We came back from HIMSS and got right to work on the March Monthly Update for Chilmark Advisory Services subscribers. As we’ve reported in a previous post, HIMSS13 afforded enormous buzz and less enlightenment regarding the state of health IT, particularly the four key areas we see as essential to this industry making a true difference in patient care. In our March update, and the reports currently underway, Chilmark Research does the opposite: provide insight without buzz. Below are abstracts from this month’s update. To find out how you can receive the full update, send an email to: info at chilmarkresearch dot com

Public vs. Private Oversight of Mobile Health
John Moore III

mHealth, known for rapid innovation and iteration, has a tendency to buck at the snail’s pace of FDA regulation. Last month, during a series of hearings considering whether smartphones and tablets with medical apps qualify as medical devices and thus require FDA approval, many charged the FDA with stifling innovation. After all, how many developers or investors want to sink resources into an industry that will be regulated in ways that have yet to be determined?

Enter Happtique and its Health App Certification Program. Happtique intends to complement the work of the FDA, and has introduced a set of standards for health apps that fall into the grey area between apps that are clearly medical and those with a clear consumer focus. This could herald a new age of credibility for mHealth. However, as both regulator and marketplace for many of the apps that it regulates, Happtique could end up in a very sticky situation. They will need to tread carefully to maintain their objectivity in both certifying apps while at the same time providing a marketplace for mHealth apps.

The March Toward Better Patient Engagement
Naveen Rao

The open question in health IT these days is whether patient engagement will gain traction or if it will suffer the same fate as PHRs. One thing is certain; healthcare needs far better patient engagement methods, processes and techniques than what one finds today as most current efforts in engagement have very little to do with helping a patient manage a condition. Time and again in our discussions with healthcare institutions of all sizes we find the same scenario being played out – engagement today is focused on building patient/customer loyalty to the institution – they are simply no more than marketing efforts.

Stage 2 meaningful use is requiring a deeper level of patient access to their records via view, download and transmit requirements and there is even a requirement for some email messaging between provider and patient. But there is a bigger issue at play, payment reform wherein providers will be taking on more risk for the patient populations they manage. Without deeper engagement with the patient regarding a chronic disease, providers will struggle with these new payment risk models.

Several related markets, such as telemonitoring and wearable tech are taking off. Chilmark analyst Naveen Rao spent near-exclusive attention to the patient-engagement tracks, vendors, and sessions at HIMSS13. In his article for the March update, Naveen identifies three factors that will define if and how well the patient-engagement market will stay afloat in the coming years.

CommonWell Alliance Intends to Tackle Interop
John Moore

The announcement of CommonWell Health Alliance was likely the biggest story to come out of HIMSS (Allscripts acquiring longtime HIE partner dbMotion may have been a close second). The group’s stated purpose is to enable interoperability across the five founding members’ EHRs. For starters at least, this includes: Allscripts, athenahealth, Cerner, Greenway, and McKesson’s RelayHealth division. In its simplest form, CommonWell will establish a set of standards and services that enable query-based health information sharing in a heterogeneous EHR environment.

Part of the challenge with interoperability within a community of heterogeneous EHRs is that standards are useless when it comes to things like patient matching, consent management, or locating records, all of which are fundamental to interoperability and all of which require standardized services model. CommonWell founders know this and have plans to address it. The greatest challenge facing CommonWell, however, may be the market itself as adoption of HIE tech within the ambulatory sector remains a challenge.

Each month, subscribers to the Chilmark Advisory Services (CAS) receive an update of our research on the most transformative trends in the healthcare IT sector. Exclusive to CAS subscribers, monthly updates are part of the continuous feed of information and analysis we generate to keep subscribers on top of the rapid-fire changes in this market.

Merge Healthcare Announces Tender Offer and Consent Solicitation for 11.75% Senior Secured Notes Due 2015

CHICAGO, April 2, 2013 (GLOBE NEWSWIRE) -- Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that it has commenced a cash tender offer (the "Tender Offer") for any and all of its $252,000,000 outstanding aggregate principal amount of 11.75% Senior Secured Notes due 2015 (CUSIP Nos. 589499AB8 and 589499AA0) (the "Notes"). The purpose of the Tender Offer is to improve Merge's financial position by refinancing its indebtedness outstanding under the Notes at a lower interest rate.

In connection with the Tender Offer, Merge is soliciting consents (the "Consent Solicitation") to effect certain proposed amendments to the Notes and the indenture governing the Notes (the "Indenture") that would eliminate substantially all of the restrictive covenants and certain events of default contained therein, would release all of the collateral securing the Notes, would shorten the minimum redemption notice period required for Merge to redeem Notes from thirty days to three business days prior to the redemption date, and would modify certain other related provisions contained in the Indenture. The Tender Offer and Consent Solicitation are being made pursuant to an Offer to Purchase and Consent Solicitation Statement dated April 2, 2013 (the "Offer to Purchase"), which more fully sets forth the terms and conditions of the Tender Offer and Consent Solicitation.

{snip}

As described in the Offer to Purchase, the "Total Consideration" for each $1,000 principal amount of Notes validly tendered and related consents delivered at or prior to 5:00 p.m., New York City Time, on April 15, 2013 (such date and time, as the same may be extended, the "Consent Expiration Time") and accepted for purchase will be $1,066.96 per $1,000 principal amount of such Notes, which includes a consent payment of $30.00 per $1,000 principal amount of such Notes (the "Consent Payment").

{snip}

The Tender Offer and Consent Solicitation are conditioned upon, among other things, (a) the receipt of tendered Notes from the holders of at least two-thirds of the aggregate principal amount of the outstanding Notes (excluding any Notes owned by Merge or any of its affiliates), (b) receipt of funds from certain refinancing transactions, on terms and conditions acceptable to Merge, in an amount sufficient to enable Merge to purchase the tendered Notes, make the Consent Payments and pay related costs and expenses, and (c) certain other general conditions, each of which is described in more detail in the Offer to Purchase...

Like the plumber whose house is full of leaky taps, my blog has been sorely neglected over the past few months. In an attempt to bring things up to date, here’s a project I finished last year for Macquarie University.

Soon I'll be heading back to the HIMSS Southern California  Annual Health IT Conference - April 10th in Los Angeles.  This is a special event for me because my presentations over the years have followed my expeditions across technologies:  RHIOs, Telehealth/Telemedicine, HIE, mHealth, Social Media

This year's theme is healthcare consumerism and I've been invited to participate in a panel to discuss

Social Media in Healthcare: Promoting Patient Empowerment and Engagement, Healthcare Value, and Patient Centered Care

My TOWER colleagues, Sue and Megan, will join a panel discussion on

PHRs and Patient Portals: Realizing Patient Empowerment and Personalized Healthcare

 Take a look at the entire agenda and register to join us at this event.  We hope to see you there!

A (conceptual) model is a description of the most important concepts and their respective relationships within a certain domain of interest. Whatever domain of interest that you focus on, your model will consist of (conceptually simplified) parts that interact with each other in some way. This leads to three different types of models:

1. The static model describes WHAT the (most important) parts are about.
2. The dynamic model describes HOW these parts interact with each other.
3. The intentional model describes WHY they display this behavior.

As we will see, these modeling types can often be mixed into a single model, and then these different types should be thought of more as “aspects” or “perspectives” of the model.

Brain Computer Interface is the term used for a very advanced kind of man machine interface. They allow to send orders to a machine through thought. Sensors are directly connected to the brain of the user and a computer interpret the neural signals to transform them in orders.

Yet these systems are still curiosity of laboratories, them announce a quantum leap forward, for the disabled.
In the US, the NINDS has an active research program on this field. See for example this video of the BrainGate system, shot in the Massachusetts General Hospital. It helps understanding how promising this technology is for tetraplegic people.

Behind these devices, there are a lot of software. Given the high complexity of the technical problem, a few research teams developed framework solutions, like BCI2000, BF++, and OpenVibe, developed by a research laboratory of INRIA.
Openvibe is available under LGPL license and easy of access with graphic programming. If you're channelling the soul of a brain computer interface designer, you can download it and start developping the next generation of medical device!

Today, Caradigm and Orion Health announced their partnership wherein Caradigm will go to market with Orion Health’s HIE solution suite and likewise Orion Health will take  Caradigm’s analytics solution, Caradigm Intelligence Platform (CIP) to market to its existing and future customers. Existing Caradigm customers (~20) who are now on the eHealth platform will be put on life-support and encouraged to make the transition to Orion’s solution in the coming year.

Orion Health has had a long relationship with Microsoft, including acquiring Microsoft’s Amalga HIS solution and partnering with Orion to combine the then Amalga UIS with Orion’s HIE solution. Shortly after this announcement was made though, Microsoft threw in the towel on the clinical market combining its assets with a collection of those from GE which resulted in the NewCo, Caradigm.

As part of the establishment of Caradigm, GE contributed eHealth, its HIE solution suite that was co-developed with Geisinger and Qualibria, a quality management platform developed in conjunction with InterMountain. With the death of eHealth and a product which has yet to see the light of day (Qualibria) its beginning to look like GE brought very little to the Caradigm relationship.

Back to the Orion-Caradigm partnership…

As we have written in the past the core services that HIE vendors offered in the past are quickly being commoditized by such things as Direct secure messaging being embedded in future certified EHRs for stage two meaningful use requirements. With the recent announcement of CommonWell Health Alliance, even query type services may also become commoditized.

Clearly, to stay competitive and relevant, HIE vendors need to move to what we term as HIE 2.0, providing more advanced services that leverage the data flowing through the “pipes” of an HIE to more effectively manage the health of a given community the HIE serves. This is particularly important for enterprise clients ( a market Orion is now targeting) and can also assist public HIEs (Orion’s traditional market) in providing value-add services that may help them reach nirvana (sustainability). With CIP, Orion can provide a more compelling offering. The big challenge here for Orion will be in effectively pricing and deploying CIP, (Amalga UIS was notoriously expensive and difficult to deploy. Caradigm has rebranded Amalga Version 3, a much improved version architecturally, as CIP to distance themselves from the stigma of the Amalga brand).

While the relationship provides value to Orion, it may provide even greater value to Caradigm, a company that has stumbled to gain traction in the market. Orion provides a ready channel to market via Orion’s existing broad HIE customer base – one of the world’s largest. Orion also provides Caradigm an effective exit from directly participating in the HIE market with a solution that frankly was not up to the task. The announcement also claims that Orion has agreed to develop applications for the CIP which contributes to Caradigm’s goal of being perceived as a platform play in the market. What those apps may be is still an open question. Based on the language in the PR, it looks like not a lot of thought has gone into that aspect of the relationship yet.

Now we’ll just have to wait and see how this plays out in the market.

What to watch:

1. Joint customer wins – who and where.
2. How many existing eHealth clients transition directly to Orion or jettison for another HIE vendor entirely.
3. Apps that Orion builds for CIP.
4. Existing Orion clients that purchase CIP and whether or not we see accelerated growth in such purchases or an initial surge followed by stagnation.

A common myth about Anesthesia Providers is that their work simply involves giving anesthesia to the patient undergoing surgery. In reality, they have more responsibilities like creating a customized anesthesia plan for a patient, monitoring the health status prior to and after giving anesthesia, and more. Anesthesia providers may range from Anesthesiologists, Certified Registered Nurse Anesthetists (CRNA), and Anesthesiologist Assistants. Like how treating a patient with the right anesthesia is vital, billing anesthesia services the right way is also very important. Different from the usual healthcare billing process, it has some unique requirements. The most challenging part of anesthesia medical billing is the clear documentation of records which are briefed below,

1. 1.    Pre-operative Review: In this review, the patient’s health history is thoroughly analyzed to find risk factors like cardiac complications and more. It helps anesthesiologists to tailor a custom plan for the respective patient.
2. 2.    Anesthesia Sheet: It involves the documentation of the following factors,

• Base Units: They are derived by measuring the complexity and skill set required in providing anesthesia services. More intricate procedures earn a higher number of base units.
• Time Units: The amount of time required to render anesthesia services helps derive time unit factors.
• Modifiers: Factors like patient’s physical status, co-morbid conditions, emergencies, concurrencies and more have to be taken into account in anesthesia medical billing.
• Conversion Factor: A fixed dollar amount set by the anesthesia group belonging to each state.
• Formula: (Base Units + Time Units + Modifiers) x Conversion Factor = Anesthesia Reimbursement       

1. 3.    Post-operative Review: Monitoring a patient’s health condition and rendering appropriate pain-block services after surgery is very important. Anesthesiologists are expected to document them for proper anesthesia medical billing.  

Improper Documentation: Sometimes, anesthetists fail to document their services properly or their documents might be erroneous due to their busy schedules. It may lead to claim denials or underpayment, thereby affecting the revenue cycle management. The ideal solution to overcome this situation is to outsource anesthesia medical billing to an offshore company like e-Care India.

I believe the most important aspect of my role as a CIO is communication. A mediocre strategy well articulated will produce greater results than an excellent strategy that is not understood by those that must execute and support it.

There are many communication vehicles, but those of us at the senior management level must be able to stand in front of a room with a few hundred people and deliver a 30 minute presentation that is effective and engaging.

I enjoy this aspect of my job and I am constantly seeking to get better at it. I think I am better than average, but short of where I want to be. No matter how good one gets at this, an engaging presentation requires time to craft and practice to deliver well. I can still fall on my face if I do not have enough preparation time.

Every time I start to prepare a new presentation I do so with the intent of rivaling what Steve Jobs would do. The limitations of time and talent will keep me well short of that, but that is the mindset I start with.

Most folks in the corporate world start their presentations using a PowerPoint template created by the marketing department; and, most of those templates are awful. When Steve Jobs introduced a new product did his slides have the top 1/3 reserved for a giant title? Did every slide need to be branded with the an Apple logo and tag line. Did those slide use bullet pointed lines of text which he would read to the audience? Be brave, dump your corporate PowerPoint template.

There are a couple of books that I have found helpful and would recommend to anyone wanting to become better presenters. Garr Reynolds’ Presentation Zen has lot of suggestions about the entire process of creating and presenting a presentation. It really shines in the guidance it gives on creating engaging slides, the kind of slides Steve Jobs would use.

Another book that I have recently begun to re-read is Granville Toogood’s The New Articulate Executive. It is filled with presentation wisdom.

If anyone has presentation tips or book recommendations I would appreciate appreciate it if you left them as a comment to this post.

A few words about guidances in Europe. News are rare enough to point them out.
First, the guidance on electronic labelling came into force on 1st march 2013, see the MHRA website for some explanations and the original decision on the EU website.

Second, the guidance on vigilance and field safety notifications. The last version of this guidance aka MEDDEV 2.12-1 was released by the EU. It will come into force in july 2013.
This the revision 8 of this guidance. Height revisions! It proves that the vigilance management is a concern of EU authorities and that the system is obviously perfectible.

The change visible is in the title of section 3.1.2 in the document. For manufacturers of IVD, was replaced by For manufacturers of devices that are not intended to act directly on the individual.
The guidance adds two new types of products in its sight: in vitro fertilisation (IVF) and assisted reproduction technology (ART). It also namely adds software qualified as medical devices in its sight. Hence standalone software can be the cause of indirect harm to patients.
By extension, software that are accessories to IVD, IVF, and ART, also are in the sight of this guidance.

Section 4.6 of the document defines what a field safety corrective action (FSCA) is. It's interesting to notice that the notes under the definition add a few informations about software. These informations were not present in the last version of the guidance. A proof that software becomes a truly visible cause of incidents.

Please share/ suggest links to research studies.

Hi ,

Are there any SAP modules for Healthcare informatics/Managment? And what are the career options for these ?

thanks

Prashanth

The importance of modifiers in Coding is that they play a vital role in medical claims processing. Therefore, Healthcare Facilities and Providers must show extra care while using modifiers in the medical billing and coding process. If they fail, then there could be serious repercussions concerning reimbursement. In general, what are modifiers and why are they so important in the medical insurance billing and coding process? Let’s get into these details,

Elucidation: In simple terms, modifiers are two digit alpha, numeric or alpha-numeric codes, which shed more light on the Codes for a specific procedure or service performed by a Provider. These modifiers will be of great help to third-party payers, especially when they process medical coding & billing claims of a Provider. They contribute a great deal to the proper reimbursement for a Provider’s services.

Role: Modifiers clarify insurance payers on the following aspects,

• They explain whether the provider services had technical component or professional component or a combination of both
• They specify if more than one physician was involved in rendering a particular service or procedure
• If a service was performed in more than one location, then it is clearly indicated
• Modifiers also clarify if a service was performed completely or partially
• If an optional extra service or a bilateral service was performed, then they are coded with their respective modifier codes
• They clearly indicate if a service was performed more than once
• If mishaps occurred during the course of service, they are coded in detail

Thus, modifiers have a great responsibility in deciding the accuracy of medical billing and coding.

Impact: If the medical coding/billing staff show negligence while coding modifiers, then the respective Healthcare Facility or Provider will face a huge revenue loss. For instance, if a provider has performed bilateral services, then the billing report must be coded with Modifier 50. On failing to code properly, the provider will be underpaid. Modifiers like 26, 23 and QZ help prevent the denial of claims.

Why Outsource? Coding modifiers requires a lot of knowledge and can be performed only by highly-experienced coders. With increasing pressure on in-house Coders due to Compliance and ICD-10 migration, medical coding outsourcing would be the prudent choice!

The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials.

As discussed in our earlier posts on apps regulation (here and here), an app is a medical device if its meets the congressionally mandated and FDA enforced definition of a medical device as something whose intended use “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”.  As stated in the FDA’s Draft Guidance, omitted from this definition, and therefore not medical devices, are apps “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.”

Some manufacturers have identified this health and wellness exception as fertile ground for asserting that their product falls within this exception, and therefore is free of FDA before-market scrutiny. In some cases this ground is plowed in the form of an express disclaimer, even though such a disclaimer may not be particularly credible. For example Brad Thompson, in a post for MD&DI cites the example of a urinalysis phone app and hardware system that includes the disclaimer that the device “is intended to be used for health and wellness information purposes and as a demonstration of technology. It is not intended to be used for diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease and should not be used as a medical device.” In other words, the manufacturer expressly disclaims the very definition of a medical device. (And, no, you do not urinate directly on the phone.)

This disclaimer might be fine if it made sense that you would do self urinalysis just for wellness purposes, and if the company did not also make assertions on its website that appear to be to the contrary, e.g. ”can help you analyse, interpret and trend your urinalysis data to help you understand and manage diseases like diabetes and its, urinary tract infections and pre-eclampsia.” If the device is being used to manage disease it pretty much sounds like a medical device, despite the disclaimer. We, and presumably the FDA,  then have the issue of whether claims can be offset by disclaimers, i.e. is it a balancing act in which the greater weight prevails, or do claims establish intended use regardless of disclaimers.

An interesting thing about an express disclaimer based on the very definition of a medical device is that it demonstrates that the manufacturer was fully aware of FDA requirements and was actively trying to avoid falling within the regulatory framework. This is different from those app developers who remain ignorant of FDA regulation (or so they may claim). Avoidance and or ignorance of FDA regulation is not limited to the app arena. I recently attended a talk by a company that aggregated and moved around medical data over the hospital network and that appeared to me to be in the MDDS space, if not of an even higher classification. When asked about their FDA status (and not even by me), the response was a shrug and general denial that they were covered.

If disclaimers actually are enough to free oneself from engaging with the FDA, there is no reason why their efficacy would be limited to mobile apps. For example we have discussed the disclaimer that a VoIP hospital phone system was not intended for primary communication, and that Clinical Decision Support (CDS) systems might carry a disclaimer to the effect that the advice provided by the CDS should not be relied on. This leads to one form of the ultimate disclaimer: “This product may or may not do what we have claimed it can do. Therefore it should only be used for personal entertainment, or as an adjunct to the use of other devices that can confirm that this device actually works.” Or going one step further: “Do not use this product.”

In this more general regard  I recently had occasion to review a device’s direct-to-patient brochure where it was alleged that the information in the brochure was misleading if not not outright false. Part of the manufacture’s defense of this allegation was the asserted expectation that the patient’s discussion with their physician would offset the lack of being forthcoming in the brochure.  One might characterize this as asserting that it was OK to be misleading in one document if you told the truth elsewhere. i.e. you had to add up (and maybe weight) the misinformation and the correct information across multiple platforms and assess the net weight to determine net truth or falsity.

By the way, medical apps are/were the subject of House hearings on 3/19-21 following a March 1 letter to the FDA by house Republicans asking about both regulation and taxation under the Medical Device Tax. In part the letter asked what I thought the FDA had already answered, e.g. does running a medical app on an off-the-shelf general purpose platform make that platform a medical device? Answer: No. More on these hearings to come.

William Hyman is Professor Emeritus of the Department of Biomedical Engineering at Texas A&M University. He recently retired and has moved to New York City where he continues his professional activities.

CMS just released the December 2012 attestation data, and one thing is abundantly clear—many EHR vendors will not be around to see Stage 2.

Of the 472 EHR vendors offering certified “Complete EHRs” in early 2012, many lacked even a single physician who had attested to meaningful use by the end of the year. And while it is not surprising that large vendors dominate the EHR market, they do so to a far greater extent than the 80/20 rule would predict. The top 24 EHR companies (just 6% of the 392 ambulatory EHRs with attestations) account for 80% of the total attestations to date—only 19 companies have delivered over 1,000 attestations and only 32 have exceeded 500. At the other end of the spectrum, 112 of the vendors produced only 1 to 5 attestations and a full 252 report 50 or fewer.

So what does this mean for the future? Consider why so many vendors have so few attestations. It could be that they are small companies, new to the market, with limited revenue, resources, and staffing—which suggests they likely lack the significant development resources required to meet the increasingly complex certification requirements of Stages 2 and/or 3. Or it could be that their software is challenging to use and their physicians were unsuccessful at demonstrating meaningful use. In either case, these vendors will not survive in the long run—if lucky, they will be acquired by one of the large vendors. The survivors will most likely be those who have already established themselves in the top tier, and whose physicians experience only minimal disruption in the process of satisfying the government’s requirements. Was it the intention of CMS and ONC to force market consolidation? Or is the demise of small, innovative EHR companies an unintended consequence of the complexity of the EHR incentive program?

CMS just released the December 2012 attestation data, and one thing is abundantly clear—many EHR vendors will not be around to see Stage 2.

Of the 472 EHR vendors offering certified “Complete EHRs” in early 2012, many lacked even a single physician who had attested to meaningful use by the end of the year. And while it is not surprising that large vendors dominate the EHR market, they do so to a far greater extent than the 80/20 rule would predict. The top 24 EHR companies (just 6% of the 392 ambulatory EHRs with attestations) account for 80% of the total attestations to date—only 19 companies have delivered over 1,000 attestations and only 32 have exceeded 500. At the other end of the spectrum, 112 of the vendors produced only 1 to 5 attestations and a full 252 report 50 or fewer.

So what does this mean for the future? Consider why so many vendors have so few attestations. It could be that they are small companies, new to the market, with limited revenue, resources, and staffing—which suggests they likely lack the significant development resources required to meet the increasingly complex certification requirements of Stages 2 and/or 3. Or it could be that their software is challenging to use and their physicians were unsuccessful at demonstrating meaningful use. In either case, these vendors will not survive in the long run—if lucky, they will be acquired by one of the large vendors. The survivors will most likely be those who have already established themselves in the top tier, and whose physicians experience only minimal disruption in the process of satisfying the government’s requirements. Was it the intention of CMS and ONC to force market consolidation? Or is the demise of small, innovative EHR companies an unintended consequence of the complexity of the EHR incentive program?

The NHS Commissioning Board will work with a charity to offer 100,000 people access to training in online health literacy over the next year, it has announced.

The board’s national director for patients and information Tim Kelsey said on Thursday it had made the agreement with UK Online Centres, an organisation which specialises in tackling digital exclusion.
The work comes in the run up to the board’s deadline of 2015 for patients to have access to their GP health records. ...

Health literacy training on offer for 100,000, Health Service Journal. 14 March 2013, p.10.