2017 has undoubtedly been a standout year in the realms of telemedicine and digital health.

In telehealth alone, much has happened over the past 12 months.

A new law in Texas officially gave physicians permission to utilize telemedicine services to treat patients they haven’t met in person, quashing a previous requirement that physician-patient relationships had to be initially established with an in-person visit.

The change in policy allowed various telehealth providers to assist patients when Hurricane Harvey struck the Lone Star State in late August. Those same companies came to the aid of Hurricane Irma victims in September.

But perhaps the most significant 2017 accomplishment for telehealth came from the Centers for Medicare and Medicaid Services, which released a final rule for the 2018 Medicare Physician Fee Schedule in early November. The document outlined how the agency will be paying for more telehealth services. CMS created multiple new codes, which cover instances of lung cancer, health risk assessments, psychotherapy, chronic care management and interactive complexity.

As a press release regarding the rule notes:

To strengthen access to care, especially for those living in rural areas, CMS is transforming access to Medicare telehealth services by paying for more services and making it easier for providers to bill for these services. Improving access to telehealth services reflects CMS’s work to modernize Medicare payments to promote patient-centered innovations.

In a phone interview, Ida Mantashi, senior product manager at Modernizing Medicine, said the change came at the right time. The healthcare software company is based in Boca Raton, Florida.

But despite the opportunities this rule provides, it’s accompanied by numerous challenges.

For one, it’s difficult to control the regulatory piece of the puzzle. Although it does bring security, it makes it hard for providers to care for patients across state or even country lines.

“If I’m going to Spain for a month, I may want to continue practicing,” she said. “We would love to see the government taking a role in that and making it easier on the provider so they can travel.”

The final rule does more than alter telemedicine payments. It also shakes up remote patient monitoring, enabling physicians to be reimbursed for checking and analyzing patient health data, at a minimum of 30 minutes of time per month. Reimbursement is set at about $60 per month per patient per an expert analysis.

As the rule notes:

[W]e are finalizing separate payment for CPT code 99091 (Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified healthcare professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time, for 2018 pending anticipated changes in CPT coding.

As part of this RPM change, providers have to obtain beneficiary consent and must document it in the patient’s record. Additionally, they can’t use CPT code 99091 more than once every 30 days per patient, according to a blog post written by Jodi Daniel and Maya Uppaluru, attorneys from Crowell & Moring.

Dennis Robbins, a healthcare thought leader and advisor to the American Heart Association’s Center for Health Technology & Innovation, weighed in on the news.

“When I initially heard this, I thought, ‘Wow, does that mean we can start getting information off a Fitbit or Garmin and get paid for getting people healthy?’ However, welcome to America — we haven’t gone that far,” he said in a phone interview. “Apparently this is for managing chronic diseases, particularly managing cardiac diseases and diabetes.”

Though it’s a move in the right direction, Robbins said it’s not enough. This allows physicians to more closely examine illness and disease, but the industry needs to move toward improving individuals’ overall health.

“We’ve got to change our tune,” he noted. “This needs to go from looking at episodic instances of unhealth and talk about creating a culture of health.”

Having access to so much data can allow providers to focus on getting their patients healthy. But instead, we’re waiting until a patient’s health gets out of hand and then aiding them. Yet perhaps beginning with this rule around chronic diseases will propel the industry forward to zero in on health as well, Robbins added.

CMS is not the only agency to begin developing a framework for rewarding digital health technologies.

This summer, the Food and Drug Administration unveiled its pre-certification pilot program for digital health, the intent of which is to help the agency define its approach to digital health regulation. The program also seeks to help companies introduce new products approved by the FDA. By September, the FDA parsed through more than 100 applicants to select the nine winning companies: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.

In a recent phone interview, Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, said the agency selected the companies because it expected to learn the most from them.

“They represent a very broad perspective,” he said. “It was more about, ‘Where do we learn about the most variation of what happens in the space?'”

Additionally, the FDA announced a new Entrepreneur-in-Residence program this year, which is intended to generate feedback for the pre-cert program. The initiative is headed up by the CDRH. Patel noted the EIR program seeks to find those “who would be willing to come into the FDA a little more than just being in the pilot program.”

More recently, the agency released a trio of guidances — two draft and one final — on digital health. The most talked-about draft guidance, “Clinical and Patient Decision Support Software,” seeks to reduce confusion over which clinical decision support and patient decision support tools need to be reviewed by the FDA. The draft has been awaited since 2011, according to Politico.

Despite being long-promised, some critics have already expressed qualms over this specific guidance. Experts believe it’s preventing startups from bringing technologies to healthcare, according to CNBC. And Bradley Merrill Thompson, general counsel of the Clinical Decision Support Coalition, said the FDA “seems to have walked away from making a risk-based determination.”

“What I think many of us in [the] industry were hoping for was an effort by FDA to distinguish high from low risk as a basis for regulation,” he said in comments sent via email. “We didn’t get that. Worse, it appears based on the guidance that FDA is not interested in drawing that line.”

But Patel had a response to these critics, noting that the draft guidance is precisely that: a draft.

“This is exactly why we go through this process of draft guidance,” he said. “We take all criticism equally. We are actually hoping we will get really strong input in terms of how this guidance should be shaped.”

While 2017 gave telemedicine and digital health room to hit their stride, it also left plenty of room for improvement and adjustment. For that, 2018 awaits.

Photo: chombosan, Getty Images