Introduction
The legal, regulatory, and reimbursement aspects of incorporating telehealth into a neurological practice are likely the aspects of this technology that have been the source of the most trepidation for neurologist and other practitioners. The novelty of this modality of practice has led to an ever-changing legal landscape over recent years. Prior to March 6, 2020, one may argue that progress being made in creating a more favorable regulatory landscape for telemedicine in the United States was slower than many of us would have hoped for. However, the world changed in March 2020 with several sentinel events that started a chain reaction that profoundly ushered telemedicine onto center stage. On that day, President Trump closed the US borders to international travel, the NBA abruptly canceled its season and any games that were being played at the time, and Tom Hanks revealed that he was infected with COVID-19 and was in self-quarantine; the citizens of the United States of America realized that COVID-19 was becoming a crisis on US soil.
In the days that followed, the US underwent an unprecedented national shutdown of all nonessential businesses and, in an instant, all of the country’s nonemergent medical practices came to a screeching halt. When the age-old art of patient care seemed to enter one of its darkest moments, the savior was the budding technology of telemedicine. The days that followed produced an unprecedented flurry of regulatory changes that released the genie of telemedicine out of its restrictive bottle and allowed it to prop up the medical community during its most critical time. The ensuing days and weeks showed regulation after regulation and state after state passing laws that allowed physicians across the United States to practice telemedicine without the shackles that had bound them previously. For the first time, millions of patients and doctors established relationships virtually and were able to continue and initiate care from the safety of their homes.
By the time you read this book, we are confident that the laws will have changed as the COVID-19 pandemic continues to evolve and the appetite of the world grows for convenient care from the comfort of home. For this reason, writing a chapter on the laws, regulations, and reimbursement opportunities for your practice is a nearly impossible task, but a necessary one. The laws that govern your practice in your state at the time you are trying to implement telemedicine into your practice will be very different from where they are at the time this book goes into print. Therefore, our approach will be to provide a framework for you to understand the concepts at play that govern our practice of telehealth and provide you with the resources to navigate the undulating waters of telehealth regulation.
To start the journey in the regulation of telehealth, we must first start to define a few terms and concepts. In regards to what telemedicine is, one may look at it as a modality through which one may practice medicine rather than a subspecialty of a medical practice. The technology through which one may practice telemedicine is ever evolving. The American Telemedicine Association refers to the different modalities of telehealth delivery as services. They, along with many other institutions, define four basic services or modalities of telehealth delivery ( Fig. 16.1 ) :
- •
Live Videoconferencing or Real Time Audio-Video Communication (Synchronous)
This is the traditional model of delivering telehealth services that most people think of and is the model for which many of the initial laws on telehealth are written. This is when a practitioner and a patient communicate in real time using a secure means of video/audio communication. The communication may also be between two health care professionals.
- •
Store and Forward (Asynchronous)
This modality of health care utilizes nonreal time ways for a practitioner and a patient to communicate. It utilizes the storage of medical information (images, vital signs, electroencephalography (EEG) data, etc.) and the subsequent transmission of that data for the review by a practitioner at a later time. This may be an important area in the future, as it allows patients to upload information, and the doctor to review and make decisions, both in their own time.
- •
Remote Patient Monitoring (RPM)
This modality of health care involves the use of devices to remotely collect medical data from patients in their homes or other nonmedical related locations and transmit that data to a central location for evaluation. Such information my include electrocardiogram (EKG), vitals, EEG, or even polysomnographic data that could be monitored remotely in real time. This modality can be helpful for patients who are housebound, or even during diagnostic testing when real-time information could be lifesaving or prevent hospitalization.
- •
Mobile Health (mHealth )
This refers to the exploding industry of consumer-based medical wearables. These devices are able to track heart rate, EKG, sleep data, and much more. Many direct-to-consumer companies are engaging in this tech space and we will be seeing more companies and devices come to the market in the future.
When considering incorporating telehealth into your practice, there are several medical/legal topics you should consider, which include:
- 1.
licensure;
- 2.
practice standards;
- 3.
privacy and security;
- 4.
credentialing;
- 5.
contracting;
- 6.
reimbursement;
- 7.
fraud and abuse;
- 8.
operational; and
- 9.
international.
Licensure
The first step in starting using telemedicine in your practice is to make sure you understand licensing. Fortunately, the rules regarding this topic are well established and relatively straightforward. A doctor must be licensed in the state in which the patient is located at the time of the telehealth consult. So, if you wish to see a patient from Louisiana, you need to have a Louisiana license. However, if you plan to see patients from different states, the rules are such that you will need to have a license in each state in which you are planning to see patients and you will also need to be aware of the unique rules each state has, such as Continuing Medical Education (CME) requirements. Additionally, there are four types of licensure through which a state may regulate a telehealth practice.
The first is full licensure, which would require a physician or other health professional to obtain an unrestricted license. The second is a recognition of licensure policy, in which one state may “recognize” the license of another state. This would be facilitated by an endorsement, mutual recognition, or reciprocity agreement. Endorsement permits a state medical board to issue a license to a physician from another state when equivalent licensing standards are in place. Mutual recognition permits a state medical board simply to accept the licensure policies of the physician’s home state. A reciprocity agreement allows a physician in one state to have equal privileges in another state without being required to register for a separate license. The third is a consultation exception. This is an older mechanism in several states, which allows physicians from outside states to consult occasionally with patients within the state in question without obtaining an additional license. This is usually applicable when a physician licensed by the state of the patient has primary responsibility to care for that patient. The fourth type is special licensure, which was promoted by the Federation of State Medical Boards starting in 1996 and has been adopted by 22 states thus far. This proposal is now known as the Interstate Medical Licensure Compact and is very similar in concept to the second type of licensure approach discussed above. More information about this can be found at www.imlcc.org . This approach requires special licensure procedures for physicians practicing telemedicine across state lines, and at the same time preserves the current state licensure systems. The fifth model would be national licensure, which currently does not exist in the US for private practice. An existing system analogous to national licensure would be physicians practicing telemedicine in the Armed Forces or the Veterans Affairs hospital system.
These systems have multiple nuances, so it is important to consult your health care attorney to review your specific needs before starting your new multistate telemedicine program.
Practice standards
The concept of practice standards exists on a state-by-state basis. They are governed by your state medical boards and typically can be reviewed on a state medical board’s website. Many states have a telemedicine section and should list any practice standards that may exist. Each state has different standards, so this will be required reading for you prior to you initiating your telehealth practice. Many of the rules are not very complicated, but you need to be aware of the ones that govern the states in which you plan to practice. There is tremendous variety in the propensity for disciplinary action based on each state’s medical boards and their norms. For example, Delaware has the highest amount (10.27) of yearly disciplinary actions rate per 1000 physicians compared to the District of Columbia, which has the lowest (1.74). A variety of topics are covered in the practice standards, and a few common ones are listed in Table 16.1 .