Employers! You Work to Achieve Lean Six Sigma

Yet You Pay for Healthcare This Is Riddled with Waste and Variation.

Eliminating waste and reducing variation are key concepts in the way you run your business. Years ago, Japanese car makers almost destroyed the American auto industry by doing a much better job with these concepts. Now you are much better at reducing waste and variation and you are much more competitive.

Six sigma is a very high bar. It is only 3.4 defects per one million products. Some auto makers achieve that high bar. That is why a Honda will just keep on running if you maintain it. It is built to that standard.

This space focuses on better treatment for heart disease and related conditions, so let’s just take a hard look at waste and variation in that setting.  Employers provide insurance benefits for 180 million Americans. That is half the population. The costs for this benefit are very high. The average annual premium to cover a family last year was $22,463 and the worker contribution was over $6000. General Motors spends more on healthcare than it does on steel. Despite this very high cost, there is huge variation in the quality of care that your employees receive. One sigma is 690,000 defects per million products. The healthcare your employees receive doesn’t even remotely approach that level of quality.

Just consider statin therapy in patients who have known heart artery disease. Statin treatment in those people is as essential as having wheels on the car when it leaves the assembly line. It is a life or death issue. In a study of hundreds of thousands of people like this, patients who took their statin less than half the time were 30% more likely to die than those who took their statin 90% of the time. That is the evidence. That is a fact. Despite these impressive benefits, in real-world clinical registries, statin therapy use in high-risk patients is very low. Fewer than half of patients with artery disease are taking it at one year, and less than a third after two years. Seeing a cardiologist may be no help. Among the top 10% of cardiologists, 73% of their patients are taking statins regularly. However, among the bottom 10% of cardiologists, only 39% were taking them. That means you can be seeing a cardiologist for your heart artery disease and and experience care with 610,000 defects per million. That is a huge difference in a very simple, inexpensive treatment that prevents deaths, hospitalizations, and very large, related costs. This is a system failure. Atorvastatin can be bought without insurance for about $10 a month. Cost is not a barrier. The system is the barrier.

Here is the most important point to understand. 610,000 defects per thousand is just one sigma. That is not the benchmark. Teams of nurses and pharmacists at Kaiser Permanente consistently achieve statin treatment rates of about 90%. That is much better but it is still only 1.64 sigma. There are still 100,000 defects per million. That is the benchmark and that is just one issue. Optimal medical therapy (OMT) or best practice care for patients with arterial disease is not just about statin treatment. It also includes blood pressure control to less than 130/80 using certain medications, stopping smoking, and aspirin treatment. 99% of the Kaiser Permanente patients treated by this team are on aspirin or another blood thinner.  If the patient with arterial disease also has diabetes it includes achieving a hemoglobin A1c of less than 7. Achieving these five goals together occurs far less often than 37%. The financial and clinical consequences of these failures are catastrophic.

Just as car needs to come off the assembly line with much more than wheels, there are many more evidence-based elements to OMT for heart artery disease. Kaiser Permanente in Colorado is one of those rare American institutions that uses a process resembling lean six sigma to produce OMT. The benefits of achieving OMT for patients who have had a heart attack at Kaiser Permanente are almost unbelievable. At five years, ten times as many patients in usual care are dead compared with those receiving OMT. The usual care patients cost over $20,000 more per patient per year. In the broader community, we fall far short of OMT.

The landmark COURAGE trial had seven goals for OMT. Aspirin use, blood pressure less than 130/85, bad cholesterol less than 85 on a statin, fasting glucose less than 126, nonsmoking status, body mass index <25, exercise ≥4 days per week.

A study from 2014 showed that the COURAGE goals for aspirin treatment, blood pressure, and cholesterol control were only achieved concurrently in 16% of patients who had had a heart attack. That is 840,000 defects per million people when consider only three variables. That is worse than one sigma. It is a fraction of a sigma in a situation where OMT is a product made up of well-defined components. Six sigma is completely applicable to this situation.

Today we understand the components and benefits of OMT at a much higher level. Consistently producing the OMT product involves the goals for blood pressure, diabetes, cholesterol, smoking, and aspirin that have already been mentioned. OMT also involves medications that do much more than control the target risk factor. The statins that we have mentioned already switch on the master genetic metabolic switch AMPK which switches off mTOR. mTOR is another metabolic switch— the mechanistic target of rapamycin. Rapamycin is an antibiotic occurring in nature that is used now in heart artery stents. When rapamycin leaks out, it prevents the stent becoming blocked with scar tissue and inflammation. These other components of optimal medical therapy do the same thing in all arteries. Included are losartan or lisinopril for hypertension with spironolactone or eplerenone if the pressure is not well controlled, along with metformin for diabetes. Jardiance can be added for additional sugar reduction if needed.

If the blood pressure is controlled with lisinopril alone, there is no need to add eplerenone, but many with heart artery disease will have thirteen elements that should be applied in every patient every time. We are no better with achieving any of those than we are with statin therapy.

The evidence for the systems to consistently produce optimal medical therapy is just as solid as the evidence for the components that it consists of. Quality is a systems property and you must set up the systems required to reduce defects. You can only achieve a 91% statin use rate with an advanced primary care team where the lion’s share of the work is done by nurses, nurse practitioners, and pharmacists using a protocol and managing care without checking with the doctor. Their entire job is to develop a trusting relationship with the patient and help them understand how their disease works and why optimal medical therapy is so important. There job is to assure that all 13 elements are applied consistently where appropriate. That is what works for your employees

The benefits of OMT are incredible. High-risk patients who take a statin regularly lower their risk of death by about a third. Patients who have had a heart attack on OMT don’t lower their risk of dying by a third or even three-fold. They lower their risk of dying ten-fold while saving tens of thousands of dollars a year. It is not just their risk of dying from heart disease, there is a ten-fold reduction in all cause mortality. Patients with type 2 diabetes on OMT lower their risk of heart attack 4-fold, stroke 5-fold, and needing dialysis 6-fold. They lower their risk of being hospitalized for heart failure by 70% and they live 8 years longer. Why would you do anything else?

These results can be achieved by small rural communities. We have worked with a worksite clinic in Southwest Louisiana to help them produce OMT. We have provided training and protocols to their clinicians and the analytics to measure their results. Compared with patients seen in the broader community, patients seen in the clinic cost half as much. They are hospitalized one fifth as often and visit the ER one third as much.

This is the craziest part. The evidence supporting OMT for heart disease is overwhelming, but lean six sigma approaches to produce it are almost nonexistent. Our entire health system is still focused on finding artery blockages and opening them. The evidence is equally overwhelming that opening arteries in stable patients does nothing. It does not keep you from dying or having a heart attack. Every dollar spent opening arteries in stable patients is waste, but that is what we still do and it is dramatically increasing your costs. Your employees get their catheterization and stents. They don’t get optimal medical therapy.

The only way an employer can know if their employees are getting best practice medical care at a reasonable price is through robust analytics. The stakes are higher now. Under the provisions of the Consolidated Appropriations Act, employers now have a fiduciary obligation to assure that employees are getting good care at a fair cost. The data in this post proves that most employees are not receiving those benefits. I work with other stakeholders to provide the data support and other elements of a comprehensive solution to make sure that you are meeting those requirements by reducing waste and variation in your employees.

We all have a stake in this. Singapore has advanced primary care clinics with teams of pharmacists that treat high blood pressure, diabetes, and cholesterol. They have the systems to produce OMT. They spend 5% of gross domestic product on healthcare and they live longer. We spend 20% of GDP on healthcare for highly variable results. It seems Winston Churchill was right. “Americans will do the right thing after they have tried everything else.”