As Telemedicine Evolves, So Do Policies Aiming to Ensure Patient Safety
Cover Story — July 2014
Tex Med. 2014;110(7):18-24.
By Amy Lynn Sorrel
To James Luecke, MD, and Thomas J. Kim, MD, pictures are worth more than a thousand words. They are worth their patients' very lives.
In the middle of a delivery, Dr. Luecke suspected the baby was in respiratory distress but did not have access to a neonatologist at Big Bend Regional Medical Center in remote Alpine, Texas. So the family physician went down the hall to connect to a subspecialist in Lubbock through Texas Tech University Health Sciences Center's (TTUHSC's) telemedicine program. The neonatologist saw through the video and from x-rays that the baby was in trouble and helped Dr. Luecke stabilize her in time for transfer.
Those pictures not only opened the door to a subspecialist, but they also "saved the baby's life," Dr. Luecke said. "You don't know it's a rash until you know it's a rash. You don't know it's a fracture until you know it's a fracture. In situations where you need help, and you need a visual for somebody who does it every day, that's where telemedicine works perfectly and where it saves lives."
When Dr. Kim was out of town at a conference, the Austin internist and psychiatrist got a phone call from his care team reporting suicidal tendencies in one of his juvenile detention center patients. Dr. Kim quickly determined the youth was upset about a recent court decision. The boy's family was there to testify, and Dr. Kim knew they had a rocky relationship. He told the boy to "pull it together" and he would see him via videoconference the next day.
Because the two had developed a therapeutic relationship via telehealth, Dr. Kim could "leverage his [patient's] trust to engage him at a critical moment and use telehealth to offer a timely response that avoided a costly emergency room visit and an unnecessary potential hospitalization."
That's the thrust of a new Federation of State Medical Boards (FSMB) model policy that aims to create a roadmap for the safe and appropriate practice of telemedicine amid growing interest in the technology. The guidelines — which parallel long-standing Texas Medical Association policy and reinforce existing Texas Medical Board (TMB) rules — say that whether physicians and patients meet virtually or in person, the standard of care remains the same. That means taking appropriate steps to establish the physician-patient relationship for proper evaluation and treatment and following established principles for other key areas of medical practice, FSMB says.
The advisory document for state medical boards says physicians can safely practice telemedicine using a wide range of electronic technologies that include videoconferencing, phone, text, and email interactions. But a provision that has sparked debate goes on to say a telephone call or online visit by itself won't suffice for newly established patient relationships.
Proponents say the growing national attention validates telemedicine's place in today's health care system. Dr. Kim, who prefers the broader term "telehealth," (see "Glossary") describes the model as simply another environment — like clinics or emergency departments — in which physicians treat patients. But different care environments do not mean different care standards.
"We have the opportunity to create all sorts of innovative engagements with patients on the remote end for the betterment of their care, to take care of at-risk populations who aren't cared for at all or so minimally that it costs everyone," said Dr. Kim, who has testified on telemedicine on behalf of TMA before the Texas Legislature. But the first step, he says, "is to establish a therapeutic relationship. To do that, I need a picture, and I need sound. Without both, I do not know how I would be able to render an assessment, opinion, or recommendation, including and especially the prescribing of medications. In my opinion, this is the minimum bar for telehealth care."
But the FSMB policy has sparked criticism from some corners that the restrictions could hinder telemedicine and the thousands of patients it now reaches.
American Telemedicine Association (ATA) Chief Executive Officer Jonathan D. Linkous says the group agrees with "90 percent" of FSMB's guidelines, and most of the group's diverse membership — which includes academic medical centers, as well as hospitals, clinicians, government agencies, vendors, and companies — offers a combination of video and audio services.
But if telemedicine is going to be held to the same standard of care, "treat it the same," he said. Several hundred thousand patients access care using just the phone, and excluding it "would cut down on patient access and what doctors do every day. If you ask consumers if they want to be able to email or talk to their doctor when they have a question, you know what the answer is. This is what they want. Telemedicine is a tool, and we don't think you should have an arbitrary guideline to say you can only do certain things with this tool. We are all concerned about patient safety. But telemedicine is the future, and we hope state boards don't put a cap on that innovation."
Telemedicine Gains Momentum
As telemedicine gains momentum, so does policy interest at the state and federal levels.
Physicians, patients, and policymakers agree the technology can help spur health reform, ease care shortages, and cut down on high health care costs. At the same time, patient, employer, and insurer demands for affordable, convenient access to care have attracted a flood of companies promising to bring medicine directly to the patient via a phone call or virtual online visit. TMA has tracked several new companies expanding their business into Texas.
At the national level, Congress is considering the Telehealth Modernization Act and the Telehealth Enhancement Act, among other bills aiming to define the services and broaden Medicare payment policies, for instance. In February, a group of former Senate leaders created the Alliance for Connected Care to promote policy reform around telehealth, which includes member companies such as Verizon, WellPoint, CVS, Walgreens, Teladoc, and Doctor on Demand.
Meanwhile, Texas and other states have considered their own legislation to open up telemedicine use. TMA testified on a handful of bills introduced during the 2013 legislature, and officials expect the issue to resurface in 2015.
TMA and the American Medical Association are vigilantly monitoring legislative proposals at the state and federal levels to ensure that in all of these discussions, patient safety is paramount. At the same time, organized medicine is working within those bounds to remove potential barriers to appropriate telemedicine use related to licensing, credentialing, and payment.
FSMB President and Chief Executive Officer Humayun J. Chaudhry, DO, says his organization's policy, which included input from every state medical board including TMB and from AMA, is part of an effort by the state regulatory boards to keep pace with the rapidly changing environment of telemedicine. "I'm asked about what impact this will have on the financing and profitability of one technology or industry or another. I have no idea. We don't get into that. Our primary mission is to protect the public and promote patient safety."
The policy redefines telemedicine as care that "typically involves the application of secure teleconferencing … to provide or support health care delivery by replicating the interaction of a traditional encounter in person between a provider and a patient." It is not "an audio-only telephone conversation, email/instant messaging conversation, or fax." Nor does "treatment, including issuing a prescription based solely on an online questionnaire … constitute an acceptable standard of care."
Patient Safety First
Dr. Chaudhry says the updated guidelines reflect the fact that technological advances allow physicians to remotely, but safely, treat patients as if in the same room, but without first requiring an in-person encounter. At the same time, "we do feel that the standard of care for an in-person encounter should be similar to what goes on online."
The policy does not intend to exclude tools like phone and email. But by themselves, "they are going to have a harder time meeting all of the other requirements about the standard of care," he said.
In addition to establishing a physician-patient relationship, those standards include requirements that telemedicine physicians:
- Disclose their credentials and verify the patient's identity and location;
- Perform a documented medical evaluation of the patient before treatment, including obtaining a clinical history, medical records, and informed consent;
- Maintain patient privacy and security; and
- Provide avenues for follow-up and emergency care.
Physicians providing care via telemedicine also must be licensed in the state where the patient is located.
"Everyone talks about how wonderful technology is until something goes wrong. And that resident in one state has little recourse if nobody knows the physician practicing 3,000 miles away," Dr. Chaudhry said. "We are trying to balance the need to support telemedicine with the need to assure patient safety, and we think this is a good approach."
TMB Executive Director Mari Robinson says the federation guidelines closely mirror formal rules Texas has had in place since 2010.
Those rules, developed with input and support from TMA:
- Require a proper physician-patient relationship;
- Define telemedicine as the use of "advanced telecommunications technology that allows the distant site provider to see and hear the patient in real time";
- Allow telemedicine at an established medical site that has the required medical professionals and equipment;
- State that "an online or telephonic evaluation solely by questionnaire does not constitute an acceptable standard of care"; and
- Mandate other specific, written protocols to guard against fraud and abuse.
The state and national developments "recognize the idea that telemedicine has been advancing and has really started to become more readily and widely available as a valid tool to use in treating patients. But there are limiting things about it," Ms. Robinson said. "In our policy, you have to be able to gather objective information about the patient. That is the bottom line. And I am unaware of any way in which somebody speaking over a telephone can gather anything but subjective patient information on things like symptoms and history. The standard of care is the standard of care. Period."
Phone: A Critical Tool
Some telehealth advocates suggest the FSMB policy creates a separate standard for telemedicine that could ultimately harm access to care.
In a May letter, eight patient advocacy groups asked FSMB to reconsider the policy for fear it does "not account for the many safe, secure ways patients are accessing health care today, including audio-only telephone. … Our mutual goal is patient access to safe, secure telemedicine and this may be thwarted if the existing policy is allowed to stand."
In written comments during development of the FSMB policy, ATA agreed that "although there is an important move toward the use of video in providing telemedicine consults, the fact remains that the telephone is an important tool for current patient interactions," and "state policies that prohibit any such use could set back the practice of medicine and significantly limit the delivery of care."
Given the option of phone or video, 95 percent of Dallas-based Teladoc users choose the phone, says the company's Chief Medical Officer Henry DePhillips, MD. The national company contracts with insurers and employers and uses physicians to treat patients over the phone or via secure online video, although Teladoc does not conduct video consultations in Texas.
Excluding the phone could exclude a swath of patient groups, including poorer patients or seniors who can't afford or don't regularly use video-enabled devices, he adds.
"At the end of the day, the care delivered absolutely must meet the standard of care. That said, there are certain common, uncomplicated problems that can get diagnosed and treated appropriately meeting the standard of care without needing an in-person visit" or video, Dr. DePhillips said. He adds the company serves as an alternative for those who cannot access their usual source of care. "We have really worked hard to build a program that has the least amount of interference into the existing physician-patient relationship: If somebody has a relationship today with a primary care physician and can't get in to that physician timely, we are another option."
Teladoc treats minor illnesses, like sinusitis, for which he says diagnoses can be made primarily based on patient history. The company collects that information through a combination of web- and phone-based patient interactions and electronic health records, which it can access as an employer-sponsored service.
(Teladoc disagrees with TMB rules, and the two are tangled in ongoing litigation. See "Digital Diagnosis," June 2013 Texas Medicine, pages 16-22.)
Dr. DePhillips also pointed to a 2014 RAND Corp. study published in Health Affairs showing the company has safely used the services to expand access to care, particularly for younger patients without a usual source of care. Researchers also found using Teladoc to replace at least some emergency and office visits could generate savings for health plans.
But the same study concluded that such services could lead to "unintended consequences, such as fragmentation of care," and the impact "on quality of care is unclear."
A Jan. 14, 2013, report published in the Journal of the American Medical Association also showed mixed results for e-visits: Physicians ordered fewer tests but were more likely to prescribe antibiotics, compared with office visits.
Ms. Robinson says patient demand should not trump patient safety.
And while Dr. Kim agrees the phone is an important tool for all physicians, as are what he called other "single-mode" technologies, such as secure messaging and email, that exist to support care delivery, "people need to understand the risks, benefits, and appropriate use of these technologies." He says they can work, for example, as part of a broader telehealth model design and for those willing to pay for the convenience. "But don't call it a therapeutic relationship. And as for a stand-alone solution, I fear we would swing the other way and continue to offer limited support to patients."
Nor is telehealth an easy proposition.
As chief medical officer and chief medical information officer for the Houston-based Brighter Day Health, Dr. Kim manages the technology and operations involved to ensure successful care delivery. That success also means "redefining how you communicate and work with people remotely," he said, adding that continuity of care also is important. "I specifically design my clinics so I can tell my patients, 'I'll just see you next week.'"
That meant one incarcerated 15-year-old girl could see Dr. Kim weekly, instead of waiting in long lines for an appointment at a community mental health center.
Debbie Voyles, director of TTUHSC's telemedicine program, adds that privacy and security can be concerns with telemedicine. To address those concerns, the program has a number of protocols in place: Patients visit an established medical site, which could be a school or a rural-based clinic where they routinely seek care. Care teams document the visit. Patients sign consent forms and provide copies of identification and insurance cards.
"The people on the other end know who the patients are, and the patients know them. That's where our security is built in to make sure we are appropriately treating," she said. "Taking a credit card for $39 to treat or prescribe a medicine based on a survey you fill out or a phone conversation? I don't think that's good quality care."
Licensure, Credentialing Barriers
Despite the benefits of telemedicine, some regulatory and legislative barriers still exist.
For one, because telehealth programs typically involve physicians treating patients in different geographical locations, state licensing restrictions can deter adoption. Dr. Kim recently submitted his 14th medical license application. He works in several states for his multistate company.
He's encouraged, however, by FSMB's proposal for an interstate medical licensure compact that would allow physicians to practice in multiple states without having to go through each state's individual licensure application process. State boards would mutually agree to a common set of requirements to help streamline licensing, but participation would be voluntary.
Dr. Chaudhry says the proposal, more than a year in the making, is not exclusive to telemedicine. But demand for the technology bolstered support for the idea.
Neither TMA nor AMA has taken a position on the compact, but AMA is working with state medical associations and FSMB as it's developed.
Some physicians have expressed concern such a compact could undermine states' licensing and disciplinary authority, especially in Texas, which has some of the toughest licensure rules in the country.
As proposed, however, Ms. Robinson says the compact would include eligibility requirements that exceed Texas rules, by requiring board certification, for example. Other standards would mandate a clean criminal, state licensure, and prescribing history.
TMB recently decided to move forward in discussing the idea, which would require a statutory change, with lawmakers. If physicians don't meet the heightened licensure standards, nothing prevents them from pursuing a license the old-fashioned way by going through each state's full application process, Ms. Robinson adds.
The compact would not require federal approval but has garnered some congressional support.
The move also could help streamline hospital credentialing policies to promote telemedicine.
In 2011, the Centers for Medicare & Medicaid Services (CMS) and Joint Commission promulgated rules allowing hospitals using telemedicine to rely on credentialing conducted at the distant facility where the physician is located when making local credentialing decisions.
But TMA officials say some physicians report hospitals still frequently require complete credentialing, even when doctors in another geographic location only deliver services via telemedicine.
As one of a number of payers that recognize telemedicine's benefits in increasing access and decreasing costs, Texas Medicaid is researching the credentialing barriers, as well as others, through its Quality Based Payment Advisory Committee. TMA and the Texas Hospital Association are working with the committee to help develop a uniform approach to telemedicine credentialing in line with CMS and Joint Commission regulations and state rules.
Committee Chair Mary Dale Peterson, MD, says part of the problem may stem from the fact that hospitals must rewrite their bylaws to incorporate telemedicine and the new CMS rules, and many have not done so. She also heads the children's Medicaid managed care plan Driscoll Health Plan, which contracts with The University of Texas Medical Branch at Galveston to provide child psychiatry telemedicine services to medical professional shortage areas in South Texas.
Seeking Payment Parity
Medicaid and TMA also are looking at possible payment barriers.
While the state revised Medicaid rules to eliminate rural requirements for telemedicine payment, Medicare has not, and it only covers certain services, Dr. Peterson says.
The discrepancy could pose problems when it comes to providing telemedicine services for dual-eligible patients in Medicare and Medicaid, for example.
"Telemedicine is a tool physicians can use to improve access to care not only in rural areas but also in urban areas for people who have difficulties with transportation," she said, adding Driscoll also supports tele-dermatology and sees both rural and urban shortages for pediatric specialists.
But Dr. Peterson agrees, "We have to do this safely."
Medicaid rules also say telemedicine means "the use of interactive telecommunications equipment that includes, at minimum, audio and video equipment," according to Medicaid.gov.
Dr. Peterson says Medicaid managed care plans have leeway to pay for telehealth services, but the fee-for-service rates on which the state bases managed care plan payments are inadequate.
On the commercial side, rates tend to vary, but Ms. Voyles says health plans largely have adopted the same payment rules for telehealth services as for conventional care. Texas is one of 20 states that require private insurers to cover telehealth services as they do in-person care.
However, in 2013 testimony before the Texas House Insurance Committee, Dr. Kim cautioned against insurers who contract under exclusive relationships with vendors that provide after-hours telephone access to physicians, while disallowing payment for the same activity among community physicians. House Bill 2017 by Rep. Four Price (R-Amarillo) would have required payment parity for such telephone consultations — without altering the standard of care under Texas' regulatory and statutory framework for telephonic services, specifically demonstrating an established physician-patient relationship, Dr. Kim testified.
On the contrary, TMA physicians testified against two other telemedicine bills introduced last session — House bills 1806 and 830 — that were inconsistent with care standards.
When 32 Texas counties have no practicing physician at all, and 12 counties have no physician, no nurse practitioner, and no physician assistant, "we have to be flexible enough to figure out how to take care of patients where they are," Ms. Voyles said. "But ultimately, patient safety has got to be the priority."
Amy Lynn Sorrel can be reached by telephone at (800) 880-1300, ext. 1392, or (512) 370-1392; by fax at (512) 370-1629; or by email.
- Connected care: An evolving term used to describe telemedicine or telehealth activities.
- Telehealth: Refers to a broad scope of remote health care services that may include clinical care but also encompasses educational and administrative components, according to the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA).
- Telemedicine: Refers specifically to the delivery of remote clinical services. Telemedicine is not considered a separate medical specialty.
- Telemonitoring: The process of using audio, video, and other telecommunications and electronic information processing technologies to monitor the health status of a patient from a distance.
- Uses and applications: Technologies include videoconferencing, the Internet, store-and-forward imaging, streaming media, and land and wireless communications, according to HRSA. The American Telemedicine Association considers patient consultations via video conferencing, transmission of still images, e-health including patient portals, remote monitoring of vital signs, continuing medical education, consumer-focused wireless applications, and nursing call centers part of telemedicine and telehealth.
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Telemedicine by the Numbers
- An estimated 10 million people use some form of telemedicine, a number projected to double in the next few years.
- More than half of all U.S. hospitals use telemedicine, most often for radiology, stroke, and intensive care unit services.
- 20 states (including Texas) and the District of Columbia require private insurers to cover telehealth as they do in-person services.
- 43 states (including Texas) and the District of Columbia provide some form of Medicaid payment for telehealth services.
- 9,748 Texas Medicaid patients received telemedicine services in 2011, a 113-percent increase from 4,269 patients in 2009.
Sources: American Telemedicine Association, Texas Health and Human Services Commission, National Conference of State Legislatures
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