In this second part of three, join me to examine some specific considerations and look into current legal precedent relating to malpractice claims involving telehealth.



Unique Considerations in a Telehealth Climate


In part 1 of this three-part Telehealth series, I discussed what exactly telehealth is and identified some broad challenges and considerations that are likely to arise with the increasing utilization of telemedicine. What follow are some specific considerations that merit more in depth discussion:

1. Communication One potential factor that could lead to increased claims involves communication, which is often the root cause of many medical malpractice claims. A 2015 study analyzing more than 23,000 medical professional liability cases concluded that as much as 30% of those cases involved communication difficulties.[8] Of these 30% of cases, 55 % involved a provider-patient miscommunication. Given the inherent often complex nature of medical malpractice claims, and that they often involve weighing a patient’s account of a situation against a treatment provider’s, telemedicine could further complicate this due to the technological component, either where one party is not technologically savvy or where there are issues relating to technology malfunctions. Conversely, tele-ICU setups are uniquely primed to significantly reduce the risk of medical error due to their providing constant, continuous exchange of patient information, where they can fill those times where bedside providers may not be available to communicate with families, patients or other health care providers.

2. Online Diagnosis & Prescribing Flexible or undefined requirements for telehealth can potentially lead to incorrect diagnoses or incorrect prescribing, due to challenges of not seeing a patient in person and conducting a complete physical exam. For example, if a patient sends a picture of a physical impairment, such as a rash, distortion or poor quality could lead to an incorrect diagnosis, which, in turn, could be the basis for a malpractice claim. Practitioners also need to ensure proper clinical evaluation of a patient occurs before prescribing medications, given early court holdings that review of a patient’s online questionnaire, without more, is insufficient to establish a doctor-patient relationship and to support prescribing medications.

3. Informed Consent Informed consent is often an issue in medical malpractice claims that do not involve telemedicine. Because of the absence of in-person interaction, it is imperative that a clear and complete informed consent procedure is established for all telemedicine providers. Best practice for this procedure would involve a written form including: the names, credentials, and locations of every involved healthcare provider; the names, credentials, and locations of any other staff that may help facilitate the telehealth service; and descriptions of every telehealth service that will be performed and the technology that will be used.

4. Applicable Standard of Care Geography plays a significant role when malpractice claims are filed against a physician, specifically with respect to what standard of care is applied to judge a practitioner’s care and treatment. Some states, like Idaho, utilize a community-based standard of care, while other use a uniform state-wide standard or a national standard. Technology enables people to communicate from anywhere; however, standards haven’t yet been explicitly set forth for physicians who give medical advice and virtual care across state lines. Since care is provided in a patient’s state, that state’s laws may well prevail. With the exception of Hawaii, Colorado and Texas, most states have not yet determined a standard of care specifically applicable to telemedicine. It is not hard to fathom that even where a state sets a telehealth standard of care, it may become obsolete quickly due to changes in technology.

5. Cost Savings? Some research has suggested that telehealth can drive significant cost savings. According to an analysis by NTCA – The Rural Broadband Association, telehealth services have been shown to result in annual per-facility savings of $5,718 in travel expenses and $3,431 in lost wages for patients, and $20,841 for hospitals. For rural hospitals, that figure could exceed $100,000. Despite these arguable benefits, barriers exist to more widespread adoption of telehealth, including strict limitations on Medicare reimbursement for telehealth services and various state licensing requirements for telehealth providers.

Other studies, however, have questioned telehealth’s potential to reduce costs of care. A recent study in Health Affairs suggested that while less expensive than in-patient visits, telehealth may actually raise overall healthcare costs by increasing utilization. Nevertheless, a growing number of health systems are now offering telehealth services, as providers are looking for ways to boost care access and quality while cutting costs.

6. Impact on Malpractice Insurance It would be advisable for physicians seeking insurance, and insurers themselves to implement telehealth policies allowing for reporting of facts and circumstances that might lead to a claim, otherwise known as “incident reporting”. A policy with “incident reporting” language allows the insured to report potential claims or bad outcomes as soon as they become known to the insured party, which would prove helpful in telehealth cases given the lack of current legal precedent for these types of claims. The carrier would then bear the burden for that claim after proper notice is given, even if the insured changes carriers before a written demand for damages should occur. Insurers and physicians may also benefit from negotiating specifically how any sexual abuse claims and punitive damages are handled for telehealth insurance coverage relating to medical professional liability coverage.

Additionally, while some malpractice liability policies cover multiple states, most specify that coverage is only available for claims occurring in a specific jurisdiction, which means that a telehealth physician sued in a state other than the one in which he is covered may not be covered.

7. Licensing Most telemedicine providers make reasonable efforts to ensure that a patient is treated by an appropriately licensed professional in the state where the patient is located at the time the telehealth services are provided. While many telehealth providers may be able to confirm patient location via geolocation data provided by the device or conferencing platform used by patients, that may not always be the case.

One can envision a myriad of scenarios in which licensure issues could arise. As a couple of examples, consider a scenarios where a patient begins a video consult in one state while a passenger in a vehicle that then crosses into another state prior to the consult being completed, or a situation where a patient begins a video consult utilizing a virtual private network (VPN) that actively conceals his or her true location for various security reasons, or an event where a physician who is licensed in Idaho but resides in Oregon has a telehealth visit from his or her home with a patient who lives in Idaho.

Telehealth providers using traditional technology, such as a land line telephone, must confirm the exact patient location before matching the patient to a duly licensed professional, and the licensed physician would also be wise to additionally confirm the patient’s location. Most telemedicine providers employ physicians and other professionals that are licensed in multiple states to help address these potential concerns.

Healthcare providers must be aware that some liability policies exclude coverage if a healthcare provider is not appropriately licensed in the state in which the patient is located at the time virtual services are provided. Further, coverage exclusions for treatment rendered by an individual who fails to obtain the proper professional license in the state or locality in which the treatment was provided may also exist in a medical professional liability policy, as well as exclusions for criminal activity, which could be implicated if the practice of medicine without a proper license is deemed criminal in the jurisdiction where treatment is provided.

While current licensure requirements for practicing telemedicine across state lines vary among states, the majority still require a physician to be licensed in the state in which the patient is located. Nine states’ medical boards issue special licenses or certificates related to telehealth that could allow an out-of-state provider to render services via telemedicine in a state where they are not located or allow a clinician to provide services via telehealth in a state if certain conditions are met, while some states have laws that do not specifically address telemedicine licensing but make allowances for contiguous states or for certain situations where a temporary license might be issued, provided the specific states licensing conditions are met.

8. Data Breaches It is axiomatic that medical information, including patient health information, is protected under a number of laws, including HIPAA, the Health Information Technology for Economic and Clinical Health Act, and the Child Online Privacy Protection Act. As is recognized with the use of any internet, cloud-based, or online usage, there is always the potential for data breaches, which pay put patient information at risk of public exposure. Telehealth providers and insurers must be actively aware of this risk and take steps to safeguard confidential and protected information from public disclosure. Additionally, telehealth providers must take extra precaution to not conduct telehealth sessions in areas where patient information could be overheard, seen, or otherwise interpreted by third-parties.




Legal Precedent for telemedicine malpractice claims?

Recent advances in medicine and technology have transformed the way in which patients access health care services. Unfortunately, these same medical advances also pose new complications for traditional medical malpractice claims, such as jurisdictional and procedural issues and duty of care concerns. As of this writing, the legal community has seen very little legal precedence on telemedicine malpractice claims, compared to general medical malpractice actions. The main reason for this lack of precedent is that telemedicine is still a relatively new tool being used in the administration of health care services. Nevertheless, the lack of precedent is likely to be short lived.

The majority of legal actions that have been brought against telehealth providers proceeded as a result of telemedicine practitioners prescribing medications over the internet, rather than actions having been brought because care was negligently administered through telemedicine:

- In Hageseth v. Superior Court of California, a California court asserted jurisdiction over a Colorado-licensed physician criminally charged with practicing without a license where the physician prescribed a generic version of Prozac over the internet to a patient in California who then committed suicide. The doctor prescribed the medicine after the patient filled out an online questionnaire; this was the extent of the doctor-patient interaction. The California Court of Appeals held that California had jurisdiction over the case even though the doctor never physically entered the state, because the defendant intended his acts to have effects in California. See 150 Cal.App.4th 1399, 1417 (2007).

- In U.S. v. Kanner, the defendants owned and operated PharmaCom, an online prescribing company that allowed customers to receive non-controlled prescription drugs over the Internet by answering questions on a medical questionnaire. Physicians never saw the patients, and there was no previous physician/patient relationship. See 2008 WL 2663414 (N.D. Iowa).

- In U.S. v. Hernandez, a Florida physician administered non-controlled substances over the Internet without previously examining the patient. See 07 Crim. 60027 (S.D.FL., Apr. 6, 2009).

Other potential issues include procedural and ‘duty of care’ concerns:

  • Telehealth providers administering care across state lines may have to confront the issue of personal jurisdiction; that is, the state court’s ability to require the defendant (i.e. the physician) to appear in the plaintiff’s (i.e. the patient) home state.

  • In cases involving medical malpractice and telemedicine, the Court will look at the defendant’s presence in the state seeking personal jurisdiction in deciding whether an action can be brought in the plaintiff’s home state, rather than in the defendant’s home state.

  • Choice of law issues may also arise, that is, which state’s law will govern the case. In telemedicine malpractice lawsuits, neither the defendant nor the plaintiff should automatically assume that the laws of the state where the case is being heard will automatically govern the case. Instead, the court may analyze where the event took place, as well as where a majority of the defendant(s) and/or plaintiff(s) reside. As of the date of this post, choice of law has not yet appeared as an issue in telemedicine cases.

  • Duty of care: physicians providing care via telemedicine have the same responsibilities and obligations to their patients as physicians practicing medicine without the use of telemedicine technologies. However, in situations in which the telemedicine practitioner provides a medical consult to another physician at a distance, a physician-patient relationship is not typically established, which may pose unique situations in future litigation.

In Roush v. Southern Arizona Ear, Nose & Throat (Ariz. App. Div., Feb. 13, 2009), a “tortious slander” action was brought against the defendant physician, who during a telemedicine consultation stated, in front of two medical assistants, that the plaintiff’s “problem was never an ear problem” but a “brain disorder” and that his “problem was all in his head.” While not a true medical malpractice case, this case does underscore that telemedicine practitioners are held to the same professional standard of care as practitioners providing care without the use of telemedicine technologies.



--------------

In the third and final part of this telehealth series, I will outline some practical suggestions for facilities, insurers and practitioners, as well as issues for attorneys to ponder, given the overall increasing upward trend in telehealth utilization and in numbers of initiated medical malpractice claims.


Learn More!

Center for Telehealth & e-Health Law (CTeL): www.ctel.org

The American Telemedicine Association: www.americantelemed.org;

The Centers for Medicare and Medicaid Services: www.cms.gov and www.medicaid.gov;

The Telehealth Resource Centers: http://www.telehealthresourcecenter.org/legal-regulatory.

How Telemedicine is evolving to support variety in healthcare delivery: https://www.healthdatamanagement.com/opinion/how-telemedicine-is-evolving-to-support-care-delivery


Footnote

[8] Malpractice Risks in Communication Failures, Crico Strategies Annual Benchmarking Study (2015).


Previous Post | Teleheath: What is it, and what new challenges does it bring?

Telehealth, or the delivery of health -related care, services, education and information through telecommunications technology, is quickly and continually growing into a multi-billion-dollar industry. As its popularity and utilization grows, increasing numbers of medical malpractice claims are likely to arise, and will undoubtedly involve novel legal issues stemming from communication errors, misdiagnosis, prescribing medications, standard of care breaches, malpractice insurance coverage, physician licensing, and data breaches. Follow me for a 3-part series to learn more about (1) what telehealth really is and what new challenges and considerations it generates; (2) current legal precedent relating to medical malpractice claims involving telehealth; and (3) practical suggestions for facilities, insurers and practitioners that can help minimize legal risk.

What is Telehealth?


Telehealth, or the delivery of health-related care, services, education and information via telecommunications technology, which includes videoconferencing, remote monitoring, electronic consults, and wireless communications, is an already widespread practice that continues to grow among employers, patients, and hospitals. Telehealth and telemedicine are often used interchangeably, but telemedicine is a more specific term referring to clinical care delivered by a licensed health-care provider at one location to a patient at another site by means of health information and telecommunications technologies. From video-conferencing with patients in remote locations to monitoring ICU patients from centralized command centers, telemedicine is increasing patient access, improving quality of care, and lowering health care costs.


Telehealth has immense potential to increasingly promote better patient care and faster access to medical services. According to a fairly recent industry report, the global telemedicine market is expected to be a $35 billion industry by 2020,[1] and an $86.7 billion-dollar industry by 2023[2]. The American Telemedicine Association estimates a majority of hospitals now use some form of telemedicine, and the overall number of telemedicine video consultations is expected to increase to about 160 million by 2020—a 700 percent increase over a five-year period.[3] Additionally, the Medicare Telehealth Parity Act of 2015 expanded telehealth coverage to Medicare beneficiaries to include both rural and urban areas, and to streamline the payment system.


Employers are also becoming increasingly onboard with offering telemedicine services to their employers. Estimates suggest that one-third of employer group plans already cover telehealth in some form. A 2014 Towers Watson study concluded that U.S. employers could potentially save up to $6 billion per year if their employees routinely engaged in remote consultations for certain medical problems instead of visiting emergency rooms, urgent care centers and physicians’ offices.[4] Telemedicine providers vary in technological sophistication, and a wide variety of medical specialties are now common offerings of telehealth services. Because telehealth can be provided 24-hours per day from any location, it is often an optimal choice to those seeking care on an alternative basis to traditional physician clinical settings or hospital facilities, or for patients unable to access in-person services due to factors such as distance from providers or nontraditional work schedules.


Telehealth Challenges & Considerations


Studies have suggested that there is little difference between the care given in-person and the care given via telemedicine appointments[5], and medical malpractice-related claims substantiate that data. Further, state and federal government, as well as medical associations, including the American Medical Association (AMA), are encouraging and assisting with the utilization of telehealth. To date, there have been only a handful of reported telemedicine malpractice claims. While this may largely be due to the low number of telemedicine visits as compared to in-person visits, it may also be the case that liability suits have been settled out of court and not reported; even when claims are settled, confidentiality agreements may prevent any information from being disclosed. However, it would be imprudent to turn a blind eye to potential liability issues as telemedicine use continues to grow.


A number of legal and regulatory issues may arise with the use of telehealth, including cross-border licensure, prescribing, credentialing and cybersecurity. Many telehealth skeptics have long argued that the nature of remote or virtual consults would lead to an increased risk for medical professional liability, or medical malpractice claims, given the nature of how telehealth care services are provided, but this argument has not been supported by the data thus far.


The Physician Insurers Association of America (PIAA) published a July 2015 article that compared telephone-treatment medical malpractice claims versus overall medical professional liability results within the PIAA Data Sharing Project (DSP), and found:


• Of the 94,228 total claims in the DSP during the period from 2004-2013, a total of only 196 claims were linked with telephone treatment.


• Of those 196 reported claims, 56 resulted in some form of claim payment.


• The total indemnity loss for related to telephone treatment was only $17 million, compared to $8 billion for the total of all medical professional liability losses in the DSP.


• Telephone treatment claims thus represented only about 0.21% of all medical professional liability losses.


• The average indemnity loss was also lower for telephone treatment at $303,691, compared to $328,815 for all medical professional liability claims within the DSP.


Additionally, a 2014 study by a large multistate, nonprofit health care system that implemented a tele-ICU program in 2006, covering 450 ICU beds across five states, found that the frequency of malpractice claims and incurred costs for critically ill adults were significantly lower at sites with a tele-ICU than at those without a tele-ICU.[6] Nevertheless, as telehealth usage increases, we will likely see a natural increase in medical professional liability claims, and telehealth providers must be prepared to protect themselves from this exposure.[7]

With rising populating of telemedicine, physicians and insurers are increasingly needing to plan how to handle telemedicine from a malpractice perspective. Doctors may be incorrect to assume that practicing telemedicine will raise liability. Theoretically, telemedicine tends to be low liability: telemedicine physicians are more likely to deal with routine checkups and prescription-writing than complex, high-risk procedures. Additionally, rather than simple phone call consultations as would occur between on-call physicians and patients in years past, secure video chat platforms that replace these phone calls often provide a platform to capture notes from the online visit, arguably leading to better documentation and less liability in the event a claim does arise.


-----------------------

In the second installment, I'll discuss specific considerations unique to telehealth, including communication, online diagnosis and prescribing, informed consent, cost-savings, data breaches, and licensing - stay tuned!



Learn More!

Center for Telehealth & e-Health Law (CTeL): www.ctel.org

The American Telemedicine Association: www.americantelemed.org;

The Centers for Medicare and Medicaid Services: www.cms.gov and www.medicaid.gov;

The Telehealth Resource Centers: http://www.telehealthresourcecenter.org/legal-regulatory.


Footnotes

[1] Global Telemedicine Market—Growth, Trends and Forecasts (2016–2021), Mordor Intelligence (Aug. 2016).


[2] Telemedicine Technologies and Services Market to reach US$ 86.7 Bn in 2023, https://globenewswire.com/news-release/2016/07/13/855662/0/en/Telemedicine-Technologies-and-Services-Market-to-reach-US-86-7-Bn-in-2023.html


[3] Telehealth Video Consultations, available at https://www.tractica.com/ research/telehealth-video-consultations/.


[4] Current Telemedicine Technology Could Mean Big Savings, available at https://www.towerswatson.com/en-US/Press/2014/08/currenttelemedicine-technology-could-mean-big-savings.


[5] “Research Outcomes: Telemedicine’s Impact on Healthcare Cost and Quality.” American Telemedicine Association.


[6] Lilly C.M., Kempner K., Eriksson E., et al., Critical Care Telemedicine: Evolution and State of the Art. Critical Care Medicine, November 2014, Volume 42, Number 11: 2429-2436.


[7] Global Telemedicine Market Outlook 2020, RNCOS (May 2015).


Updated: Mar 29, 2019

A recent study from the Penn State Cancer Institute reported that an increasing number of medical malpractice payments now involve claims related to thyroid cancer; states with higher malpractice payouts also had higher rates of thyroid cancer. The thyroid is a gland located in the base of the neck near the “Adam's apple” that aids in managing blood pressure, heart rate, and other functions by creating hormones. As technology has progressed, thyroid cancer has become easier to detect. Fortunately, the majority of thyroid cancer cases can be effectively treated.


In 1973, there were 3.6 cases of thyroid cancer per 100,000 people. By 2014, however, the number of cases nearly quadrupled, rising to roughly 15 per 100,000 people. Unlike for breast, prostate and colon cancer, screening recommendations do not exist for thyroid cancer. Research at the University of Nebraska prior to this study had indicated that, for thyroid cancer, which rarely leads to death, most malpractice lawsuits are related to delayed diagnoses. Other research from Northwestern University, Massachusetts General Hospital and the Mayo Clinic shows that regions with higher rates of malpractice lawsuits have higher rates of unnecessary testing.


The new Penn State study examined state-level data on malpractice payouts from judgments and settlements and thyroid cancer incidence between 1999 and 2012, and also looked at other cancer risk factors, including socioeconomic status and geographic location. The study found that states with higher rates of malpractice payouts also had higher rates of thyroid cancer; the association remained even when the researchers accounted for other thyroid cancer risk factors, such as socioeconomic status; of note, wealthier people are more likely to be diagnosed with thyroid cancer, partially due to better access to health care and screening. In contrast, the study did not find a similar association between breast, prostate, colon and lung cancer rates with malpractice payout rates. For breast, prostate and colon cancer, this could be explained because screening recommendations often help to insulate physicians.


The study explained that its "findings suggest malpractice climate may be a social determinant of being diagnosed with thyroid cancer. Indeed, there are several established social determinants of cancer risk, which have complex behavioral and biological associations. For example, people with lower socioeconomic status have higher incidence of colon cancer, largely because they are more likely to be obese, smoke, and have physically inactive lifestyles, known risk factors for colon cancer. Similarly, lung cancer is more common in those with lower socioeconomic status, much of this attributable to higher rates of smoking. In contrast, men with higher socioeconomic status are more likely to be diagnosed with prostate cancer, in large part because they have greater healthcare access, which leads to more diagnostic testing (i.e. PSA screening and prostate biopsy) and thus more frequent cancer overdiagnosis. Healthcare access does not account for this entire increase in prostate cancer incidence, however, suggesting other mechanisms may be operative. Breast cancer is similar. Women with higher socioeconomic status are more likely to be diagnosed with breast cancer, partly because they have greater healthcare access (including screening mammography) and thus greater risk of overdiagnosis, and partly because they tend to have their first child later in life and fewer children overall, known biological risk factors for breast cancer. Social determinants of health are thus important in understanding cancer incidence."


Indeed, there are several established social determinants of cancer risk, which have complex behavioral and biological associations. . . . Social determinants of health are thus important in understanding cancer incidence. If malpractice climate is a social determinant of thyroid cancer risk, it may partially explain the increase in thyroid cancer incidence seen in the past several decades.

Dr. Joshua Warrick, a researcher at the Penn State College of Medicine and the Penn State Study's lead author, stated that it is difficult to determine why there has been such a massive increase in thyroid cancer incidences, but opined that a likely contributor is that more doctors are practicing “defensive medicine” by ordering more diagnostic testing. Practicing defensive medicine often involves a doctor comprehensively treating a patient and sometimes ordering diagnostic testing beyond what is required by the standard of care in an effort to ensure he is not missing any possible diagnosis or condition; as a result, the doctor may perform procedures that the patient wants or expects even if they aren't clinically necessary. For these reasons, many critics argue that defensive medicine leads to over-testing, over-treatment, and unnecessarily increased healthcare costs because physicians want to prevent bad outcomes, even if highly unlikely. Nevertheless, defensive medicine is increasingly (and often deliberately) used by providers in other areas of medicine, including obstetrics and neurosurgery, in an effort to ward off malpractice lawsuits from patients whose cancer was missed or untimely diagnosed.


According to Warrick, the study’s lead author, most of the extra cases of thyroid cancer are considered overdiagnoses by epidemiologists. “Based on what we know about thyroid cancer outcomes, had we not detected the cancers using our diagnostic tests, most of these patients would never have been bothered by them,” he said. “In most cases, surgery wasn’t necessary to prevent mortality.” Warrick further opined that malpractice payout rates related to thyroid cancer could be a proxy for cultural differences across regions and states: “It’s possible this is not cause and effect directly but rather a marker of culture."


Full study available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6051569/