Novartis attempting to convince CMS to reimburse for their new Heart Failure Drug

Novartis' new heart failure medicine LCZ696, now called Entresto(TM), approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization

Press Release (pdf)

A new drug for congestive heart failure was fast-tracked by the Food and Drug Administration because it works so well. The results of Phase III Clinical trials prompted officials to give approval for marketing Entresto. 

Cardiophysiology of Congestive Heart Failure

What Is Heart Failure?

Heart failure does not mean the heart has stopped working. Rather, it means that the heart's pumping power is weaker than normal. With heart failure, blood moves through the heart and body at a slower rate, and pressure in the heart increases. As a result, the heart cannot pump enough oxygen and nutrients to meet the body's needs. The chambers of the heart may respond by stretching to hold more blood to pump through the body or by becoming stiff and thickened. This helps to keep the blood moving, but the heart muscle walls may eventually weaken and become unable to pump as efficiently. As a result, the kidneys may respond by causing the body to retain fluid (water) and salt. If fluid builds up in the arms, legs, ankles, feet, lungs, or other organs, the body becomes congested, and congestive heart failure is the term used to describe the condition.

What Causes Heart Failure?

Heart failure is caused by many conditions that damage the heart muscle, including:

• Coronary artery disease. Coronary artery disease (CAD), a disease of the arteries that supply blood and oxygen to the heart, causes decreased blood flow to the heart muscle. If the arteries become blocked or severely narrowed, the heart becomes starved for oxygen and nutrients.
• Heart attack. A heart attack occurs when a coronary artery becomes suddenly blocked, stopping the flow of blood to the heart muscle. A heart attack damages the heart muscle, resulting in a scarred area that does not function properly.
• Cardiomyopathy. Damage to the heart muscle from causes other than artery or blood flow problems, such as from infections or alcohol or drug abuse.
• Conditions that overwork the heart. Conditions including high blood pressure, valve disease, thyroid disease, kidney disease,diabetes, or heart defects present at birth can all cause heart failure. In addition, heart failure can occur when several diseases or conditions are present at once.

What Are the Symptoms of Heart Failure?

You may not have any symptoms of heart failure, or the symptoms may be mild to severe. Symptoms can be constant or can come and go. The symptoms can include:

• Congested lungs. Fluid backup in the lungs can cause shortness of breath with exercise or difficulty breathing at rest or when lying flat in bed. Lung congestion can also cause a dry, hacking coughor wheezing.
• Fluid and water retention. Less blood to your kidneys causes fluid and water retention, resulting in swollen ankles, legs,abdomen (called edema), andweight gain. Symptoms may cause an increased need to urinate during the night. Bloatingin your stomach may cause a loss of appetite or nausea.
• Dizziness, fatigue, andweakness. Less blood to your major organs and muscles makes you feel tired and weak. Less blood to the brain can cause dizziness or confusion.
• Rapid or irregular heartbeats.The heart beats faster to pump enough blood to the body. This can cause a rapid or irregular heartbeat.

What Are the Types of Heart Failure?

Systolic dysfunction (or systolic heart failure) occurs when the heart muscle doesn't contract with enough force, so there is less oxygen-rich blood that is pumped throughout the body.

Diastolic dysfunction (or diastolic heart failure) occurs when the heart contracts normally, but the ventricles do not relax properly or are stiff, and less blood enters the heart during normal filling.

A calculation done during an echocardiogram, called the ejection fraction (EF), is used to measure how well your heart pumps with each beat to help determine if systolic or diastolic dysfunction is present. Your doctor can discuss which condition you have.

How Is Heart Failure Diagnosed?

Your doctor will listen to your heart and look for signs of heart failure as well as other illnesses that may have caused your heart muscle to weaken or stiffen.

Your doctor may also order other tests to determine the cause and severity of your heart failure. These include:

• Blood tests. Blood tests are used to evaluate kidney and thyroidfunction as well as to checkcholesterol levels and the presence of anemia. Anemia is a blood condition that occurs when there is not enoughhemoglobin (the substance in red blood cells that enables the blood to transport oxygen through the body) in a person's blood.
• B-type Natriuretic Peptide (BNP) blood test. BNP is a substance secreted from the heart in response to changes inblood pressure that occur when heart failure develops or worsens. BNP blood levels increase when heart failure symptoms worsen, and decrease when the heart failure condition is stable. The BNP level in a person with heart failure -- even someone whose condition is stable -- is higher than in a person with normal heart function. BNP levels do not necessarily correlate with the severity of heart failure.
• Chest X-ray. A chest X-ray shows the size of your heart and whether there is fluid build-up around the heart and lungs.
• Echocardiogram. This test is an ultrasound which shows the heart's movement, structure, and function.
• The Ejection Fraction (EF) is used to measure how well your heart pumps with each beat to determine if systolic dysfunction or heart failure with preserved left ventricular function is present. Your doctor can discuss which condition is present in your heart.
• Electrocardiogram (EKG or ECG) . An EKG records the electrical impulses traveling through the heart.
• Cardiac catheterization. This invasive procedure helps determine whether coronary artery disease is a cause of congestive heart failure.
• Stress Test. Noninvasive stress tests provide information about the likelihood of coronary artery disease.

Is There a Treatment for Heart Failure?

There are more treatment options available for heart failure than ever before. Tight control over your medications and lifestyle, coupled with careful monitoring, are the first steps. As the condition progresses, doctors specializing in the treatment of heart failure can offer more advanced treatment options.

The goals of treating heart failureare primarily to decrease the likelihood of disease progression (thereby decreasing the risk of death and the need for hospitalization), to lessen symptoms, and to improve quality of life.

Together, you and your doctor can determine the best course of treatment for you.

Treatment can begin with simple health and wellness advice.

Stage	Definition of Stage	Usual Treatments
Stage A	People at high risk of developing heart failure (pre-heart failure), including people with: High blood pressure Diabetes Coronary artery disease Metabolic syndrome History of cardiotoxic drug therapy History of alcohol abuse History of rheumatic fever Family history of cardiomyopathy	Exercise regularly. Quit smoking. Treat high blood pressure. Treat lipid disorders. Discontinue alcohol or illegal drug use. An angiotensin converting enzyme inhibitor (ACE inhibitor) or an angiotensin II receptor blocker (ARB) is prescribed if you have coronary artery disease, diabetes, high blood pressure, or other vascular or cardiac conditions. Beta blockers may be prescribed if you have high blood pressure or if you've had a previous heart attack.
Stage B	People diagnosed with systolic left ventricular dysfunction but who have never had symptoms of heart failure (pre-heart failure), including people with: Prior heart attack Valve disease Cardiomyopathy The diagnosis is usually made when an ejection fraction of less than 40% is found during an echocardiogram test.	Treatment methods above for Stage A apply All patients should take an angiotensin converting enzyme inhibitor (ACE inhibitors) or angiotensin II receptor blocker (ARB) Beta-blockers should be prescribed for patients after a heart attack Surgery options for coronary artery repair and valve repair or replacement (as appropriate) should be discussed If appropriate, surgery options should be discussed for patients who have had a heart attack.
Stage C	Patients with known systolic heart failure and current or prior symptoms. Most common symptoms include: Shortness of breath Fatigue Reduced ability to exercise	Treatment methods above for Stage A apply All patients should take an angiotensin converting enzyme inhibitor (ACE inhibitors) and beta-blockers African-American patients may be prescribed a hydralazine/nitrate combination if symptoms persist Diuretics (water pills) and digoxin may be prescribed if symptoms persist An aldosterone inhibitor may be prescribed when symptoms remain severe with other therapies Restrict dietary sodium (salt) Monitor weight Restrict fluids (as appropriate) Drugs that worsen the condition should be discontinued As appropriate, cardiac resynchronization therapy (bi ventricular pacemaker) may be recommended An implantable cardiac defibrillator (ICD) may be recommended
Stage D	Patients with systolic heart failure and presence of advanced symptoms after receiving optimum medical care.	Treatment methods for Stages A, B & C apply Patient should be evaluated to determine if the following treatments are available options:heart transplant, ventricular assist devices, surgery options, research therapies, continuous infusion of intravenous inotropic drugs and end-of-life (palliative or hospice) care

Signs and symptoms of heart failure due to structural problems such as aortic stenosis, insufficiency, mitral valve disease may be treated surgically early on. Cardiac arrhythmia's should be corrected.



Treatment is progressive and adjusted accordingly.  Heart failure is chronic and may be progressive. It can present abruptly from an  acute coronary obstruction, or insidiously with aging.



ENTRESTO is not a first line drug and is intended for refractory CHF.  It is very expensive.

Could remote monitoring help Novartis persuade payers to reimburse for new heart drug?

“If you had a remote patient-monitoring device that the patient could use in their home together with Entresto, we could make an even more serious dent in hospitalization.”Beyond the Pill is a growing trend among pharma companies looking for ways to add more value to their medication with digital services aimed at improving medication compliance but also helping their physicians monitor their health between appointments. He added:

“We’re going to have to get smarter about services around the pill…and move into some areas that are different from just discovery of the drug… 

The addition of wearables, remote monitoring and new mHealth devices could make a major impact in reducing hospitalizations, by detecting symptoms early and identifying activities that cause CHF.

This report courtesy of WebMD.  It is not intended as any recomendation for treatment. Always consult with your physician for treatment.



Morning Read: Could remote monitoring help Novartis persuade payers to reimburse for new heart drug?MedCity News

CMS to test New Reimbursement System for Hip and Knee Replacements in the U.S. - FierceMedicalDevices

CMS to study and compare outcomes for hip and knee replacement procedures. Reimbursement amounts will be adjusted for poor outcomes.

Program expected to save $150M; will cover 25% of procedures in the country

STRYKER HIP AND KNEE REPLACEMENT IMPLANTS

The Centers for Medicare & Medicaid Services (CMS) has announced a 5-year plan to test a new system for how it reimburses hospitals for hip and knee replacement surgeries that currently cost about $7 billion a year.
The program, which was announced Thursday, will track patients post-surgery and then pay hospitals based on criteria that measures the quality of the outcomes of the procedures. An assessment will then be made and either a financial bonus will be
granted or a penalty levied.

About 25% of the surgical procedures in the U.S. will be affected, and the agency hopes to save up to $150 million under the program, Bloomberg reported. If approved, the program would begin Jan.
 "Hospitals and physicians would have an incentive to work together to deliver more effective and efficient care," Sylvia Matthews Burwell, the Secretary of Health and Human Services, said on a conference call with reporters.

Medicare shelled out about $586 billion in 2013 to cover more than 50 million elderly and disabled people in the country, the news service said. Reducing those costs has been a major goal under the Obama administration, which introduced the Affordable Care Act.

The test program will be mandatory for more than 800 U.S. hospitals covering 75 regions and should provide CMS with improved data on the effectiveness of the initiative. Stryker ($SYK), Zimmer Biomet ($ZMH) and Johnson & Johnson ($JNJ) are among the top medical device producers of artificial knees and hips.

- see the Bloomberg story

Related Articles:
Devicemakers to offer stronger guarantees on products if they fail to perform
Zimmer Biomet is born after knee implant divesture to S&N
J&J adds $420M to legal stockpile to resolve all-metal hip implant suits
Stryker agrees to pay $1.4B to settle recalled hip implant lawsuits



The exact details from CMS are not yet available.

CMS to test new reimbursement system for hip and knee replacements in the U.S. - FierceMedicalDevices

What Doctors Really Want from the Latest Medical Technology - The Experts - WSJ

GURPREET DHALIWAL: Technology has much to offer doctors, but it is not the health-care technology agenda you hear about in the news. Big data, the electronic medical record, and the connected patient are frequently hyped as remedies to medicine’s ills. But improving and restoring health is a messy business that requires investment in human capital more than physical capital.

Here’s a modest technology agenda from the perspective of the front-line clinician who hopes to master their craft and continually improve the care they provide to their patients.

Big data. Correlations that massive data sets churn out seldom change practice. Those associations are no different than any preliminary research finding: not ready for prime time until they are confirmed, scrutinized and distilled for daily practice. Clinicians need constant exposure to the findings of high-quality studies and synopses that already meet those criteria. Twitter, for example, is a great way to do that. Spare me your big data, send me your good data.

Electronic medical record. The medical record has devolved into a forensic document and billing tool with a subordinate role as a communication tool, but it never has become a learning tool. Doctors only improve with feedback, but workloads make it impossible to quickly answer questions like, “Is that patient I saw last week OK?” or “What did that test result show?” Some electronic medical records allow doctors to create a list of patients to track or set up scheduled reminder emails. But it should be easier and better, such as, “Siri, send me a secure email when Ms. Jain sees her rheumatologist. I want the note and labs from that day.”

The connected patient. I want updates from my patients, but the outdated emphasis on face-to-face visits often makes this impossible. Text, email and videoconferencing should be commonplace for follow-up, even though regulations and reimbursements pose formidable barriers. Many doctors already communicate electronically because it is the right thing to do—and because we believe it is more important to be connected to your health-care provider than it is to be connected to your Fitbit.

Dr. Gurpreet Dhaliwal is a professor of medicine at the University of California, San Francisco and a staff physician at the San Francisco VA Medical Center.

courtesy of the Wall Street Journal

What Doctors Really Want from the Latest Medical Technology - The Experts - WSJ

Study: Online Symptom Checkers Correct in About Half of Cases - iHealthBeat

Evaluation of symptom checkers for self diagnosis and triage: audit study

Flip a coin or guess is as good as the online web diagnosis sites.. This study from the British Medical Journal.

Researchers entered symptoms for 45 patients into the checkers, sourced from standardized vignettes used in medical student training (WBUR/Kaiser Health News, 7/9). The patients' conditions included:

• Acute liver failure;
• Bee stings;
• Meningitis; and
• Mononucleosis ("Shots," NPR, 7/9).

Study Findings

Overall, the study found about:

• One-third of the sites named the correct diagnosis as the patient's first option;
• 51% of the sites named the correct diagnosis in their top three options; and
• 58% of the sites named the correct diagnosis in their top 20 options (Semigran,BMJ, 7/9).

Overall, researchers said the checkers were about as accurate as diagnoses made through primary care physician phone services, which usually offer insight on whether patients should seek urgent care. Further, lead author Hannah Semigran, a research assistant at Harvard Medical School, said the online symptom checkers were "pretty good at effectively directing people with an (emergency) situation to seek some kind of appropriate care, and to do so quickly" (Mozes, HealthDay, 7/9).

Comments

Ateev Mehrotra, one of the study authors, said the findings show patients should use symptom checker sites with caution (WBUR/Kaiser Health News, 7/9). He said, "People who use these tools should be aware of their inaccuracy and not see them as gospel. They shouldn't think that whatever the symptom checker says is what they have" ("Shots," NPR, 7/9).

Mehrotra added, "These sites are not a replacement for going to the doctor and getting a full evaluation and diagnosis. 

The Revolution in Magazine Processes "How not to fall behind in an era when everything you think you know might be wrong."

The title could have just as well read

The Revolution 

in 

Health Processes

Conventional print magazines, newspapers have weathered a sea-change in their business model.
And so has medicine and health process.

Health care financing, and administration also are struggling to change even as our current medical system is overwhelmed with increased expenses.  The similarity between magazine process and health process are remarkably alike.

Prominent news publishers, such as the Washington Post, New York Times and many others went out of business at the same time re-inventing their 'product' in a more efficient manner.  In some cases ownership shifted quietly behind the scenes. There were major reductions in staff, overhead and outright elimination of tasks that served no purpose or had been replaced by digitalizing the industry.

Even as this is occurring health organizations are burdened with daily organizations while being mandated by government, CMS, the Affordable Care Act, Insurers, and expansion of new covered benefits such as remote monitoring, telehealth and mobile health care.  The uptick in  expenditures for health IT is overwhelming many, both large and small.  There is no room for error. During the past five years some large institutions spent millions of dollars to purchase EHRs only to find they could not perform as advertised. Providers, and hospitals did not know or have experience in systems that were new and untested in a real world setting.

Health care operated mostly on a cash basis until the birth of managed care, capitation, and other obtuse forms of risk management.  In health affairs risk management used to have to do with risk of disease and/or treatments. Insurance companies were required to have an actuarial basis for setting premium rates against history of their insured disease risks.

Today this risk is carried not just by the insurance company, it has been shifted to hospitals and providers. Other calculations are being considered such as quality of outcomes, measured by re-admission rates to the hospital. The latest in the quirky world of health high finance is the 'accountable care organization. (ACO).

The name was coined by Elliott Fisher as a philosophical term during it's germination period.  Theoretically the organization that saves the most gets a 'kickback' a larger reward incentive than the rest of the providers/hospitals.

The health care company of 2005 is gone. its processes, procedures and priorities would be nearly unrecognizable today. In fact, the medical practice that existed in 2010 is gone too. In a period of accelerated transformation, nothing is more striking than the scope—and pace—of change in the processes through which these companies engage their customers (patients)  The very terms physician and patient devolved into provider and consumer. Physicians are no longer generalists or specialists they are primary care providers. It’s not just peripheral or incremental change, either. What the industry is going through in 2015 is a revolution in processes. In advertising, content creation, marketing, back-office functions and everything in between, what was done just a few years ago has been rendered obsolete, as new ways to interact with and serve stakeholders push the old ways into the trash bin. 

What’s changed is that technology is transforming every single phase of the business. It’s ubiquitous. It’s impacting the business on a wholesale level.”  It’s a new world of “VUCA,” says Lenny Izzo, group president of legal media at ALM. “That’s an acronym for Volatility, Uncertainty, Complexity and Ambiguity. It’s an old military term

Providers and hospitals have become 'punch-drunk' much like boxers and football players suffer from TBD or traumatic brain disorder.

Uncertainty comes in the form of new competitors. It comes with the decline in traditional branding-based display advertising, and the rise of new formats like cost-per-lead sales and programmatic advertising. Complexity comes in the form of tying together new expensive technologies that cross email, web, billing, production, ad-management, and content creation. Ambiguity comes in the form of not having the expertise to evaluate expensive new systems, and sometimes not knowing the right KPIs. Volatility? How about not knowing whether a new software system that cost $1 million will be relevant in 18 months?

This report is an on-the-ground look at process change in magazine media companies and how it’s affecting, well, nearly everything, from organizational structure and staffing needs, to assumptions about efficiency and newly essential skillsets. We’ll look at overall philosophies and approaches, and then explore, mainly through case studies, what publishing companies and executives are actually doing. 

Radical changes in process are driven by several things, of course. But mostly, it’s a function of two things: emerging technologies that enable new methods of serving markets, and a quest within companies for efficiency driven by economic necessity.

The revolution in health is not just in health IT, it includes changes in medical group administration, payment reform, relationships between providers, hospitals and providers, referral patterns and a new dynamic between regulators, licensing boards and providers of health care.

Interestingly, for health provider and magazine publishers, there’s a significant paradox in process change. Because the business model is in a seemingly permanent state of flux, and because technologies become obsolete so quickly, both types of companies find themselves betting huge amounts of money on unproven ideas. “Maybe the paradox of process is that you’re forced to be hyper-efficient in the things you understand, to finance what you hope is our future,” 

Note: Much of this article has been taken word for word from anaticle found on FOLIO  an internet magazine about the publishing business. It was a simple task to substitute health for magazine or publishers.. A true example of 'convergence'

The Last Mile

"Half of heart disease , for example, is preventable and related to five risk factors-f high cholesterol, hypertension, diabetes, obesity and smoking. Although the death toll has steadily declined over the past 30 years due to prevention and treatment measures, heart disease is still the leading cause of death in the U.S., causing one in every four deaths, or 610,000 deaths each year, according to the Centers for Disease Control and Prevention. Yet, about 80% of people reported exposure to at least one of the five risk factors. Getting them to change is a big challenge.

Take this test.

What are you ?

Research like this is giving us a better understanding of patient psychographics and what makes them tick, particulary when it comes to changing their behavior. Giving people data alone does not change behavior. For information to be effective , they need the tools to change and the motivation to do so. Until then, throwing data at doctors and patients might be an interesting way to try to make a few bucks, but it's unlikely to improve outcomes."

Arlen Meyers.M.D. M.B.A. Co-Founder,President and CEO, Society of Physician Entrepreneurs at ceo@sopenet.net

Sick care and disease prevention has become one big data management exercise. Patients are data sets and doctors are data managers. In addition, in the gap between the data and the doctor, are many others including data scientists, navigators, care coordinators, and, of course, the payers.intervention has to change but, in order for any of this to do any good, there needs to be an intervention based on identified risk factors and that behavior.

Reading information taken from data does not extrapolate to changes in behavior. It is that last mile that resists change.

Take this test.

What are You ?

If you took the time to take the test, you will get some understanding of why it's so hard to change human behavior and habits and why people don't. Simply put, we're all built differently, were brought up differently and have different approaches to changing our habits

Gretchen Rubin is the author of several books, including the blockbusterNew York Timesbestsellers, Better Than Before, The Happiness Project and Happier at Home.

Better than Before: Mastering the Habits of Our Everyday Lives, Gretchen Rubin realized that all of us differ dramatically in our attitude towards habits, and our aptitude for forming them. She described four distinct groups:Upholders, Questioners, Obligers, and Rebels.

Take this test.

What are You ?

Many thanks to Arlen Meyers, M.D. M.B.A. and Gretchen Rubin  who produced most of the content posted here.

Atul Gawande on Healthcare Reform.

Atul Gawande M.D. is a well known physician-author. Soon after he began his residency, his friend Jacob Weisberg, editor of Slate, asked him to contribute to the online magazine. His pieces on the life of a surgical resident caught the eye of The New Yorker which published several pieces by him before making him a staff writer in 1998.

A June 2009 New Yorker essay by Gawande^[12] compared the health care of two towns in Texas to show why health care was more expensive in one town compared to the other. Using the town of McAllen, Texas, as an example, it argued that a revenue-maximizing businessman-like culture (which can provide substantial amounts of unnecessary care) was an important factor in driving up costs, unlike a culture of low-cost high-quality care as provided by the Mayo Clinic and other efficient health systems.

Gawande published his first book, Complications: A Surgeon's Notes on an Imperfect Science, in 2002. It was a National Book Award finalist, and has been published in over one hundred countries.^[18]

His second book, Better: A Surgeon's Notes on Performance, was released in April 2007. It discusses three virtues that Gawande considers to be most important for success in medicine: diligence, doing right, and ingenuity. Gawande offers examples in the book of people who have embodied these virtues. The book strives to present multiple sides of contentious medical issues, such as malpractice law in the US, physicians' role in capital punishment, and treatment variation between hospitals.^[19]

Gawande released his third book, The Checklist Manifesto: How to Get Things Right, in 2009. It discusses the importance of organization and pre-planning (such as thorough checklists) in both medicine and the larger world. The Checklist Manifestoreached the New York Times Hardcover nonfiction bestseller list in 2010.^[20]

Please click on the blue hash bars for a surprise.

• Humane Endeavor: Grace Bello interviews Atul Gawande
• Article on Atul Gawande in Harvard Magazine Sep-Oct 2009
• Charlie Rose - interviews 2007-2010

Pocket-Cast (Audio)

The Tower of Babel and Consumer Confusion

Are you confused yet  ? I am.  No one is telling me that my health and health care are better than it was twenty-five years ago. We've spent billions of dollars on improving our health system however today it is much more complex. We are told that knowledge has grown and readily available for the asking on the internet,  and mobile devices.  Interestingly television is not even on the map.

Medical education has shifted. At one time having an M.D. was sufficient (in addition to a specialty training program) however now an M.D./MBA carries more weight.  It took me about 10 years of belonging to my own C-suite running a medical practice to earn my O.J.T.  credentials.  That in itself should be worth some type of certificate and/or CME credits.

Where do you go when sick ? Do  you call  your M.D, or seek an E.R. or urgent care clinic ? Perhaps you 'Google' your symptoms or disease for an answer.When and if secure email becomes readily available you can email your doctor for help.

Eventually your M.D. will see a pop-up notification from your EHR and/or PHR indicating you need an appointment. Then you will receive an automatic response with a time and date. There will be no or little human-human interaction. Once you arrive at the office you will sit down at a work station that weighs you, takes your pulse, BP, and temperature. A skin sensor senses  your blood glucose and electrolyte levels as well as kidney and liver function tests.

Today we are not at that level, and are wandering in a sea of confusion about it all. Patients and consumers are overwhelmed, as most of we physicians are.  No one quite know what technology to invest in that really matters or improves quality and/or outcomes. It seems to obsolete itself every five years or so, fueled by governmental regulations, and intense marketing by device manufacturers, or software vendors..

Meaningful use has devolved into meaningless spending.

John Lynn writes at EMR & HIPAA, which you can subscribe to here.
His topic gels with my own thoughts about Health Care Confusion.

Confusing the Consumer – Defining New Healthcare Roles

Musings on Connected Health by Joseph Kvedar, MD

 As we continue our journey to change provider reimbursement to a “Pay for Value” system, the lines between health insurers and health care providers are blurring. Physician/hospital systems, like Partners HealthCare, where I work, are taking on risk for populations of patients through contracts with the Federal government and local payers. According to Secretary of Health & Human Services, Sylvia Burwell, this trend is going to continue. She stated recently that HHS set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018. Since the whole insurance industry is based on risk, we inevitably have to start thinking more like insurers if we’re going to be taking on risk.  Sadly, I didn’t learn much. Not because I didn’t listen and not because the speakers were less than talented. I walked away feeling like I hadn’t learned anything because I felt I had gone to a foreign land and was listening to talks in a foreign tongue. I simply couldn’t decipher the health plan lingo.

Tower of Babel  

Is this our inevitability, from Genesis?
As the King James version of the Bible puts it:
4 And they said, “Come, let us build ourselves a city, and a tower whose top is in the heavens; let us make a name for ourselves, lest we be scattered abroad over the face of the whole earth.”
5 But the Lord came down to see the city and the tower which the sons of men had built.
6 And the Lord said, “Indeed the people are one and they all have one language, and this is what they begin to do; now nothing that they propose to do will be withheld from them.
7 Come, let Us go down and there confuse their language, that they may not understand one another’s speech.”
8 So the Lord scattered them abroad from there over the face of all the earth, and they ceased building the city.
9 Therefore its name is called Babel, because there the Lord confused the language of all the earth; and from there the Lord scattered them abroad over the face of all the earth.

—Genesis 11:4–9^[1]

Are we pursuing the ultimate perfection in health care? Can perfection be the enemy of the good?

An aphorism which is commonly attributed to Voltaire, who quoted an Italian proverb in his Dictionnaire philosophique in 1770: "Il meglio è nemico del bene".^[2] It subsequently appeared in his moral poem, La Bégueule, which starts^[3]

Dans ses écrits, un sage Italien

Dit que le mieux est l'ennemi du bien.

(In his writings, a wise Italian says that the best is the enemy of the good) 

"Better a diamond with a flaw than a pebble without."

—Confucius,attrib.^[1]

At the highest level, it seems like we should be natural collaborators, as we bring very complimentary skills to the shared goal of building a health care system. As providers, we excel at understanding physiology, pathophysiology diagnosis and therapy. In most cases, we have strong relationships with the end users of the services offered, our patients, which often includes a high degree of trust. When someone’s doctor recommends a course of action, most people at least take it seriously and many often follow that path.

Payers, on the other hand, have always been challenged connecting with their members (you see, we are all a member, a consumer and a patient – all in different contexts – an example of the babbling). Payers excel at understanding risk and setting premium costs, something we as providers have no feel for. But if we’re going to take on risk, we’ll have to learn. Can these former negotiating foes come together to help improve your health? The current landscape does not lead to enthusiasm.

I’ll use some telehealth implementations as examples. Several national payers are adopting virtual visits as a tool for their members. For me, this is a dream come true! BUT, most payers are doing so in collaboration with one of the major vendors in the space and creating shadow physician networks to offer the service to their MEMBERS. When that member’s primary care doctor eventually sees them in the office, she will be puzzled that her PATIENT had an encounter via their health plan that she did not know about.

Walgreens just rolled out a virtual visit program as well. This could create even more confusion, as it brings in a new entrant — the pharmacy — into the battleground for that relationship. Will EMR interoperability solve this confusion? It certainly helps, but I’m also concerned about mixed messaging to the consumer/patient/member. It seems like we’re all fighting for your attention, which may lead to conflicting messages.

This reminds me of a time, about 25 years ago, when this new thing called disease management sprung up. Payers were frustrated by the cost of managing patients (members) with chronic illness. They got no help from providers, so they took matters into their own hands, hiring call centers staffed with nurses to contact patients/members with tips on how to manage their illness, and often sent generic brochures about high blood pressure and other conditions. Payers may have influenced the care of some patients/members, but no one was ever able to prove that this was an effective strategy.

There were numerous stories about patients receiving conflicting advice from these ‘disease managers’ compared to their own doctor’s advice, leaving patients confused. Doctors would get faxes from these same disease management companies and (perhaps arrogantly) throw them in the waste basket without reading them. As a result, the disease management industry collapsed in the middle to latter half of the last decade.

In the meantime, we now have workplace wellness programs, virtual visits offered by your health plan, retail clinics, virtual visits offered by pharmacies and — dare we forget — advice your doctor gives you, which should be more in tune with prevention now that providers are taking on risk.

See what I mean by a Tower of Babel? How do we fix it?

Adding to this conundrum we face increasing health information technology guiding consumers on another journey via a personal health record, a clinic portal, and numerous websites on disease, symptoms, and treatments.

In the near future "Watson" looms, a portender of artificial intelligence developed by IBM.

John Lynn concludes:

Joseph’s comparison to the Tower of Babel is a good one. The solution to all these new healthcare modalities is to make sure that everyone is speaking the same language. It doesn’t solve all of the problems, but it does help everyone get on the same page. I just hope that the business interests of many involved in healthcare don’t get in the way of this goal.

Digital Health | SOFTWARE DOESN'T HAVE AN MD

Digital Health | Andreessen Horowitz

Who is practicing medicine really ?  You are going to be surprised. The horse is out of the barn.

We only have about a million physicians in the United States — but they’re about to get reinforcements.
I don't mean nurse practitioneers, physician assistants, or other "mid-level" providers. It's not Minute Clinics, either.

If you think about the CAT scan that an MD is using, if you think about almost any modern device that a doctor is using — it’s useless without the code in it. That code was likely written by someone without an MD, someone who was evaluated as competent and hired by a commercial vendor of mission-critical medical instruments. The instruments that represent the foundation of modern medicine are thus today typically programmed by people who know how to code (but lack MDs) and used by people who have MDs (but usually do not know how to code).

So a large percentage of medicine is already being effectively practiced by non-MDs.

Moreover, the interior workings of the instruments are black boxes; MDs interface with them through vendor-provided UIs and interpret the readouts by looking up data stored in their head. As these UIs get better and smarter, less interpretive skill is required by the MD. The MD is happier — the instrument gets the right answer with less work. It’s used more frequently. Through successively more sophisticated engineering the instrument thus begins to move from the hands of the specialist to the generalist to the nurse practitioner to the nurse… and then, perhaps, to the general population in the form of a phone accessory or an app.

That last step is starting to happen as various personal genomic, quantified self, and mobile diagnostic technologies become more accessible. These technologies produce data from the body, and that data is going to be stored in our phones. The interpretation of that data is going to be performed by software.

And so that large percentage of medicine that is effectively being practiced by non-MDs is going to expand.

One center of action is likely going to be the mobile programmable medical record — the container for all diagnostics and test results — something like what Apple’s HealthKit may evolve into. Essentially just a bunch of data containers for your heart rate history, your blood pressure history, your exercise history, and the like.

All this diagnostic history isn’t necessarily “big data”; it’s just never been tracked and cross-correlated before in one place. Once technologies like HealthKit get a little more traction, millions of software engineers without MDs can build new applications on top of that data store.