Regarded

By JANE ORIENT, MD

The reported success of the Affordable Care Act (ACA or ObamaCare) is based on enrollment numbers. Millions more have “coverage.” Similarly, the predicted disasters from repeal have to do with loss of coverage. Tens of thousands of deaths will allegedly follow. Activists urge shipping repeal victims’ ashes to Congress—possibly illegal and certainly disrespectful of the loved one’s remains, which will end up in a trash dump.

Where are the statistics about the number of heart operations done on babies born with birth defects, the latest poster children? How about the number of babies saved by this surgery, and the number allowed to die without an attempt at surgery—before and after ACA? I haven’t seen them. Note that an insurance plan doesn’t do the operation. A doctor does. The insurer can, however, try to block it.

Also missing are figures on the number of courses of cancer chemotherapy given, or not given, or the time from diagnosis to death in cancer patients before and after ACA. Five-year survival of cancer patients in the U.S. is generally better than in countries that have universal coverage, or the type of plan progressives want to import. Again, the insurance plan isn’t medicine. You can get medicine without insurance, and if you have insurance it might refuse to pay.

There are selected comparisons of change in mortality rates in states that did or did not expand Medicaid (such as New York vs. Pennsylvania). On the other hand, mortality did not decrease in one state (Oregon). These estimates—guesstimates really, are based on the weakest type of data, and the differences may have nothing to do with Medicaid. Maybe it was better AIDS treatments. We hope that the FDA does not use evidence this poor to evaluate drugs.

But what effect did ObamaCare have on overall U.S. mortality?

Between 2014 and 2015, U.S. mortality rates increased for the first time in decades. This primarily affected less-educated whites. Is ObamaCare the cause? There are many factors involved, drug abuse probably being the most important. But I suspect that if repeal had happened in 2012 or 2013, it would have been blamed.

We hear many complaints about medical bankruptcies. These happen because patients got their treatment, and then got a bill. Often the bills are outrageous, and hospitals may be ruthless in collection efforts. That is a serious problem, but it is not caused by lack of universal coverage. And remember, bankruptcy is a way out of debt. Creditors take a haircut. In contrast to medical debts, student loans cannot be discharged by bankruptcy but follow a person for life.

Medicaid expansion may have alleviated fears of medical bankruptcy, but we don’t know that more patients got treatment. In single-payer Canada, there is no fear of a medical bill. But there might not be any treatment either.

We do know that after Medicaid expansion “nonprofit” hospitals are banking windfall profits, while charity is essentially gone. In Oregon, Medicaid enrollment increased from 626,000 in 2013 to 1,056,000 in 2016. Providence Health & Services now has the biggest pile of cash reserves of local companies—$5.8 billion vs. $3 billion for Nike. Hospitals are using the cash to buy new assets, not to lower prices or improve quality. They pay their executives like a Fortune 500 company.

The experts advocating for universal care know very well that resources are limited, and that spending (“costs”) must be contained. They also understand that the burgeoning bureaucracy and its minions and retainers must be well paid. So the answer is to cut services. Some plans “incentivize” doctors to make more money by skimping on care. Others call for a “global budget”—the deliberate creation of scarcity. When the money is gone, treatment is canceled. There will be fewer beds, fewer CT scanners, fewer drugs, and fewer doctors. But all will be fair. No rationing by price, just by waiting lines, political pull—and death. There will be no medical bills to pay after a service, if you get any service. Only taxes in advance, service or no service.

That’s why the universal care advocates count enrollees, not the number of services, and constantly harp on “excessive” treatment, even while planning to make patients wait months for an appointment.

Jane Orient, MD is Executive Director of the Association of American Physicians and Surgeons (AAPS) since 1989. She is currently president of Doctors for Disaster Preparedness. Since 1988, she has been chairman of the Public Health Committee of the Pima County (Arizona) Medical Society.

By ROSS KOPPEL and HAROLD THIMBLEBY

The world is reeling from the massive ransomware attack on at least a hundred nations’ computer systems. The unprecedented malware spasm infected hundreds of thousands of computers, and would have infected millions more but for a 22-year old computer science student who found a vulnerability in the malware that he used to curtail the infection. He found it looked for a non-existent URL, so he a set up that URL and found he could stop it spreading. Of course, now the hackers know that, it is an easy matter to update the malware to use other URLs and other techniques. Clearly, this iconic malware attack is not going to be the last.

What do we know about the malware? The NSA (the US National Security Agency) found that there was a vulnerability in some of Microsoft’s operating systems. The NSA was itself hacked, and ransomware was developed that exploited the vulnerability. This ransomware was then distributed on the black market. The original flaw is called “EternalBlue” and it was converted into the now notorious ransomware program called “WannaCry.” It is important to note that no special skills are required to actually use ransomware: WannaCry is just a tool a criminal buys in the hope of causing chaos or making money or gaining fame.

The NSA has an interesting problem. It discovers a backdoor that may help it fight terrorism, so it makes sense to keep it secret. In hindsight, once the flaw is known to hackers it is quickly exploited, and the rest of the world is unprepared for the consequences. In any case, Microsoft, on March 17, 2017, issued patches for the vulnerabilities for its currently supported software, which most people use on a day to day basis.
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By JIM PURCELL

Did you realize that the American Health Care Act (AHCA) recently passed by the Congressional Republican majority will allow insurers to deny coverage for mental illness? Did you realize that the AHCA permits insurers to charge women more than men because they get pregnant? That the AHCA will allow insurers to terminate a family’s coverage if they incur claims that exceed their annual premium for three straight years? That at the urging of Attorney General Jeff Sessions, a group of Republican lawmakers in the Senate has proposed language that would make medical marijuana a pre-existing condition? And that the same group of lawmakers is mulling a requirement that would grant immigration officials sweeping new powers to review records of patients suspected of committing crimes or posing as a loosely-defined “threat to community health.”

Hey, I just made that up. But we have a lot of that going on right now.

Case in point. Journalist Daniel Heyman was arrested after shouting questions repeatedly at HHS Secretary Tom Price. He was charged with disruption of government processes, a misdemeanor, and was released on $5,000 bail. Based on just those facts, that sounds outrageous. Predictably, the story has gone viral with shrieks of gestapo tactics and outraged indignation by the Fourth Estate.

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By ROBERT PEARL, MD

“Pigs get fat, but hogs get slaughtered,” the saying goes. And so may it prove to be true for the pharmaceutical industry.

Three articles, all published recently, illustrate the greed and egregious pricing by certain drug companies that are gaining public recognition and scrutiny.

Marathon Pharmaceuticals LLC serves as a case in point. Over the last 15 years, its chairman and CEO Jeffrey Aronin generated a billion-dollar valuation for the company. As reported in a Wall Street Journal article, “Drug Price Revolt Prods a Pioneer to Cash Out,” he achieved this milestone not by inventing new drugs but, rather, by buying the rights to old ones, then raising the prices excessively with disregard for patients’ ability to pay.

As an example, Marathon invested $370,000 to obtain the license for the data on “deflazacort,” a steroid available for about $1,200 a year in the United Kingdom. This medication is prescribed to treat muscular dystrophy, a condition that predominantly affects young boys. The company then secured FDA approval, renamed the drug “Emflaza,” and sold it to patients in the U.S. for $89,000 a year. Through the approach it used, Marathon invested only minimal dollars, avoided having to complete late-stage clinical trials, and was never required to compare its efficacy against other, relatively inexpensive generic alternatives.

Outrage from parents of children with muscular dystrophy, combined with harsh criticism from several U.S. senators, forced Marathon to recognize that it had painted itself into a corner. The only exit at hand was to sell the rights to the drug to another company—for $140 million plus 20% of future sales and the potential for a $50 million payment. As a result of negative publicity, Marathon’s valuation has dropped significantly, and the company’s future is uncertain.

How Big Pharma Became So Big

Of all sectors in healthcare, the most profitable is pharmaceuticals. They now account for nearly as much cost as hospitals, and prices continue to rise at a rate two to three times faster than overall medical inflation. As a result, according to the U.S. Bureau of Labor Statistics, prices for U.S.-made pharmaceuticals have climbed over the past decade six times as fast as the cost of goods and services overall.

The pharmaceutical industry is generating large profits for both its shareholders and its CEOs. Increasingly, drug companies have figured out ways to bring to market a variety of drugs with minimal to no investment in clinical research, and almost no risk. To protect its high margins, the industry spends freely on direct-to-patient advertising, as well as on promotion to doctors and campaign contributions to elected officials. And despite growing recognition of the problem and the consequences to the cost of healthcare in the U.S. from excess drug costs, little has happened legislatively to curb these abuses.

The public is learning how these practices translate into extremely high salaries and perks for drug company CEOs. As an example, last year Mylan was lambasted for increasing the cost of its EpiPen product by 550%. The drug is epinephrine, a naturally occurring protein, and is therefore not able to be patented. But the injection device that the parent or child uses to administer the drug, even though it was developed by a NASA engineer decades ago, could be and was patent protected. As reported in a Wall Street Journal article, “Big Pay Day for Mylan Chairman,” the company’s chairman received $97 million for his efforts. His golden parachute also included stock and a $1.8 million annual retainer.

Can Business As Usual Be Nearing An End?

The Marathon and Mylan stories represent the types of abuses of the patent system that have become standard. The approaches employed by these two companies are similar to what dozens of other pharmaceutical firms have done—namely, use the current patent laws to drive up prices for their medications, all without having to invest major dollars in R&D.

What is new, however, is the realization that states with federal approval might be able to upend these egregious practices and bring about a solution. And if that can happen for government-sponsored programs like Medicaid, maybe legislation could be passed to allow this approach to be used more broadly on behalf of all patients, thus slowing this dangerous, runaway train.

The State Of Louisiana As Potential Bellwether

According to a Washington Post article, “Louisiana Seeks to Tap Century-Old Patent Law to Cut Hepatitis C Drug Prices,” the state currently faces $764 million in costs for new, direct-acting antiviral medications that treat hepatitis C. This infectious disease is a major public health hazard, and Louisiana has an obligation to provide the required treatment for its Medicaid recipients. The companies that manufacture the drugs to treat this medical problem, have figured out they can raise prices exorbitantly with relative impunity—in this case close to $100,000 for a three-month course of treatment per patient.

Louisiana has a big problem. The state’s entire healthcare budget, funded through its legislature, is only $3.6 billion. If it has to pay more than three-quarters of a billion dollars for this one drug, it would need to appropriate 20% more than today to provide the medication to a relatively small number of its citizens. And to do so, the dollars would have to come out of those currently being spent on schools, public services and infrastructure programs.

As a result, Louisiana is considering invoking a law, passed in 1910, that allows federal regulators to appropriate the right to inventions and use products in the interest of the public good. This statute would apply to the treatment of hepatitis C, whose eradication would be a major health advance for the people of Louisiana and the economic health of the state. The federal government used this provision in the 1960s to good effect in order to procure 50 medications it needed during a time of war at a reasonable price. And the U.S. Army Corps of Engineers, among other government agencies, has applied this same provision as a means to serve the nation’s best interests.

For Louisiana to move forward on behalf of its Medicaid patients, it would require approval from the Secretary of the U.S. Department of Health and Human Services. Such approval would be highly significant as a warning to Big Pharma. It would counterbalance the monopolistic pricing afforded drug companies, and begin to put the needs of patients and public health first. As Peter Bach, director of health policy at Memorial Sloan Kettering Cancer Center, told the Washington Post, “This is exactly the moment and exactly the kind of scenario for doing so.” Extending this practice through new legislation could ultimately benefit the majority of people with private insurance in the country.

Protecting The Underdog

The role of government is to protect the health of all the people of the nation, and to act for the common good. It’s expected that the government will use its legislative power in pursuit of this end. Patent protection, on the other hand, is a privilege. It’s accorded companies like drug manufacturers to promote investment in R&D and to encourage the development of medications to treat life-threatening conditions. It was never meant to enable companies to raise prices with impunity for life-threatening conditions. If drug companies take the risks and allocate large R&D dollars, then it makes sense to let them earn a profit commensurate with their investments. But to permit them simply to buy the rights to well-established drugs and then use patent laws to protect themselves as they crank up prices 500 to 5,000%, that’s simply wrong.

If the pending Louisiana “purchase” prevails, it could restore the balance needed between the people of the state and the drug companies that manufacture these essential medications. Companies would still be entitled to earn reasonable and fair profits, and be rewarded for taking risks on expensive investments in R&D. But they would no longer be able to game the system, and as a result, make healthcare unaffordable for patients.

The American people should be rooting for the underdog—in this case, Louisiana and its citizens. Maybe if this approach works, it can be extended more broadly, and the excesses of the past 15 years can be brought to an end. Patients would be able to afford the medications they require, and the families of children with life-threatening allergies, muscular dystrophy and other major diseases would know they would be able to receive the essential medicines they need, now and in the future. It’s a small step toward addressing the current abuses, but at least it would represent progress.

Dr. Robert Pearl is the CEO of The Permanente Medical Group, a certified plastic and reconstructive surgeon, and Stanford University professor. Follow him on Twitter: @RobertPearlMD.

By JILL MERRIGAN

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Jill Merrigan is the Marketing Manager of Health 2.0.

BY CARL FRANZEN

While Congress ponders a true fix for the Affordable Care Act (ACA), consider this about health coverage.

Problem #1, Can’t Use It: Healthy people, or people who don’t make a lot of money, sign up for the cheapest health insurance policy available. It gives them catastrophic coverage, protecting their family and home in the event of a big-time medical condition. But it also makes them mad. They pay a monthly fee for health insurance they can’t use until a large deductible is satisfied. For example, a person might pay $300 a month but have a $7,000 deductible. Do the math. That’s well over $10,000 before that person gets to use what they are paying for every month.

Problem #2, January Comes Too soon: Health is not an annual event. Maybe you go all year and suddenly need a bunch of medical help in December. The deductible hasn’t been reached so you pay the bill “out of pocket.” Nasty, because in January you still need medical care for the same thing, yet the deductible goes back to square one. Not nice. This makes more people mad. Solution for Problem #1 and Problem #2: eliminate all annual deductibles and replace with co-pays.

Problem #3, We Need To Build a Wall: Even by eliminating deductibles there are people who are required to pay more than they can afford. Fixing or replacing the ACA needs to build a wall of protection that limits the total amount—a percentage of income—paid by individuals or families in a calendar year—a guarantee that includes the cost of prescription drugs.

By HANS DUEVEFELT, MD

Now, I’m just a country doctor, but I have to say I find it very hard to understand why folks in this country on one hand keep talking about a doctor shortage in primary care and on the other hand keep piling sillywork on those of us who are still here. The net effect is that the doctor shortage is going to be a whole lot worse than it has to be.

But it may just be a relative or imaginary shortage because of how this country defines the duties of doctors.

Public Health agendas have infiltrated health care to a degree that threatens to paralyze it. Physicians are increasingly told their primary concern should be their “population” and not their individual patients. We are charged with preventing disease rather than treat it.

But…

Public Health clinics regularly provide travelers with necessary immunizations. Pharmacists are now giving pneumonia and shingles shots on prescription and flu shots without. States are mandating immunizations for children, and penalizing physician practices with low immunization rates. There are whole departments within every level of Government trying to get people tho behave in healthier ways.

Why should we take the heat for something you don’t need a medical license to do?

A physician’s duty is first and foremost to serve each patient’s needs in treating actual disease. Isn’t that what people worry about when they imagine how a physician shortage would affect them?

Let’s think:

Who would worry that with a physician shortage, they wouldn’t get their flu shot?

Who would worry that there would be nobody to tell them to lose weight, stop smoking and eat less junk food?

Who would worry that there would be nobody to screen them for alcohol misuse or domestic abuse?

Who would worry that they’d be at risk for tripping on their scatter rug because there is no doctor to talk with them about their fall risk?

On the other hand:

You’ve had a cough for a month, and you’re short of breath. Who will diagnose your symptoms?

You have a nosebleed that won’t stop by itself. Who will cauterize it for you?

You have diabetes and can’t control your blood sugar with diet alone. Who will prescribe the right medicine for you?

You’ve become increasingly depressed and are at risk of losing your job because of your symptoms. Your therapist suggests you consider medication. Who will prescribe it for you?

America, the choice is yours: What is the best use of your primary care physicians’ time if there aren’t enough of us to be everything for everyone?

By RICHARD WAGEMAN, MD

Two recent hospital admissions and the medical record dictation records events, visits, and documentation of physical examinations that did not occur.

Hospital stay 1 was for asthmatic bronchitis.  Thru the ED I was admitted to a FP, who consulted a Pulmonary doc.  The Pulmonary did H & P and all of the treatment and exams during stay, and did a great job.

The FP spent about 2 minutes total during the stay.  He did no exam ever, yet billed Medicare for multiple visits, exams and did discharge note, including physical that was never done.

Is this the new way if generating income by false documentation and upcoding?

Hospital stay #2 was admission for removal of benign meningioma.  Early morning admission, visit with surgeon about 2 hours after surgery and no further doc visits that day.  Medical record documents extensive note from critical care team, including physical exam of me that never occurred.

Day 2 was noteworthy for increasing headache from 6 level to 7, then 8, then 9.  Complaints of severe headache and severe nasal congestion finally discovered by my own research of side effects of Kepra, started without any discussion with me.  Multiple complaints to nurses 3 times finally resulted in doc visit after he went to lunch.  Significant change in Med’s and Ct scan resulted in decrease in pain after 4 to 5 hours.  I had demanded d/c of Kepra prior to this.  At about 1 PM there is documentation in medical record of another critical care team visit with NP and MD supervisor noting another non-existent physical exam stating patient in no distress.

On contact with hospital they continue to assert that the exams did occur as documented.

Contacted IG of Medicare with no response.

Multiple letters and phone calls to hospital.

Is this new and accepted practice to compensate for low reimbursement levels?  Anything further to do or am I beating my head against the wall?

By MICHAEL MILLENSON

You (or a loved one) has cancer, but the latest round of chemotherapy has unfortunately had only a modest impact. While you’re acutely aware of the “wretchedness of life that becomes worn to the nub by [ chemotherapy’s] adverse effects” you’re also a fighter.

How do you decide whether to continue with chemo?

The answer to that question is both intimately personal and inextricably tied to health policy. Cancer is the leading cause of death among those aged 60 to 79, and it is the second leading cause of death for all Americans. With expenditures on cancer care expected to top $158 billion (in 2010 dollars) by 2020, the financial and emotional stakes are both high.

How do you decide whether to continue with chemo?

The answer to that question is both intimately personal and inextricably tied to health policy. Cancer is the leading cause of death among those aged 60 to 79, and it is the second leading cause of death for all Americans. With expenditures on cancer care expected to top $158 billion (in 2010 dollars) by 2020, the financial and emotional stakes are both high.

Last July, the Centers for Medicare & Medicaid Services (CMS) launched a five-year program meant to change how oncology practices are paid for chemotherapy. Its goals were reducing unnecessary spending, improving care, and involving patients more closely in decisions. In a recent policy report from the Urban Institute, Shared Decisions in Cancer Care: Is Medicare providing a Model? Bob Berenson and I focused on that last goal.

We concluded that Medicare’s Oncology Care Model (OCM) falls short. Yes, it is “patient-centered” in that it includes a 13-point care plan recommended by the Institute of Medicine (IOM); that’s a big step forward. Yes, the OCM tries to reduce overly aggressive use of chemotherapy and underuse of hospice services among patients close to death.

Nonetheless, a formal shared decision-making process (SDM) remains vitally important. That’s clear from repeated IOM recommendations since 1999, as well as our review of the literature. What’s also clear, though, is that no powerful groups were lobbying for formal SDM, while, not surprisingly, provider resistance remained. As a result, despite nearly two decades of policy recommendations, the formal SDM required in OCM draft regulations in 2015 disappeared from the final regulations with barely a ripple of protest.

The omission is important, because the OCM is influential.  It involves more than 195 oncology practices nationwide, affecting an estimated 155,000 Medicare beneficiaries. In addition, 16 private health insurers, including Aetna, Cigna and Highmark, are patterning their own payment models after it.

The problem of overuse of chemotherapy in late-stage cancer is well known. In 2012, an American Institute of Clinical Oncology expert panel found, that chemotherapy use among patients for which there was no evidence of clinical value was the most widespread, wasteful and unnecessary practice in oncology. Yet important doctor-patient conversations about prognosis in advanced cancer didn’t take place or occurred late in the course of an illness with someone other than an oncologist.

Many patients receiving chemotherapy for end-stage cancers do not understand it is unlikely to be curative. (Or, I suspect, the financial incentives the OCM is intended to address for oncologists to keep on prescribing chemo anyway.) In a 2016 survey of cancer patients, one-third of respondents said they weren’t getting the information about treatment options they needed to make an informed decision.

A conversation about continuing chemotherapy is not only difficult emotionally; it also requires doctors to understand how the framing of a decision and the information that underlies it can bias the results. When SDM is done right, however, it can improve care quality, appropriateness, and value without creating anxiety or diminishing hope. It may also address social disparities, since black and Hispanic patients tend to receive less information from their doctors, about the reasons for treatment recommendations.

From the narrow view of value-based care as obtaining better outcomes at lower cost, there’s inadequate evidence to tout SDM as a cure for overtreatment. However, there’s an important distinction between moral values, such as patient autonomy and peace of mind, and solely economic ones.

We found more than enough evidence to support a Medicare and private payer test of shared decision-making test either in a subset of cancers or in a subset of OCM-participating practices. The alternative to SDM, we write, is a situation in which “judgment calls about the appropriateness of chemotherapy may still be dominated by physician judgment.”

Formal SDM is doable today. As we conclude:

A large body of research indicates that many of the 1.7 million Americans diagnosed with Cancer today would greatly value more information-rich conversations with their doctors. Whether or not that desire for greater control over life-and-death decisions saves money for third-party payers, the implementation of shared decision-making shouldn’t require a moonshot-level effort.

By KENNETH BARTHOLOMEW, MD

My big brother Bill, may he rest in peace, taught me a valuable lesson four decades ago. We were gearing up for an extended Alaskan wilderness trip and were having trouble with a piece of equipment. When we finally rigged up a solution, I said “that was harder than it should have been” and he quipped in his wry monotone delivery, “There are no hard jobs, only the wrong tools.”

That lesson has stuck in my mind all these years because, as simple as it seems, it carries a large truth. It rings of Archimedes when he was speaking about the simple tool known as the lever: “Give me but one firm spot on which to stand, and I will move the earth.”

Enter the Electronic Medical or Health Record (EMR or EHR) as it exists in most forms today. As information tools for clinicians, most EMRs have been purchased by administrators who know nothing of patient care or workflow, and most of these EMRs have been reverse engineered from billing and collection systems, because the dollar drives all.

Truly value-driven care is blocked by these misguided tools. Multiple studies have demonstrated that using the EMR adds hours to our workday without corresponding benefit. This only pushes costs up and quality down. In fact, story after story tells of doctors retiring early or changing professional direction to escape the frustrating click, click, click all day long. Compounding this is the federal government mandating meaningless use criteria that say we will not get paid unless we use these programs and meet certain click-box ratios. You do not need “Validated Studies” to understand this. You just need to talk to doctors around the country. I challenge you to talk to ten practitioners at random who are involved in day-to-day emergency medicine or primary care medicine, the guys and gals on the busy front line, and find two of them who are enamored with their EMR tools.

On any given day in my primary care practice I can show you an eight to twelve page fax from the hospital that spews pages of prattle and lab data, informs me that the patient is not Hispanic and has no religious preference, yet I cannot find the diagnosis or the plan. As if that is not bad enough, these documents meet the requirement for Meaningful Use since they hit enough click-boxes. So, what has happened, and how are we going to fix it?

Since these systems were designed around billing and collections, they were never designed to help the work flow of diagnosis and management. They are, in fact, little more than dysfunctional databases that record what the doctor typed or dictated after the fact without organizing these fragments in a clinically useful manner. And sometimes not even the recording function gets done. Two documents I received last week had twelve and ten pages of printout, yet the last page, labeled “Doctor’s Summary”, was blank. Another one from three weeks ago, labeled ‘Preoperative Note’, had a single sentence “The risks and benefits of surgery were thoroughly discussed with the patient.” That was an H&P? Yet another point-and-click generated History and Physical proclaimed that a 12-point Review of Systems was performed and found to be negative (qualifying the visit for up-coding) and that the male patient had no vaginal irritation, stress urinary incontinence, or post-menopausal bleeding. And yesterday I received an operative report dictated March 24, 2017 on an operation done in December. (Honestly, I am not making this up!) Given that these tools record whatever the provider chooses to record, they can only be as accurate or inaccurate, as methodical or sloppy, as timely or late, as the mind that generated them. In short, they are not scientific tools aimed at improving diagnosis and management.

Consider a trio of astronauts climbing into the cockpit of a craft sitting on a million pounds of fuel about to blast them into the cosmos. Can you imagine them being asked to guide the craft into space, around the moon, and back to a precise landing spot, and told they had an accounting spreadsheet that was reverse engineered to run their console and their guidance system? How preposterous does that sound? But the difference is that doctors do not get into the cockpit with the patient. Those astronauts have a vested interest in their system working well. Doctors just put in their shift and grumble all the way home about how ridiculous the system has become.

I am an instrument-rated pilot with approximately 2,000 hours of flight time. I’m still alive to talk about it for one simple reason. Pilots have very precise and rigorous training requirements that we must complete every six months, or else we cannot fly in instrument conditions, which essentially means rain, fog and clouds. And we have a vested interest in that training.

It allows us to bring our craft into the airport environment on a precise heading and angle of descent that sets us up for landing when we break out of the mist and see the runway perfectly lined up with our flight path. In contrast, doctors can get a degree and never pick up a book again for years, but can legally go on treating patients based on memorized remnants from 1977. Most doctors try to do better, but must manage without proper tools or guidance systems. They tolerate this situation because they don’t have to get into the cockpit with the patient. And when that plane crashes, they still get paid and go home to their families.

So, what are we to do? To move ahead, I submit that we need to go back and start over.

The Problem Oriented Medical Record

Beginning in the late 1950s, Dr. Larry Weed saw the futility of traditional medical record tools and set out to address it. He began by conceiving a standard of care for organizing medical record data in a clinically rational manner. Known as the Problem-Oriented Medical Record (POMR), this standard established problem lists and SOAP notes, among other elements. But in the late 1970s and early 1980s, he concluded that the POMR, computerized or not, was an incomplete tool. The POMR organized clinician inputs but left the content of those inputs to the physician’s unaided mind. So he devised a system that mandated precise inputs of basic, inexpensive, raw patient data, and coupled those data with corresponding medical knowledge, before the doctor’s mental machinery was allowed to act.

Number Needed to Kill = One

We know from decades of research that humans start developing hypotheses almost immediately when inputs start. Unfortunately, the wrong hypothesis can and will make us branch off into the wrong algorithm much too quickly. (Chest pain radiating down the left arm and up into the neck associated with an abnormal ECG must be coronary occlusion, therefore act quickly and give blood thinners. Number Needed To Treat = 43. Except that you forgot to consider his dissecting aortic aneurysm. Number Needed To Kill = One.)

The Problem Knowledge Coupler

Dr. Weed’s answer was the “Problem Knowledge Coupler,” a new tool that could use computational power to cross-match signs, symptoms, physical exam findings and inexpensive lab data with the current knowledge in the medical literature about a given problem. It is critically important here to understand that patients do not present with diagnoses, they present with problems. Nor do they present with simple conditions with a single treatment option. They present with complex permutations of undiagnosed symptoms requiring individual analysis.

Point and Click Diagnosis

Many of the current click-point programs set up a progress note labeled by a diagnosis when the patient presents. An example is the “Upper Respiratory Infection” note that the nurse will start when she rooms the patient with a cough. Questions about an upper respiratory infection will be asked, heart and lungs and ENT exam findings clicked in, and then the provider will diagnose either a viral or a bacterial URI and maybe prescribe an antibiotic. However, the early lung tumor will not be diagnosed because the ‘diagnosis’ of URI was actually used as the presenting finding instead of the ‘problem’ the patient actually presented with, which was cough.

This is a matter of scientific integrity. I was trained as a chemist. Imagine that I had “data” consisting of hypothesized results rather than observed findings, and tried to publish a paper based on my supposed results. I would not get far, but something like this happens in medicine routinely whenever a physician confuses a diagnostic hypothesis with an observed problem, and then gets his usual reimbursement for his opinion and treatment plan. Not only is the patient at greater risk, but the medical record is corrupted as a vehicle for quality improvement, economic accountability, and scientific research.

Problem Knowledge Couplers do not let the unaided human mind jump to conclusions. They methodically gather the basic history and physical findings, then allow for any lab data that might be available, and only then “couple” the unique findings of that particular patient with the known information in the medical literature to give a complete differential diagnosis for that particular patient at that particular point in time. A printout can then be provided to the patient or family so that they can watch for evolving signs or symptoms that may help further delineate their evolving condition. The unaided human mind cannot do that. Studies have shown that we break down when the grid exceeds 5 or 6 findings relating to 5 or 6 diagnostic possibilities. But Dr. Weed knew that computers excel at just that type of combinatorial analysis, while humans excel at other tasks in the process.

In 1983, I was working on my first attempt at writing a novel, and I had just bought my first IBM PC with a 5.25 floppy that could hold an incredible 64K of data; several chapters on one little disk versus a stack of 64 pages of typewriter paper. I marveled at the power. But in 1983 very few people had personal computers, and in fact very few small businesses had them. At the same time I realized how little I knew of the vast store of knowledge that was out there, and I was looking for a computer program that could help me think clearly about what I was seeing in my patients. To my dismay, every article I hungrily read about “Computers In Medicine” turned out to be billing programs. They had nothing to do with medicine. They were business programs.

Then I met Dr. Larry Weed at a meeting in Minneapolis in 1985. He gave the most memorable presentation, saying out loud what I had been thinking for years. He was developing Couplers and had 12 completed at that time, but he was also developing a computerized medical record that was problem oriented, so the history and analysis of the progress of a given problem was identifiable and organized chronologically. We decided to work together, and over the next 7 years I became the Beta Test Site for the Couplers and POMR tools. Living in a town of 800, on call 24/7 for years on end, and integrating a Beta program into a busy practice was both exhilarating and exhausting. But it did show us what was possible. (For a detailed description, see my chapter, “The Perspective of a Practitioner,” in Larry Weed’s 1991 book, Knowledge Coupling: New Premises and New Tools for Medical Care and Education. For a comprehensive discussion, see Dr. Weed’s 2011 book, Medicine in Denial. That book’s table of contents, overview and introduction, including a diagram of the system components and feedback loops envisioned by Dr. Weed, are available here.)

One example comes to mind. I was in Canada with my Explorer Scout Troop teaching them outdoor survival skills, and I had a locum tenens physician filling in in Faulkton, S.D., for me. When I returned, my typist, Zelda Gebhard, brought a chart to me and thought I should review it. The elderly gentleman in question had anemia and weakness, and her question was why had the doctor not done a stool hemoccult on him? The trail was there to see because the system spelled it out, and she was so accustomed to our methodical approach. Yet the doctor had placed him on iron and let it go at that. Sure enough, the hemoccult was positive and the cecal cancer was removed a week later.

Now, it is easy enough to say, “The doctor should have known better,” and cast the blame on him. But that would be missing a huge point. This type of short shrift of patient’s problems happens every day in every city of every state. There is only one person who has a 100% vested interest in the patient’s total picture: the patient. I ask you: if a typist with a secretarial degree can arrive at a correct diagnosis with a good roadmap, why are not the doctors using those roadmaps? And the answer would be that they have spent 10 to 15 years memorizing the roadmap and are being paid large salaries to tell people how to navigate within the healthcare system.

Like Google Maps For Medicine

If you wanted to go from Minneapolis to Miami, how many of you would hire a Ph.D. in geography to go along with you and pay him $100 an hour for his advice? Of course it is a ridiculous question. You learned how to read a map in grade school, we have professional mapmakers who keep our maps up to date, and you drive yourself to Miami. And now we have electronic maps that make them all the more powerful. Yet, where is the map system in medicine? It is collated in thousands of books and resides in the memory banks of thousands of professionals who rely on the unaided human mind to ask you the few questions they have time for and arrive at your diagnosis or treatment decision. With a library of couplers, a personal computer, and an Internet connection, patients could analyze their own problems and go to the doctor for the physical exam and tests that are then indicated. And with a well thought out medical record, the physician and patient together could track progress and treatment success.

State of Interdigitation

What we have instead is hundreds of companies selling million dollar programs that are driving us mad with their helter skelter approaches and unfulfilled promises. We were promised that the program would cut down our medical record overhead by fifty thousand dollars a year, but we were not told that it would require a NEW department of IT people that would cost us twice that. We started with one computer specialist and now have 5 in our clinic alone. Adding insult to injury, we have a government that mandates using computers in a “meaningful” way because computers are supposedly proven to make things more efficient. This is like the government mandating that shippers use rail lines to move their products because they haul more cargo per gallon of fuel than trucks, yet allowing each state to have their own rail line with different gauges for their wheelbase. Forty-eight different rail lines that cannot interdigitate with one another would cause chaos in the shipping industry, but we experience that every day in medicine. And that is only the recording side of the medical record. What about the front end, when the patient arrives at our door with a new problem? Without scientific inputs, we cannot get scientific throughputs. Where is the roadmap for that chaos?

Where Are Our HIT Leaders?

Where are the leaders on the national level? Nearly thirty years ago Dr. Weed and I were asked to critique a national white paper on the EMR put out by the Institute Of Medicine and published in 1991. They did not take our advice. No one mandated that vendors use the same language or the same format because that would not allow “free enterprise.” What has happened in medicine is what would have happened in shipping if the government had not mandated that the railroads use the same wheel gauge. Nothing is getting fixed, yet all the buzz these days is about “Physician Burnout” exceeding 50% because every hour of clinical work requires 2 hours of clerical work.

Until we have a system that works, nothing is going to change. An Institute of Medicine report in 1999, “To Err Is Human”, claimed that 98,000 deaths per year were attributable to medical error. That is 1,885 deaths per week, or the equivalent of a 737 crashing every day, yet nothing gets done. Of course there is physician burnout. But what about patient burnout? They are the ones who are suffering the most. They are the ones who are complaining that the doctor has his face in the computer instead of on them.

Meaningful Use vs Meaningless Chaos

After 40 years of practice I jokingly threaten to quit my current practice, go to the mall, open a consulting office, get a pen and paper, and TALK to any patient who is willing to forego insurance papers, co-pays, massive overhead structures, and pay a 20 dollar bill for a quick consult and a roadmap of where to go next. But it is no joking matter. The system is broken and billions of dollars are being wasted on a system that doesn’t work. Why does a GP from a small town have to be the one to complain? Where are the professors from the leading institutions demanding – nay, developing – a fix? Where is a library of couplers that patients can access to help work out their problems to see if it is something that even requires testing? Where is a medical recording system that has the same “wheel gauge” across the country so that my patient with Lupus can go to the Mayo Clinic and have their record accessible and cumulative? Only then can we have “Meaningful Use” instead of the meaningless chaos we now suffer.

Daily we practitioners put together a chain of history and physical and laboratory evidence that we then try to steer into meaningful scientific conclusions, but we have the wrong tools for the job. We are pushing that chain from behind instead of pulling it from the front. Until we have the proper tools, and with no firm spot on which to stand, I guess we just have to push harder.