Counsel for Mayo clinic, Greg Anthony and Page Underwood, along with Megan Olson-Lehner, Mayo’s Compliance Program Manager, recently presented Telemedicine Law: Building a Compliance Program in a Virtual Care Center. The presentation covered a wide myriad of regulatory and legal principles related to virtual health care services and tips for navigating this particularly complex and rapidly-evolving area of law. The following is a checklist of some of the most important key points that healthcare organizations should consider when implementing telemedicine services.
Licensure
Licensing laws vary by state; however, most states require providers to be licensed in the state where the patient is located. This means that if providers offer services to patients outside of the state where they reside, multiple active licenses will typically be required.
Payment
Proper coding, billing, reimbursement, and documentation of telemedicine services are all payment-related issues that have drawn the OIG’s attention recently. Traditionally, CMS has not covered many telemedicine services. Due to greater need and fewer resources, most payment for telemedicine services has been reserved for rural patients. The types of telemedicine services covered by commercial payors can vary widely and change frequently. However, some state laws require coverage of telemedicine services comparable to in-person services.
Credentialing and Privileging
CMS requires that hospitals and other accredited health care facilities and providers have a process for credentialing and privileging physicians and practitioners. The Joint Commission has approved a streamlined process, referred to as “Credentialing by Proxy” which permits the “Originating Site,” or the facility receiving the telemedicine service, to rely on the privileging and credentialing decisions made by the entity providing the virtual services, aka the “Distant Site.” In order to take advantage of Credentialing by Proxy, certain requirements set forth by the Joint Commission must be met.
Prescribing
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires at least 1 in-person medical evaluation to obtain a valid prescription for a controlled substance. Changes have been proposed to this law, which would broaden the ability to prescribe controlled substances absent an in-person examination. (See, H.R. 5594 and H.R. 5482.) For now however, a minimum of one in-person examination remains a requirement for controlled-substance prescriptions. Even for non-controlled substances, a provider-patient relationship must be established prior to writing a prescription.
Privacy
The advent of telemedicine has brought with it a dramatic increase in privacy related risk. The virtual sharing and storing of PHI has resulted in ransomware and other cyberattacks and privacy breaches. Technology supporting telemedicine should be HIPAA compliant.
Fraud & Abuse
Providers must still comply with the Anti-Kickback, Stark, and other federal and state laws aimed at deterring fraud and abuse within the healthcare system. Providers may want to review the safe harbors that are available for the practice of telemedicine, as well as relevant OIG opinions, including Advisory Opinion 18-03 prior to offering virtual patient-care services.
Finally, the FDA also has regulations in place that apply to software and medical devices. Telemedicine itself covers a wide range of services. For many people, references to telemedicine conjure up images of virtual doctors’ appointments, in which a patient interfaces with a physician through some type of virtual platform. This is one example of virtual medical care, but many others exist as well. Think: remote patient monitoring, online patient portals, and secure messaging, to name a few.
Providers should pay close attention to state and federal laws regulating the particular type of telemedicine services they want to offer. They should also familiarize themselves with state laws affecting telemedicine such as licensing, state credentialing and privileging, and PHI security, among others, to ensure full compliance.
Gislason & Hunter LLP continues to monitor changes in the law and stays on top of current trends and developments in the evolving telemedicine landscape.
This information is general in nature and should not be construed as tax or legal advice.