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Telehealth needs clearer definition amid regulatory inconsistencies, expert says

The time has come for hospitals and vendors to answer a few basic questions.

Jeff Lagasse, Associate Editor

While telehealth shows promise in reducing costs and enhancing access to care, the definition of telehealth is still somewhat vague. Some devices and services fall under its auspices, some don't. That's creating some regulatory uncertainty, and underscoring the fact that not all telehealth services are created equally.

Do telehealth services qualify for reimbursement? Are its technologies covered by HIPAA? There are no easy answers as this sector of the healthcare industry is still nascent.

The first step in answering those questions is to define what telehealth actually is, but that's not as easy a task as one might think. 

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"It enhances access," said Pam Hepp, a healthcare professional with Buchanan, Ingersoll and Rooney, a firm that specializes in telehealth services. 

"It may be a hospital-to-hospital type of relationship. It may be a rural hospital that may not have access to certain types of specialists. It may be home health workers who lack access to patients remotely. It can run the gamut, what constitutes telehealth," Hepp said. "Then you factor in some of the personal devices, the Fitbits and those types of things that provide certain types of information. It may be important information, but it may not be readily available to the provider."

What's more, there's currently a gap between consumer devices and more traditional medical care. The consumer devices are largely good, useful products, but represent a different type of monitoring that wouldn't fall under the category of telehealth at this point. They're not regulated, which means that while many are good products, some of them aren't, at least from the perspective of usefulness.

It would be helpful to integrate all of the information gathered from personal electronic devices, but Hepp said it needs to be done in a thoughtful and useful way. Healthcare continues to be more and more expensive, and the push is for payment to be based on outcomes and eliminating waste, on keeping people out of the hospital and in the home or most appropriate care setting. Those types of care methods are preventative, so there's value in including many different types of information. It can help predict outcomes and make it easier to formulate an appropriate treatment plan.

"The problem is that all of that information can be overwhelming," said Hepp. "At the end of the day, physicians have to practice medicine. The data overload can't interfere with time with the patient. It's about gathering information that's actually useful for decision-making."

Currently, there are no personal health devices that fall under regulatory scrutiny, and Hepp said it will likely remain that way for some time.

"Look a cardiac monitors," she said. "The FDA regulates them to that they're safe and effective. Personal types of devices don't fall under that FDA scrutiny. Information gathering devices can come into play from a regulatory scheme, but those only apply to covered entities, which are your health plans, etc. HIPAA does not touch or regulate these types of personal monitors, and there really isn't a push at this time to regulate from that perspective. To the extent that it became regulated, it might be more expensive and difficult for people to get those devices … because it would be more expensive for manufacturers.

"If there came a time I was wearing an Apple Watch and my fitness tracker communicated with my physician's electronic health record once it gets into that EHR, that data is secure and subject to HIPAA," said Hepp. "But as long as it's just on my device, it isn't."

For a long time, telehealth was prohibitively expensive, particularly for smaller providers. Luckily for them, payers are now reimbursing for certain telehealth services, incentivizing providers to adopt technology that is subject to regulation. One example of this newly reimbursable type of technology is that which allows rural hospitals to communicate with tertiary care hospitals and specialists. Community providers may not have previously had access to these specialists, and virtual visits with one can be structured in a regulatorily compliant manner.

Telehealth is on its way to rivaling the quality of an in-person visit, but it's going to happen in fits and starts, said Hepp.

"It's going to depend on the specialty," she said. "It's a service line by service line issue. There's still going to be some amount of contact that's necessary with a patient. I don't see it totally replacing face-to-face visits. If patient vitals continue to remain stable, then it might be something where the frequency of visits needs to be less, but there are certain services that need to be done over time."

Twitter: @JELagasse
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