Recap: Telemedicine and Legal Issues You Should Know
Telemedicine is a rapidly growing industry that uses telecommunications to gather, store, and communicate clinical information. It is a subcategory of telehealth, which is the broader term encompassing all uses of telecommunications in the healthcare context. Telemedicine can be asynchronistic, where information is stored and then forwarded, or it can be used in real-time.
Telemedicine presents many benefits, such as improving access to care, promoting care coordination, fostering patient engagement, and reducing costs. Additionally, telemedicine programs can and have been implemented in a variety of ways, such as facilitating remote second opinions, on-demand and scheduled appointments, and triage in emergency departments, as well as promoting provider-to-provider communications. However, there are many legal pitfalls that are important to consider when implementing a telemedicine program.
- Licensure
Most states require physicians to be licensed in the state where they are practicing medicine. As telemedicine has enabled providers to cross jurisdictional boundaries to provide care, it raises legal concerns related to licensure. Generally, a physician is considered to be “practicing medicine” at the location of the patient. Therefore, it is critical for the provider to verify the patient’s location at the time of the consultation and ensure that he or she has the appropriate license to provide the requested services. Some states offer expedited pathways to licensure under the Interstate Medical Licensure Compact or limited licenses for the practice of telemedicine.
- Medical Malpractice Coverage
Another important consideration in the practice of telemedicine is medical malpractice. It is important to be aware of differing standards of care across jurisdictions. While some states apply the same standard to telemedicine as to in-person services, others may have more restrictive or otherwise differing standards. Further, it is important to carefully review all medical malpractice insurance policies to ensure that the insureds are properly covered for telemedicine services.
- Physician-Patient Relationship
It is also important to consider the establishment of the physician-patient relationship in the context of telemedicine. Many states prohibit the use of telemedicine services before a physician-patient relationship is established through an in-person examination. Additionally, informed consent requirements vary by state.
- Tele-prescribing
There are many restrictions on the use of telemedicine to prescribe controlled substances. In 2008, the federal government passed the Ryan Haight Online Pharmacy Consumer Protection Act (the “Haight Act”). This was primarily in response to the proliferation of online pharmacies and “pill mills” providing patients with sham prescriptions over the internet. Under the Haight Act, a provider may not prescribe a controlled substance without first examining the patient in-person. There are some exceptions to the Haight Act for the “practice of telemedicine,” such as when the patient is being treated in a hospital or clinical or is in the physical presence of another provider. All of these exceptions also require compliance with state laws, which are highly variable.
- Reimbursement Concerns
Coverage for telemedicine varies widely. Under Medicare, telemedicine is currently only covered if (1) the service utilizes real time, two-way, audio-visual telecommunications, (2) the patient is at a qualified originating site (e.g., physician practice or hospital) in a rural Health Professional Shortage Area or in a county outside a Metropolitan Statistical Area, (3) the provider is a type authorized for telemedicine (e.g., physician or physician assistant) and credentialed with the patient site facility, and (4) the service is approved by CMS for telemedicine. For Medicaid, states have significant flexibility to decide whether to cover telemedicine and what, if any, restrictions they impose on the provision of telemedicine. Similarly, private payor coverage for telemedicine varies greatly. A provider should review state law and regulations prior to billing Medicaid and review their payor contracts carefully before billing private insurance.
- Potential for Fraud and Abuse
Providers of telemedicine should be aware of the potential for liability under state and federal false claims acts, anti-kickback statutes, and self-referral laws. Failures to follow state law regarding licensure and scope of practice, billing Medicare and Medicaid without following the appropriate regulations, or offering or accepting free or discounted telemedicine services or equipment could all lead to significant liability.
- Privacy and Confidentiality
Telemedicine heightens the risk of a data breach or other unauthorized disclosure. As such, for any telemedicine delivery system, a covered entity should ensure that it signs a business associate agreement with the vendor and ensure that the vendor is using fully encrypted data transmission, secure networks, and all other technical safeguards required under HIPAA. Further, a provider practicing telemedicine should update their HIPAA workforce training, their patient privacy policy, and their risk analysis.
This is meant to be a high-level overview of issues involved in implementing a telemedicine program. Each state treats telemedicine differently and state laws vary in terms of their sophistication and various requirements. If you have questions about a particular state’s law related to telemedicine or would be interested in additional blog posts on this topic, please reach out to the Health Law Gurus.
Arielle Lusardi and Benjamin Waters of the Health Law Gurus presented on the topic of Telemedicine at the recent Association of Corporate Counsel’s In-House Counsel Convention.
