Telemedicine/Telehealth: Update on Regulatory Issues
This article was originally printed in Dallas County Medical Society’s Dallas Medical Journal, November 2019.
This article will focus on updates to regulatory issues that could impact a physician’s practice of telemedicine or any other provider’s practice of telehealth.
The terms ‘telemedicine’ and ‘telehealth’ are often used interchangeably, but there is a growing difference. Telemedicine can be defined as a healthcare service delivered by a licensed physician (or someone having delegated authority from that physician) to a patient using telecommunications or information technology. Telehealth, in contrast, is usually a health care service using telecommunications or information technology by a general health professional. For example, receiving health consultations remotely regarding dietary issues or exercise regimens would be considered telehealth.
Changes in Medicare Reimbursement
Medicare has evolved, and is still evolving, in its approach to reimbursement for telehealth and telemedicine services. Centers for Medicare & Medicaid services (CMS) has been busy in this area and the following are some highlights of recent changes.
- CMS is making changes to add additional originating sites and geographic exemptions for the treatment of end-stage renal disease and acute stroke. As it does every year, CMS also considered new codes for inclusion in its list of services eligible to be delivered through telehealth, and have added G0513 and G0514, both codes related to prolonged preventive services. CMS also added new codes (99453, 99454, and 99457) for remote physiologic monitoring, as well as a new code (99491) for chronic care management.
- The agency is also experimenting with a program that would reimburse providers using Mobile Integrated Heath (MIH) services to reduce unnecessary emergency room visits.
- CMS also released its finalized 2019 Physician Fee Schedule containing many changes for Medicare. Among the changes, the proposed rule not only expands telehealth reimbursement, but communicates a new interpretation by CMS of the applicability of its statutory requirements for reimbursement of telehealth. Telehealth-delivered services under Medicare limits the use of telehealth to certain services, providers, technology (mainly live video) and patient locations (e.g., certain types of healthcare facilities in rural areas). The new rule expresses CMS’s belief that their obligations to impose those restrictions only apply to “the kinds of professional services explicitly enumerated in the statutory provisions, like professional consultation, office visits, and office psychiatry services.” Certain other kinds of services that are furnished remotely using communications technology are not considered “Medicare telehealth services” and, thus, are not subject to the restrictions. This includes interactions between a medical professional with a patient via remote communication technology. Thus, CMS has finalized reimbursement for virtual check-ins, remote evaluation of pre-recorded patient information and inter-professional internet consultation, which CMS believes fall outside the scope of Medicare telehealth services. All of these services have restrictions and physicians are strongly encouraged to analyze these restrictions carefully.
- CMS has also taken action for Medicare Advantage plans:
- In a recent announcement about changes to the telehealth rules, it said, “Historically, Medicare Advantage plans have been able to offer more telehealth services, compared to Original Medicare, as part of their supplemental benefits.” CMS added that it will be more likely that plans will offer the additional telehealth benefits outside of supplemental benefits, whether they live in rural or urban areas.
- In January, CMS updated its Value-Based Insurance Design (VBID) model of care, introduced in 2017, to give providers treating people on Medicare Advantage plans more leeway in using telehealth in place of in-person checkups.
Federal Enforcement Actions in Telemedicine/Telehealth
As telemedicine becomes more common, it has, unfortunately, attracted some shady characters looking for physicians to participate in illegal reimbursement schemes. Several recent indictments and guilty pleas show that federal prosecutors are looking closely at fraudulent billing for telemedicine services. To quote from a case involving an order of bogus genetic tests via telemedicine, the Department of Justice said:
“Often, the test results were not provided to the beneficiaries or were worthless to their actual doctors. Some of the defendants allegedly controlled a telemarketing network that lured hundreds of thousands of elderly and/or disabled patients into a criminal scheme that affected victims nationwide. The defendants allegedly paid doctors to prescribe CGx testing, either without any patient interaction or with only a brief telephonic conversation [emphasis added] with patients they had never met or seen.”
In another case, the Justice Department’s Criminal Division described a conspiracy as “exploiting telemedicine technology [emphasis added] meant to help elderly and disable patients in need of health care.”
All these cases reinforce the fact that “medical necessity” is still required for any medical treatment and show that kickbacks and bribes are not lawful in telemedicine, just as they are illegal in all other facets of medical practice.
Federal Safe Harbors for Telemedicine Ventures
There are two Anti-Kickback Statute safe harbors particularly relevant to telemedicine: (1) when a provider receives free electronic prescribing technology or training; and, (2) when a provider receives free electronic health records software, information technology, or training. Thus, adherence to one of these safe harbors could, in theory, potentially reduce or eliminate associated kickback risks. In addition to regulatory considerations, the American Medical Association (AMA) emphasizes certain ethical consideration, including that:
- All physicians who participate in telemedicine have an ethical responsibility to disclose to the patient any financial or other interests in connection to the application or service;
- All physicians inform patients about the limitations of the service;
- Physicians advise about follow-up care if needed; and,
- Physicians encourage patients to inform their primary care provider about the online consultation.
Are Digital Health Devices “Telemedicine” or “Telehealth”?
There have been concerns that some interactions between digital health devices and healthcare providers could be construed as practicing “telehealth” or “telemedicine.” These concerns include the necessity of obtaining FDA approval for some devices that could be construed as a “medical device.” The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software and other digital health products as a medical device. The updated guidance documents reflect the need for a more flexible, risk-based approach to regulation that accommodates a rapidly evolving technological landscape.
The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” to exclude five distinct categories of software or digital health products – e.g., “off-the-shelf” devices or some “clinical decision support” devices — from the definition of “medical device.” These changes will take away some of the regulatory restrictions on bringing digital health devices to market and should make telehealth more convenient to physicians and patients.
All of these changes should provide more clarity about how to practice telemedicine and, as to the litigation, how not to practice telemedicine.
Scott Chase, JD, has practiced health law, corporate law, and intellectual property law for more than 40 years. Mr. Chase is Board Certified in Health Law by the Texas Board of Legal Specialization. Mr. Chase is a partner at Farrow-Gillespie Heat Witter, LLP. His primary practice focus is business transactions for physicians and healthcare facilities, as well as healthcare regulatory issues, such as the Affordable Care Act, HIPAA and peer review. Mr. Chase handles general corporate matters and trademark/copyright issues for physicians and also for a variety of non-healthcare clients.