Sunday, November 28, 2010

Electronic Medical Records: Medical Malpractice Shield or Magnet?

Several posts on this blog have been devoted to tort reform. More than any other subject, this topic generates more heat than light. Indeed, I describe these debates and commnets on this blog and elsewhere as duels, not discussions.  Many folks on various sides of this issue earnestly believe that they have the better argument. Other viewpoints are not purely held and are clearly contaminated by self-interest. I have written repeatedly that I believe that the current system is unfair and does not serve the public well. The public understands the issues and the controversies. In general, I don’t think most Americans believe that we have too few lawyers or lawsuits in this country.

It is astonishing that people can defend a medical liability system that

          Misses the vast majority of patients injured by medical negligence

          Ensnares many more innocent physicians than negligent ones.

Shouldn’t these two inarguable facts be sufficient to demand at least an examination of the current system? If a diagnostic test only detected a medical condition in 5% of cases, and caused harm in a sizable percentage of healthy individuals, would we defend it, or try to improve it?

When new medical development occurs, it has legal ramifications for physicians, patients and the plaintiff’s bar. Physicians are held to a certain standard of care – as we should be – which is evolving. It can be murky to determine when a new standard becomes established in a dynamic situation, but this is a critical legal issue. For example, a new treatment may be introduced, and even approved by the Food and Drug Administration (FDA) , against a specific disease. Does FDA approval signify a new medical standard?   Is common usage alone, without FDA approval, define the standard of care?  How many physicians need to be prescribing a medicine for the treatment to be considered standard? 10%? 20%? Could a physician successfully argue that lack of FDA approval of a treatment indicates it should not be regarded as the standard of care? If a conservative practitioner like me delays prescribing new medicines until there is a longer track record safety and efficacy, could I be charged with deviating from the community standard? I recall my  reluctance to prescribe a new irritable bowel syndrome medicine years ago, because I didn’t feel there was sufficient clinical experience for this new drug that was treating a benign, albeit troubling, disease. Sometime afterwards, the drug was pulled from the market after some patients died. I suggest that prescribing new treatments or diagnostic tests too soon might constitute a deviation from a judicious standard of medical care.

As Whistleblower readers know, our office instituted electronic medical records (EMR) this past September. It has been a spirited contest of man vs machine, but I think that we will ultimately prevail. The battle has been more prolonged than we anticipated. We knew there would be many challenges. We didn’t expect, however, that there would be so many unforeseen obstacles, which continue to try to derail us. When your smiling EMR vendor shows up in your office and shows you an awesome demo, think WWRD, or what would Reagan do. ‘Trust, but verify.’

EMR has been advocated as an advance that will diminish physicians’ legal vulnerability by providing much better documentation and communication with colleagues. While this may be true, the nascent technology has created gaps and fissures that are portals for lawsuits to sail through. The New England Journal of Medicine has published a review highlighting the medical malpractice risks of EMR in its November 18th issue. I have disseminated this article to my partners and staff and strongly urge readers to do the same. Here are some of the essay’s highlights, including some of my own observations.
  • EMR usage and reliance upon various clinical support capabilities that advise on clinical decision making and practice guidelines may change the existing standard of care. In other words, failure to rely upon these increasingly available clinical support resources could be considered to be a deviation.
  • EMR use may become the standard of care itself, making those who cling to paper charts legally vulnerable.
  • Physicians are especially vulnerable during the transition phase from paper to EMR when they are caught between the two systems. Our practice has experienced numerous snags and setbacks during this time period. I have had to repeatedly return to EMR notes to correct errors that were inadvertently or mysteriously inserted. Some are easy to identify, such as when a hysterectomy is listed on a male patient’s past medical history. Other goofs may be much tougher to spot in the lengthy and formulaic computer notes. When several individuals are responsible for entering data in a patient’s record, errors are invited.
  • Does the EMR software permit the physician to document his treatment plan, explaining his thinking and judgment involved in the medical recommendations? Or, is the ‘plan’ limited to a list of diagnoses? The latter might not provide much assistance to your defense counsel if you have to rely upon these thin record years after the visit.
  • Does your practice have a plan in place when the inevitable computer crash occurs?
  • How has your practice documented that all medical information in the paper record has been transferred to the EMR record?
  • The cut & paste technique that many physicians use in EMR risks omitting important new medical information and perpetuating inaccuracies.
  • Computer technology now gives access to various patient data bases at the time of the visit. Are physicians obligated to search through area hospitals’ and other organizations’ patient data bases to review all records contained there? Many patients have years of lab and imaging study results in various locales that we now have access to. The legal ramifications of this are obvious.
Of course, EMR will also protect us if we use the system well and are meticulous about our usage. If we document phone calls that direct patients to the emergency room or to a specialist, then this can stifle a lawsuit. Similarly, the EMR record can document that patients were notified of test results and were given instructions on when to follow up with us. But, I fear that, at least in the short term, the legal risks for us exceed legal protections. We need to be vigilant, not only to protect our patients’ health, but also to protect ourselves.

Alas, EMR will not be the Era of Medical Liability Reform.

Sunday, November 21, 2010

Big Tobacco - The Government's Favorite Scapegoat

Smokers of the world unite! It’s strange for a physician to be sympathizing with the tobacco companies, purveyors of the opium of the people. Am I a stealth nicotine addict, an apologist for Big Tobacco who supplies me with my daily fix? This scurrilous allegation can be vaporized in a one-question quiz.

Identify which two of the three individuals listed below are cigarette smokers.

John Boehner, newly elected Speaker of the House , 3rd in line to the presidency

Barack Obama, Commander-in-Chief and leader of the free world

Michael Kirsch, Hemorrhoid examiner

I’ve never smoked and I detest the habit. It kills people and separates lower income Americans from money that could likely be devoted to more worthwhile endeavors. I remember caring for folks with end stage emphysema as a medical resident and thinking that this disease was worse than cancer. I haven’t changed my mind.

Yet, I have felt for years that Big Tobacco is demonized by the press and the government as Big Scapegoat, and this blame shift has always troubled me. I am well aware that the tobacco companies are guilty of many offenses. They have lied about their corporate practices, advertising strategies and manipulation of nicotine content. These companies – like any individual or business – should be held accountable with available legal remedies. If crimes were committed, then I’m sure this nation has a few idle and altruistic attorneys who can fight them in the courts.

My quarrel is blaming these companies for the decisions that individual smokers have made. Assuming that every nefarious allegation against the tobacco companies is true, and throw in a few more, it doesn’t change the fact that smokers for several decades knew (or should have known, a favorite lawyers’ phrase) that cigarettes steal life and breath. This was common knowledge even before cigarette warnings appeared on cigarette packages. I think it an abuse of the justice system and an assault on morality when an individual who is suffering a horrible consequence of a habit that he freely began, blames the manufacturer for his misery.

We all remember the billion dollar settlements that the tobacco companies paid to the states, ostensibly to be used to reduce cigarette use, but were largely devoted to general operating expenses. The phrase ‘up in smoke’ applies here.

While I personally oppose the habit, and counsel my smoking patients to cease and desist, this is a free society. Folks can choose to engage in a variety of activities that span the risk spectrum.

In my state of Ohio, it is legal to
  • Ride your motorcycle in the rain without a helmet
  • Become an alcoholic
  • Flush your life saving medicines down the toilet
  • Hunt
  • Ski on a Black Diamond path when you should be on the Bunny Hill
  • Gorge yourself on a diet of crème brulee, cheesecake and assorted deep fried delicacies
The federal government has issued new regulations that will require cigarette manufacturers to incorporate new labels that will cover half of the cigarette pack or carton. These 36 color photos will be graphic and ghastly portrayals of the ravages of nicotine addiction. The labeling will be a veritable slide show of horror, including a corpse with a toe tag, a man blowing smoke out of a tracheostomy hole in his neck and a wasted and cadaverous individual who looks too weak to lift his last cigarette.

Cigarettes must not be entirely evil, or else the government would outlaw them. Here are some pesky realities that anti-tobacco company zealots must overcome.

  • The product is legal
  • Tobacco directly and indirectly creates jobs and income in all 50 states
  • Smokers pay a fortune in taxes to the states and to the federal government
  • Many smokers enjoy the habit
Don’t misunderstand this post. I will never smoke and hope that no person I care about will pursue this habit. I encourage all inhalers to exchange their habit for a more salubrious addiction. What I do oppose is blaming tobacco companies for the woes of their customers. I also am uncomfortable with the government slowly suffocating these companies who are entitled to advertise and sell their legal wares. If, as a matter of public policy, cigarettes’ adverse health consequences outweigh their economic benefits and the rights of smokers, then have the guts to outlaw them outright, rather than incrementally bleed the companies.

If you support the government’s strategy of pursuing the demise of Big Tobacco by a thousand cuts, then who will be the next targets? Should every product that is not on an approved health and wellness list be attacked? Who decides which companies and activities should be on the list?

Beware! We may soon see similar scenes of ghoulish horror on Hershey bars, Frosted Flakes and even Twinkies. Ronald McDonald will be behind bars, wearing a different set of stripes. Sesame Street's Cookie Monster will be in shackles.  When you pop a champagne cork at your next family celebration, the label won’t be a pastoral scene of a vineyard, but will be a jaundiced alcoholic vomiting blood.

I’m not scared of the government’s new cigarette horror show. I’m scared it won’t end.

Sunday, November 14, 2010

Health Care ‘Reform’ Reforms Legislature

Thank you, Obamacare.

The GOP, demoralized and frustrated, as they endured the Obama liberal juggernaut that trampled across the country these past 2 years, has been resuscitated. It’s more fun to be in the majority, as Nancy Pelosi can recall. Democratic hubris and rising public disapproval provided not just a strong wind, but a tornado, behind the GOP’s backs. Obviously, there’s nothing revolutionary here, as midterm elections tend to favor the minority, with rare exceptions. What is noteworthy here is the depth of disapproval with the current administration’s policies, affecting every demographic. The gains that the Republicans achieved, particularly in the House, have left Democrats numb and glum.

Whistleblower readers will not be shocked to learn that I did not vote for Obama in 2008, but I was inspired by him. I wanted to believe that he would be the transformational figure that his campaign promised and that the country desperately needed. In particular, I was moved by his speech on race relations that he gave at Constitution Center in Philadelphia in March 2008, as a candidate. He certainly has the intellect and the vigor to serve as our chief executive. Additionally, he accomplished a political feat that I thought no living human could perform. He vanquished the Clinton political machine that assumed that Hillary’s campaign was a mere formality that would precede her coronation. As the president-elect, he spoke of collaboration, reaching out and reconciliation. Then, he was inaugurated.

What happened to the idealism and the abandonment of partisanship? There was plenty of audacity, but not the type we were promised.

The public would only allow Obama to blame George Bush for so long. At some point, the president must assume ownership of the nation’s challenges. We expect, of course, that newly elected officials always state after they take office that they didn’t realize how serious and deep our problems are. This strategy is an attempt to transfer blame to their predecessors, but the public will not provide an indefinite grace period for this buck passing The gaziillons of dollars of Obama stimulus hasn’t dented unemployment, and the public is not persuaded by arguments of ‘imagine how much worse we would have been without our bail outs’. We physicians often use this specious reasoning also.

Doctor, Granny has been on the medicine for a year, and I don’t think her dementia has improved at all.

Well, she would have been much worse without it.

Even many of Obama’s stalwart supporters have turned away. Independents and women defected to the GOP. He managed to alienate both the right and left political wings of the country, no easy feat. Our economy may be mired for years, China’s currency devaluation is costing us jobs, no progress thus far on immigration reform, Iran closing in on a nuke, cap and trade policy that many Democrats oppose and a war in Afghanistan that does not seem to be following a soaring trajectory toward victory. (Watch for the definition of victory to change.)

While the economy is the proximate cause of this electoral reversal, Obamacare receives Best Supporting Actor in the Election Day performance. Obamacare is a symptom of arrogant overreaching by Democrats to give the public what the government prescribes. This political paternalism lit the Tea Party fuse and caused rising suspicion and discontent among ordinary folks and businesses that came to realize that they were being force fed medicine they didn’t want or need. The reason that most Americans oppose Obamacare is not because the administration hasn’t communicated its message well. To the contrary, the more the public understands what Obamacare will mean for them and their families, the more vigorously they oppose it. This was a colossal misfire that helped to retire Nancy Pelosi’s gavel.

Leadership is convincing folks that they should follow a new path. It is not herding them over a cliff. Both of these tactics bring folks to new destinations, but isn’t one of these 2 methods the preferred strategy?

The public does not believe that Obamacare will save money or improve medical quality. They believe – and with good reason – that this plan will break the bank, ration care, micromanage health care delivery and create a pathway toward government control. They do not want our health care system, despite its flaws, to be dismantled.

The repudiation of Obamacare is symbolic of why Obama’s shining veneer has faded so quickly. He didn’t care what the GOP or the public thought. He was determined to force his plan through to earn a legacy for accomplishing what no president since Harry Truman could accomplish. I think health care reform will earn him a place in history, but not the one that he seeks. He will join list of American presidents who served only one term. When this happens, he won’t be able to blame it on George Bush.

This election could allow the president to have a more successful end to his first term. He will likely decide to take turn toward the center and work with Republicans and independents. Can Obama leave the left behind, or will he be left behind?

As always, your comments are welcome.

Sunday, November 7, 2010

Can CAT Scans Prevent Lung Cancer? Smoke and Mirrors

I still marvel at the accomplishments of CAT scans and imaging studies.  These technologies have revolutionized the medical profession.  Imagine foretelling 50 years ago that a new technology would emerge that could perform ‘exploratory surgery’ without an incision.   This prediction would be greeted with disbelief, if not scoffing.  Of course, there would be similar reactions if decades ago other technological feats, such as fax machines, personal computers, emails and internet, were predicted.
CAT scans save patients’ lives, prevent surgeries, make accurate diagnoses and refine treatment plans.  This is the good news.  However, as expressed repeatedly on this blog, there is a darker side of the story.
  • Without doubt, too many CAT scans are performed.
  • Accumulated medical radiation has health consequences.
  • Resources expended on unnecessary CAT scans could be devoted to worthy health care endeavors
  • Radiologists suffer from litigophobia and identify every tiny abnormality, which generates patient anxiety and more medical tests chasing these trivial results.   Off the record, radiologists will confide that these ‘abnormalities’ are inconsequential, but their formal dictations always suggest that these lesions may be ominous.  Their dictated recommendation?  Mores scans!
  • CAT scans can provide patients with false security, which is the premise behind total body scans that are scamming the public.
  • CAT scanning and other technologies have eroded physicians’ bedside physical examination skills.   Does anyone think we are as skilled using a stethoscope as our predecessors were?  Of course, one can argue that we don’t really need these antiquated skills anymore. 

Recently, the press went ga ga over a new study that concluded that screening CAT scans on cigarette smokers could save lives. They hyped headline of The New York Times was CT Scans Cut Lung Cancer Deaths.   The study concluded that annual chest CAT scans on smokers could reduce the risk of death by lung cancer by 20%.   Why is my reaction so cynical to what was heralded a groundbreaking development in oncology? 
First, I am always wary when study results are presented in relative terms, such as a 20% decrease in the number of deaths.  Relative percentage terms always exaggerate the clinical benefits and are misunderstood by the public, as well as the press.  For example, assume that a new cholesterol-lowering medication is prescribed to 500 people who are compared with a control group of untreated individuals to determine if the drug can prevent heart attacks.    If 4 folks in the medication group develop a heart attack, and 5 control patients do also, then the drug company can correctly claim it lowers heart attack rates by 20%.  This sounds impressive, although the true benefit that an individual realizes is trivial, since 99% of all patients suffered no cardiac event.   Can’t you just see the headline Drug Cuts Heart Attack Rate by 20%?
In the chest CAT scan study, 300 people must be screened to save one life.  Is this worth it?  Of course, if the lucky individual is in your family or mine, then any cost would justify the outcome.  However, we cannot make public policy based on anecdotes or rare favorable outcomes.   For those who argue that saving lives is worth enormous expense at the expense of others, do they also support the following positions which would save lives?
  • Lowering the highway speed limit to 40 mph
  • Outlawing air travel
  • Prohibiting swimming
  • Eliminating skiing
  • Forbidding contact sports
Assuming the CAT scan study’s conclusions are correct, 299 smokers have to be screened to save a fellow inhaler.  Twenty-five percent of the scans had ‘abnormalities’ discovered that led patients into the medical labyrinth described above.  So, in the group of 300, 1 life was saved and 75 were targeted for subsequent medical assault.  When you consider that there are nearly 50 million smokers in America, imagine the billions of dollars that will be spent and the hundreds of thousands of patients who will be subjected to medical care evaluating harmless lesions.   
In addition, as doctors who have been around a while know, one study shouldn’t change the course of medical practice.  Over the past decade or two, many other groundbreaking studies were subsequently refuted.   I’m sure that physician readers can cite many examples of these medical retreats.  In six months’ time, we could learn of new study that concludes that smokers who are screened with CAT scans have a higher death rate.
A better strategy that is considerably cheaper and more effective is to try to reduce the number of cigarette smokers.  The CAT screening study cost $250 million.  What if those funds were used instead to treat nicotine addiction?  Would this have saved more lives than annual CAT scan screening?  The low tech approach, at least, is more focused on low hanging fruit, rather than aiming buckshot style at every smoker.  Moreover, I would imagine that if a smoker is told that his annual CAT scan is negative, that he will have less incentive to consider quitting.  For him, a negative scan may reinforce his belief that he will avoid a malignant fate.
Other bloggers, including KevinMD and Gary Schwitzer didn’t drink the CAT scan Kool Aide.  My advice?  When the press is serving up Kool Aide, hire a food taster.
Do I think there may a reasonable role for CAT scans in smokers?  I’m not holding my breath on this one.