Testing Technology vs. Enabling a System of Chronic Care – Results of the NIH Tele-HF Trial

by Randy Williams, MD FACC, CEO of Pharos Innovations

The results from the National Institutes of Health (NIH)-sponsored Tele-HF trial are in, and the findings are worth considering . The results are counter to most of the findings of other studies examining telemonitoring for heart failure and at face value are disappointing to us, and the industry. Upon closer examination, however, this study offers us an excellent opportunity for further innovation, refinement of solutions and continuous improvement. It also provides a snapshot of how significant the challenges remain in transforming U.S. healthcare – from a system that is episodic, reactive, acute care based to a system of care that incorporates proactive, interactive, continuum-based chronic care management. 

The genesis for this study stretches back nearly 10 years, from conceptualization to the results we see reported today. This randomized, controlled multi-centered trial was designed to compare an automated, daily symptom and self-reported weight monitoring technology with “usual care” in reducing hospital readmissions and mortality among patients recently hospitalized with decompensated heart failure. The boldness of vision should not be underrepresented: Tele-HF is the largest study of a non-pharmacological intervention for heart failure ever conducted. 

At a high level, the results showed “no significant differences” between the group receiving usual care and the group randomized to receive telemonitoring. I cannot say that these are the results we were hoping for. However, I urge those in our industry and other key stakeholders to take a closer, more informed view, and to reach their own conclusions and insights. 

The Details

First, I want to thank and acknowledge the great work of the investigators, study sites and everyone involved in this trial. It was a long process and everyone worked with the utmost integrity and professionalism. We were privileged to have been selected for participation.  I also want to acknowledge the value of conducting large, multi-centered, randomized, controlled trials in terms of advancing medical science. 

The patient interventions in this study took place in 2006-09 and omit many of the processes and techniques Pharos uses today to achieve the necessary critical mass of physician and patient involvement. Here are the limitations of this particular study – from my perspective: 

Appliance or Application? The Choice Finally is Coming to Health Care.

My wife Jill loves her  iPhone…she raves about it. Last night she showed me an application she had recently acquired for her iPhone. She was able to explain and demonstrate the app and its functionality to me (yes, to ME!) in about 30 seconds. 

I’d describe the app as Garmin-like but running on the iPhone. You type in the address at which you’re going to start your drive and then you type in the address of the location where you want to drive to. The iPhone displays a map and step-by-step directions. Want to zoom in on a section of the map? …just put your fingers on the screen, spread them, and instantly you see the map in greater detail. The app uses the GPS built into the iPhone to display your current location and progress on the map.

A few years ago you would have had to purchase a separate Garmin or Garmin-like appliance to get this type of functionality. Is this iPhone app as good as the Garmin? For many people, the answer might well be “No”, but that’s not the point.  For many people the iPhone app WILL be good enough — and having that choice is what creates a vibrant marketplace.

So what does this have to do with health care? A lot.

To date, health care has not had an iPhone like platform on which to run multiple high value applications. If you wanted specific functionality, you had to buy an independent appliance. For more on the appliance vs. platform distinction, start reading at Chapter 2 of Harvard Law Prof. Jonathan Zittrain’s excellent (and freely available) book, The Future of the Internet and How to Avoid It.

If you rethink health care, just about ANY technology or service can be reconceptualized as an app that COULD run on a common platform. Mull this over for a while…

The Medical Home: Pull the RUC Out

This third and final post in the series addresses questions about the future of the Patient Centered Medical Home (PCHM):

  • What’s problematic about using the RUC methodology with the PCMH?
  • What’s the optimal level for a PCMH care management fee?
  • Should primary care leaders pull the RUC out? How?

What’s Problematic About Using the RUC Methodology with the PCMH?

There are at least two reasons for not having the RUC methodology seen anywhere in the same county country as the PCMH. First, the RUC methodology doesn’t account for technology and services needed for optimal care management. Second, the RUC methodology is conceptually flawed.

1) The RUC methodology doesn’t account for technology and services needed for optimal care management. Here’s what the RUC recommended methodology for the PCMH pays for:

Table of contents for the series--The Medical Home: End of the Honeymoon

  1. The Medical Home: Confusion Over Care Management Fees
  2. The Medical Home Hits the RUC
  3. The Medical Home: Pull the RUC Out
  4. Extra: Will $87 Per Hour Rescue Primary Care?

The Medical Home: Confusion Over Care Management Fees

The honeymoon is over.

Prior to April 29, 2008, reviews of the Patient Centered Medical Home (PCMH) model  had been uniformly enthusiastic and positive.

Today the PCMH model is hitting reality — someone’s going to have to bring home money to pay the bills. On April 29 the American Medical Association/Specialty Society RVS Update Committee (RUC) released a  report making recommendations relating to payment levels of care management fees for the PCMH.

This report has stirred cries of confusion and outrage. I’ll elaborate on these cries in the second posting of this series, but if you can’t wait, read here, here, here, here, here, here, here, and here.

Welcome to a series of three blog postings discussing the PCMH, care management fees, and the RUC report.  I can’t claim to smooth the uproar, but I hope to frame the issues so that they can be understood and discussed constructively.

The series will address numerous questions. This first post:

  • What is the PCMH care management fee?
  • Why is the PCMH care management fee important?
  • Why are people confused?

The second post:

  • What is the American Medical Association/Specialty Society RVS Update Committee (RUC) ?
  • What is the RUC’s role in the Medicare Medical Home Demonstration project?
  • How are people reacting to RUC recommendations for PCMH reimbursement levels?

The third post:

  • What’s problematic about using the RUC methodology with the PCMH?
  • What’s the optimal level for a PCMH care management fee?
  • Should primary care leaders pull the RUC out? How? 

Table of contents for the series--The Medical Home: End of the Honeymoon

  1. The Medical Home: Confusion Over Care Management Fees
  2. The Medical Home Hits the RUC
  3. The Medical Home: Pull the RUC Out
  4. Extra: Will $87 Per Hour Rescue Primary Care?

Data Incompatibility Remains A Barrier to Remote Patient Monitoring (RPM) Devices Reaching the Mainstream

The Continua Health Alliance is doing a good job in getting remote patient monitoring (RPM) devices to become plug-n-play — where devices and peripherals from different manufacturers complying with Continua Guidelines will be able to talk to one another.

Continua’s work-to-date is a necessary, but not yet sufficient effort to make RPM devices mainstream.

Knocking down the barrier of device-incompatibilty exposes the bigger barrier of lack of data interoperability among RPM technologies and between RPM devices and health care IT systems.  Jonathan Edwards, research VP and lead telemedicine analyst for Gartner, nails the issue:

What Will Microsoft’s HealthVault Mean to the Telehealth Community?

My colleague Tim Gee and I are guest bloggers on the Get-Connected Forum at the Center for Connected Health.  We speculate on:

What Will Microsoft’s HealthVault Mean to the Telehealth Community?

Our bottom line:  HealthVault overall is a positive for telehealth industry growth and scale, even though it will speed the inevitable commoditization of remote patient monitoring (RPM) devices.

Microsoft’s HealthVault: User Manual = C-, Strategy to Create a New Ecosystem = A

Would you like to have the experience of being parachuted into a deep forest with no map of where you are or clues about how to get out?  If so, I suggest that you go directly to Microsoft’s new PHR at www.healthvault.com and just TRY to figure out where you are or where you’re headed.

Initial confusion put aside, I think HealthVault is strategically brilliant.  While I’d give Microsoft a C- for explaining HealthVault (HV), I’ll give them an A for laying the strategy and foundation for what can become an extremely powerful platform for the appropriate, free flow of interoperable and transportable personal health information (I’ve chosen my words carefully here).

Here are four initial impressions about HealthVault — please comment as I’m still trying to figure out myself exactly what HV is and isn’t.

Disease Management Going Mobile & Retail: QUALCOMM’s Health Care MVNO

An article in Wireless Week announces the creation of a new species: a health care MVNO named LifeComm. LifeComm promises to move disease management, wellness, and fitness into new territories.

What is a MVNO?

More acronyms!  What is a MVNO? A Mobile Virtual Network Operator (MVNO) is a mobile operator that does not own its own spectrum and usually does not have its own network infrastructure. Instead, MVNOs have business arrangements with traditional mobile operators to buy minutes of use (MOU) for sale to their own customers.

You’ve seen MVNOs advertised on TV: Amp’d Mobile, Disney Mobile, ESPN Mobile.

What Will the LifeComm MVNO Do?

Here’s some information from the Wireless Week article:

Evidence for Remote Patient Monitoring (RPM): The Glass is More than Half Full

Over the years, there have been a number of meta-analyses examining hundreds of studies relating to effectiveness of RPM.  The latest one of these is Systematic Review of Home Telemonitoring for Chronic Diseases: The Evidence Base, published in the May/June 2007 issue of the Journal of the American Medical Informatics Association (JAMIA).

My colleague Tim Gee, respected fellow blogger and world renowned connectologist, summarizes this latest study under the headline “Impact of Remote Monitoring Still Inconclusive”.

Tim, I’m concerned that folks might draw the wrong impression from your use of the word “inconclusive”.  While I’d have to concede that the word “inconclusive” is technically correct, I don’t think your headline conveys an accurate picture of the state of RPM development.

The word “inconclusive” accurately applies to the quality of the evidence in the studies, but doesn’t accurately describe the robust state of developments occurring in RPM.  The quality of the evidence refers to the methodologies of the studies: lack of a control group, lack of randomization, small sample sizes, heterogeneity of studies, etc.

Here’s a related example.  The x-ray was invented in the year 1895.  An article in the year 1900 might have noted that the “evidence” to support the value of medical imaging was “inconclusive”.  Should we have backed off the future development of this technology?

Researchers tend to be a cautious bunch by nature and training. So while a researcher might accurately use the word “inconclusive” to describe the scientific evidence supporting RPM, an executive, manager, clinician or strategist shouldn’t necessarily draw that same conclusion.  

Let’s probe a little deeper into the very article that you characterize as “inconclusive”.  There are two sections of a scientific paper where researchers sometimes let their hair down — the “Discussion” and “Conclusions” sections.  Take a look at the conclusions the authors draw in the JAMIA article:

Five Lingering Questions Holding Back Remote Patient Monitoring (RPM) Adoption

Technology adoption often takes longer than expected, and remote patient monitoring (RPM) is no exception. More specifically, I’m referring to multiparameter RPM of patient vital signs. There are currently over 25 companies with multiparameter RPM offerings, including Philips, Honeywell HomMed, Health Hero, ViTel Net, and many others.

I am a big believer in RPM technology — it WILL revolutionize delivery of health care.

However, I’m also a realist. Consider the following questions a collective “voice-of-the-customer” from my six years working in this market space.

The questions are tough ones, and some aren’t obvious. In this post I’m only listing the questions; I’ll offer perspectives on possible answers in a future post.

Here are the five questions: