Telemedicine Legal Issues You Should Know: Medical Malpractice

Since the emergence of COVID-19, the Centers for Medicare & Medicaid Services (CMS) engaged in an unprecedented effort to utilize telemedicine as one of the primary weapons against the disease. Among numerous other steps, CMS waived the originating site requirement, expanded the list of telehealth codes for which providers can be reimbursed, and equalized payment rates between in-person (facility) and telehealth visits.¹ The Federal Trade Commission, the Drug Enforcement Administration, the US Food and Drug Administration, and numerous other federal and state agencies have also issued guidance, announced programs, and procured funding to better support the use of telemedicine.^2-4 As a result, telemedicine usage has reached critical mass as between 50% and 70% of all physicians have integrated telemedicine platforms to communicate with patients.^5,6 Prior to COVID-19, telemedicine usage and overall buy-in within the medical communication was <30% primarily because of state licensure barriers, payer reimbursement restrictions, Health Insurance Portability and Accountability Act (HIPAA) patient data privacy requirements, and practitioner concerns about malpractice.⁷

Accordingly, there has been a paradigm shift where urologists are able to provide safe and effective care without the necessity of an in-person patient exam. We estimate that approximately 60% of urology patients in some way or another can be managed using telemedicine. However, with limited physical interaction with the patient, this will trigger both professional regulation and the potential for increased liability.

FAIR Health, the nation’s largest repository of private medical claims data, reported that telemedicine malpractice claims in the Midwest region grew 4.86% in June 2020 compared with June 2019 and 5.19% in the South region during the same time period.⁸

This article discusses recent changes to telemedicine guidelines in the midst of COVID-19 and when a urologist should consult a healthcare attorney who is familiar with the legal concept of medical malpractice and telemedicine regulatory requirements.

Medical Malpractice and Telemedicine

Medical malpractice and medical negligence are 2 very different, but interrelated, concepts. These concepts also have to coexist with the telemedicine regulations that can lead to medical negligence, deviation from the standard of care, and/or practicing outside one’s specialty. This creates a problem because not only does a urologist have to adhere to the standard of care and scope of practice as it applies to traditional brick-and-mortar care, but also as it applies to a virtual encounter and whether the virtual care can be appropriately rendered remotely. In addition, urologists need to be familiar with their state’s telemedicine regulations and what is needed to create the physician–patient relationship through a virtual platform. A urologist’s failure to strictly adhere to his or her state’s regulatory mandates increases the risk of licensure violations in addition to malpractice liability. This leads to an array of legal issues regarding malpractice liability and the underlying concepts of standard of care and scope of practice when it comes to telemedicine. As restrictions for the use of telemedicine are lifted by legislators, as occurred in March 2020, and insurance companies are reimbursing telemedicine virtual visits at the same rate as in-office care, healthcare providers will have to take charge of defining the standard of care in their particular specialty and community as it applies to the use of telemedicine and devise ways to mitigate these issues.

What constitutes negligence that leads to medical malpractice in urology practice? Medical negligence is defined as care by a doctor which causes harm to a patient unknowingly, either through simple ignorance or failing to take action where it is needed; it is only one element of medical malpractice. Negligence is an act or omission (failure to act) by a medical professional that deviates from the accepted medical standard of care.⁹ The concepts of medical negligence and medical malpractice are critical when it comes to telemedicine. The central question in most medical malpractice cases is whether the provider complied with the generally accepted “standard of care” when evaluating, diagnosing, or treating a patient. This standard typically takes into consideration the provider’s particular specialty—in this case urology—as well as all the circumstances surrounding the consultation.

Physicians or medical providers usually define the standard of care for medical professionals in their own particular specialty. Narrowly defined as it applies to in-person visits by a physician, the medical “standard of care” usually means the degree of care and skill of the average healthcare provider who practices in the provider’s specialty, taking into account the medical knowledge that is available in the field. This standard can be community- and locality-based. Furthermore, in most states, the law is well established that the medical professional (medical boards) define the applicable standard of care and scope of practice in any particular circumstances in patient care. However, during the COVID-19 pandemic, legislators and not healthcare providers have defined the use and concepts of telemedicine and consequentially the concepts around medical malpractice as it pertains to telemedicine.

Under normal circumstances, a urologist encountering a potentially high-acuity condition via telemedicine who does not refer the patient for an in-person office visit or to the emergency department could face a potential liability risk if an adverse event were to occur. That liability is essentially the same liability the provider would face after failing to make a needed referral following a face-to-face visit or provide the appropriate care.

This concept does not change for telemedicine, but raises several issues of what is negligence as it applies to telemedicine, what is the duty of care in practicing telemedicine as a urologist, and when does the deviation from the standard of care and the use of telemedicine rise to the level of medical malpractice in urology. For example, if a middle-aged man who is an existing patient of a urologist calls the office for a telemedicine visit with a chief complaint of hematuria and if the doctor prescribes a course of antibiotics but does not request any follow up visits or urinalyses, he has deviated from the normal standard of care and could be negligent. Soon after the patient returns several months later, an invasive bladder cancer is discovered. Although the patient was seen via telemedicine, which is allowed, and examined, the urologist did not move forward with an in-person visit and this would be a deviation from the standard of care and the urologist could be held accountable.

Best Practices to Avoid Medical Malpractice

To avoid these issues there are best practices to mitigate liability. The best practices to avoid medical malpractice with the use of telemedicine in urology practices include:

1. Malpractice Insurance. Obtain telemedicine coverage with your malpractice carrier. Make sure you contact your malpractice carrier and obtain written confirmation that your policy covers telemedicine and does not make a distinction between traditional care and telemedicine care.
2. Documentation. Telemedicine does not change the fact that physicians should use their best clinical judgment and document their medical reasoning behind a patient’s care in the patient’s medical records. Should the patient require an in-person visit to another practitioner or to your office this should be completed and documented as well. If the patient does not want to be seen in person due to COVID-19 fears, the physician should weigh the risks of any emergent condition against the risks for COVID-19 exposure for this patient, make the assessment, and document the reasons for the telemedicine visit versus the inpatient visit.
3. Informed Consent for Telemedicine Visits. Informed consent is an important issue when it comes to medical malpractice claims. In some states, no different informed consent is required than what a physician or his practice is required to do in person because the same standard of care applies to telehealth as to face-to-face visits. Physicians should make certain an informed consent discussion occurs surrounding the use of technology to treat a patient. There should be an informed consent form signed by the patient/family member, along with a documented informed consent discussion. Ideally, healthcare providers should document the results of the informed consent conversation with the patient in the medical record. In addition, the provider should verify and authenticate the patient’s identity.
4. Licensure. During the COVID-19 pandemic, some but not all states may have relaxed licensing requirements to encourage medical professionals to cross state lines to assist in the emergency. However, now those same states put restrictions back in place not only for licensure, but also the scope of practice of their healthcare providers. In addition, many states have licensing requirements specific to the use of telehealth that were waived during the most critical time of the pandemic but are now back in place. Crossing state lines and practicing without proper licensure in that particular state can lead to several issues, including negligence and malpractice claims that are not covered under the provider’s insurance policies.
5. Scope of Practice. During the most critical point in the pandemic, some states were allowing mid-levels (eg, nurse practitioners and physician assistants) to practice at the top of their license without any supervision or collaboration agreements. Now, many of the requirements of supervision and collaboration are back in place and practicing outside the scope of practice can lead to negligence and more so to malpractice by a supervising or collaborating physician.
6. HIPAA and Privacy Concerns. Currently, to assist medical practices in accelerating implementation of telehealth services, the Health and Human Services Office for Civil Rights implemented HIPAA waivers that allowed providers to use noncompliant HIPAA platforms that were not public facing. However, this can also lead to negligence and claims of damages should patient records be obtained or if proper documentation is not completed in patient records.

Bottom Line

Telemedicine is like a tube of toothpaste: the toothpaste is now out of the tube and cannot be put back. However, the toothpaste may be laced with a jalapeno pepper and may have a bitter taste if you do not adhere to some basic legal guidelines. We hope that we have provided you with guidelines for the use of telemedicine which will help you avoid the landmines that can occur if there is a failure to adhere to the rules and regulations regarding this new technology. For those of you who have any questions regarding the legal issues for implementing telemedicine, contact a healthcare attorney who has experience in the application of telemedicine.

References

1. Centers for Medicare & Medicaid Services. Medicare telemedicine health care provider fact sheet. March 17, 2020. www.cms.gov/newsroom/fact-sheets/medicare-tele medicine-health-care-provider-fact-sheet. Accessed September 14, 2020.
2. Center for Connected Health Policy. COVID-19 telehealth coverage policies. April 30, 2020. www.cchpca.org/resources/covid-19-telehealth-coverage-policies. Accessed September 14, 2020.
3. Drug Enforcement Administration Diversion Control Division. COVID-19 information page. www.deadiver sion.usdoj.gov/coronavirus.html#TELE. Accessed September 14, 2020.
4. US Food and Drug Administration. Digital health. August 27, 2020. www.fda.gov/medical-devices/digital -health. Accessed September 14, 2020.
5. eHealth Initiative. How to grow your practice through telehealth with reimbursement considerations. April 23, 2020. www.ehidc.org/resources/how-grow-your-practice -through-telehealth-reimbursement-considerations. Accessed September 15, 2020.
6. Abrams K, Shah U, Korba C, Elsner N. How the virtual health landscape is shifting in a rapidly changing world: findings from the Deloitte 2020 survey of US physicians. July 10, 2020. www2.deloitte.com/us/en/in sights/industry/health-care/physician-survey.html#end note-sup-2. Accessed September 15, 2020.
7. Deloitte. The future of virtual health: executives see industry-wide investments in the future. www2.deloitte.com/us/en/insights/industry/health-care/future-of-virtual- health.html. Accessed September 15, 2020.
8. FAIR Health. Monthly telehealth regional tracker. www.fairhealth.org/states-by-the-numbers/telehealth. Accessed September 14, 2020.
9. Goguen D. Medical negligence. www.alllaw.com/arti cles/nolo/medical-malpractice/negligence.html. Accessed September 14, 2020.