Health technology oversight growing more complicated as innovation continues

As health information technology (HIT) evolves and the industry increasingly relies on it, the field represents a niche opportunity for young lawyers. At the American Health Lawyers Association (AHLA) Fundamentals of Health Law conference, presenters Ryann Schneider and Sidney Welch emphasized the necessity of understanding both the technology and regulations as well as maintaining close oversight of vendors. This area presents many pitfalls and compliance is difficult, but essential.

Innovations

At the close of the third quarter of 2016, $6.5 billion in digital health deals were recorded. Clinical operations are finding more uses for technology, as providers use telehealth for specialty consults, chronic care management, monitoring, and diagnosis while patients continue to rely on personal health applications and wearables. These innovations require continued development of oversight strategies.

Statutes and regulations

One challenge for compliance is understanding the changing (and conflicting) rules surrounding telemedicine. CMS has issued and updated telemedicine regulations for Medicare, while Medicaid reimbursement differs between the states. States have also implemented various non-payment laws, such as the definitions of a valid telemedicine encounter and requiring a full license to practice medicine in the state in which the patient is located. There are also intellectual property considerations, as well as dealing with a long list of regulatory agencies from the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ) to the Federal Trade Commission (FTC) and Internal Revenue Service (IRS).

Vendors

When health care entities hire technology vendors, each side has a different level of understanding and priorities. Health care customers are particularly sensitive to safety, outcome commitments, and security than other technology customers, and often overestimate the time and resources required for projects. Vendors are experts on their technology, and have a better idea of the partnership required to successfully implement sophisticated projects.

The speakers noted that counsel does not have to understand the nuts and bolts of the technology, but emphasized the need for a team comprised of both business and tech experts to ensure that all bases are covered. Additionally, if in-house counsel focuses on regulatory understanding, outside technology or intellectual property (IP) counsel can supplement with specialized expertise.

Highlight on Louisiana: State loosens telemedicine requirements for physicians

Effective June 17, 2016, physicians engaging in the practice of telemedicine in the state of Louisiana need not have a physical practice location in the state, nor are they required to enter into an arrangement with a physician who does have a Louisiana practice location to provide for referrals and follow-up care. The new telemedicine law, which also allows physicians to utilize interactive audio without video in certain circumstances, was proposed in reaction to regulations issued by the State Board of Medicine in 2015, which created the physical practice requirement.

In-state practice location

In November 2014, the American Telemedicine Association (ATA) issued comments to the Board, stating that its then-proposal to require physicians to maintain a physical practice location or enter into arrangements with in-state physicians “would be the most anti-telemedicine in the nation, especially for patients needing medical experts outside the borders of Louisiana or in an [sic] natural disaster,” and went on to opine that the proposal “reflect[ed] more of a concern of protecting economic markets rather than having anything to do with providing health services to the residents of Louisiana.”

The new law eliminates the physical practice requirement but retains the Board rules stating that physicians need not conduct an in-person physical examination or patient history prior to providing telemedicine services as long as they hold unrestricted licenses to practice medicine in the state and have access to patient records with consent.  However, it adds requirements for doctors to create a medical record for each patient and make it available to the Board upon request and, when necessary, to provide a referral to an in-state physician or otherwise arrange for in-state follow-up care.

Audio communications

The 2015 Board rules also required physicians to provide telemedicine services via simultaneous two-way video and audio communications. The new law, however, allows doctors to utilize interactive audio communications without video communication, provided that they first access and review a patient’s records and determine that they can meet the same standard of care as if they were providing face-to-face services.

Controlled substances

The new law did not affect existing Board rules prohibiting physicians from prescribing controlled substances via telemedicine services unless the physician has had at least one in-person, in-state medical visit at a practice location within the past year, the prescription is entered for a legitimate medical purpose, it conforms with the in-person standard of care, and is otherwise permitted by state and federal laws and regulations.

 

AHRQ’s telehealth evidence map will lead the way to better policy

Advancing telehealth policy and practice was the goal of a draft technical brief released by the HHS Agency for Healthcare Research and Quality (AHRQ). Due to the rapid advancement and complexity of telehealth technology as well as an expansive quantity of research, AHRQ evaluated and synthesized literature and studies to arrive at an evidence map, which can be used to identify what is known about telehealth and what requires further investigation. The draft brief explains that the agency hopes that by identifying and describing available telehealth research, decision makers, and other stakeholders will be able to act on a straightforward and helpful body of information.

Telehealth

In the process of constructing the evidence map, AHRQ relied on the Health Resources and Services Administration (HRSA) definition of telehealth: “the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health, and health administration.” In part due to the expansive nature of telehealth and the complex association it shares with related terms like ehealth, telemedicine, and telecare, multiple stakeholders—including Senators, medical, patient advocacy, and industry groups—supported a call for a comprehensive literature review. Because of the volume and variability of literature on telehealth, stakeholders realized that is not possible to quickly assess telehealth literature to determine if there is support for a particular policy decision.

Method

In order to meet stakeholder needs, AHRQ surveyed telehealth research and produced an evidence map. AHRQ describes the evidence map as “a form of rapid or abbreviated review.” Although the map is not intended to be exhaustive, the goal is to arrive at a practical and more useful body of information to direct stakeholders. To obtain information for the map, AHRQ conducted interviews, searches of databases, and reviewed literature. After identifying a subset of reviews, AHRQ extracted relevant telehealth data and synthesized it into an evidence map combining graphics, tables, and text.

Findings

Out of over 1,300 articles, AHRQ selected 562 for full-text review. Of those, AHRQ chose 44 that met the agency’s inclusion criteria for the evidence map. The agency only chose reviews with “content that was organized, analyzed, and presented in a way that could support policy and practice decisions about telehealth.” The most-often included reviews focused on more than one technology, mixed chronic conditions, and communication and counseling. As a result, it was those types of reviews that AHRQ identified as having the highest relative benefit from a literature review standpoint. The agency also examined gaps in the literature that still need to be closed. For example, AHRQ identified urgent/primary care as an area that has not been adequately reviewed.