continue prescribing medications via telehealth, because it is just a continuation of their initial in-person visit. What follows is that the standard of care during follow-up telehealth visits must be commensurate with the standard of care during in-person visits. This will allow insurance companies to pay the same amount for telehealth visits as in person visits, as they are doing currently because of the pandemic, incentivizing physicians to use the technology. This will be relieving for patients who can be confident in their treatment going forward, as the equal compensation will help ensure that highly skilled, experienced physicians will be willing and able to provide telehealth services. Under this proposal, telehealth will be considered “a tool of medicine” that is used to continue treating the patient after an in-person visit.90
Note that there are two issues within this proposal that would need to be addressed. First, there needs to be a limit as to how long the telehealth visits would be a “continuation” of the initial in person examination. It certainly wouldn’t make sense to allow an in-person visit that took place 10 years ago to continue through telehealth under this theory. Therefore, physicians and legislators must come up with a practical and medically appropriate timeframe that renders the initial visit effective for the future follow-up visits. A simple, once-a-year, in-person examination may be appropriate and hopefully not too burdensome for patients.
The second issue with this proposal is that it contradicts one of the main purposes of telehealth; to increase healthcare access to rural Americans. Requiring an initial in-person examination is counterintuitive and much too onerous for the individuals who need telehealth the most. Therefore, under this proposal, an exception must be implemented.
The Exception: Hawaii Five-O
If it is too taxing or impractical for an initial in-person visit to take place, patients should still be able to utilize this technology and have access to healthcare. Therefore, there must be circumstances in which the in-state licensure requirement can be waived. An exception based on Hawaii’s definition of telehealth will help establish a system that provides healthcare to those that cannot be seen initially in-person. Hawaii’s telehealth regulation states:
Treatment recommendations made via telemedicine, including issuing a prescription via electronic means, shall be held to the same standards of appropriate practice as those in traditional physician-patient settings that do not include a face-to-face visit but in which prescribing is appropriate, including on-call telephone encounters and encounters for which a follow-up visit is arranged.91
Under this framework, telehealth can never be treated as “in-person” care. Rather, it will be held to the standards of a non “face-to-face” visit. This means that although a physician-patient relationship can be formed and prescribing practices will be permitted, the quality of care, and consequently the standard of care, will be lower because it is often difficult for physicians to glean the necessary patient information through a screen.92 Sacrificing the “in-person” standard of care is a worthy compromise if it will finally provide rural patients with access to healthcare that has been lacking.
In order for this exception to be effective, it should include a geographical limitation. For example, patients can only use this mode of telehealth when the closest healthcare provider for their needs is over an hour away by car.
Under this framework, it is unlikely that states and physicians would object to such a practice. First, since this will be a modified, and arguably inferior form of medicine, insurance companies will pay significantly less for the rendering of its services. For many doctors, maintaining an online-only telehealth practice will be economically unfeasible. Therefore, in-person physicians may not worry that their market will be oversaturated. For similar reasons, the states will not have to worry about losing control of the healthcare industry.
Telehealth is no longer a futuristic abstract idea; it is our new reality. Although the pandemic didn’t create telehealth, it did provide an opportunity for its benefits to be displayed on the world scale. Legislators are faced with the difficult task of creating laws that satisfy the needs of multiple players in the healthcare system, including patients, physicians, and the states. This article proposes a compromise solution that may be palatable to all stakeholders by creating a federal statute that requires an initial in-person visit between the physician and patient. This requirement will: 1) allow states to maintain regulation over the industry; 2) provide doctors with the comfort that their industry will not be over-saturated by online-only physicians; and, 3) provide patients with the comfort that they are receiving quality care. Under this model, if an in-person visit is impossible, an exception to the rule will be made, ensuring that rural patients have adequate access to care. The exception would allow telehealth treatment to be conducted even without an initial in-person visit, but this form of telehealth will be considered a modified, and arguably inferior, form of healthcare. Based on Hawaii’s telehealth legislation, the standard of care will be lower, and therefore the prices charged will be cheaper. This will alleviate the concerns of the states and physicians while providing a much-needed service to those in dire need of remote health services.
Most importantly, under this proposal patients like Maki Inada will no longer have to worry about driving three and a half hours to the Massachusetts state line to receive cancer treatment from her car.93 In such a world, Maki would only have to make an initial trip to Boston, and after that, her physicians would be equipped with a tool called telehealth to continue providing her treatment.