Obtaining Informed Consent in Telehealth

How does informed consent in telemedicine differ from that of in-office visits? Learn about the issues you need to consider if you see patients online.

Your patient signed informed consent documentation the first time they saw you in your office. Now that COVID-19 has pushed many routine medical visits onto online platforms, surely that same informed consent applies. Or does it?

Practitioners should be obtaining brand new informed consent from patients seeking care via telehealth—even if they were already patients of the practice. Because you don’t have the opportunity to physically examine your patient, measure vital signs, or assess other factors in person, you need to inform your patients about the inherent limitations of the visit. 

What may seem obvious to you is not always apparent to your patients; while they may see your in-office physical exams as routine or minimally necessary, you understand their clinical utility. It’s crucial to take this opportunity to educate your patients about the true distinction between a telehealth-based visit and an in-office encounter.

Is Telemedicine a Lesser Form of Care?

Remember that your standard of care is not diminished just because you’re treating via telemedicine. In other words, the law requires you to treat your patients with the same high level of care that you exhibit for in-office visits. Thus, whenever you cannot adequately address a patient’s symptoms or condition via telehealth, or when you believe the patient may be harmed by their inability to see you in person, you should consider referring that patient for in-person care.

Does the Telehealth Platform Matter?

As telemedicine becomes more widely used, practitioners are developing relationships with telehealth platforms. While telemedicine is, in many ways, a new frontier of medicine, it’s important to note that it has been around for a while, and many healthcare fraud laws do already address some of the nuanced relationships to which it can give rise.

Practitioners should remember a few things:

• Always tell your patients if you have a financial or business relationship with the telehealth platform. Your patient should provide consent to seeing you via this technology with full knowledge of this relationship.
• Ensure that your relationships with telehealth platforms comply with the Anti-Kickback Statute, Stark Law, and the state equivalents. Remember that many technologies are developed by those who are not licensed healthcare professionals and, thus, don’t comprehend the complex regulatory scheme that governs the industry.
• Understand how your patients are being charged for these visits. While the micro-details of medical billing need not be part of your Pandemic 101 education, you need to know the differences between the ways that your patients are scheduling and paying for your time, for instance:
  •  They may book a flat-fee visit and pay cash. 
  • Their health insurance company may offer a telemedicine portal through which they schedule and pay nothing. 
  • Your practice or hospital system may allow them to book a “regular” visit with you, pay their copay, and then “see” you via telehealth rather than in-person. 

All of these end with the same result—an online visit. However, the manner in which your patient found and booked you may reflect their expectations for their appointment. This only underscores further the importance of ensuring they’re providing informed consent to the true nature, capabilities, and limitations of the visit.

Primary Care vs. One-off Telemedicine Visits

Typically, if your patient cannot visit you in person, they will book a visit with you via telehealth. But in other situations, they may schedule the visit with another provider—whether through an established telehealth platform (think Maven Clinic), in response to an automated invitation for follow-up care after taking an at-home test, or because your office is temporarily closed during the pandemic. 

Conversely, a new patient may book their very first appointment with you via telehealth. The patient comes to you as a blank slate (or, rather, chart) with “just a quick question.” Whether the patient presents with symptoms of a cold or a heart attack, it’s challenging for you to adequately assess them without knowing their medical history. Further, a patient’s report of their medical history may differ from the picture painted by their medical records.

Therefore, at the onset of the visit, you should obtain the patient’s informed consent to treatment with you, clarifying that they understand the risks and acknowledge that an alternative is to see their regular physician. For more discussion on this, see our previous blog, “Starting a New Patient Relationship over Telemedicine.”

New Telehealth Patients and Prescriptions

Treating a new patient also raises questions around prescriptions, especially if you have no or limited access to the patient’s prescription history. Depending on the patient’s reason for the visit and the potential prescription, this situation may require that you call the patient’s primary care physician. In some cases, it may mean that you decide it to be unwise to proceed with the visit. 

Some practitioners have opted to prescribe controlled substances via telehealth only to patients with whom they had a preexisting relationship and have seen in-person. (Note that while the Ryan-Haight Act has been temporarily suspended during COVID, the future permissibility of this practice remains uncertain. For more on this, see our previous blogs “Prescribing Controlled Substances Through Telehealth: How COVID-19 Is Changing the Game,” plus our pre-COVID “Online Prescriptions: Innovative or Illegal?”)

Coordination With Primary Care Providers

Finally, you’re faced with communicating the results of the visit to the patient’s primary care provider. You can decide whether you’ll assume this responsibility, or instead, inform the patient of the importance of doing so themselves. Remember that if you have any contact with the patient’s other providers, you must first obtain the necessary HIPAA releases. You should also inform the patient of the risks of not sharing information between providers and how that might hinder care. 

Patients may have specific reasons for compartmentalizing their care, too, and your sensitivity to that is crucial; you can only share and transmit information that they’ve authorized for sharing. While some HIPAA waivers have been issued in response to the public health emergency, they wouldn’t apply to this situation. For more discussion, read our blog, “HIPAA Enforcement Changes Among COVID-19: Fact Versus Fiction.”

Ending a Telehealth Visit

Telehealth visits typically end in a handful of ways: a prescription, a recommendation for in-person care or testing, or a recommendation for a follow-up telehealth visit at a future date. When concluding a telehealth visit (and when obtaining informed consent at the onset of the visit), ensure that your patient understands how this appointment might fit into the bigger picture of their health, and be upfront about whether they’re likely to require in-person care. If a patient presents with a potential broken bone, for example, they can and should be immediately referred to urgent or emergency care, but you should also be diligent in educating them about the risks, benefits, and alternatives of not following your care guidance.

If a patient requires in-person care, be sure you’ve explained how they can obtain it and clarified expectations about who will see them. When appropriate, request that your support team or mid-level practitioners directly contact a patient to arrange in-person follow-up care. This can be appropriate when:

• The telehealth technology is challenging for the patient and interferes with the visit’s effectiveness.
• The patient requires an in-person medical exam.
• The patient requires in-lab testing.

When referring a patient for in-person care, you should also briefly discuss any concerns they have about potential exposure to COVID-19. Use the opportunity to help reduce their risk of transmission while visiting a medical office or lab and inform them of inherent risks during the current crisis.

Other Things to Remember About Informed Consent and Telehealth

Informed consent is a conversation, not a form. This is especially true when conducting telehealth visits, which present new and unfamiliar challenges for patients and providers. A few other important reminders to include in your discussions with patients include:

• Obtain informed consent to the use of technologies that might affect the privacy of the patient’s medical, personal, or billing information.
• Ensure that the patient understands how to obtain copies of medical records from the visit. Provide patients with your records retention and data storage policy, and ensure it complies with your practice act.
• Understand and explain the legal and ethical limitations of care via telehealth. Be ready to clearly explain to your patients what you can and cannot do over telemedicine, and be prepared to assist them through the process of obtaining the right level of care. (For more on making the shift to telemedicine, read this article.)
• Require that your patients—and any mid-levels or other providers treating your patients through your office—use appropriate forms of technology for telehealth visits, and be sure to identify the patient themselves at the onset of the visit.

Finally, one of the biggest challenges presented by telemedicine is compliance with the various authorities and organizations with whom you maintain relationships. By accepting government payers like Medicare, Medicaid, or TRICARE, your practice becomes subject to a complex web of regulatory compliance mandates. Similarly, contracts with individual private insurance companies often spell out your obligations for offering care via telemedicine. State law—including your practice act and healthcare fraud, waste, and abuse laws—restricts the type of care you can offer via telemedicine and the kinds of financial or referral relationships into which you can enter. 

Even if you offer exclusively cash-based care, you’re still held to your practice act, ethical obligations, and a slew of state and federal laws that govern your engagement with the public. This may include consumer protection laws, communications laws, and others. Depending upon the nuances of your practice, you may be required to inform your patients of the limitations of the care you can provide or the nature of your relationships with other parties like the telehealth platform or the patient’s insurance company.

As your practice transitions to telehealth, work with an experienced healthcare attorney who can provide guidance on the applicable laws and regulations, and draft forms tailored to the medium. For information about how Jackson LLP can help you build a compliant telemedicine practice, schedule a consultation today.

The COVID-19 pandemic is a dynamic and evolving public health emergency. The laws and situation are fluid, and this article may not reflect the most current situation.

This blog is made for educational purposes and is not intended to be specific legal advice to any particular person. It does not create an attorney-client relationship between our firm and the reader and should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.