Words to live by

Words to live by

“There’s a lot of foaming at the mouth and market estimates .. the part that is missing in mobile health is the part that convinces people they have to use it.” This insightful comment came from Dr. Joseph Kvedar, director of the Center for Connected Health, an affiliate of Harvard Medical School. They come at time when Apple, Google, Samsung, heck just about every tech company is jumping into the deep end of the pool.  It seems everyone sees mobile health as the key to helping patients achieve better outcomes; this is the cornerstone of the movement towards interconnected diabetes management (IDM).

The only thing missing from Dr. Kvedar comment is not just convincing people to use the system but also getting it paid for. The fact is IDM offers huge potential provided patients use it, a fact that will be enhanced if patients don’t have to pay for the privilege or the cost is very reasonable. While tech companies everywhere are foaming at the mouth to jump into this market one has to wonder how they see themselves getting paid for this technology. Will the patient pay for the app? Will they pay a monthly fee? Perhaps employers will pay? And what about payors who could see costs decline as outcomes improve, will they pay?

The reason this is such an important issue comes down to analytics, who is going to analyze all this data the patient is gathering? Will the patient’s physician be reimbursed for the time? Will the physician even be in the loop? What about liability where will that reside, with the physician, the patient, the provider?

These are very relevant questions for patients with diabetes, in particular insulin using patients. Sophisticated algorithms can analyze some of the data, however it’s unlikely the FDA, who’s sure to get involved here, would allow any changes to therapy without a physician’s input and/or approval.  Which brings up another piece to the cost puzzle, what happens when tech companies are asked to conduct long and expensive clinical trials? Can an app or IDM system generate enough revenue to offset these costs?

The interesting aspect here that hasn’t been discussed much is what happens to all the systems already on the market, only a handful of which have received FDA approval.  Nearly every one of these apps or systems carries the standard liability language that patients should not make any changes to their therapy regimen without first consulting with their physician. This language might make the lawyers happy but provides little comfort when it comes to how patients act in the real world.  The real world where patients; for better and worse, are more proactive than ever when it comes to managing their diabetes. Patients who increasingly are seeing their out of pocket costs increasing and who just might want to avoid paying another co-payment for an office visit.  For some it’s cheaper and faster to surf the web for answers than to see their physician.

Which brings about another intriguing question, using IDM would a physician be allowed to bill for a text or email consultation?

This to Diabetic Investor is the gap that must be bridged to make IDM a reality. So far it’s been mostly about how the data is obtained, where it’s stored and who has access to it. Little attention has been paid to who will analyze all this data and who will pay for them.  IDM will become useless should all this data, however it’s gathered, stored and accessed is not be combined with analytics. Software can do some of this work but given the current regulatory environment combined with physicians who will protect their turf and incomes, we don’t see analytics coming cheaply.

Even when we transition from a fee for service model to an outcomes based reimbursement model, physicians will want their piece of the pie. Keep in mind this is the same group that has fought against nurse practitioners from handling simple medical tasks. Think of how this fight will evolve as pharmacists become more involved in diabetes management.

This is where Diabetic Investor begins to wonder just how drastically diabetes management is about to change as tech giants like Apple and Google become more committed to the space. Will they stick with just the technology piece and perhaps partner with pharmacies or physicians for the analytics? Or will they blaze new territory and try to become vertically integrated? Will these companies known for their innovation bring about the change that is desperately needed at the FDA? Can companies used to a 6 month product cycles withstand the rigors of regulatory oversight?

There are many reasons why we call this the wacky world of diabetes and the quest for IDM will just add to the wackiness. Change is coming and coming quickly, whether its change for the better is subject to how these and other questions get answered. This is going to be fun.