What Your Doctor Isn't Allowed to Tell You and the Hope that Patients can Pave the Way to Interoperability by David H. Fater

One of the best gastroenterologists in a major city known for top-notch medicine and a friend/colleague of ALDA is not usually ruffled or irritated. But he was sorely irritated when he told us the story recently of giving a patient anesthesia and performing a medically unnecessary procedure. The sticking point was that he hadn't known it was unnecessary because the patient's electronic health record, or EHR, didn't function appropriately.

If you have heard of EHRs (and I am sure most people have), you know that many doctors consider them a pain in  a certain part of their anatomy. Not much is said, however, about the potential harm EHRs can cause to patients. There is a reason for that. Most, if not all, vendor contracts for Electronic Health records contain "Gag Clauses that prevent EHR users from talking publicly about their specific problems and idiosyncrasies.

At its core, the electronic health record is a great idea. The technology was intended to replace paper records in the interest of efficiency, quality and safety. Since the beginning of time, physicians have written notes to record what they see, think and do in the care of their patients. Those notes began to develop into primitive electronic medical records as early as the 1970s, but things changed dramatically during the Great Recession.

In an effort to stimulate the economy, the federal government (in their infinite wisdom) decided to computerize the health-care sector as a whole (as well as change the entire health care system but we leave that subject for a later day). The EHR system was created by the Health Information Technology for Economic and Clinical Health Act of 2009, known by the acronym Hitech. It modernized an industry and gave the economy a boost. It also created the great distraction of 2010 for physicians because of incentive payments they could receive and introduced the concept of "meaningful use". So 2010 became a year where almost every health care provider had at least one person or physician engrossed in the EHR conversion process and, at last count, there are probably in excess of 500 different systems being marketed by vendors.

Unfortunately, in their haste to get this accomplished, the powers that be did not look back at other industries that introduced something similar to EHRs so they could learn from the past. All they had to do was look at the retail industry in the 1970's. They recognized the need for electronic information to be shared amongst retailers, manufacturers and others. So before they did anything, they formed a standards committee comprised of 12 members from all the affected industry groups. This group developed uniform standards for what they were going to develop.  As a result, the most recognizable product of their standards was  the UPC or Universal Product Code. This enabled all the factions of manufacturing, distribution and retailing to communicate seamlessly. Most major retailers, for example, have their system designed so that when a product is scanned at the cash register, the inventory position is updated and, if necessary, a replenishment order is electronically transmitted to the manufacturer. Simple, Clean and Easy!! Not so in health care.

Most EHRs suffer from unfortunate and non-intuitive user interfaces, in part because some were initially designed for medical billing, not clinical work. The vast majority of doctors have found that today’s EHRs make their work harder, slower and in some cases less safe than the paper records of old.  In studies published in the past year, researchers from MedStar Health analyzed data from hundreds of health-care organizations and found repeated instances of poor EHR usability associated with patient harm. Confusing displays and default settings for medication led, for example, to patients receiving incorrect doses, discontinued drugs and even medications intended for other patients altogether.The studies found similar errors in the treatment of children, as well as others in which pounds were entered instead of kilograms and patients received alarmingly wrong doses. EHRs are imperfect—like every other medical intervention, from baby aspirin to pacemakers—but the challenges are surmountable.

Now nearly every clinician in the U.S. uses EHRs—and most  don’t like it. For an EHR to comply with the Hitech Act, it must be used for the collection of very specific diagnosis and treatment data. These data are irrelevant to the care of individual patients but helpful to the government as it manages the health-care system as a whole. That’s one new task EHRs created for doctors which has become the quality metrics by which physicians can rewarded or penalized by the government in their reimbursement rates.  But there are plenty more: Each hospital or hospital group customizes its EHR to meet local corporate and legal goals.

The solution is to have open and uncensored medical literature allowing clinicians to publish their experiences, drug makers and device manufacturers to learn how to improve their products, and health-care providers to learn how to implement them better. But that happens only if the information can get out. One of the problems is that some EHR vendors have such overwhelming market power that they insert gag clauses into their contracts with hospitals, ostensibly  to protect their intellectual property but instead, those clauses  prohibit the free exchange of information which includes discussion of safety-related issues.
 
This can’t continue. The British National Health Service has already banned gag clauses for many new EHR contracts. On Feb. 11, a decade after the Hitech Act was passed, the Office of the National Coordinator for Health Information Technology, which oversee EHRs in the U.S., proposed draft rules that would eliminate existing and new gag clauses in EHR vendor contracts. Still, there is more to be done.

These new rules are merely a draft and will be finalized only after review of comments, which must be submitted by early May. Secondly, we must go beyond removing gag clauses to encourage open discussion of the risks and benefits associated with EHR use. As we have seen with other important new medical interventions, meaningful improvement can be achieved on a short timeline through the creation of a national reporting system to identify and address EHR safety hazards. Some EHR vendors will likely respond to the new proposed rules by lobbying hard to keep the gag clauses unchanged or perhaps weakened minimally. To protect patients, doctors need the same uncensored academic freedom with regard to EHRs that they have for medical devices, pharmaceuticals and all the other tools they use.

Will putting patients in charge of their own health records pave the way for interoperability?

 Now that we have examined the EHR side of things and recognize the lack of interoperability, let's examine whether giving patients control over their own health information will be a solution. If patients have control of their own health information and share it with each provider, will those providers be able to close the gaps in care.  This is new mantra coming out of Washington that will earn providers merits or demerits. Can they close those gaps in care which will enable them to improve the quality metrics and patient outcomes while at the same time lower the cost to the system as a whole?

The new data exchange looks different from the past and is more comprehensive and has discrete elements rather than coming in clunky PDF files. CMS has announced a proposed rule to make over meaningful use to give patients more control over their own health information.The program is now called "Promoting Interoperability" but not much else was  provided by CMS. It does create a new concept of interoperability with the thought being that if patients hold their own data, they, in effect, could be the means of interoperability. They would become the central hub tying together the providers and other relevant parties.
 
We worked with a company several years ago that tried to promote this model with a "credit card" that contained a USB port and special software to retain high resolution images and the providers would load information from each visit onto the card and download information from other providers so that each patient had a complete medical record in his/her possession. Despite the fact it was being used commercially in France, it did not gain traction here.

Now, patients are being provided apps on their smart phones but this time, there is agreement that before the data can be exchanged standards have to be developed for doing so.  That in itself will increase the probability of success. Apple has become the standard bearer for what is referred to as FHIR ("FIRE") which stands for Fast Healthcare Interoperability Resources. Apple is the logical leader because of its mission relating to the consumer experience and thus it will be consumerizing what is a difficult arena of medical information. 
 
The consumer support for this knowledge power becomes even more important as value based medicine increases and the patients are being asked to pay more of the costs.  By having their own health data, they will be in a stronger position to determine the appropriateness of some procedures and its costs.  No one should second guess a trained physician but enabling a  meaningful discussion about your health and outcomes will also aid the system in producing quality outcomes at a lower cost.
 

Is International Business Right For You? by Richard M. Cohen Ph.D.        

International business is older than the ancient Phoenician traders and the trans-Asian caravans, yet only during the past century has the world become truly a global marketplace.  The development of modern transportation and telecommunications technology has allowed business people in almost every nation on earth to sell their products and services to customers virtually everywhere else.

THE DECLINE AND FALL OF THE AMERICAN EMPIRE?
 

For most of the past four decades, the United States held a position of preeminence – if not outright dominance – in the global marketplace.  American industrial productivity became the envy of the world; American distribution networks spread into every country; American marketing techniques achieved unprecedented effectiveness.  The United States not only won the Second World War, but also established what, at least in commercial terms, proved to be the American Empire.
 
But now America’s leadership has eroded.  Several countries outstrip the United States in productivity; foreign goods often cost less than ours; other nations’ marketing campaigns increasingly succeed at wooing American and foreign consumers alike and we have a President that is indifferent to instigating trade wars even though he perceives himself as the skilled negotiator and the Master of the Art of the Deal. The most dramatic result of this erosion is that the U.S. trade deficit continues to grow.  An equally disheartening consequence of this situation is more specific:  individual American companies keep losing sales to foreign competitors, with harmful side effects both for corporate health and for the well-being of individual employees.
 
What accounts for this country’s decline in commercial leadership?  What has brought about the loss of American dominance in international trade?

Four commonly offered explanations for this situation are increased materials costs, increased labor costs, trade protectionism, and the overvaluation of certain currencies.  Many raw materials have become steadily more expensive since the World War II era, with further increases likely as supplier nations grow more sophisticated and organized in dealing with their customers.  Meanwhile, labor costs within the United States have risen as well, so that many American firms compete at a disadvantage with companies in foreign countries where wage scales are far lower.  Laws and regulations in other countries have created worries about trade protectionism, and consequently about American companies’ access to foreign markets.  Finally, the periodic overvaluation of the U.S. dollar has made some American goods more expensive than comparable foreign products.
 
These factors unquestionably contribute to the problems of lost sales and trade imbalances.  However, a couple of other factors over which we have more control also make a difference – factors that are uncomfortable to face but important to accept if American companies are to regain a position of strength in the global marketplace.  These factors are cultural presumptions and hasty or inadequate business strategies. 

Cultural Presumptions
 
Beliefs, customs, traditions, and ways of doing business all vary from one country to another, and even within individual countries.  No one from one culture can know all the subtleties of another.  Still, the reason many U.S. businesses fail overseas is that management refuses to grasp even the possibility of cultural differences.  Too many American business people presume that the whole world does business our way.  Worse, they say as much.  How often have you heard Americans speak of other nationalities in words like theses?  “Back home, we wouldn’t waste so much time.”  Or: “I can’t understand how these people get anything done at all.”  Or: “What this place needs is some good old American know-how.”
 
People in other cultures use time, space, and language so differently from us that we often totally misread their intentions.  For instance, Americans often feel uncomfortable with silence.  We want a conversation to keep moving.  On the other hand, the Japanese and many other nationalities prefer a less “crowded” style of verbal interaction. 
 
The issue isn’t merely linguistic.  Food, clothing, and personal customs also can create vast obstacles for the international business traveler to surmount or avoid.  Almost everyone who has worked abroad can tell stories about mishaps and embarrassments while on assignment.  The point isn’t to avoid every conceivable misunderstanding or misstep.  Rather, the point is to prepare yourself and your company for dealing with the new cultural rules overseas.  To be unprepared is to damage your efforts – and, in some cases, to doom them altogether.

Hasty or Inadequate Business Strategies
 
Perhaps the most common factor contributing to lost international sales is faulty strategy.  Businesses that routinely plan their domestic ventures with careful, thoughtful, long-term research and strategizing often throw caution to the wind when moving into the global marketplace.  Some managers even prefer “winging it” to any kind of planning at all.
 
Instead of doing market research and planning a sound strategy, many American companies prefer a “U.S. Marines” approach to international ventures.  Invade the foreign land!  Establish a beachhead!  Take the country by storm!  Unfortunately, the usual result of this attitude is that companies fail miserably in their first foreign endeavor and resolve thereafter not to pursue international operations at all.  “Oh, we tried going abroad once and lost our shirts,” management says, “so we stick to selling where we understand the rules.”  The irony is that with proper forethought, research, and planning, you can come to understand the rules overseas.  You can even use these rules to your own advantage.

THE PROMISE OF DISTANT SHORES
 
The fact remains:  foreign markets offer vast opportunities for American companies.  The benefits in sales alone are difficult to overestimate.  Other advantages include increased brand name recognition, potential product diversification, company expansion, and protection of domestic markets through more effective competition with foreign firms operating in the United States.  Success in the international arena is a goal best achieved through careful planning.  As such, it is a goal accessible even to small and medium-sized companies. 
 
Any stable, healthy business should at least investigate the prospects of going international.  The minimum requirements are the following:

• An open mind.  Any international venture will bring you fact to face with unfamiliar business practices; with different customs, beliefs, attitudes, expectations, and tastes; and with unaccustomed kinds of potential risk and benefit.  To succeed overseas, you must set aside at least some of your assumptions about what makes sense and how to get things done.
• Careful planning.  Commerce abroad differs from commerce at home, but the difference doesn’t mean that the global marketplace is a free-for-all.  Just entering a new domestic market requires research, goal setting, and strategy, entering a foreign market requires careful planning.  In a field where competitors are abundant, shrewd, and experienced, “winging it” is an invitation for disaster.
• Aggressive, strenuous action.  When great geographical distances, cultural differences, and logistical complexities come into play, business people must act with foresight, clarity of mind, and energy.  The effort involved is often considerable, but so are the potential payoffs.

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If you are interested in exploring the benefits of becoming an international company, please contact Richard M. Cohen at rcohen@alda-associates.com or David H. Fater at dfater@alda-associates.com.
 

Representative Engagements

• Initiated and developed a de novo Accountable Care Organization to participate in the Medicare Shared Savings Program which grew to over 250 physicians over three years which successfully generated savings.
• Financial advisor to large physician practice in connection with a potential acquisition transaction where engagement includes determination of strategic and fair value and assisting in negotiations for closing the acquisition and in post acquisition integration.
• Review and in-depth analysis of new Medicare Reimbursement rules for subsidiary of Fortune 50 insurance company and assistance in developing a business model enabling the capture of a new revenue stream for both physician practices and affiliated providers.
• Acquisition due diligence and integration assistance for a public healthcare staffing company involved in numerous acquisitions. Retained by parent company to manage acquired company for 22 weeks through ALDA developed integration plan.
• Turnaround assistance for a near bankrupt client company, including tax and financial restructuring, and ultimate sale at a significant cash price.
• Leadership of development of client company's strategic plan for the next decade and assistance in repositioning the company.
• Determination of strategic value of a client company, packaging for sale and assisting in negotiations.
• Providing the entire management team for several life science and healthcare companies from early stage through obtaining additional patent protection, guiding clinical development plans, navigating the pathway through the FDA, establishing the manufacturing processes, initiating commercial sales and eventually transforming the Company into a publicly traded Company.
• Determination of strategic implications of a line of business with weak performance; development of strategies to maximize profitability contribution.
• Turnaround assistance for a troubled venture-backed company, including raising additional debt and equity capital.
• Acquisition and financing assistance for a public, international railroad in connection with a $300 million cross-border acquisition and refinancing.

Our experienced professionals are dedicated to helping clients unlock inherent value and create new value.

The ALDA Team includes, among others:

David H. Fater - Chief Executive Officer

Strategy, capital markets, restructuring, and mergers and acquisitions experience with public healthcare companies focused on physician management, rural healthcare, nursing homes, HMO's, diagnostic imaging and medical devices. Deeply involved in the implementation of the Affordable Care Act with Accountable Care Organizations, Independent Practice Associations and Management Services Organizations. 

Richard M. Cohen - Senior Operations and Business Development Executive

Healthcare operations and worldwide sourcing experience. Skilled in healthcare (physician management, clinical trials, medical and patient process flow, diagnostic imaging and life science) operations as well as in issues dealing with importing, exporting and manufacturing operations in South America, Far East and Europe. 

Thomas J. Bohannon - Senior Financial Executive

Accomplished, creative CPA, outstanding analytical and technical abilities. Has experience for over 40 years in public accounting and private industry including nursing homes, medical device companies,  hospitals, not-for-profits, retail, manufacturing, import/export and natural resources.

A. Ronald Turner - Senior Healthcare Executive

Senior healthcare industry executive with strong entrepreneurial focus including CEO and COO positions with start-up hospital companies and a publicly-traded hospital company. Extensive and successful operations experience for more than 50 hospitals and 9 nursing homes, and senior reimbursement experience for a major publicly-traded hospital company and a national accounting firm. Experienced in mergers and acquisitions, led operational turnarounds and debt restructurings that created significant value.

Mark W. Caton – Senior Healthcare Executive

Senior hospital executive with over 30 years experience in operating not-for-profit and investor-owned rural/community hospitals as CEO or COO, and Regional COO with several national hospital companies.  Skilled in strategic planning and business development, operations management, revenue cycle management, medical staff development, and quality/resource management.

Daniel N. Weiss, M.D., F.A.C.C. - Chief Medical Officer

Medical devices and healthcare practice experience, engaged in a private medical electrophysiology practice where he performs numerous invasive cardiac procedures and has served as a consultant for several Fortune 500 Medical Device Companies including Philips, Boston Scientific/Guidant, St. Jude and Medtronic, as well as for several medical device and drug start-up companies. 

David Bott - Senior Information Technology Executive

Systems and network support solutions experience, proviedes analyis of strategic business needs and assessment of business models and their integration with technology.  

Santiago Guzman - International Executive

Experienced in new project development for companies in a variety of industries from start-up to Fortune 500. Client relations management, fluent in English and Spanish. Skilled facilitator for introductions with influential leaders in South America including those in the health care industry. 

With offices in:

• Delray Beach/Boca Raton, FL
• Atlanta
• New York
• Quito, Ecuador

For additional information, please contact:
David H. Fater, Chief Executive Officer
ALDA & Associates International, Inc.
751 Park of Commerce Drive; Suite 128
Boca Raton, FL 33487
(877) 845-4657
dfater@alda-associates.com