|April 2013||Julie A. Blehm, MD, FACP, ACP Governor|
From the Governor
Spring certainly is slow in arriving this year in the eastern part of North Dakota. I am tired of snow. Last year at this time some people were putting in the docks at their lake cabins. I am hopeful the snow will start melting soon but not produce a flood.
I want to remind everyone that the ACP Internal Medicine 2013 is being held in San Francisco, CA May 11-13 with precourses on May 9th and 10th. This is always an excellent meeting and I would encourage you to attend.
Please let me know if you are going to be attending the meeting. Also it would be helpful to know if anyone who has become a fellow will be attending convocation. Dr. Brian Willoughby and Dr. Ebima Okundaye are planning to attend convocation as fellows. Please let me know if anymore of you are attending convocation as fellows and will march with North Dakota.
Sunita Sharma, one of the internal medicine residents from the UND IM residency, had her research abstract "Hypocalcemia with Denosumab" Is it worth the spasm?" chosen as one of the 10 national winners in the 2013 National Associates Competition. It is a great honor to have a research abstract chosen as one of the winners in the Associates Competition. She will be presenting her abstract on Friday, April 12 at 1:32 pm. It is in CC –Room 124. Please attend and support Dr. Sharma if possible. We are very proud of her. It is an honor for our chapter.
Leadership Day is May 21 and 22 in Washington for those 2 days. We will be setting up appointments to visit with our representatives and senators in Congress. We would encourage anyone who is interested to join us for those days. Dr. Katie Hall will be our representative this year along with myself (I will already be out there for a committee meeting) and Dr. David Newman.
Mark your calendar for October 4, 2013. This is the date for our state ACP educational meeting. It will be held in Fargo this year at the Southeast UND campus.
Please contact me if you are willing to be part of the planning committee for our fall meeting. It will be held in Fargo this year on October 4.
I would appreciate a call or an email from anyone who is willing to serve on our advisory council, membership committee or finance committee.
Please let us know if you have been part of any health care advocacy work- ie lectures to public groups on health care, work with legislators, volunteer work such as mission trips. We would like to include these items in our newsletter and annual report. I know many of you are involved in this work.
Also please consider becoming a Fellow of the ACP. If you have questions about it, do not hesitate to contact me.
The Time magazine has an interesting article in the March 4th issue. “Bitter Pills, Why Medical Bills Are Killing Us.” If you can find a copy it is well worth reading and makes some very good points.
The article below is from Kevin MD blog. Again thought you might find this interesting as we are all interacting with EMRs in our work lives.
The Ethics of EMR: How Unproven Technology Affects Patients
Wes Fisher, MD | TECH | February 4, 2013
The implementation of the electronic medical record (EMR) in American medicine gained a powerful foothold in medical care with the passage of the American Reinvestment and Recovery Act (ARRA) in 2009. With the passage of this act came the promise of improved efficiencies, safety and ultimately reduced cost delivery for health care. Also, some $18 billion dollars in financial incentives were offered to physicians to offset costs to deploy these systems nationwide. To assure adoption, if the systems were not implemented by 2015, doctors and care providers will suffer payment penalties from the government. For physicians who care for Medicare patients, there was no alternative than to deploy these systems.
In 2010 alone, the EMR market was pegged at $15.7 billion dollars, a cost that is ultimately passed to all Americans. In addition, despite all of the changes that health care reform has brought to date, people in some states continue to see their insurance premiums mushroom over 20% in 2013 from the preceding year. Simply put, patients are finding health care anything but “affordable.”
We should acknowledge that there might be cause, ethically, to deploy a technology that truly benefits patients at some cost. After all, you have to break a few eggs to make a good omelet. If interoperability of EMR systems between facilities were commonplace and clinical data were shared with ease while patient privacy was vigorously upheld flawlessly, the cost of these systems might be ethically justified.
But the promise of improved efficiencies to our health care system, improved patient safety and (especially) reduced cost for our health care system remain elusive. More importantly these goals remain unproven. In fact, examples that the opposite is occurring abounds as doctors struggle to enter ever-increasing amounts of information of no relevance to the patient’s presenting problem just to prove they’re using the EMR in a “meaningful” way, health data security breeches continue, data-mining of patient information is occurring not just for patient care, but for marketing purposes, and the direct costs of health care for patients continues to rise, not fall. Proponents of these systems will argue these issues are nothing more than “growing pains” of these novel systems.
So should we step back for a moment and ask ourselves if we are being ethical to patients with the deployment of this technology? Does the ends of presumed cost savings to our national health care system justify the deployment of poorly integrated, difficult-to-use systems? Are patients being subjected to new risks heretofore never considered with the adoption of this technology? Could a tiny programming error occur that negatively impacts not just one patient, but millions? If so, what are the safeguards in place to prevent catastrophic error? Who will be responsible? Who is the oversight body that assures the guiding principles of the Belmont Report (respect for persons, beneficence and justice) with respect to EMR deployment are followed? The Secretary of the Department of Health and Human Services or a more nebulous body like Congress?
If we accept that the benefits of the EMR are at least uncertain to patients in terms of risk and cost, we should demand they be studied before deploying them. The guiding medical ethics tenets would demand nothing less. So, would not such study qualify as human research? After all, we should remember that the United States and other countries have a precedent of human research programs performed by government agencies that were usually highly secretive, and in many cases information about them was not released until many years after the studies had been performed.
From a sentinel paper in 1966 by Henry J. Beecher, MD on Ethics in Research:
I should like to affirm that American medicine is sound, and most progress in it soundly attained. There is, however, a reason for concern in certain areas, and I believe the type of activities to be mentioned will do great harm to medicine unless soon corrected. It will certainly be charged that a mention of these matters does a disservice to medicine, but not one so great, I believe, as a continuation of the practices cited.
Experimentation in man takes place is several areas: in self-experimentation; in patient volunteers and normal subjects; in therapy; and in the different areas of experimentation on a patient not for his benefit but for that, at least in theory, of patients in general.
While Beecher’s paper was addressing ethical research errors in general, his words are oddly prescient for EMR development. Ethical errors, as he pointed out, “are increasing not only in numbers but in variety.” He points to one of the biggest drivers of ethical conflict: money.
Of transcendent importance is the enormous and continuing increasing in available dollars for research, as shown below:
Money Available for Research
Massachusetts General Hospital
National Institutes of Health
These data, rough as they are, illustrate vast opportunities and concomitantly expanded responsibilities.
Taking into account the sound and increasing emphasis of recent years that experimentation in man must precede general application of new procedures in therapy, plus the great sums of money available, there is reason to fear that these requirements and resources may be greater than the supply of responsible investigators.
The need for “responsible investigators” remains significant; funding for all of the National institute of Health in 2011 was $142.5 billion dollars. Annually, EMR companies have received the equivalent of 11% of the entire NIH annual research budget from US citizens without having to prove their safety or value to patients.
Again, from Beecher’s paper:
The ethical approach to experimentation in man has several components; two are more important than others, the first being informed consent. The difficulty of obtaining this is discussed in detail. But it is absolutely essential to strive for it for moral, sociologic, and legal reasons. The statement that consent has been obtained has little meaning unless the subject or his guardian is capable of understanding what is to be undertaken and unless all hazards are clear. If these are not known this, too, shall be stated. In such a situation the subject at least knows that he is to be a participant in an experiment. Secondly, there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.
Because EMR deployments are cloaked in intellectual property, non-disclosure and restrictive hospital employment agreements, doctors are often prohibited from voicing specific concerns about an EMR system publicly. In addition, by adopting EMR systems as cornerstones of the American health care system, Congress, the President and the ARRA side-stepped patients’ informed consent regarding the short-comings of these systems, advertising only their desired benefits instead. Furthermore, rather than Congress turning to “conscientious, compassionate, responsible investigators,” they turned to lobbyists when deciding to fund the deployment of unproven EMR systems. As a result, doctors were relegated to becoming nothing more than stewards of data entry subject to new, ever-evolving documentation requirements as these systems evolve for cost-saving benefits and care “efficiencies.”
Patients and doctors alike understand the need for improved efficiencies and value in our era of exploding health care costs. We must strive to find a solution to our health care cost crisis that is transparent, cost-effective and ethical. Without such an effort, our health care system will collapse. Only recently has the Office of the National Coordinator of Health Information Technology recognized the problem and opened their Health IT Patient Safety Action and Surveillance Plan for public comment. This plan asks the EMR companies and interested stakeholders to develop their own methods to assure patient safety and reporting systems – a move that approaches the same ethical standards as equivalent of asking the foxes to watch the henhouse. Nonetheless, we should acknowledge their efforts.
But we should be cautious of EMR systems as we move forward. After all, these clinical systems have not been subjected to the same cost-benefit and ethical scrutiny as other clinical tools we use in health care. The scrutiny of EMRs should be no different than that found with pharmaceutical or medical device research where Institutional Research Board approval and proof of no conflict of interest is demanded. Why should clinical EMR systems be any different?
Given the profit motives and market consolidation occurring amongst the purveyors of these EMR systems and the potential for lethal EMR errors both from software and human interface issues, doctors and patients must especially question the ethics of the movement to deploy untested, novel technology on our patient population under restrictive covenants. As part of informed consent, patients should have full understanding of how and where their clinical data are used, including when it will be used for direct-marketing campaigns, prioritizing care delivery, or for research. Patients should be able to opt out of the use of their clinical data for these or any other purpose if desired, without restricting payment for care. Finally, physician and patient concerns about EMR systems should be allowed to be vetted publicly and without threat of professional or personal reprisal or the withholding of payments for care rendered, especially and particularly if these disclosures are performed in the best interest of patient care.
To do otherwise is unethical for our patients and the public at large.