A discussion of telehealth is important both in terms of telehealth’s potential to improve patient access to care and because of uncertainty over its future after the COVID-19 Public Health Emergency (PHE) ends.

The Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) defines telehealth as “the use of electronic information and telecommunication technologies to support long-distance clinical health care, patient and professional health-related education, health administration, and public health.”

Telehealth includes the use of internet, land and wireless communications, video conferencing, and streaming media for synchronous two-way communication. It can also include so-called store-and-forward or asynchronous communication for the secure transmission of x-rays, scans, photos, lab results, etc., a practice most used in radiology, pathology, and ophthalmology.

The Office of the National Coordinator for Health Information Technology specifies that telehealth differs from telemedicine “because it refers to a broader scope of remote healthcare services.”

Background

Physicians recognized the potential to diagnose illness and prescribe care remotely in real-time almost immediately after the invention of the telephone in the 1870’s. In separate letters to the editor of The Lancet in 1879, writers envisaged the use of the telephone, rather than the stethoscope—another 19th century invention—for auscultation.[1]

In 1910 the editorial staff of The Lancet suggested the combined use of the telephone and stethoscope, observing that it was “possible for the physician, say, in London to examine a patient, say, in the country stethoscope topically, and to arrive at a correct diagnosis.”[I]

Historically, healthcare has been quick to adopt emerging communication technologies. In the 1920’s, physicians at Norway’s Haukeland Hospital used radio links to provide consults for crew members of ships at sea. In the 1950’s, physicians at the University of Nebraska communicated with patients at the Norfolk State Hospital in Nebraska via a two-way closed-circuit microwave link. This, in turn, inspired a National Institute of Mental Health-funded project to establish a closed-circuit link between Dartmouth Medical School’s Department of Psychiatry and a rural hospital in New Hampshire.

Telehealth as it is currently understood—using computer technology and the transfer of information over the internet—was made possible by the development of the internet and Transfer Control Protocol/Internetwork Protocol (TCP/IP) in the 1980’s and HyperText Markup Language (HTML) in 1993. With the internet offering a framework for the transfer of information and personal computers becoming comparatively affordable, there was a rapid growth in number of websites: from 130 in 1993 to over 100,000 in 1996. According to HRSA’s Office for the Advancement of Telehealth, “telemental health” programs grew from nine to over 100 in the same period.

Before 2020, the telehealth landscape was shaped incrementally by technological advancements, state and federal policy, and consumer preferences. Adoption of telehealth was steady, but slow. In 2019 a JD Power survey of healthcare consumers found that just 10% had ever used telehealth services.

Telehealth and the provider/patient relationship

The technological advancements which laid the foundation for telehealth closely followed important changes in the psychosocial understanding of the provider/patient relationship in Western medicine.

From the mid-18th century onward, the relationship between a physician and a patient had been asymmetrical in terms of both knowledge and authority. Guided by the Hippocratic principle of beneficence and bolstered by their access to emerging scientific evidence, Western physicians generally came to assume a paternalistic relationship with their patients. Physicians typically focused on disease or injury and made decisions for “the patient’s own good” separate from any understanding of, or personal relationship with, the patient.

The shift from a paternalist model to the patient-centered model of care, which is the stated—if not realized—ideal of today’s Western medicine, can be traced to the work of Michael Balint in the 1950’s and ‘60’s. Balint and his colleagues believed that “the most frequently-used drug in general practice was the doctor himself”[iii]and advocated for a holistic model of care delivery that focused on the patient rather than the disease.

In Crossing the Quality Chasm, the Institute of Medicine (now the National Academy of Medicine) defined patient-centered care as “providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.” As the name suggests, in a patient-centered care model, the healthcare provider’s focus is on the patient rather than the illness. It emphasizes the value of two-way communication, a team-based approach to health management, and shared decision-making. There is evidence that the patient-centered care model can have a positive impact on quality of care and patient satisfaction, while decreasing rates of hospitalization and emergency department use.

However, patient-centered care can also be time-consuming and disincentivized by fee-for-service reimbursement models. Telehealth advocates believe that telehealth has the potential to advance patient-centered care, beginning with the scheduling of appointments at a patient’s preference. Patients communicating from the comfort of their chosen space, in the presence of selected friends and family members as team members and advocates, may feel greater agency. Telehealth also offers providers the opportunity to “meet patients where they live.”

Commercialization of telehealth

Telehealth has presented new opportunities for investors and a new entry point to the healthcare sector. One of the earliest telehealth-specific companies was Teladoc, which was founded in Texas in 2002, by Michael Gorton, an entrepreneur and adjunct professor of astronomy at Richland College in Dallas. Teladoc began by offering cost effective flat-rate healthcare consults for individuals by telephone. The company also contracted with employers and health insurance companies who were, in turn, able to offer their employees or members the option of a virtual healthcare visit as an employment perk or insurance benefit.

Teladoc noted and leveraged the decrease in the number of Americans reporting an established relationship with a primary care provider, even after the passage of the Affordable Care Act. Teladoc offered individuals without a medical home almost immediate access to “a national network of board-certified physicians.” Its business model attracted investments from HLM Venture Partners, Cardinal Partners, and Trident Capital before the company went public on the New York Stock Exchange in 2015. Today Teladoc is contracted with major commercial insurers including Aetna and Centene. Teladoc services are available through some Medicare Advantage and Medicaid managed care plans.

Medical professional organizations and telehealth

The American Medical Association (AMA), the American Academy of Pediatrics (AAP), and the American Association of Family Physicians (AAFP) have been on record in support of the expansion of telehealth programs and funding since before the pandemic.

In a policy statement issued in January 2015 and reaffirmed in August 2019, the AAP’s Committee on Pediatric Workforce stated that “when used appropriately, telemedicine can be used to connect patients to needed, yet otherwise inaccessible, high-quality care.” Importantly, AAP specified the value of telehealth within—and as a means of expanding the reach of—a patient-centered medical home model.

AAFP echoed this support for telehealth as part of an established relationship with a healthcare provider within a traditional context in its call for “incentives for patients to seek telehealth services from their usual primary care physician when possible, rather than from those with whom they have no ongoing relationship.”

The statements from AAP and AAFP reflect concern on the part of both individual practitioners and healthcare systems over the competition posed by the entry into the telehealth space of large tech companies including Alphabet, Amazon, and Apple, as well as niche providers such as Musely and Betterhelp.

Some individual providers and state medical societies have purportedly tried to limit competition in telehealth by seeking legislation to require medical licensure in the state in which telehealth care is provided. In a statement delivered to Congress in March 2021, the American Medical Association stated unequivocally that “(the) AMA believes that it is essential to ensure that physicians and other health care providers are licensed in the state where the patient is located to provide telemedicine services in a secure environment.” However, states also have a vested interest in protecting their public’s health through effective oversight from state licensure.

Federal direction

The federal government has shaped telehealth through legislation, funding initiatives, and Medicare payment policy.

The Health Insurance Portability and Accountability Act of 1996 [Pub. L. 104-191] (HIPAA) is best known for specifying security and privacy protocols for protected health information (PHI). However, HIPAA also called for CMS to complete an “ongoing study of Medicare reimbursement of all telemedicine services and submit a report to Congress on Medicare reimbursement of telemedicine services.”

The Balanced Budget Act of 1997  (BBA) played a key role in promoting telehealth programs by mandating the establishment of Medicare reimbursement for some forms of telehealth care and requiring funding for telehealth demonstration projects.

Specifically, the BBA provided for payment to physician or qualifying practitioner providing care to a patient in a region “designated as a health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A)), notwithstanding that the individual physician or practitioner providing the professional consultation is not at the same location as the physician or practitioner furnishing the service to that beneficiary.”

The BBA was critical in CMS’s specification of what qualifies as an originating site—the physical location of the patient during delivery of telehealth care—for reimbursement under Medicare Part B. Qualifying sites may include physician offices, hospitals, critical access hospitals (CAHs), hospital-based or CAH-based renal dialysis centers, federally qualified health centers (FQHCs), rural health centers, skilled nursing facilities, mobile stroke units, and community mental health centers. HRSA’s Medicare Telehealth Payment Eligibility Analyzer allows for quick confirmation of the geographic eligibility of an originating site.

Importantly, except for patients with end-stage renal disease receiving dialysis at home, a patient’s home does not qualify as an originating site for Medicare Part B reimbursement under pre-PHE policy.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act [Public Law 115-271] (SUPPORT for Patients and Communities Act) included provisions for the expansion of the use of telehealth services in both Medicare and Medicaid programs for the treatment of opioid use disorder and other substance use disorders.

Federal laws are generally silent on telehealth delivery methods in Medicaid programs. As a result, individual states have exercised broad discretion in the incorporation of telehealth services in Medicaid, while meeting federal requirements of efficiency, economy and quality of care. A 2019 review showed that Medicaid programs in all 50 states and the District of Columbia had provisions for the reimbursement of telehealth services. Notably, states had the flexibility to cover and pay for Medicaid audio-only telehealth services even prior to the PHE and will continue to have this flexibility after the PHE’s end.

Privacy and security

Patients, providers, payers, and state and federal governments have expressed concern over the security of telehealth-specific platforms and the exchange of PHI over the internet. The risk of data breaches and security gaps and associated costs was an obstacle to widespread adoption of telehealth before the pandemic and will continue after PHE waivers are lifted.

The Health Information Technology for Economic and Clinical Health Act (HITECH), part of the American Recovery and Reinvestment Act of 2009, encouraged the “meaningful use” of electronic health records through incentive payments under Medicare and Medicaid. It also addressed privacy and security concerns associated with the electronic transmission of health information.

Subtitle D of the HITECH Act addresses the privacy and security concerns associated with the electronic transmission of health information, in part, through several provisions that strengthen the civil and criminal enforcement of the HIPAA rules.

HIPAA requires the encryption of identifiable health information by “covered entities.” Prior to the pandemic, healthcare providers were regularly reminded of their responsibilities in the storage and transmission of any PHI and to protect themselves by having formal business agreements in place with all business associates. Under HIPAA, a protected entity—which may include a health plan, health care clearinghouse or provider—can face a penalty of up to $50,000 per breach of PHI, up to a maximum of $1.5 million per year per violation. This can include breaches on the part of business associates. Understandably, this made providers particularly circumspect in their adoption of and approaches to telehealth.

Importantly, patients are not considered covered entities. When HHS’ Office of Civil Rights (OTC) announced enforcement waivers for telehealth during the PHE, the security landscape changed dramatically. Providers who had selected telehealth platforms with an emphasis on HIPAA compliance were advised that they could conduct patient visits using “any non-public facing remote communication product that is available to communicate with patients.”

Among the key security issues identified among telehealth providers are malware infections and a failure to regularly install software security patches.

Telehealth and health equity

A key promise of telehealth is its potential to connect patients with specialists whom they might otherwise not be able to see. Proponents of telehealth expansion say that it can help address inequities in access to care, especially in rural areas. But, ironically, the same populations most likely to have difficulty accessing healthcare—lower income households, racial or ethnic minorities, and those living in rural or frontier regions—also have difficulty accessing telecommunications resources.

While a study published this week in Health Affairs concluded that Medicare beneficiaries in disadvantaged neighborhoods increased telemedicine use during the pandemic, the Pew Research Center has previously found significant differences in broadband access and computer ownership by race and ethnicity. Hispanic and Black populations are more likely than Whites to report relying upon smartphones rather than computers for internet access.

The New England Journal of Medicine has cited research and anecdotal evidence that implementation of telehealth programs increases disparities in the provision of care. The AMA has identified broadband internet access as a social determinant of health and actively supports funding for “broadband internet infrastructure in rural areas and support for under-served urban communities and households to gain access to affordable internet access.”

Telehealth and the pandemic

The onset of the COVID-19 pandemic required that healthcare providers make a rapid pivot between models of care delivery. This happened concurrent with evolving regulatory and policy changes on the part of federal and state governments, as well as private payors.

On March 18, 2020, HHS and the Office for Civil Rights (OCR) issued a public notice stating that “OCR (would) not impose penalties for noncompliance with regulatory requirements under the HIPAA rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.” This policy flexibility allowed providers to use such non-public-facing communication platforms as Facebook Messenger, Zoom, and Apple’s FaceTime in telemedicine.

Under an interim final rule released on March 30, 2020, CMS added telehealth coverage for 80 additional codes, including emergency department visits. The agency noted the importance of assuring that “physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics (RHCs), and federally qualified health centers (FQHCs) (were) allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks to health care providers, patients, and the community.” It also instructed providers to report the place of service (POS) code “that would have been reported had the service been furnished in person.”

April 2020, CMS issued exemptions specific to the delivery of  “services and treatment for (substance use disorder) under Medicaid delivered via telehealth, including assessment, medication-assisted treatment, counseling, medication management, and medication adherence with prescribed medication regimes.”

CMS also approved telehealth flexibilities for state Medicaid and the Children’s Health Insurance Program (CHIP) programs through section 1135 waivers. These included the use of non-HIPAA compliant platforms including Facetime, WhatsApp, and Skype for telehealth visits in requesting states, waivers of face-to-face encounter requirements for FQHCs and RCHs in California, and approval of the use of telephones rather than computer technology for the delivery of care in Maryland’s Medicaid and managed care programs.

Telehealth in home health and hospice

Telehealth’s ability to link clinicians and patients remotely would seem to hold special potential in home health. Yet, its adoption within the discipline has been inconsistent because of federal regulations and wide-ranging reimbursement models on the part of private payers.

CMS defines home health as inclusive of a variety of healthcare services for illness or injury delivered in a patient’s home rather than a hospital or skilled nursing facility, with coverage provided under Medicare Part A. Home health includes the provision of wound care, intravenous therapy, and administration of injections—all very much “hands on” procedures. But home health also encompasses patient and caregiver education, patient monitoring, and care coordination, each of which can be accomplished remotely.

Under current CMS policy, home health care agencies (HHAs) may conduct telehealth visits with patients as part of a plan of care developed by a qualified provider. However, the visits are not reimbursable under Medicare Part A. Nor can telehealth visits be counted towards an HHA’s low-utilization payment adjustment (LUPA), under which reimbursement is recalculated from a payment episode to a generally lower per-visit payment structure.

Waivers during the PHE have allowed hospice providers the ability to use telehealth to conduct encounters for recertification. A preliminary review of virtual recertification visits indicates that they are as efficient as face-to-face encounters and reach comparable levels of satisfaction on the part of providers, patients, and caregivers.

Advocacy groups and lawmakers point to the potential of telehealth to expand home health access as the country faces a constricting healthcare workforce and aging population. The National Association for Home Care and Hospice, the National Council for Hospice and Palliative Care, and the American Academy of Hospice and Palliative Medicine have joined in calling for the expansion of telehealth in the provision of home health and hospice care. Proposed federal legislation including the bipartisan CONNECT for Health Act would permanently expand telehealth in hospice. We can expect that data collected during the extension of PHE waivers will be critical in determining the future of telehealth in home health.

Audio-only telehealth

A key policy question in telehealth is whether it includes all means of telecommunications or only video-enabled visits between providers and patients. While CMS extended acceptance of audio-only visits under the PHE, there is uncertainty as to future policy. Many states have legislation under which audio-only or “telephonic care” does not qualify for reimbursement or is reimbursed at lower rates than video visits. In some instances, the onus is on providers to demonstrate that audio-only is the only available option for remote care delivery.

Under legislation passed earlier this year in Tennessee, a healthcare provider seeking reimbursement for an audio-only encounter must confirm and maintain documentation that a patient does not own the technology necessary to complete a video visit, is at a location where a video visit is not possible, or has a physical disability prohibiting their participation in a video visit.

Advocates of reimbursement for audio-only visits point to gray areas in the definition of access. If an individual typically accesses the internet through a public space—a coffee shop, fast food restaurant, or library, for example—can they reasonably be expected to conduct video visits with healthcare providers in these locations?

Proposed legislation in Hawaii specified that “‘[t}elephonic service’ does not constitute telehealth,” echoing existing state statute that “standard telephone contacts … [do] not constitute telehealth[.]” While the bill would “permit, but not require, Medicaid, insurance providers, and health maintenance organizations to cover telephonic behavioral health services under certain circumstances[,]” the bill specifies that telephonic behavioral health services may only be covered when, among other things, “[t]elehealth services are technologically unavailable at the time enrollee is scheduled to receive a behavioral health service.”

The Hawai’i Psychological Association requested a clarification of the term “technologically unavailable,” asking if the category included elderly patients hindered by vision issues and limited manual dexterity or those with anxiety about video platforms. The Hawaii Primary Care Association argued that restricting telehealth to video visits and, therefore, to individuals with computers and broadband access, made it more likely that historically marginalized populations would ultimately seek care through emergency departments.

In a statement delivered to the House Subcommittee on Health of the House’s Committee on Energy and Commerce in 2021, the American Hospital Association (AHA) advocated for the extension of waivers allowing for the payment of audio-only telehealth services. In addition to citing concerns over disparities in access to equipment and the internet, the AHA noted the importance of an audio-only option in instances of the more mundane, but common problem of dropped video connections.

More data may help establish the efficacy of audio-only care, but the opportunity to gather it was missed when CMS extended flexibilities under the PHE without requesting specificity in delivery models. In its March report to Congress, the Medicare Payment Advisory recommended that CMS require clinicians to use a claims modifier to identify audio-only telehealth services in order to make it possible to gather information regarding the modality’s clinical benefit in comparison to audio-visual communications.

Fraud, waste, and abuse

Telehealth currently comprises between 13 to 15 percent of utilization across medical specialties. As telehealth has grown as a proportion of a sector that represents nearly one fifth of the country’s GDP, so has the potential for fraud and abuse. In a single announcement last September, the U.S. Department of Justice announced that it had charged 138 defendants with healthcare fraud totaling $1.4 billion in losses. Nearly 80 percent ($1.1 billion) of this was attributed to telehealth.

Acknowledging the potential of telehealth to improve “care coordination and health outcomes” Christi A. Grimm, HHS-OIG Principal Deputy Inspector General, has also noted that her office’s assessment of telehealth fraud and abuse during the public health emergency will inform her recommendations regarding making the telehealth flexibilities extended during the public health emergency permanent.

Business competition in telehealth

Telehealth has become a commodity and given its digital nature and potential financial footprint; it is not surprising that large tech players are making significant investments in the telehealth space. Chief among these is Amazon. The Amazon Care program, which is now available in select cities including Washington, D.C.; Austin, Texas; and Seattle, Washington, offers personal care and prescription delivery through a hybrid model. Based upon an initial virtual consultation, an Amazon Care provider may dispatch a nurse to a patient’s home to collect blood samples or conduct other tests as indicated.

In February, Amazon announced a collaboration with Teladoc which will enable Amazon’s voice-activated Echo Dot to be used to initiate general medical virtual care. According to promotional material, Amazon customers will be able to request a visit with a healthcare provider simply by saying, “Alexa, I want to talk to a doctor.”  The cost per visit is expected to range from $0 for beneficiaries of participating health plans to $75 for those without participating insurance.

Technological expertise may put companies such as Amazon, Alphabet, and Apple at advantage in the telehealth market, while traditional healthcare providers scramble to understand and finance their tech needs within an evolving regulatory environment. In a 2017 survey of hospital executives, the American Hospital Association found that telemedicine was a top-five priority, but half of respondents reported that they were hesitant to adopt new technologies because of associated costs or concerns over operational burdens.

The question of whether an investment in technology is worthwhile is valid. Trilliant Health recently described the telehealth market as “already oversupplied” and suggested that providers should not invest in telehealth programs in the expectation of downstream revenue or consumer loyalty. Of course, the great unknown in any discussion of telehealth is whether the waivers granted during the public health emergency will be extended.

The regulatory future

There is uncertainty as to telehealth’s future immediately after the end of the PHE and in the long-term. Change will not be immediate. The FY 2022 Omnibus spending bill includes provisions for the extension of Medicare telehealth flexibilities for five months after the end of the PHE.

Testifying before the Senate Finance Committee in April, HHS Secretary Xavier Becerra stated that the Biden Administration was “committed to supporting a temporary extension of broader telehealth coverage under Medicare beyond the declared COVID-19 Public Health Emergency to study its impact on utilization of services and access to care.”

The Alliance for Connected Care, an advocacy group whose members include Walmart, AWS (Amazon Web Services), and Johns Hopkins Medicine, currently lists over 40 pieces of legislation specific to telehealth pending in Congress. The majority of these have bipartisan support.

The millions of Americans who first used telehealth during the pandemic came to know it in its least restricted form. As waivers end, clinicians and healthcare systems will no longer be able to offer patients the options of using non-HIPAA compliant platforms such as FaceTime. Additionally, as states have rolled back COVID-19 restrictions, many have let waivers for telehealth lapse. The result is a telehealth landscape that looks very much like that from before the pandemic without incorporating the lessons learned.

It remains to be seen what aspects of the enthusiasm for telehealth as a point of access to care in an emergency will survive the country’s transition to a post-pandemic reality.

 

[1] Auscultation involves the listening to the internal sounds of the body as part of a medical exam.
[i] “The telephone as an aid to diagnosis.” The Lancet 175, 1910-05-07
[ii] Balint, Michael. “The doctor, his patient, and the illness.” The Lancet 265, no. 6866 (1955): 683-688