Rounds Online

The following is rather dry reading but these are the official guidelines for future stem cell research as formulated by the National Institutes of Health Resource for Stem Cell Research and adopted by Congress and the President to determine eligibility for federal funding.

Guidlines On Stem Cell Research

The National Institutes of Health Resource for Stem Cell Research

On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

These Guidelines implement Executive Order 13505, as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH policies and procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH stem cell research.  Full Document

First of all let’s define some acronyms:
EHR: Electronic Health Records
AHIMA: American Health information Management Association
HIPPA: The Health Insurance Portability and Accountability Act of 1996 - The Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes.
ARRA: American Recovery and Reinvestment Act of 2009 – among thousands of other issues, the “meaningful use” requirements now being defined under federal rulemaking will address the use of EHRs.

OK. Just about everyone agrees that EHRs if universally accepted and implemented would bring down healthcare costs and improve patient care. Setting aside for the time being the sticky problem of where doctors will come up with the capital to convert their paper files to EHRs, there are a host of other issues that are emerging as EHRs begin moving into the system.

The AHIMA just wrapped up a two day conference in Chicago. On the agenda was how to apply existing new and old federal laws (designed to address legal issues regarding the reproduction and release of printed medical records) to the brave new world of EHRs. It seems that EHRs were originally “positioned as a physician’s tool”, according to Donald Mon, VP of Practice Leadership at AHIMA. They were not designed to be the legal record. Why does that matter?

In a recent court case, a plaintiff attorney requested a patient’s records from a practice that had converted to EHRs. The software the practice was using was not designed to efficiently create uniform printed pages. As a result the printed forms spit out by the software had no page numbers, headers or standard format. Some pages had a single paragraph or bullet point. The record for the single event at question ran to over 2000 pages!

But the problems run deeper than that. Because most EHR software was never designed to create secure legal documents as defined by federal law, the edit process allows the records to be modified by virtually anyone at any time, writing over previous entries and creating new, back dated entries. Some software removes the original author of a file and replaces it with the author of the most recent update. Obviously this can create enormous legal problems.

Almost all software has some audit capability. In the case of EHRs some audit functions go to the file level but not the data level. So in some cases you can determine when a file was created, who the original author was – but not what was entered! And on top of all of these issues you have those of patient access and privacy. A patient now has the right to request a record of all access to their personal files…many EHRs are not equipped to track and report all such data.

It is obvious that if EHRs are to become the accepted level of record keeping at America’s medical facilities a great deal of work needs to be done on the formats, standards, functionality and security of the software. Leading the evolution of these systems will be the AHIMA. Doctors need to keep track of the work of this organization and the impact rules and regulations may have on their own EHRs.

What’s that old saw that if you put a pair of rabbits on an island, even in the absence of predators, they will reproduce until the food supply regulates their population?  Its all about supply and demand…rationing of resources.  Anyone who believes that health care rationing isn’t already a reality is out of touch with reality.  Rationing is happening and will happen.  What the debate is about is WHO will do the rationing.  Who will decide where the finite number of health care dollars are spent… gets treated and who is made as comfortable as possible until they pass.  Here is an article that takes the issue straight on.

Health Care Rationing Rhetoric Overlooks Reality

The New York Times

By David Leonhardt

Rationing sounds like something out of the Soviet Union…or at least Canada.  The r-word has become a rejoinder to anyone who says that this country must reduce its runaway health spending, especially anyone who favors cutting back on treatments that don’t have scientific evidence behind them. You can expect to hear a lot more about rationing as health care becomes the dominant issue in Washington this summer.

In truth, rationing is an inescapable part of economic life. It is the process of allocating scarce resources. Even in the United States, the richest society in human history, we are constantly rationing. We ration spots in good public high schools. We ration lakefront homes. We ration the best cuts of steak and wild-caught salmon.  Health care, I realize, seems as if it should be different. But it isn’t. Already, we cannot afford every form of medical care that we might like. So we ration.   Full Article

Those of you who follow my blog know that I am no big fan of current healthcare reform legislation. I am unconvinced that the government can effectively manage anything as complex as the delivery and funding of healthcare (for that matter I am unconvinced that the government can manage anything effectively). But I am very concerned with the recent disruptions at town hall meetings where politicians have appeared to answer questions about their position on healthcare reform.

Now, I have not been at a town hall meeting that has been disrupted. I have been at meetings in our suburban Chicago community and I have made it a point to make myself heard. But I was not shouted down and the meeting was quite tranquil (and poorly attended). I can only judge other meetings by what is being reported in the press (always a risky policy). But all Americans should be concerned when unruly mobs gather and shout down public discourse. If you are upset and concerned with a politician’s position you have many options in a democracy:
• Write a letter registering your position. A representative wants to know where his or her constituents stand. Emails work equally well.
• If you have the means and feel strongly enough, visit your congressman…either in Washington or in his local office when he visits.
• Attend a town hall meeting and voice your opinion or ask your questions…in a civil and orderly manner. Respect the right of others to do likewise.
• If you feel that it will gain support for your position you can demonstrate with signs and slogans outside the meeting, or outside the congressman’s office or outside the White House if you think it will do any good. But demonstrate in a civil manner. Don’t trod on the rights of others who don’t share your views.

There is no justification for organized mob action designed to squash public discourse. And there is no excuse for individual behavior that attempts the same. Now I know all about the 1st Amendment. But a democracy cannot endure if mob rule is the order of the day. Issues should not be determined by the loudest or the most aggressive opinion put forth.

I was particularly disappointed in the weak stand taken by Senate Republican Leader Mitch McConnell on one of the weekend talk shows. His comments were unworthy in my view.

“Look, I don’t think either side ought to be trying to engage in disrupting meetings, either the Democratic side or the Republican side. But “to demonize citizens who are — you know, who are energetic about this — strikes me as demonstrating a kind of weakness in your position,” McConnell said. “In other words, you want to… change the subject…..

“Attacking citizens in our country for expressing their opinions about an issue of this magnitude may indicate some weakness in their position on the merits,” McConnell said. “This is an enormously important subject. Of course American citizens are concerned about it. And many of them are upset about it.”

No one is suggesting that American’s should be demonized for expressing their opinions Senator. The issue is storm trooper behavior, intimidation and physical confrontation. You know what is going on and you should be as outraged and concerned as every other American who believes in free and open debate.

When writing about healthcare issues, I like to try to find analogies outside the industry to help make my point. When pondering the growing shortage of emergency room physicians and the resulting waiting times, cost and crowding, I asked myself why more doctors are not attracted by the drama, challenge and reward of this category of medicine.

I settled on the job of snake charmer. Talk about a rush. You always draw an admiring crowd when practicing your trade. No question that there are challenges and risks. But in most of the Indian villages where the charmer plies his trade, the practitioner is a highly regarded and in most cases compensated professional. The problem is that the standard of performance demanded in the trade is PERFECTION. After all, the snakes you are charming have poison tipped fangs and evil dispositions. There would probably be more snake charmers if the snakes were more forgiving and reasonable and if you pulled their fangs. Stick with me here and I’ll try to bring this analogy home.

Many primary care physicians who are otherwise qualified will not accept shifts in the ER. Fewer medical students are selecting Emergency Medicine as a career track. Emergency rooms are over crowded and under staffed. The reason most often cited…the fear of litigation…and by a wide margin.

Making life and death decision in a pressure cooker environment can sometimes lead to poor outcomes. I can’t think of another profession (other than that of snake charmer) where the standard of performance upon which professionals are judged is perfection! The doctors I talk to tell me that they refuse to put their lives, their careers and their financial future at risk by being second guessed by attorneys who, with the luxury of hind site and with all the time in the world to review, evaluate and speculate, judge decisions made by those on the front line of medicine.

One of the most challenging, exciting, rewarding and fulfilling medical positions out there is that of Emergency Room physician. Each day ER doctors are faced with true life and death decisions. They have access to the best technology that medicine has to offer. They are performers on the most demanding stage imaginable.

A good place to start healthcare reform might involve pulling some of the fangs from the legal profession…a charming if somewhat unrealistic expectation.

They say silence is golden. Never more true than in healthcare reform legislation. Silence on the abortion issue in pending legislation has raised red flags in the camps of abortion foes.

Up to this point abortion opponents have largely been successful in their battle to prevent public funding of abortion. The center piece of their legislative success has been a law called the Hyde amendment. It basically prevents Medicaid from providing low-income women with reimbursement for abortions. If states want to fund the procedure they have to come up with the money. Federal employees and military personnel are also denied coverage.

But healthcare reform is prepared to rearrange the deck chairs on the ship of state. In pending legislation the federal government would set up a health insurance exchange. In this government run bizarre low income and middle-income citizens will be allowed to buy either private policies or a public policy (the jury is still out on the public option). Any plan purchased through the exchange would be subsidized with public funds to make coverage affordable.

Here is where silence comes into play. Abortion is a legal medical procedure. The Democratic healthcare legislation that is currently making its way through congress does not mention abortion…no simple oversight I’m sure. With the new stream of public funds flowing through the exchange joining a mixture of personal co-pays and employer contributions, both the public and private plans would be free to offer coverage for all legal medical procedures not specifically excluded under the reform measures.