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House of Cures

The Healthcare Blog - Sat, 02/06/2016 - 02:19

Lawmakers in Washington are gearing up to pass major, far-reaching legislation on drug approval and cancer research. This is a good thing in the main but—no surprise here—Republicans and Democrats differ on approach and details, and things are already getting messy.

This makes the proposed legislation very risky. It could all implode in an election year, but momentum is building fast and both parties have something to gain by passage.

This blog is a primer on what’s happening. Future posts will track the legislation’s progress and delve into some of the issues at stake. Comments are invited.

As you’ve no doubt heard, the White House—with Joe Biden in the lead—has proposed a “moon shot” on cancer research. The administration is expected to propose, in its FY 2017 budget request, $755 million in funding for the initiative, with $195 million of that earmarked for the National Institutes of Health (NIH) and around $75 for the FDA.

Importantly—and you’ll see why below—under the budget deal agreed to in December for FY2016, NIH’s budget was already boosted by $2 billion, with $264 million going to the National Cancer Institute. That was an unprecedented 6% boost after many years of minor or no increases. (A promise of an additional $9 billion for NIH over the next 5 years was also made.)

Among the major goals of the moon shot initiative, according to the White House: launch and complete clinical trials for up to 20 kinds of cancer in as many as 20,000 patients by 2020, with a focus on advancing breakthroughs in immunotherapy—by all accounts the most promising area of cancer research at the moment.

Researchers are already lining up to capitalize. On January 12, a group of leading researchers and drug companies, including Amgen and Celgene, launched “The National Immunotherapy Coalition: Cancer MoonShot 2020.” The stated aim: accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients.

Meanwhile, lawmakers in Congress are processing a bill dubbed “The 21st Century Cures Act.” (I’ll abbreviate as “Cures.”) It was written by Republicans and emerged from the House Energy and Commerce Committee led by Rep. Fred Upton (R-Mich.). The bill, in a nutshell, gives FDA a batch of new tools to expedite the approval process for new drugs and medical devices. One of those tools would allow the FDA to approve new drugs based on a wider range of research results than is the case now.

The House passed the Cures bill in July, with bipartisan support.  Notably, however, support from Democrats came almost entirely from a provision in the bill that increased NIH funding by $2 billion.  Most Dems were worried about the FDA provisions but strategized that the Senate would very likely modify those anyway—hence the bill got their vote.

As referenced above, that $2 billion increase for NIH was “borrowed” from the bill in the 2016 federal budget agreement, which became law in December. That served to undermine support for the Cures bill in the Senate, and some thought it might be dead—if not forever at least until after the election.

Then along came moon shot. It appears to have reenergized chances for the Cures bill. Upton and other Republicans are doing everything in their power to leverage moon shot to gain Senate passage. The White House—or more precisely Biden—has signaled a willingness to go along with that. But Republicans in the Senate now say they plan to chop the bill up rather than pass a single piece of comprehensive legislation.

The Republicans move reportedly blindsided Democrats and threw the process into chaos, with Democrats suspicious of Republicans’ motives (again, nothing new about that). Democrats have also stated clearly—led by Patty Murray of Washington state, the ranking Democrat on the Senate Health, Education, Labor, and Pensions (HELP) committee—that they will not support the Cures bill without the additional funding for NIH and FDA that the White House is now calling for, and over multiple years.

Meanwhile, Sen. Lamar Alexander (R-Tenn.), chairman of the HELP committee, has said that breaking the legislation into parts allows the committee to agree on the least controversial parts first and then figure out the rest.

On yet another and separate track is the President’s Precision Medicine Initiative, launched in 2015. It’s been funded to the tune of $200 million so far, with more likely to be proposed in the 2017 White House budget request. In the White House’s words the initiative is “a bold new research effort to revolutionize how we improve health and treat disease….that takes into account individual differences in people’s genes, environments, and lifestyles.”

All these initiatives are related, of course. And it is a positive development that policymakers are focused on increasing the funding of and improving medical research and new ways to treat disease.  But buried in the Cures Act, the cancer moon shot, and the precision medicine initiative are some poorly conceived ideas and unrealistic assumptions.

For example, the House version of Cures has been roundly criticized for creating a possible end run around the gold standard for drug approvals: controlled clinical trials. And the cancer moon shot has spurred jeers in some high-level corners of medical research for being overly optimistic about the pace of scientific progress against what is a highly complex constellation of 100 or so different diseases.

Those issues and more will be the subject of future blogs.

Steven Findlay is an independent journalist and editor who covers medicine and healthcare policy and technology.

Categories: OIG Advisory Opinions

An Oncologist’s List

The Healthcare Blog - Sat, 02/06/2016 - 01:02

Disclaimer: I have never had cancer. Therefore, at the most basic level, I do not have the right to pontificate about dealing with the dread disease.

Rather, I have been the servant and support of those that struggle with cancer. I thought it might be of some assistance to share my observations from the other side of the bed rail. Perhaps, their secrets of survival may help you.

1. Cancer is a team sport; do not do this alone. Never show up to an important appointment by yourself. You are dealing with a physical impairment, as well as a complex mental challenge, at the same time that you are frightened and do not feel well. Have someone with you to listen, ask, take notes and simply carry your things. This is true not only during treatment, but at home. Accept support. Build a team. Work together to fight this awful thing.

2. In the same way, whether you like it or not, a family goes through this together. Those that love you, also “get cancer.” Working together helps everyone deal with the affects of the disease. You are not a burden. You reap what you sow.

3. Nonetheless, it is also important to get time for yourself. You need grounding time; quiet moments to heal. Take a deep breath; rebuild. If your family does not understand the importance of “me time,” show them this note.

4. Be on time for your appointments, tests and treatments. This is my own hang-up, but being on time is part of being organized and I have noted that the patients that are punctual are organized and those that are organized do better.

5. Be whiney. Really, complain a lot. Tell your doctors what is happening. Take notes. Email. Call. Will the doctor give you his cell number? Do not ignore a fever for five days, crawl into the doctor’s office, and say, “By the way, I feel terrible.” That will result in the doctor saying, “By the way, time to go to the hospital.” This is why women make better patients then men; malignant macho.

6. Get in shape. Before cancer. During cancer. After cancer. The more physically active, the better your body can fight illness and the less side effects you will have. Exercise not only prevents recurrence, but allows more rapid recovery. Walk. Row. Swim. Bike. Sex. Do not be a dead blob.

7. Taking the exercise theme a step further, I have seen that those that do “alternative exercise” seem to do better. Yoga, Tai Chi, Pilates, Jazzercise, kickboxing, Recki, and a host of others seem to have remarkable benefits. Acupuncture, acupressure, Shiatsu, Jin Shin Do and chiropractic techniques rejuvenate many of these same patients. Stretch your comfort zone.

8. Be on time for your appointments, tests and treatments. This is my own hang-up, but being on time is part of being organized and I have noted that the patients that are punctual are organized and those that are organized do better.Be whinny. Really, complain a lot. Tell your doctors what is happening. Take notes. Email. Call. Will the doctor give you his cell number? Do not ignore a fever for five days, crawl into the doctor’s office, and say, “By the way, I feel terrible.” That will result in the doctor saying, “By the way, time to go to the hospital.” This is why women make better patients then men; malignant macho.

9. No, I do not believe in vitamins. I have never seen them help. The data is poor and I can think of no reason that a pile of chemicals thrown into a tablet in some mad scientist’s lab, can improve on the body’s natural nutritional intelligence. The body knows what it wants and expects to receive vitamins in the balanced form of food. If it tastes bad, the body does not want it. If it tastes good, your body is broadcasting a need. Eat lots of fruits, vegetables. Limited red meat. Hydrate, hydrate, hydrate, hydrate, hydrate. Did I mention the importance of hydration?

10. Do not smoke. Stop immediately. To be clear, if you have cancer and continue to smoke you are wasting your time and money visiting a doctor. You are screwed. Stop. Patients who continue to smoke, die.

11. Limited alcohol. Note, I did not say none…1-2 drinks a week, seems to be OK. However, the 96 year-old who consumes two scotches a day is exceedingly rare.

12. Understand your disease and therapy. It is your body, your life; you have to be in control. I love doctors, some of my best friends are doctors, but they are only teachers and guides. If you are going to get the best care, it will be the care that you think and understand to be best. Ask questions… lots of questions … create lists. Your doctor does not mind, because it focuses the conversation.

12. In the Internet era, it is easy to build a baseline of knowledge. However, take anything you read online with a grain of salt. It is general knowledge, not personal prescription. The Internet can be a scary place, so use it only as a place to start. Ask your doctor.

13.Find ways to deal with the stress. Family is the start, but support groups, counseling, hobbies, short trips, reading, writing, Facebook, can help the cure. Emotional suffering can drain you and make it hard to go on. Talk to your friends, family and doctor about alternatives. The most “successful” patients achieve emotional balance.

14.Joke. Tease. Humor is a powerful weapon against despair and depression. Watch comedies. Read funny books. Joke with your caregivers. This is no more arbitrary than oxygen.

15.Sob. Scream. Fight. Break things. Yell. Bitch. Get really pissed off. Shout now, apologize later. Purge the pain that is trying to eat you up. Let it out. “F**k this s**t.”

16. Did I mention laughter?

17. Recognize that your life has changed.Permanently. Cancer is like other major transitions in life … graduation, marriage, kids. It is just one you did not want … like divorce, flood, losing your job. Work to understand the new you.

18. Recognize that life is the same. You are still you. The things you love (or hate), your view of life, the things most important, are the same. When the chaos settles, in the moments of quiet, you are still there.

19. I do not understand this one, but pets definitely have healing powers. I am not certain what it is about a sad-eyed dog or a purring ball of fur that gives solace. My mother had two cancers. Her cat, Linda, used to bring in dead birds when she was weak in bed. Somehow, that motivated her to get up and going again.

20. Make sure your doctors are communicating with each other. In the best of all possible worlds, they would do this without your prodding. However, you must play secretary; bring back and forth notes and records. Confirm they are talking to each other. Like I said, this is a team sport and it is vital that your professional caregivers function as a team. The most “successful” patients track records and the interactions of everyone involved in their care.

21. Get a second opinion. Or third. Fourth? The worst thing that can happen is that everyone will learn something. Your doctors do not mind. If they do, they probably should not be your doctors.

22. Care about your appearance. Stay groomed and clean. Dress nicely. As they say, the cloths make the man … or woman … and a well-clothed patient is a healthy patient.

23. Try to leave the cancer and the treatment in the doctor’s office. This is very hard to do, but as much as you can compartmentalize the disease, leave the burden somewhere else, the better balanced your life.

24. Attack… attack … attack. Successful patients and doctors know that persistence works. Uncover every stone. Destroy every disease. Be realistic, do not ruin your life with worthless toxic therapy, but consider every chance to kill cancer.On the other, other hand, stay involved with day-to-day life. We are social beings. Go to weddings, picnics and holiday events. Children’s soccer games mend better than antibiotics. Yes, it can be discouraging that you are too weak to dance, and frustrating to use a wheelchair in an airport (although the airlines are great about it, just call ahead). It is hard when you are at the Thanksgiving table and cannot eat. It is much worse, even dangerous, not to show up at all.

25. Do not crawl into a corner and become a cancer patient. In your body, somewhere, is the growth called cancer, but that disease is not you. You are not cancer. You are a wonderful, powerful, intelligent, important, loving and magical being. Do not sit and wait for the disease to go away.

26. Live. Love. Life.

James Salwitz is an oncologist based in New Jersey.

Categories: OIG Advisory Opinions

David Vivero, Amino– Yes, We Need Another Doctor Search Company!

The Healthcare Blog - Fri, 02/05/2016 - 20:47

Those of you dismayed at the dearth of recent interviews of notable health tech startups on THCB will be glad to hear I have several in the can and will be putting them up starting with Amino today. And the rest of you can move along….

David Vivero made his money at a company matching renters to apartments that ended up part of Zillow. That was too easy, so now he’s decided to match people up with the right doctor. Amino came out of stealth late last year with about $20m in funding and it has acquired large data sets (including being one of the few with official access to all CMS physician data) and some complex ways to match patients to doctors–the primary one being doctors near you that have seen a lot of patients like you. Why are they in a  market that already has several well known & well funded players like Vitals, Healthgrades, Better Doctor and more? David told me that and more in this interview.

Categories: OIG Advisory Opinions

Physician Burnout is an Epidemic

The Healthcare Blog - Fri, 02/05/2016 - 03:58

There is a disease sweeping the nation that has significant consequences for every person living in this country, even if they never contract it directly. And despite its lethality, there is precious little being done about it.  It’s called physician burnout, and it affects all of us.

Doctors, on average, spend at least eight years in college, followed by years of postgraduate training during which time they work 80 hours a week. They graduate with a mountain of debt, face the constant fear of malpractice litigation, and are burdened by incessant demands to see more patients in less time with more administrative paperwork. On top of which, there’s compassion fatigue – helping the sick, the injured and the dying is rewarding no doubt, but often emotionally draining. All of this leads to physician burnout.

More than any other profession, doctors face burnout, and the rates have been increasing. A recent study by researchers at the Mayo Clinic found that the number of physicians suffering from burnout is 54%, up from 45% in 2011. And physicians are more than twice as likely to commit suicide than non-physicians; every year, 400 doctors in this country take their own lives.

Why should you care?  Because the emotional health of doctors has a direct effect on the broader public. There are a plethora of stories of physicians who describe the chilling consequences of their depression. One surgeon wrote in a recent blog, “my depression…was exacerbated by work. I clearly wasn’t performing to the best of my abilities, and my patient complications and complaints were increasing. A patient died from a post-operative bleed. Would I have managed it better if I wasn’t suffering myself?  (When I spoke to the patient’s wife, as he lay dying 20 feet away, she asked me if I was OK.)” Burnout causes a lack of clarity in thinking leading to medical mistakes. “Given the extensive evidence that burnout among physicians has effects on quality of care, patient satisfaction, turnover, and patient safety, these findings have important implications for society at large,” researchers from Mayo Clinic told Forbes.

But it’s not just that doctors who are burned out are more likely to make errors –  they’re also more prone to biases noted a recent report. And, it’s clear that bias clouds judgment and causes physicians to treat certain patients differently than others.  “Physicians who are burned out, stressed and generally frustrated over near-term crises or long-term concerns are more likely to react negatively to patients,” said a recent study.

Beyond medical errors and poor patient interactions, physician wellbeing also affects access to care. A recent Physicians’ Foundation survey found that 44% of physicians were planning on reducing patient access by either cutting back on patient load, working part time, closing their practice to new patients or retiring. Physicians are getting tired of the “turnstyle” medicine they are being forced to practice – seeing more patients in less time – rather than building the relationships that inspired them to enter the profession. Increasingly, however, the physician-patient relationship is being supplanted by the economic demands of a medical machine. While some have tried to fight back with efforts to unionize, others simply retire or find alternate careers.  Such erosion of the profession, especially when coupled with an expected doctor shortage over the coming decades due to fewer trainees, has the potential to seriously impede access to care.

As physicians, we have the humbling privilege of caring for the sick, the weak and the injured. We spend years perfecting our skills in diagnosis and treatment so much so that the idea that we may be suffering ourselves is difficult to accept. We can no longer afford to ignore the fact that burnout affects not only ourselves and our families, but our patients as well.

This is not an issue physicians can address alone. Indeed, a concerted effort is required across all stakeholders. Hospitals must work to foster environments where the economic demands of a viable enterprise are balanced against the need for a happy and healthy physician workforce. Policy makers must consider the ramifications of increasing administrative burdens and reducing reimbursements which only serve to fuel physician fatigue. As a society, we need to ensure we look after the professionals we entrust with our health. When over half of all physicians are burned out and the trend is continuing to rise, there is a silent healthcare epidemic in this country that needs to be addressed. How long can we continue to ignore what is becoming a “critical condition”?

Anees Chagpar is a Yale associate professor of surgery and Director of The Breast Center — Smilow Cancer Hospital at Yale-New Haven.

Categories: OIG Advisory Opinions

The Search for the Elusive Elixir of Life

The Healthcare Blog - Thu, 02/04/2016 - 12:15

Here’s the executive summary: Most disease and health spending is age-related. As we age we get infirmities ranging from dementia to cancer to vascular disease. Nothing can prevent aging. Period. For millennia mankind has been been on a futile search to prevent aging.

Search for the Elusive Elixir of Life

For 3500 or more years mankind has been searching for the mythological Elixir of Life, the fountain of youth, the philosophers stone, pool of nectar, etc, that will defeat aging and extend life, if not achieve immortality.

According to Wiki, “The elixir of life, also known as the elixir of immortality and sometimes equated with the philosopher’s stone, is a mythical potion that, when drunk from a certain cup at a certain time, supposedly grants the drinker eternal life and/or eternal youth.”

All around the globe from 400 BCE alchemists, from India to China to Europe, were seeking the elixir of life. Many thought gold was an essential ingredient of such an elixir.

The Fountain of Youth, also known as the water of life, was part of the search for the elixir of life. That search was in full throttle during the crusades, and was carried to the New World by Spanish explorers, the most famous of whom was Ponce De Leon in the 1500’s. Even the Mayans had legends about waters of eternal youth.

The search for the elixir of life didn’t end there.

In the 19th century in the US many believed that bathing in special springs had healing powers. During that era people flocked to Eureka Springs, Hot Springs, Healing Springs, and many many more. So called healing spas are still very popular today.

“Snake oil” salesmen were peddling various cure-alls and panaceas into the 20th century. A search on the internet will reveal a large number of “promising” balms and salves, some of which actually worked for minor scrapes and burns.

If you’re over 60 or so you may recall Carters Little Liver Pills. It was advertised to treat biliousness and other ailments. The FTC made them drop the word liver from the name. Carters Little Pills are still sold but as a laxative.

If you watched the Lawrence Welk show, you saw ads for Serutan, which is “natures” spelled backwards. It’s a “vegetable hydrogel”.

Today the search for an elixir of life, by various names, is still in high gear and salesmen for that notion are abundant today.

People today are still pursuing the same version of living longer and healthier lives by pursuing a mix of vitamins, supplements, wellness, incentives, education, exams, tests, etc., that will push the time of their death out a few years.

But, alas, the human body and its organs simply wear out over time. No insurance plan, wellness plan, patient education program, or prevention combination, can defeat the inevitable. As we age our bodies just wear out. For example, the reason brain aneurysms and strokes occur in the elderly is that blood vessels get thinner and more fragile with age. The same applies to other vascular diseases. Joint diseases are common as we age. Why? Joints just wear out over time. Dementia is usually related to aging. The list goes on and on.

According to NIH data all cancer rates begin to skyrocket at about age 65. That is partially the effect of age-related diminishing immune systems. Our immune systems wear out as we age.

Companies are paying huge dollars to elixir of life promoters today when all the facts show it just doesn’t work as advertised. Such companies’ intentions are good, even noble, but doomed to fail. Lesson: whatever you want and seek, someone will find away to sell it to you.

We are all going to have a mortal illness someday unless we die sooner from something else like an auto accident. My grandfather died at age 99. Every organ in his body was failing. His kidneys were failing, as was his vascular system, his brain, and his liver, etc. Why? He simply outlived his body. I’ve known a number of good people who in the end died a miserable terrible death after years in nursing homes. I wouldn’t wish that on my worst enemy.

Another factor driving up costs in the US has been the creation of the emergency phone number system of dialing 911 and having a life-saving trained team show up at your door in few minutes. The dial 911 system saves live no doubt, but there have been unintended health cost consequences too. If one survives a heart attack the average cost is about $250k. Because of the 911 phone system some 80 year olds are surviving three heart attacks in 9 months just to die from the fourth one, adding $750k to their last 12 months. Now they are even putting ventricular assist devices to keep people like that alive for one more day at a cost of $900k.

I’m not making a comment on the morality of deferring and elderly person’s death for 9 months at a cost of $750k to $2M. But we need to have an adult conversation in American about how we are going to pay for all this. By any measurement Medicare and Social Security are both totally unsustainable unless huge changes are made that will impact everyone. Beware of proposed changes that promote intergenerational rivalries.

This chart shows death rates by age (source WIKI). When people hit about age 50 the death and sickness rates begin to skyrocket.

This chart shows leading causes of death (source WIKI). See the strong correlation to aging and heart disease. People are simply outliving their hearts and blood vessels. In 1900 people rarely died of heart disease because they didn’t live long enough to develop chronic conditions. Most of the chronic diseases we worry about are simply a consequence of aging. They are irreversible. Like the Hydra of Greek mythology, if you defeat one chronic condition, three others will pop up in its place.

The third chart shows health spending by age (source Incidental Economist), again correlating disease to aging. That will always be that way until someone comes up with a way to prevent aging or finds an “elixir of life”. That chart also illustrates the massive wasteful spending on end-of-life care in the US compared to peer countries.

People in born in the US today can expect to die along a bell curve centering on age 80. If we all do everything we can possibly do to be healthier for all of our lives there will be slightly fewer deaths around ages 78 or 79. (A great source of information on This topic is Nortin Hadler’s The Last Well Person: How to Stay Well Despite the Health-Care System available on Amazon.)

In any case if you are able to add a year to your life it will be added to the end of your life. For most people that will mean another year in a nursing home, in assisted living, or as an invalid at home. (For a Washington Post article on just how nasty nursing homes can be click here. Again, I would not wish that on my worst enemy.) People sometimes tell me about someone who was more or less healthy and independent at age 90. For every person like that there are a hundred in nursing homes or dementia units.

Most people retiring today don’t have enough in savings to support themselves for more than a few years, let alone enough to pay for assisted living and/or nursing homes when they are elderly and frail. Medicaid nursing home budgets are likewise unsustainable. Don’t count on that. For many people living a year or two longer will simply mean being a burden to your children for another year or two, both financially and emotionally.

What about your children’s lives? Do you really want them to have to look after you well into their 60’s. At that age they should be concentrating on their own welfare.

As people age into their 80’s and 90’s, many become demanding in an irrational way. Some people age 55 and up are relieved when their elderly parents pass away, but often with feelings of guilt. Most people have witnessed this in their own families.

Someday researchers may discover a way to delay the effects of aging. Personally I believe such is the province of science fiction. If that ever happens, God help us. That would be very destructive to mankind.

Imagine our world populated by a billion or more centenarians. Imagine a nation with an average age of 65. Imagine yourself at age 90 with a 120 year old parent or two. Who will look after whom? Will 70 year old children or their 45 year old children be able to look after and support such parents, grandparents, and great grandparents? The news from Asia is that many young people are no longer willing to support their centenarian parents or grandparents today, let alone great-grandparents.

What should we all do then? Simple. Spend less time wringing your hands over which illness will get you in the end, rather make the most of the time you have. Worry will never add a day to your life.

The Romans had a blessing: May you live well and die suddenly.

Tom Emerick is the President of Emerick Consulting, LLC, and Partner and Chief Strategy Officer with Laurus Strategies, a Chicago-based consulting firm, and co-founder of Edison Health. 

Categories: OIG Advisory Opinions

Blog Notes

The Healthcare Blog - Thu, 02/04/2016 - 01:00

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Categories: OIG Advisory Opinions

Gawande, Frankl, and Why “Less Is More” Is More of the Same

The Healthcare Blog - Wed, 02/03/2016 - 18:47

My last post was prompted by a reader’s comment where Victor Frankl’s Man’s Search for Meaning and Atul Gawande’s Being Mortal were juxtaposed.  Since receiving that message, I have had occasion to notice that others also associate these two books.

For example, both are mentioned positively in this moving article by Dr. Clare Luz about a friend’s suicide, and in these tweets from Dr. Paddy Barrett’s podcast program:

Friends and patients of mine have likewise mentioned these two works to me, expressing praise and testifying to the deep impact the books have had on them.

I suspect that many readers of this blog will at least be familiar with these two books.  If not, summaries are here (Frankl) and here (Gawande).

I read the books in succession and found the difference between the two striking.  Frankl and Gawande seem to be at polar opposites on the question of life and death.  In this post, I will explore this difference, starting with Gawande’s point of departure.

Trajectories of life

In the second chapter of his book, Gawande provides three sketches which, in my opinion, provide the basis of understanding on which the remainder of his book rests.

The first graph represents how things were before the advent of technological medicine:

In those days, Gawande says, “Life and health would putter along nicely, not a problem in the world. Then illness would hit and the bottom would drop out like a trap door.” (Henry Holt, Kindle edition, p25-26)

With the advent of modern therapies, things change, and life may proceed along the following pattern:

“[O]ur treatments can stretch the descent out until it ends up looking less like a cliff and more like a hilly road down the mountain.” (p. 27)

But then, Gawande adds that:

“The trajectory that medical progress has made possible for many people, though, follows neither of these two patterns. Instead, increasingly large numbers of us get to live out a full life span and die of old age…[where] the culprit is just the accumulated crumbling of one’s bodily systems…The curve of life becomes a long, slow, fade” (p.27-28)

For the rest of the book, Gawande describes our struggles dealing with this “long, slow fade:”

“medical science has rendered obsolete centuries of experience, tradition, and language about our mortality and created a new difficulty for mankind: how to die. (p. 158)

Now, at first glance, these life trajectories seem helpful in conveying the ideal we all desire and the course we want to avoid.  Who wouldn’t wish a life that goes along a smooth horizontal path until “woosh,” we cut to the bottom in one fell swoop?  Who would care to experience “the accumulated crumbling of one’s bodily systems” that Gawande so artfully describes? (His rendition is one of masterful realism.  You can feel your teeth soften and your arteries crunch as you read).

But the peculiarity of the graphs, compelling as they may be, is that the y-axes have no label or unit.  What quantity is this that we’d like to hang on to so dearly, and then give up all at once when our time is up?  Gawande does not say.

The figures originally come from several articles (see, here and here) authored by gerontology scientists at the RAND corporation.  In those papers, the y-axis is often labeled function.  As we age, our functional abilities decline: our senses deteriorate, our bones and muscles weaken, our joints harden and, as a result, our ability to go on with life declines. At times, though, the papers also imply that the y-axis has to do with “well-being” or “symptoms.”

The graphs are similar to the illustration that depicts the concept of “Quality-Adjusted Life Years,” or QALY, used by health econometricians to make comparisons between the effect of different interventions. In the QALY graph, the y-axis contains two concepts at once: health and quality.

Now, one difficulty with all these figures is that well-being, functionquality of life, orhealth are not obviously quantitative measures that can be conveniently charted on a graph.

We may have “pain scales” and “functional assessment indices,” but these can only help measure a symptom or a performance in isolation.  Symptoms and functional capacities cannot be combined to give a global sense of where one individual might fit on one of the charts above.

And what is health anyway, let alone “perfect health?”

A few years ago, Dr. Herbert Fred wrote an insightful editorial in which he noted that the phrase “to be in good health”

“…applies only to the moment at hand, provides no guarantee, risks giving a false sense of security, and represents nothing more than an opinion, professional or otherwise

I wrote a letter in response in which I commented that:

“In 1986, an editorial in CMAJ dealt with the question of defining disease and health.3 Contributors from diverse academic and private-practice backgrounds offered their perspectives, and others responded.4 There were as many definitions and viewpoints as there were essays.

What about quality of life?

Consider Stephen Hawking, who was first diagnosed with a progressive neuromuscular disorder at age 21, had to use crutches soon after that, and stopped lecturing a few years later.  By the late 1970’s his speech was hardly intelligible.  He had a brush with death from pneumonia in the 1980’s.  He is now dependent on a ventilator and the use of facial muscles to activate his aid devices.  Yet, despite these unimaginable difficulties, he has managed to produce some of the greatest accomplishments in theoretical physics of the last 50 years.

When Hawking dies and is asked by St. Peter to draw his life trajectory, how do you think he would sketch it?  How would you sketch it?

Now, Gawande might object that these graphs are purely conceptual and need not convey a specific sense of mensuration for the variables in question.  But if that’s the case, what is the point of using graphs?  Clearly, according to him, there is something which, as life progresses, diminishes either gradually or abruptly.  If something diminishes, it is a quantity.  A quantity of what?

Besides, there are other parts of the book that lead me to believe that Gawande does take these graphs as literally pointing to a “quantity” of well-being, but before we get to those parts, we need to take…

A philosophical detour

Gawande, the RAND scientists, and QALY wonks are not the first ones to attempt to turn qualities into quantities.  In fact, that conceptual alchemy is at the root of a philosophical paradigm elaborated two hundred years ago and which is still widely influential in our culture to this day.

Jeremy Bentham was an early nineteenth century thinker whose philosophical contribution was to propose that passions, emotions, and feelings are quantitative entities which we combine into a “felicific calculus” by considering each feeling with respect to seven circumstances: intensity, duration, certainty, propinquity, fecundity, purity, and extent.

Man, Bentham believed, is driven to maximize his happiness and minimize his pain or suffering in accordance with this putative calculus.

As Murray Rothbard put it:

Bentham sought to reduce all human desires and values from the qualitative to the quantitative; all goals to be reduced to quantity, and all seemingly different values—e.g., pushpin and poetry—are to be reduced to mere differences in quantity and degree.¹

And by extending this personal utilitarianism to the community, Bentham famously proposed that “it is the greatest happiness of the greatest number that is the measure of right and wrong,” a maxim about ethics now known as the principle of social utilitarianism.

Bentham’s idea would perhaps have ended as a quaint footnote in the history of thought were it not for the rise of social democracies and the advent of statistical science.  When political systems emerged that would take it upon themselves to distribute “benefits” to the population, the felicific calculus was reincarnated into a much more respectable concept: the cost-benefit analysis.

The mathematical models that underlie modern cost-benefit analyses might be more “robust” or “sophisticated” than Bentham’s simple algebraic methods, but the principles are the same.  Qualities have been turned into quantities and, in recent years, happyismhas become a legitimate field of “scientific” research.²  As Eric Posner and Cass Sunstein recently remarked, Benthaminism is alive and well.

The story of our life

To return to Gawande’s views on life and death, we should recall that Bentham was a disciple of David Hume, and lived at a time when philosophy was entirely captivated by Newton’s mechanics.  In those days, intellectuals increasingly viewed the world as bodies in motion, colliding, acting, and reacting on one another, under the immutable laws of classical physics.

As a thoroughgoing empiricist, Bentham accepted Hume’s philosophical stance that reason is “slave to the passions” and that the self is nothing more than a bundle of experiences.  And it is from that anthropological framework, from Hume’s conception of the mind as essentially subject to impressions, that Bentham proceeded to conceive of his felicific calculus.

Well, the concept of the self as a “bundle of experiences” is implicitly at the heart of Gawande’s book.   Consider the following passage:

“For human beings, life is meaningful because it is a story. A story has a sense of a whole, and its arc is determined by the significant moments, the ones where something happens. (p. 238)

Being Mortal is chiefly a collection of stories and is a commentary about the importance of stories, of how lives are formed by their experiences (e.g., p. 87), and how wisdom is “gained from long experience in life.” (p. 94).  There is no mention at all in his book of any effect one’s reason might have on one’s outlook on life, independent of experience.

Instead, Gawande proposes that life is interpreted on account of the “experiencing self” and the “remembering self:”

“When our time is limited and we are uncertain about how best to serve our priorities, we are forced to deal with the fact that both the experiencing self and the remembering self matter. We do not want to endure long pain and short pleasure. Yet certain pleasures can make enduring suffering worthwhile. The peaks are important, and so is the ending. (p. 239)

If I read him correctly, this distinction between the “experiencing self” and the “remembering self” only means that it is the totality of one’s life experiences that matters and that determines the richness and meaning of life.

Perhaps Gawande’s most explicit expression of his empiricist position is a passage later on where he states that:

“No one ever really has control. Physics and biology and accident ultimately have their way in our lives. But the point is that we are not helpless either. Courage is the strength to recognize both realities. We have room to act, to shape our stories, though as time goes on it is within narrower and narrower confines. A few conclusions become clear when we understand this: that our most cruel failure in how we treat the sick and the aged is the failure to recognize that they have priorities beyond merely being safe and living longer; that the chance to shape one’s story is essential to sustaining meaning in life; (p. 243, italics mine)

One might wonder that if “physics and biology and accident ultimately have their way,” then who is the self who is not helpless, the “one” who’s shaping the story? Neither Hume nor Gawande give satisfactory answers to that question.

To return to the question of personal utilitarianism, Gawande seems at one point to precisely preempt such a charge:

“Measurements of people’s minute-by-minute levels of pleasure and pain miss this fundamental aspect of human existence. A seemingly happy life may be empty. A seemingly difficult life may be devoted to a great cause. We have purposes larger than ourselves. (p. 238)

But how does Gawande explains these “purposes larger than ourselves?” By the fact that:

Unlike your experiencing self— which is absorbed in the moment— your remembering self is attempting to recognize not only the peaks of joy and valleys of misery but also how the story works out as a whole. (p. 238-9)

So measurement does matter, after all, since meaning results from the totality of peaks and valleys as our life story unfolds.

At any rate, the notion that life’s meaning derives from the stories we author—our “ego-dramas,” as Robert Barron would likely put it—is where Gawande is clearly at odds with Viktor Frankl.  For Frankl advocated that meaning is transcendent.  It resides outside of or beyond the human person, and is not simply the result of one’s cumulative life experiences.

One passage from Man in Search of Meaning makes that point clear:

“I wish to stress that the true meaning of life is to be discovered in the world rather than within man or his own psyche, as though it were a closed system.  I have termed this constitutive characteristic the “self-transcendence of human existence.”  It denotes the fact that being human always points, as is directed, to something or someone, other than oneself–be it a meaning to fulfill or another human being to encounter. (Boston:Beacon Press, 2006, paperback edition, p.110)

Granted, Frankl also says that one of the ways that meaning can be discovered is

“by creating a work or doing a deed or by experiencing something–such as goodness, truth and beauty–by experiencing nature and culture or, last but not least, by experiencing another human being in his very uniqueness–by loving him. (p. 111, italic mine)

But this experience of life leads to meaning and is not the meaning itself.

More important for this discussion, Frankl was clear that another way to find meaning is by suffering: 

“We must never forget that we may also find meaning in life when confronted with a hopeless situation, when facing a fate that cannot be changed.  For what then matters is to bear witness to the uniquely human potential at its best, which is to transform a personal tragedy into triumph, to turn one’s predicament into a human achievement. (p.112)

Now, the differences between Frankl and Gawande are not vague abstractions for salon discussions, but have real life consequences.  One example is the proper attitude toward suicide.

Frankl describes that in the Nazi camps, prisoners would commonly commit suicide, often by hurling themselves against electric fences.  The justifictation seemed eminently reasonable: an outcome of death was near certain and would be an unspeakable horror if it took place in a gas chamber.  And why give that satisfaction to the Nazis?

For Frankl, the response is not to grasp at straws of false hope that one could miraculously escape from the nightmare.  Instead, one can find meaning and purpose in suffering, even in the godforsaken despair of a concentration camp.  He relates one instance here:

For Gawande, on the other hand, since ultimate authority belongs to physics and biology, the suffering of aging or of a terminal illness is unnecessary and can ruin an entire life’s experience: “[I]n stories, endings matter.” (p. 239).  Suicide is not only reasonable, but may be “assisted” and even be a “right.” (p. 243)

One final note:

Although he may not acknowledge it, Gawande is a notable figure in the current “less is more” movement in medicine.  That movement seeks to counter the costly hubris of the technology and corporate-driven healthcare trend of the last fifty years.

If we accept the “trajectory of life” graphs as useful conceptual tools, then the old trend sought to push the line along the x-axis of time, come what may to the y-axis of quality.  The new trend, on the other hand seeks to do the opposite: maximize quality on the y-axis, even if quantity of life, on the x-axis, is neglected or abridged.

Therefore, to the extent that both movements view human lives as graphs to be manipulated according to the whims of third parties, “less is more” is really more of the same: an objectification of the patient for the sake of one’s own interest or worldview.

“Michel Accad practices cardiology in San Francisco and blogs at alertandoriented.com where this post originally appeared.  He can be followed on Twitter @michelaccad

Categories: OIG Advisory Opinions

Short-selling Private Practice

The Healthcare Blog - Wed, 02/03/2016 - 18:45

Today is a remarkable day for me. I’m officially leaving private practice after almost 18 years, to return to academic medicine with a faculty position in a highly regarded California department of anesthesiology.

Why would I do that?

There are many positive reasons. I believe in the teaching mission of academic medicine:  to train the anesthesiologists of the future, and the scientists who will advance medical care. I enjoy teaching. The years I’ve spent at the head of the operating room table, anesthetizing patients every day, have given me a great deal of hands-on experience (and at least some wisdom) that I’m happy to pass along to the next generation.

But the other, more pragmatic reason is this. I’ve lost confidence in the ability of private-practice anesthesiology in California to survive in its prevalent form — physician-only, personally provided anesthesiology care.

MD-only:  A viable model?

California is an outlier among all other states in its ratio of physicians to non-physicians in the practice of clinical anesthesia. Nationally, there are slightly more non-physicians — including nurse anesthetists (about 47,000) and anesthesiologist assistants (about 1,700) — than physician anesthesiologists (about 46,000) in the workforce, according to 2015 National Provider Identifier (NPI) data.

But in California, there are about 5,500 physician anesthesiologists and only 1,500 nurse anesthetists in the workforce, while anesthesiologist assistants can’t yet be licensed here at all. Though some other states, chiefly in the western half of the U.S., also have more physicians than nurses in the anesthesia workforce, none tops California’s ratio of more than 3.5 to 1.

It’s hard to see how such a physician-skewed model of anesthesia care can continue to be financially viable, no matter how much affection I have for it. I genuinely love safeguarding my patients through anesthesia for complex surgical procedures, from beginning to end. But there’s no way that it makes sense for many of the tasks involved to be performed directly by a physician. If the Institute of Medicine advocates for nurses to practice “to the full extent of their education and training” in order to provide cost-effective care, it stands to reason that physicians ought to work at the top of their licenses too.

Many of the daily tasks involved in MD-only, personally-provided anesthesia care could and should be delegated to nurses, pharmacists, and technicians. Easy examples include starting IVs, drawing up medications, labeling syringes, and monitoring a patient’s blood pressure. Surgeons don’t perform these tasks during surgery, intensive care physicians don’t perform them in ICUs, and hospitalists don’t perform them on the inpatient wards. And we haven’t even mentioned other routine tasks such as changing the suction tubing on the anesthesia machine between cases — a duty that is well within the skill set of the OR clean-up crew. It makes no fiscal sense, in our cost-conscious time, for physicians to be performing these tasks personally.

Logically, it’s an appropriate use of physician anesthesiologist skills to decide, for example, if a patient’s heart condition has been adequately optimized prior to proceeding with surgery. If there’s a problem during anesthesia with a sudden change in blood pressure, an abnormal heart rhythm, or any other severe medical problem, a physician is the logical person to diagnose the problem and prescribe treatment. The duty of the nurse or any other non-physician practitioner is to monitor the patient, administer prescribed care, and alert the physician to any new problems.

The new multidisciplinary world

The best solution to cost-effective medical care is the use of teams. The American Society of Anesthesiologists (ASA) endorses the concept of the anesthesia care team, a model in which a physician anesthesiologist supervises anesthesiologist assistants, residents, and/or nurse anesthetists in the delivery of anesthesia care, just as an intensive care physician supervises a clinical team in the care of multiple patients.

A January 6, 2016, editorial in JAMA, written by two anesthesiologists and a surgeon, describes how the concept of  “captain of the ship” has become antiquated in an era of complex perioperative care requiring multiple specialists. “When done properly,” the authors believe, “multidisciplinary team-based care is the key to good health care delivery.” That care is likely to involve “intensivists, fellows, residents, midlevel professionals, nurses, pharmacists, physical therapists, nutritionists, and others.” All right, fine; that statement seems inarguable, and may even qualify as old news.

The real surprise in the JAMA article, though, is this. The authors advocate changing the administrative structure in which the teams work. They favor “institutes, centers, or other consolidations that focus on a specific disease process, e.g., a heart institute that houses cardiac surgery, cardiology, cardiac anesthesiology, and cardiac ICU.” In other words, a traditional department structure — such as a private, MD-only anesthesiology practice — would have no place in this brave new multidisciplinary world. The remarkable fact to me is that two out of three of the authors of this editorial (Michael Nurok, MBChB, PhD, and Bruce Gewertz, MD) hail from Cedars-Sinai Medical Center, where I worked up until today.

Is there any hope for physician-only anesthesia groups?

It may be that the MD-only anesthesiology practice is about to become an endangered species. In the last few years, we have witnessed numerous examples of formerly successful practices succumbing to market forces they didn’t expect. In 2011, for instance, New York-based Somnia Anesthesia Services won the contract to provide anesthesiology services at Kaweah Delta Medical Center in Visalia, California, displacing the physician-only group that had held the contract for 16 years. Somnia brought in a new chief of anesthesiology from outside, and proceeded to recruit nurse anesthetists to complete the switchover to a more cost-effective care team model.

The Kaiser Permanente system, California’s largest nonprofit health plan, for decades has staffed its operating rooms and procedure locations according to an anesthesia care team model. The major academic medical centers in California, including the University of California hospitals, Loma Linda University, Stanford University, and the University of Southern California, all utilize the care team model with physician anesthesiologists supervising residents and nurse anesthetists. Without fanfare, these programs are all teaching their residents how to practice anesthesiology in a team-based environment.

Yet it’s too early to ring the death knell for California’s private anesthesiology groups. The smart ones are already making changes to increase the likelihood of their survival. They are getting more involved outside the operating room, in the overall management and financial success of their hospitals.

In the San Francisco Bay area, Keith Chamberlin, MD, MBA, a physician anesthesiologist, has led the formation of an Accountable Care Organization (ACO) at Marin General Hospital, and is currently the President of the ACO’s Board of Directors.

In Pasadena, anesthesiologist Rick Bushnell, MD, MBA, is leading Huntington Memorial Hospital in a Perioperative Surgical Home project designed to improve the patient experience and outcome. As Dr. Bushnell explained recently in the Anesthesia Business Consultants Communique, the physician anesthesiologists will focus their attention “on the most complicated 20 percent of patients,” seeing them both preoperatively and after discharge in order to prevent costly readmissions.

“If our specialty is to maintain its relevance,” Dr. Bushnell said, “as anesthesiologists we must assume more responsibility. We must extend and improve our management to include the complete perioperative process, a continuum from the moment of decision to operate to the completion of recovery.” The anesthesiologists work with “intervention teams” of nurses, physician assistants, nurse practitioners, and nurse anesthetists, as he explained in his article, to improve post-op and post-discharge surveillance and intervention on the hospital floor, in the home setting, in the emergency department, and in the post-discharge clinic.

Would care be even cheaper without physicians?

Certainly health care would be cheaper if we didn’t utilize physicians at all, and simply allowed non-physician practitioners — nurse practitioners, nurse anesthetists, physician assistants — to practice independently. But that idea carries its own risks. Perhaps it has some merit for primary care in underserved areas. The acute-care environment of the operating room, however, is different and much more hazardous.

In my opinion, the answer to rising health-care costs is not to give non-physicians such as nurse anesthetists the regulatory authority to practice medicine without a license, and to administer anesthesia without consulting with or accepting advice from a physician anesthesiologist. Patients want a fully licensed physician in charge of their care, just as they want a lawyer — not a paralegal — managing their legal affairs, and an experienced, fully qualified pilot flying the jet plane.

I’m placing my bet on the likelihood that California’s anesthesia practices will continue to move away from physician-only, one-to-one anesthesia care, and more in the direction of the anesthesia care team model. The CSA’s efforts to gain the right for anesthesiologist assistants to work in California, it seems to me, will give us an excellent additional option for expanding the anesthesia care team. It will be fascinating, and possibly alarming, to watch how the anesthesia marketplace in California continues to evolve.

Karen Sibert is an anesthesiologist in Los Angeles.

Categories: OIG Advisory Opinions

Adjusting the Sails | Leader’s Edge Magazine

The Healthcare Blog - Wed, 02/03/2016 - 11:15

“The pessimist complains about the wind; the optimist expects it to change; the realist adjusts the sails.” —William Arthur Ward

Looking confidently past the skeletons of drowned state and federal healthcare experiments, America’s health insurance exchanges set sail in January 2014. Disregarding the rough seas ahead, healthcare reform pundits and legislators applauded the Affordable Care Act’s signature public expansion vehicle as an impenetrable solution for achieving affordable coverage and competition.

Less than two years later, the exchanges are taking on water.

In November, United Healthcare lowered earnings projections, a move driven primarily by its hesitancy to commit to enrolling new exchange members until risks are better understood. While other insurers were quick to reassure investors that the public exchange market remains a viable means for organic growth, a low-pressure system of doubt is already building over the nascent public exchanges.

Initial enrollment projections for 2016 are fewer than 10 million members—about half of the 20 million target estimated by the Congressional Budget Office. In their rush to expand coverage to the uninsured and under insured, many public officials and industry neophytes failed to consult with those who have firsthand experience with the difficulties of underwriting those who are obtaining insurance for the first time.

FAST FOCUS 

Enrollment projections for 2016 are fewer than 10 million members—about half the Congressional Budget Office target of 20 million.
The rush to participate in public exchanges has attracted inexperienced players seeking a piece of a $300 billion premium opportunity.
Investors want desperately to believe healthcare is ripe for transformational disruption.

Rush to Judgment

The rush to participate in public exchanges has launched a flotilla of inexperienced players all seeking to get a piece of what many have described as a $300 billion premium opportunity. The reassurance of a functional distribution system of consumer purchasing portals, reinsurance dollars to hedge against adverse selection and penalties for failure to purchase insurance seemed to signal a sure thing. Public exchanges would foster new competition, prune excessive insurer margins and eliminate self-serving industry practices that have left an ever expanding number of Americans uninsured—many of whom were working for small businesses that simply could not afford to cover employees.

It is indeed an irrational time. Consider Oscar Health Insurance, a commercial and public exchange insurer with a market cap exceeding $1.5 billion. While Oscar lost close to $30 million in 2014 and has only 40,000 members, it boasts a valuation multiple above the nation’s largest insurers. It seems that investors want desperately to believe that healthcare is ripe for transformational disruption—think self-service health apps that can capture the hearts and minds of millennials and Gen Xers.

While these are innovative, consumer-friendly solutions, most of their target consumers either don’t buy insurance or don’t consume many of the services that currently drive costs (e.g., specialty drugs or hospital inpatient services for chronic conditions and other illnesses endemic to older populations). The fact is, money and resources are pouring into this newly expanded market of potential insureds, yet many of them are sick or low-income people who are less likely to engage or adopt the technology—unless it comes with a cheap policy.

Ovid once said, “The man who has experienced shipwreck shudders even at a calm sea.” Indeed, national insurers who still bore the scars of past expansion experiments were nervous about the exchanges. They counseled caution and slow going, even as newcomers eagerly entered the marketplace, casting aside these warnings—and 20,000 pages of unread legislation.

Many were buoyed by reassurances from the U.S. Department of Health and Human Services that any losses arising from adverse selection and uneven enrollment would be reimbursed by the 3Rs—risk adjustment, reinsurance and risk corridors.

But they underestimated the complexities and unintended consequences associated with administering and enrolling an entire segment of our society that had not been participating in commercial or public health insurance systems. The actuarial results in 2014 were sobering—more than $250 billion in losses against a paltry $300 million in excess profits. As of November 2015, Health and Human Services can refund only 12% of the 2014 losses to underperforming plans. And an increasing number of new entrant co-op healthcare plans are in bankruptcy or in dire financial straits.

So what went wrong?

Affordability and Access

Both the federal and state-based exchanges were immediately riddled with administrative hassles and consumer access problems. The embarrassing miscues and failures of healthcare.gov were ameliorated only when federal officials turned to industry-based specialists at Optum to assist them in repairing their flawed technology and process. In that same period of time, we have witnessed spectacular failures in more than half of the state-run exchanges.

We have also seen a marked increase in public exchange health premiums—in some cases well above the 10% increase benchmark that HHS established as “egregious.” These price increases discourage reenrollments. In fact, the largest public exchange participant, Anthem, recently reported an 8% decline in 2016 reenrollments. In a market driven by two simple axioms—affordability and access—many have failed.

One wonders if the architects of the S.S. Affordable Care Act have ever left shore. Few seem to understand traditional commercial underwriting or the volatility wrought by such a highly regulated file-and-approve rating process. File-and-approve pricing requires insurers to submit rates for approval well ahead of effective dates of coverage—often with little visibility of the risk attributable to the members currently enrolled.

Under the law, the actual time lag between when a carrier sets an annual premium for a specific product and the period in which claims reveal the true underlying risk is hopelessly out of step. Exchange insurers have essentially less than one month to assess the risk profile for their Jan. 1, 2015, enrollees before submitting 2016 rates for approval. To quote one insurance CEO, “ACA regs put you two years out of sync with the reality of the economics of the business.”

Insurers must now either build in excessive margins to hedge against adverse selection, which leads to less competitive premiums, or take the risk and hope the reinsurance pools and risk corridors will make them whole.

Carolina Journal Online recently reported: “Health insurers across the country are experiencing massive losses despite healthy inflows of federal cash. The scope of the problem varies by state. But the problem is essentially national. It stems from the very architecture of the ACA, which offers too heavy a subsidy for some customers and then attempts to spread that cost over too narrow a set of other ones.”

As if the legislation is not difficult enough to manage, Health and Human Services is violating basic rules of risk selection for the sake of garnering maximum membership. The agency is allowing applicants to apply after open enrollment periods have concluded, which is tantamount to allowing people with houses on fire to purchase property coverage. Insurers have determined that the loss ratio on “special enrollment” membership is a full 15 points worse than the traditional open enrollment risk pools.

Jumping Financial Guardrails

Take, for example, the state of New York. When it established its minimum loss ratio of 75% for small business, it promised to use the excesses of those insurers that achieved lower loss ratios to reimburse insurers who lost money. Aside from the obvious misguided incentives this created for some insurers to under-price, it quickly resulted in few carriers actually experiencing medical loss ratios below 75%. The state quickly determined there would not be enough excess premiums available to compensate those who experienced higher loss ratios—leading to industry exits and higher rate increases.

Future attempts to cover New York’s uninsured occurred through Healthy NY, which offers comprehensive health insurance to small businesses. But even though it was supported by risk corridors and risk reimbursement, Healthy NY failed to offset losses incurred by underperforming insurers. And in some cases, the losses did not come from bad risk selection.

The law also provides a misguided incentive for new entrants to compete without adequately resolving obvious shortcomings, such as inferior network discount contracts with providers, limited medical management and, in some cases, aggressive pricing to win new members. When these firms finally sobered to the fact they would not be made whole for losses, that there were no excess dollars available to pay them, these same insurers either failed or left the market.

The Affordable Care Act uses risk adjustment, risk corridors and reinsurance to help insurers weather the first few years of uncertain demand arising out of newly covered uninsureds. The risk corridor program, which expires in December 2016, is failing. According to one industry observer, “The legislation suggests that HHS will try to make these insurers whole, (yet) a conservative Congress is not likely to appropriate more dollars to prop up underperforming insurers. The result would be catastrophic, as it would prevent the natural selection of a free market from eliminating its poorest performers.”

The observer went on: “Despite administration claims that incoming payments from profitable insurers would cover losses from unprofitable ones, the risk corridor program shortfall exceeded $2.5 billion in 2014. Insurers with lower-than-anticipated claims owed about $360 million, and insurers with higher-than-anticipated claims requested about $2.9 billion from the program.”

Failed pricing is now manifesting itself in 2016 exchange pricing. Consider a sampling of the following states:

  • CareFirst of Maryland: 34% increase for its PPO plan, 27% for its HMO
  • North Carolina: 26% increase from Blues
  • Oregon: 25.6% increase from largest market share insurer
  • BCBS of Tennessee: 36.3% increase
  • Georgia: 19% average increase
  • Iowa: 43% increase
  • Kansas: The increase could be as high as 38%.

Adverse Selection Is Real

The Kaiser Foundation estimates that “65% of individuals expected to purchase health insurance through the Exchange, transition from being uninsured…. (More than) one third of individuals expected to enroll in the Exchange have gone more than two years without a checkup (37%), nearly two in five did not have a usual source of care (39%), and more than a quarter had no interaction with the healthcare delivery system during the year at all (29%). The findings on access barriers indicate … these Exchange enrollees may have a large pent-up need for medical care once they gain insurance. It will be important to monitor whether individuals who gain insurance coverage through the Exchanges continue to have difficulty accessing care and whether there are adequate primary care providers to address their healthcare needs.”

Despite federal and state reports that suggest there is an adequate demographic spread of young, middle-aged and older Americans accessing care, adverse selection will continue to reign supreme. It’s logical to assume those who sign up for care are more likely to consume it than those who choose to pay a penalty. With less than one quarter of the target uninsured population likely to sign up, a fiscal storm is brewing.

Beginning of the End?

The concerns over the viability of public exchanges are real and legitimate. Insurance underperformance, the government’s commitment to make losing parties whole, dramatic spikes in healthcare costs (such as those for specialty drugs) and the potential for Congress to repeal the Cadillac tax provision, which was expected to raise up to $120 billion over 10 years, are bringing to bear the full weight of the legislation. And we fear the ship is sinking.

As far as exchanges go, we could be in a temporary period of enrollment attrition and risk pool deterioration. And this expansion experiment may not be salvaged without more congressional funding and enabling intervention. If that is the case, Congressional Budget Office estimates of a $140 billion surplus in 10 years will be obliterated, and yet another entitlement program will further accelerate our deficit and rising public debt.

But the news is not all bad. Survival is possible on the public exchanges, but it will take stamina to weather early storms and execute across a wide range of stakeholders. Anyone taking risk must have the following:

  • A trusted brand that resonates with consumers
  • Access to capital to withstand the lower margins of heavily regulated public exchanges
  • The ability to serve as a nexus to aggregate lives
  • The ability to manage risk
  • A clinical footprint wide enough to serve a target population
  • The ability to change patient behavior.

But perhaps the most important attributes of anyone playing the exchange game are emotional intelligence and the ability to achieve a collaborative culture across stakeholders often working at cross purposes. Healthcare delivery is fundamentally changing, and this type of transformation requires a strong and united crew to succeed.

Michael Turpin is frequent speaker, writer and practicing benefits consultant across a 27 year career that spanned assignments in the US and in Europe. He served as the northeast regional CEO for United Healthcare and Oxford Health from 2005-2008 and is currently Executive Vice President for Benefits for the New York based broker, USI insurance Services. He blogs regularly at Usturpin’s Blog.

Categories: OIG Advisory Opinions

Don’t like CB Insights’ numbers? Just wait…

The Healthcare Blog - Tue, 02/02/2016 - 23:17

Last year I got in a modest Twitter spat with Anand Sanwal the CEO of investor analytics company CB Insights. Anand writes a very amusing newsletter, has built a wildly successful business tracking venture investing (at $20-50K a client) and has recently taken on $10m in VC himself to build out his business which was already profitable. The spat was because in August 2015 (5 months ago) CB insights said that “Digital Health” investments totalled $3.5 billion in 2014. You can go read the article Stephanie Baum concocted from the Tweetstream but my point was that when CB Insights, a generalist analyst company, said that the investment in digital SMAC health was $3.5bn in 2014 they were wrong because 4 specialists (Health 2.0, Mercom, Rock Health and Startup Health) all said it was over $4.5bn.

What’s a billion between friends? Not much, but what I left unsaid until now is that if they’re 25% off the average in one sector, where are they in the other sectors they cover? But other than a few amused readers of MedCity News no one much cared and the world moved on.

Then everyone stared putting out their Q4 2015 numbers. Amusingly, but probably only to me, both Rock Health & Startup Health put out their Q4 numbers 2 weeks before the quarter/year ended, and missed a bunch of late deals! But by the time the revised numbers came in everyone was again in that middle $4 billion range and there was general agreement that funding was about flat in 2015 compared to 2014–albeit at a high level compared to what the Cinderella sector had been recently.

Health 2.0’s numbers in our report were $4.8 billion for the year, as shown on the left. (You can see more on these and some other data in our Q4 report here. In case you don’t know I co-run Health 2.0 as my day job and yes I own THCB). OK. All so far so ho-hum.

Then as the other numbers started coming out I noticed something a little odd. CB insights came out with its numbers for 2015, but something was different.

You’ll recall that I had poo-poohed their 2014 number shown as $3.477 Bn in their blog post here and displayed in the chart below. These are 2014 numbers shown in a post about investment in 2015, published in August 2015.  And that was the number I’d started the original spat about. But when I looked at the post they released in January 2016, not only was the number for 2015 at $5.7 billion (remember Rock Health, Mercom & Health 2.0 all put it in the mid-high $4s) but the 2014 number had somehow climbed from about $3.5 billion to $5.1 billion. Again check the January post and check the chart I’ve lifted from it below. You’d think this was a curious jump and you’d be right. But nowhere in the post does it say why the total for 2014 in August 2015 was so different from the total for 2014 in January 2016.

Of course being the troublemaker I am, I asked about this on Twitter and got a classic no reply from Anand at CB insights. 

So then I sent all this info off to Stephanie Baum at Medcity News thinking that she might like to write more about it.

And a funny thing happened. Instead of writing the article I wanted her to write (i.e. this one!) She found yet another number for 2015 from CB Insights, and wrote about how they were now back in the pack with everyone else.

Here’s the money graph from CB Insights new report (p24), and as they didn’t give a total but Stephanie added it up, I’ve snipped it direct from her piece and kept her helpful math where she totaled their 2015 numbers from a big report they put out in January.

Now apparently the CB Insights number is $4.6 billion for 2015. Which is either $1 billion more or $500 million less than they think it was in 2014. Moreover, if you’re following along apparently CB Insights is saying that digital health investment for 2015 is over $1 billion less than CB Insights said that digital health investment for 2015 was in their blog post last month.

So as I said in the title, if you don’t like CB Insights numbers, just wait–soon they’ll have some out you do like.

Categories: OIG Advisory Opinions

Should Your Employer Have the Right to Track Your Weight?

The Healthcare Blog - Mon, 02/01/2016 - 21:51

Suppose there were:  (1) a widely held but false perception that gays had lower productivity and higher healthcare costs than straights; (2) false literature that companies with gay conversion programs outperformed the stock market; and (3) a mandate that companies disclose to shareholders the percentage of gays they employ.

Obviously, many corporate CEOs would stop hiring gays, de facto require gay conversion among current employees, and fire gays who failed the program, in order to maximize stock price and hence their own net worth.

Preposterous? Of course, but if Johnson & Johnson (J&J), Vitality Group and a few pharmaceutical companies get their way, this exact same scenario will befall overweight employees.  Indeed, two-thirds of this dystopian scenario is already in place:

  1. Despite proof to the contrary, the popular misperception is that working-age thin people have higher productivity and spend less on healthcare than working-age overweight people;
  2. To help bring weight discrimination into the boardroom, some wellness apologists — led by Ron Goetzel, of course — published a facile and misleading study in a third-tier journal (that had already admitted poor peer review practices) showing companies with wellness programs (the obesity equivalent of gay conversion in ineffectiveness, and almost as likely to harm participants) outperformed the stock market. The opposite is actually true, if one uses sector indexes as benchmarks. (This is the correct methodology with small numbers of companies concentrated in a few industries.  And it’s the correct result given the fact that conventional “pry, poke and prod” wellness loses money, period.)

To complete this trifecta of weight discrimination, all that remains is to require publicly traded corporations to disclose the weight of their employees…and that’s exactly what this cabal — led by J&J and Vitality —  proposed at Davos.  (They also want companies to disclose their stress levels. I have no idea how one measures stress. The one company that tried measuring stress, Keas, failed both miserably–and, this being the wellness industry, hilariously.)

Weight measures used by companies are also facile and misleading.  Typically — as with Vitality Group, an outspoken advocate of this proposed regulation — they use the Body Mass Index, or BMI. The BMI was invented by a mathematician 200 years ago, using a simplistic formula that he could never really justify…and yet has been the de facto standard for measuring overweight ever since. It’s misleading along many dimensions. Further, it now turns out that the whole workplace BMI obsession might be pointless, as people with normal BMIs are at higher risk than people with high BMIs, if their weight is distributed badly.

While I can’t explain why PepsiCo would be signing on other than for corporate image reasons, the agendas of J&J and Vitality are quite clear: a regulation that worker weight be disclosed to shareholders would encourage publicly traded companies to use “pry, poke and prod” workplace wellness services, which they coincidentally happen to provide.  (The drug companies involved, such as Novo Nordisk, stand to benefit from selling more drugs.)

Unintended Ironies: A Hallmark of Wellness  

Ironically, though, during that same Davos meeting, Vitality also candidly admitted that their wellness services don’t work even in the best-case scenario of their own employees.  That admission undermines the entire fiction that this requirement would somehow benefit the employees being fat-shamed.

Here is another irony.  (One hallmark of the wellness industry is its obliviousness to its own many ironies.) This industry thrives on being totally unregulated — uniquely in healthcare, wellness companies and individuals face no licensing, education, training, oversight or certification requirements.  Consequently they can and do get away with whatever they want. And yet now they want every other company to be regulated, for no purpose other than enhancing their own bottom lines.

Still another irony: The prime schemer behind this initiative, David Yach of Vitality, assured STATNews that existing laws would prevent employees from bring fired due to weight. But “existing laws” don’t prevent anything in wellness now. A federal court says it’s fine to deny insurance to employees for failing to participate in wellness. And despite flouting federal health guidelines with impunity, no wellness vendor has ever been prosecuted for doing things to employees that would get doctors sent to jail.  And as Health Fitness Corporation learned, you can lie to states as much as you want about anything — including saving the lives of cancer victims who don’t have cancer — and not be prosecuted. Indeed, no wellness company or program has ever been successfully prosecuted or sued for anything under “existing laws.”

The Inevitable Result: Institutionalized Weight Discrimination

Many things in life have unforeseeable consequences. However, the consequence here is perfectly foreseeable:  If you are overweight or especially if you are obese, you should be able to keep your current job if your company likes your work. But your chances of getting hired anew by a publicly traded company — if you are competing for the job with an almost-but-not-quite-equally qualified thin person — would nosedive.

I rarely editorialize in this blog, because I don’t have to — facts are the wellness industry’s worst nightmare.  (See the Vitality example above.  I don’t need to come out and say they’re clueless. I merely highlight the data they themselves helpfully provided to make that conclusion self-evident.)  However, I’ll make an exception here: I find it appalling that J&J, Vitality, and Novo Nordisk advocate subjecting huge numbers of employees to institutionalized discrimination and to programs that they admit don’t work, simply to make a few bucks.

Categories: OIG Advisory Opinions

Iowa Is Voting On Health Care Tonight

The Healthcare Blog - Sun, 01/31/2016 - 23:46

In his last State of the Union address, President Obama stated that “anyone claiming that America’s economy is in decline is peddling fiction”. I agree. The American economy has roared back from the Great Recession with 14 million new jobs, a ridiculously low unemployment rate, a booming stock market and 57 brand new American billionaires in 2015 alone.

The American people on the other hand are in a completely different boat. Almost a third of us are not working. Half of us have practically no savings and a record number is surviving on public assistance. Wages are stagnating and the middle class is shrinking. Student debt is skyrocketing and 20% of our kids live in poverty. Whereas in the immediate past the economy and the welfare of the people used to be one and the same, nowadays these terms have little if anything to do with each other.

The President did acknowledge that “the economy has been changing in profound ways” and therefore “a lot of Americans feel anxious”. To allay our collective anxiety, the President announced an unemployment program that will pay up to $10,000 to those who lose jobs to the economy fixing racket, money that can be used to retrain machinists, welders, builders and such, to flip burgers in the booming job market of the fixed economy.  The anxiety reduction program will also ease the transition to a “work-sharing” economy, where lower wages and no benefits, augmented by public assistance, a.k.a. the Walmart and Uber models, are the new normal.

Health Care is about the Economy

After fixing the economy, our government is now full throttle ahead with fixing our health care. My expectations would be that health care will be fixed in very short order, with very similar results. Health care expenditures will plummet, uninsured rates will be near zero, quality measures based on cost and utilization will be stellar, and most people will end up with little if any medical care when they fall sick. To ease our anxiety, or in health care parlance, to provide us with “peace of mind”, everybody will be awarded a Medicaid managed care card, if you’re lucky, or a high deductible insurance exchange plan that kicks in after you go bankrupt.

In the midst of the previous century, when people talked about “the economy”, the term conjured visions of molten iron being forged, of combines sliding gracefully through oceans of golden wheat, of gigantic cranes towering over monumental construction projects, of dusty rugged Americans building and making with pride and determination, of former soldiers poring over text books, of men walking on the Moon. Today, “the economy” brings to mind images of stock tickers, conference rooms with sweeping views of Alcatraz or Central Park, fancy men in fancy suits getting in and out of black limos, and endless streams of brightly colored graphs, percentages and statistical trends. The economy is no longer about us.

Health care is no longer about us. Health care is about waste, fraud and abuse. Health care is about “bending the curve”. Health care is about global competitiveness of corporations. Health care is about carving up a $3 trillion opportunity. Health care is about private equity, mezzanine funding, return on investment, valuations and public offerings. Health care is about the economy, and the economy is no longer about us.

Perhaps this was never about us, but if “time is the fire in which we burn”, America was the one unique experiment where a group of people came together to protect each other’s rights to freely determine how they wish to burn. The idea spread a little bit, but not much, and now it is collapsing under the hubris of an Information Revolution, which looks more like a slow motion coup d’état to transfer control of the burning process from millions of hands to a global “digital assembly line” where physical objects, virtual algorithms and human beings are melded into one efficient production system. This is a kinder and gentler slavery nation.

John C. Calhoun

Historically, the enslavement process was physically harsh and cruel, because back then the work of a slave was physically harsh and cruel, and because the only tools available for recruiting and maintaining slaves were physically harsh and cruel. Today you give a guy an iPhone app and he willingly and painlessly joins the driving plantation. You give a guy a free Internet search tool and he unconsciously and painlessly joins the advertising plantation. This is a major improvement, since as grandma used to say, you catch more flies with honey than with vinegar, and from a respectable distance it looks like you’re generously feeding the dumb little critters.

The grand objective of slavery has always been the amassment of wealth by the magnificent few on the backs of the faceless many. The only things that changed over the millennia are the means by which this is accomplished, and the rhetorical subtleties used to justify the practice of slavery. Notably, health care has been playing an increasingly prominent role in the intellectual quackery employed by evil people towards their evil ends. As early as 1837, John C. Calhoun was extolling the superiority of health care benefits available to the enslaved, especially the compassionate palliative care at the end of life, when compared to the “forlorn and wretched condition of the pauper in the poorhouse”.

It never occurred to Mr. Calhoun that there ought to be a third option, that his own young country has challenged the world order by simply stating that all men are created equal, and challenged the most powerful King in the world, and his mighty armies, precisely so that those equally created men can be free men. But John C. Calhoun was not speaking about us. His oration was about the economy, and the economy thrives on servitude, pauperization, and wretchedness, mitigated only by the “kind superintending care” of masters. If John C. Calhoun were alive today, he would probably be running a billionaire foundation to help “all people lead healthy, productive lives”.

Alexander Hamilton

It must have never occurred to Dr. David Blumenthal either that 200 years after our Declaration of Independence, for a brief moment in time, we had a third option. After watching a Broadway show and perhaps reading one biography of Alexander Hamilton, Dr. Blumenthal found it necessary to write the strangest article in defense of the Hamiltonian version of Calhoun’s “superintending” care, which Obamacare essentially is, or aspires to become with the help of its equally superintending technology bonanza. The article is a case study in demagoguery and the building of alternate realities from partial truths and innuendos, which is how health care reform was and still is being advertised to the masses.

Perhaps we shouldn’t be surprised by Dr. Blumenthal’s admiration for Alexander Hamilton, because Alexander Hamilton was not about us. Mr. Hamilton had great misgivings about the “imprudence of democracy”. He admired the British aristocracy, and insisted with all his might that the “first class” of “the rich and well born” should be awarded a “distinct, permanent share in the government” to counterbalance the bad judgement of the masses, and to prevent change to the status quo. If Mr. Hamilton, the champion of strong central government run by financiers and corporations, were alive today, he would probably be equally smitten with what Dr. Blumenthal represents.

This Night in Iowa

Tonight in the great State of Iowa, we the people are kicking off the only peaceful process available to us to make health care, the economy, and the entire political process, about us. This year we seem to have a bountiful crop of candidates seeking greatness. Some are “rich and well born” asserting their Hamiltonian right to that “permanent share” in government. Many are lifelong corporate servants looking for the next step in their pitiful enterprise. And two are very different than the rest. Two are challenging the status quo, which is so near and dear to the “first class” and its vast infrastructure of minions and pundits, feeding at the commandeered public trough, and whose entire job now is to convince us that neither one of these two men are fit for office.

One is a career public servant, a man of principle, of lifelong held beliefs that health care should be about us, and the economy should be about us, and that central government should be by, of and for us. The other is rich and well born, a swashbuckling traitor to his “first class”, who realized that he cannot possibly have a great country when the great majority is enslaved. The two couldn’t be more different in personal style and fiery rhetoric, but at the heart of it all they both want to reclaim the “permanent share in the government” that was stolen from us by the “first class”, and unlike their corporate serving competitors, who say one thing and do another, neither man is accepting patronage from those who they aim to disempower on our behalf.

For decades the “first class” owned media and punditry, carefully nurtured the appearance of an “ideological divide” designed to keep us engaged in mortal combat over hyped minutia, while the enslavement process proceeded at a brisk pace in the background. Tonight, the people of Iowa have the opportunity to begin refocusing our sights on the real ball. This election is not about Republicans vs. Democrats, it’s not about Planned Parenthood or ISIS coming to kill us in little Toyota trucks, it’s not about men vs. women, blacks vs. whites, young vs. old, educated vs. uneducated or poor vs. less poor. This election is about all of us, it’s about being a nation of free people vs. a replaceable cog in the global “digital assembly line”, and it’s about our hard fought right to govern ourselves, centrally, locally and individually.

We can’t make health care about us until we make the economy about us, and we can’t make the economy about us until we make government about us, and we can’t make government about us until we make the political process about us. We can’t make the political process about us until we dethrone the “first class” from its permanent power perch, and deny the “rich and well born” the ability to buy every election and serve us with a nauseating mélange of sleek and polished John C. Calhoun disciples, promising “kind superintending care” for the rest of us.

Tonight Iowa will vote for Bernie Sanders, will vote for Donald J. Trump, or will vote for the status quo. These are our only choices in 2016. Choose wisely, America.

Margalit Gur-Arie is a THCB contributor based in St. Louis.

Categories: OIG Advisory Opinions

What Trump’s Plan to Negotiate With Pharma Should Tell Us

The Healthcare Blog - Sun, 01/31/2016 - 05:31

Donald Trump’s proposal to allow the federal Medicare program to negotiate prices with drug companies should be a wake-up call for the pharmaceutical industry.

Trump is leading in the polls for the Republican nomination and is even drawing the support of Tea Party conservatives who, just a year or two ago, never would have supported a candidate endorsing such strong government intervention into a private-sector industry.

Characteristically, Trump didn’t give a lot of detail about his plans. He claimed $300 billion in savings per year (about 10 times more than is realistic). But that doesn’t matter. If the leading GOP presidential candidate—a man who has proved masterful at reading the public mood and playing to it—has signed on to this idea, it proves that change has come.

I know that many veterans of the pharmaceutical industry think they have seen this horror movie before and know how it ends. There have been several past public furors over the price of prescription drugs, and each one gradually faded without major disruption for drugmakers. But this time feels different.


Trump’s proposal is just the latest indicator of the increasing bipartisan support for government action on drug pricing is one reason why things are different this time.

One reason for that is this is the first big drug price controversy since Medicare Part D kicked into effect 10 years ago. That means this issue is not only hammering seniors—the most sympathetic and most-likely-to-vote segment of the population—but it also affects the federal budget.

Republicans in Congress, if you haven’t noticed the past few years, are not eager to run up federal spending. Remember Marco Rubio saying in October that some drug companies are engaging in “pure profiteering” and that high prices could “bankrupt our system”?

Another reason the drug price controversy is different this time is that consumers are more exposed than ever to high drug prices. One out of every four Americans covered by an employer is in a high-deductible health plan, according to Mercer’s latest survey. That up from just 3 percent in 2006. And pretty much everyone buying coverage on the Obamacare exchanges is in a high-deductible health plan.

High deductibles mean all those patients are exposed to the full brunt of high-cost drugs.

So then it’s no wonder that 77 percent of Americans said in an October tracking poll by the Kaiser Family Foundation that the top health priority of the president and Congress should be “making sure that high-cost drugs for chronic conditions … are affordable to those who need them.” Even 73 percent of Republicans agreed with that statement.

Nearly two-thirds of Americans—63 percent—supported “government action to lower prescription drug price.” Such actions also drew support from a majority of Republicans, 56 percent.

If the drug price controversy is different this time, it means the response from pharma needs to be different. At least if the industry wants to avoid draconian limits on its ability to reap rewards from its most innovative research.

One interesting idea floated on this blog recently by Dr. Soeren Mattke, a senior scientist at RAND Corp., was for the industry to voluntarily limit price growth on mature drugs.

“A solution could be for the research-based companies to adopt a voluntary code of conduct that would limit price increases on established products to inflation or to the cost of inputs,” Mattke wrote, adding, “This would be a small step for multi-billion dollar companies, but a giant leap towards becoming a respected partner when decisions about the future of healthcare are being made.”

Here’s another idea: create an industry-wide information service for patients and their doctors that combines the findings of comparative effectiveness studies with price information. Such a service would extend pharma’s medical commitment to deliver the right medicine to the right patient at the right time into the financial realm, delivering the right-cost medicine for each patient’s circumstances.

If drug companies were working hard to make sure heart patients who only need and can only afford a low-cost generic statin get it, or that diabetes patients who only need and can only afford metformin don’t get sold a high-priced diabetes drug, they would have a lot more credibility  charging higher prices for medicines those patients need when their conditions worsen beyond first-line therapies.

Last, pharma companies could ramp up the donations and discounts they give patients—and not just to the poorest customers. Indianapolis-based Rx Help Centers has been having success getting drug companies to give discounts or, via their foundations, donations to moderate-income patients. These patients have commercial insurance—yet still face crippling costs from a high-cost prescription drug.

If drug companies voluntarily removed the sting off their high-cost medicines for both poor and working-class Americans, they’d likely be accomplishing both their missions: promoting health and promoting profits—because they would fix a problem before public outcry makes politicians do it for them.

J.K. Wall is a reporter and editor at the Indianapolis Business Journal, where he has covered health care since 2007.

Categories: OIG Advisory Opinions

Love and Measurement

The Healthcare Blog - Sat, 01/30/2016 - 19:11

Many of us recall the final scene of Mad Men where Machiavellian dealmaker, philanderer, and ad mogul Dan Draper sits in lotus position finding either true inner peace or the next cynical direction from which to profit. This scene came to mind as I read another apparent conversion experience by Robert M. Wachter, MD in his recent opinion piece in the New York Times on how the metric measurement business fails physicians and teachers.

Remarkably, Dr. Wachter, once the Chairman of the  American Board of Internal Medicine (ABIM) that is responsible for “continuously” measuring, re-testing, and re-certifying US physicians, seemed to pivot from his former self by quoting a few of Avedis Donabedian’s words on quality assessment suggesting “the secret of quality is love.” Unfortunately, Dr. Wachter conspicuously failed to acknowledge the full context of Donabedian’s words.

“I think that commercialization of care is a big mistake. Health care is a sacred mission. It is a moral enterprise and a scientific enterprise but not fundamentally a commercial one. We are not selling a product. We don’t have a consumer who understands everything and makes rational choices — and I include myself here. Doctors and nurses are stewards of something precious. Their work is a kind of vocation rather than simply a job; commercial values don’t really capture what they do for patients and for society as a whole.

“Systems awareness and systems design are important for health professionals but are not enough. They are enabling mechanisms only. It is the ethical dimension of individuals that is essential to a system’s success. Ultimately, the secret of quality is love. You have to love your patient, you have to love your profession, you have to love your God. If you have love, you can then work backward to monitor and improve the system. Commercialism should not be a principal force in the system. That people should make money by investing in health care without actually being providers of health care seems somewhat perverse, like a kind of racketeering.” Avedis Donabedian

I suppose if he can transition from a physician executive to a “down to earth” Bob Wachter, MD hitting “high notes” as Elton John at the Mandalay Casino while simultaneously profiting from a company that now under federal investigation for overbilling Medicare, why not?  Such is our current reality of politics, medicine, and corporate cronyism.

It was nearly four short years ago that Dr. Wachter wrote that we needed the ABIM’s Maintenance of Certification program “more than ever.” Perhaps the lucrative Digital Party in medicine was just too big for the ABIM leadership and the members of its Foundation to ignore. At the time, those in Wachter’s World held the view that assuring physician quality meant physicians not only had to be re-certified every ten years but soon had to participate in some form of the ABIM’s measurement program every two years for the sake of  “external stakeholders and a troubled public.”  As a result, physicians were required to perform unproven practice improvement exercises, perform un-monitored research on themselves, and become glorified data entry personnel to continuously “maintain” their “board certification” or risk losing their right to practice. All of these exercises were subsequently revealed to be primarily for the medical industrial complex’s extraordinary monetary gain and undisclosed political activities.  Such “love,” indeed.

The expanded ABIM board certification requirements after 1990 have served as the goose that laid the Golden Egg for condo purchases, chauffeur-driven Mercedes rides, spousal travel fees, undisclosed corporate consulting arrangements, corporate mergers, political influence and the program’s continuing transition to Assessment2020 – much of these occurring while Dr. Wachter served as a Director or Chairman of the ABIM. For the ABIM and its parent organization, the American Board of Medical Specialties (ABMS), success in the digital medical world still appears to mean the doctor-patient relationship has to be owned, bartered, and commoditized to serve their bottom line without really understanding all that this entails to the doctor, their patients, and the credibility of our profession.

If Bob Wachter, MD is a true physician advocate and is now having a genuine conversion experience, he would be speaking out about these abuses of physicians’ trust. In fact, as the “Most Influential Physician Executive and Leader 2015,” he would be leading this charge. Or perhaps I am missing something.

Meanwhile, despite all of the fast-paced changes in health care under way, the same rubber soles continue to speed down linoleum hallways, call lights blink, keyboards pound, family meetings are held with tears shed, young physicians wonder how they’ll pay their educational debt, productivity quotas expand, administrative meetings multiply, patients grow furious about their rising premiums, co-pays and deductibles, physician autonomy and morale withers, and patient access to their doctor shrinks.

Fortunately, rather than standing idly by, practicing doctors are mobilizing. They are realizing that the bloated and costly bureaucratic arm of our profession has lost its way and are working to restore its integrity. Practicing physicians are finding they have a voice and are not powerless against these corporate entities that unjustifiably risk compromising their ability do their job. With these efforts, members of Wachter’s World are beginning to realize they’re at risk of losing their golden goose:

Last week, Andy Slavitt, Medicare’s acting administrator, announced the end of a program that tied Medicare payments to a long list of measures related to the use of electronic health records. “We have to get the hearts and minds of physicians back,” said Mr. Slavitt. “I think we’ve lost them.”

Despite these concerns of a few of our bureaucratic medical policy elite, practicing physicians remain little more than an account to be landed, a work to be optimized. To them, practicing physicians represent an opportunity to invest in new corporate ventures like Health2047, no doubt for the “love” that’s involved. The respectful partnership that practicing physicians would like to have would not include the many corrupt financial practices and undisclosed conflicts of interest of the AMA and the ABMS specialty board credentialing system, their collaborating subspecialty societies, and numerous for-profit physician reporting businesses. They invoke ethics, morals, and “love” at their own risk.

In my career, I’m unaware of a broader breach of the trust of working physicians and of medical ethics by fellow colleagues than by those who secretly created the ABIM Foundation in 1989 and then funneled over $55 million of testing fees collected from working physicians while hiding its existence from physicians and the public until 1999. Yet many in our academic and bureaucratic physician community continue to support this testing agency that appears to have been expanded solely for political, corporate, and personal gain, and are indifferent to them using strongman tactics with physicians. What a perverted form of “love.”

This system must change.

As health care moves forward in these uncertain times, a few of Donabedian’s (other) words on quality assessment, uttered a month before his death, are prescient:

“It is the ethical dimension of individuals that is essential to a system’s success. … Commercialism should not be a principal force in the system. That people should make money by investing in health care without actually being providers of health care seems somewhat perverse, like a kind of racketeering.”

Perverse indeed.

Right now there are residents who have no idea how they’ll ever pay off their educational debt and millions of patients who can’t afford insurance or their drugs. If the House of Medicine can’t look inward at its own bloated, self-serving, bureaucratic ranks of the ACGME that are sucking the life from direct patient care, what does this say about the prognosis for US health care?

As Tina Turner once sang, “What’s love got to do with it?”

Categories: OIG Advisory Opinions

There Is Nothing Free About the Health Care Free Market

The Healthcare Blog - Sat, 01/30/2016 - 18:32

“Universal Health Care”, “Single Payer”, “National Health Insurance”, “Socialized Medicine” are all semiotics symbolizing the subjugation of physician and of patient autonomy to government control for the sake of the common good. This is not sophistry. Max Weber was a Prussian political philosopher who laid the foundation for modern sociology with such books as The Theory of Social and Economic Organization (1920, English translation 1947) in which he proclaimed, “Bureaucratic administration means fundamentally the exercise of control on the basis of knowledge. This is the feature of it which makes it specifically rational.” (p. 339).

However, Weber knew that the goal of a rational bureaucracy was more often elusive than realized, if it is ever realized for long. As Karl Marx observed in a mid-19th C critique of Hegelian political philosophy, “The bureaucracy takes itself to be the ultimate purpose of the state.” That observation is mirrored in a televised speech delivered by Ronald Reagan on October 27, 1964, “No government ever voluntarily reduces itself in size. Government programs, once launched, never disappear. Actually, a government bureau is the nearest thing to eternal life we’ll ever see on this earth!”

The upshot is that society has an inherent love-hate relationship with bureaucracy. As I discuss in Citizen Patient, till the end of the 20th Century American medicine contained and controlled its own bureaucracy and was willing to downplay such short-comings as inequities in the delivery and quality of care. Even the legislating of a Medicare bureaucracy had little impact on the medical hegemony; the legislation delegated clinical indications and fees to medicine’s own bureaucracy and much else that is costly to the marketplace. American medicine remained secure in its autonomy. Meanwhile, elsewhere, in nearly all similarly “advanced” countries, the will to tackle inequities in the distribution and quality of care and in cost-effectiveness had come to predominate by early in the 20th C. These countries sought a solution in the evolution of governmental bureaucracies. Several of these bureaucracies, these national health insurance schemes, remain examples of Weber’s rationality. Several of the national health insurance schemes, such as in the United Kingdom and France, are fraying.

The ACA

Enter Obamacare. The Patient Protection and Affordable Care Act (PPACA) – also known as the Affordable Care Act or ACA, and often referred to as Obamacare – is the landmark health reform legislation passed by the 111th Congress and signed into law by President Barack Obama in March 2010. It is America’s attempt to create one of Weber’s rational bureaucracies to the serve America’s ill. The ACA is meant to salve the afflicted who are disaffected and disavowed and all else who were not well served in the 20th C by America’s institution of medicine and the “health care delivery system” it had commandeered. The ACA is a fatally flawed attempt.

The ACA was born of controversy and limps along in controversy, some as a reflection of false starts and unintended consequence. However, more is a reflection of the philosophical divide that was circumvented with compromises rather than confronted. David Blumenthal likens the political process that resulted in the ACA to Jefferson and Hamilton debating against and for a Federal finance bureaucracy. But I disagree. Both Jefferson and Hamilton had principled platforms and constituencies. The ACA emerged from a cacophony of prejudices and agendas, which were further inflamed by compelling but unverified inferences emanating from the academy. David Blumenthal was of the latter ilk and was brought into the Obama administration as the new National Coordinator for Health Information Technology. He was charged with building a private, secure nationwide health information system and to support its “meaningful use”. With unprecedented speed, America completed one of its largest ever, publicly funded infrastructure investments. THCB is laden with posts describing shortcomings and decrying some consequences, many of which must be close to the mark since CMS has now announced an impending revamping of “meaningful use”, which term has gained the baggage of an Orwellian oxymoron.

The shame of this chapter in the history of American medicine is that unlike the Jefferson-Franklin debates and unlike the debates regarding the moral underpinnings of the bureaucracy, the ACA was born out of debates on form and function but not on substance and ethic. Economists, policy wonks, politicians and all the various stakeholders came together to devise an insurance scheme that would be sufficiently granular to define who is at risk, for what and at what price. Health care insurance was likened to an enormous aggregation of personal articles floaters. All we had to do is capture the number of individuals, itemize their valuables, and calculate a premium that would cover replacement costs. The debate was in defining the premium that underwrote the system, not necessarily the premium that indemnified what was of value to the individual. It’s the same mindset that can price a year of quality living at $50,000 or more.

It is a mindset that turns health into a commodity, disease into a product line and physicians into a sales force. It is a mindset that believes that the free market champion those who are ill and in need of caring. It is a mindset that has been fooled. As Søren Kierkegaard said, “There are two ways to be fooled. One is to believe what isn’t true; the other is to refuse to believe what is true.”

The “Free” Market

Every serious student of political philosophy and economics knows of Adam Smith and probably his book, The Wealth of Nations, which he published in 1776. It is a text that remains oft quoted and still stimulates scholarship. I’d recommend a brilliant essay in the New Yorker by Adam Gopnik for starters. Adam Smith believed that a perfectly competitive market would benefit society at large. Further, whenever purveyors conspire with regulators, freedom is at risk. Smith’s dictum is, “It is not from the benevolence of the butcher, the brewer, or the baker, that we expect our dinner, but from their regard to their own interest. We address ourselves, not to their humanity but to their self-love, and never talk to them of our own necessities but of their advantages.”

Smith knew that a perfectly competitive market, an unblemished exercise in supply and demand, required “an invisible hand.” Smith never defined this notion; many a subsequent scholar has attempted to fill the void. It is generally agreed that Smith was not a deist. Certainly, his close friend David Hume was an irreligious radical epistemologist. So, you can make what you will of Smith’s “invisible hand”, as many have including the Nobelist Joseph Stiglitz who simply dismissed it as non-existent. “Invisible hand” aside, Smith’s notion of this unfettered free market has influenced important scholars for 250 years. Ever since Friedrich Hayek commanded the rapt attention of the Reagan and Thatcher administrations, an unfettered free market has become a shibboleth for right-leaning politicians and policy. Central authority, it is argued, can never have complete enough information to reliably allocate resources. Society is far better off if it relies on the price of goods and services in a free market to determine allocation. Hayek’s formulation of this principle earned him the Nobel Prize in Economics in 1974.

Caveat Emptor

By its very nature, the ACA is a denial of this line of reasoning. It is assigning the control of the provision of health care to a central authority, even to the extent of defining, demanding and enforcing “meaningful use”. What is not under the thumb of the Federal bureaucracy is delegated to the burgeoning bureaucracies of stakeholders including the “health” insurance and hospital/clinic enterprises along with PHrMA and the device industries. This dialectic stands in opposition to Adam Smith and all the political philosophy that has followed his example, including the powerful body politic that dominates legislatures across the country today. Hence, there was no way to marshal the ACA through Congress without compromise. The compromise that won the day for Obamacare and its myriad bureaucracies was to leave the definition of “care” and the pricing of “care” unspecified in the Act. It was assumed that the free market would work its magic.

Neither Smith nor his “invisible hand” could have imagined the “health care market” that awaited the ACA. Supply and demand is not under the control of the consumer; both are the purview of the bureaucrats who populate the front offices of the stakeholders. I do not mean to imply that these front offices are populated just by greedy misanthropes. Rather, these stakeholders have become the bureaucracies Weber feared and Marx foresaw. They are rational in their collective drive toward self-service but they are irrational in terms of their ethical mandate. As Richard Gunderman said in a recent THCB post, “Financial priorities begin to take precedence over why the organization exists in the first place – to care for patients.” Gunderman ascribes this to “…the growing bureaucratization of healthcare, driven in part by consolidation among healthcare organizations.” This tautology misses the mark. The reason these bureaucracies are immoral is that they are not held to a transparent, definitive and articulated standard of decency because society has been sold a bill of goods in the free marketplace.

More Foxes than Hens in the Henhouse

Despite the FDA and the EBM establishment, much that is sold to patients as beneficial remains a pig-in-a-poke, devices in particular. Much that is licensed and marketed as offering efficacy is supported by data that has been tortured or generated in studies that are too methodologically flawed to be interpreted with any confidence.  Furthermore, much that passes methodologic muster offers evidence for trivial if not elusive benefits. All these shortcomings are overshadowed by aggressive marketing designed to bolster the “margins” of purveyors, salutary or not. It follows that pricing in the health care market is far more a reflection of marketing prowess than of the value of the goods to the consumer. Stakeholders in the private sector garner adulation from shareholders for milking this market. This shell game also results in largesse that hides under blankets that only not-for-profit entities can contrive: minions of highly paid administrators housed in shiny facilities and plied with whatever perks they consider appropriate. All of this is immoral.

To my mind, the most immoral aspect of the evolution of this marketplace in the 21st C is in depriving the patient of access to the evidentiary basis for saying, “Thanks, but no thank you.” What kind of free market deprives the consumer of choice? Furthermore, most purchases are for goods without face value. It’s not as if one is asked to choose between automobiles. One is asked to purchase between putative benefits. That requires an informed and empowered patient, which in turn requires a trustworthy dialogue with a physician. To nurture this dialogue requires a marketplace that considers this dialogue a valuable priority. Rather it is rapidly becoming an overlooked demand and an endangered supply by an ever more irrational bureaucracy and a duped citizenry.

Nortin M. Hadler, MD is a graduate of Yale College and Harvard Medical School. He joined the faculty of the University of North Carolina in 1973 and has been a professor of medicine and microbioogy/immunology since 1985. His assaults on medicalization and overtreatment appear in many editorials and commentaries and 5 recent monographs: The Last Well Person (MQUP 2004) and UNC Press’ Worried Sick (2008), Stabbed in the Back(2009), Rethinking Aging (2011) and Citizen Patient (2013).

 

Categories: OIG Advisory Opinions

Guideline-Centered Care

The Healthcare Blog - Fri, 01/29/2016 - 23:26

Doreen, Ahmed and Henry have recently had their medication changed in response to a new guideline for prescribing Statins, cholesterol-lowering drugs.

None of them came to ask for a change in their medication. In each case the change was recommended by a clinician in response to a new guideline against which our practice will be judged and financially rewarded or penalised.

Here are the NICE guidelines 2015:

The NICE guideline on lipid modification recommends that the decision whether to start statin therapy should be made after an informed discussion between the clinician and the person about the risks and benefits of statin treatment, taking into account additional factors such as potential benefits from lifestyle modifications, informed patient preference, comorbidities, polypharmacy, general frailty and life expectancy.

and

NICE recommends that statin treatment for people with CVD [Cardio–vascular disease] (secondary prevention) should usually start with atorvastatin 80 mg daily.

It is very easy to judge whether or not people with CVD are on Atorvastatin 80mg, but almost impossible to judge whether the decision to start therapy has been made as a result of thoughtful deliberation between the patient and the clinician. Thoughtful deliberation is at the heart of patient-centered care – not doing whatever the patient wants, as is often confusingly assumed.

Increasingly, financial incentives are being used to ‘improve quality’ in healthcare, which usually means that payment depends on the proportion of patients with condition ‘a’, receiving treatment ‘z’.

The assumption is that good quality medicine is about drugs like ‘z’ treating conditions like ‘a’. It says very little about Doreen, Ahmed or Henry.

Doreen is 67 and has CVD, chronic pain, depression, COPD, and recurrent vertigo. She lives alone, is socially anxious and isolated, frequently misses appointments, hates going to hospital, forgets to take her medication less often than she chooses not to take it – which is very often. She smokes about 30 roll-ups a day and has never exercised, and is very thin.

Ahmed is 47, has had two heart attacks, has type 2 diabetes with complications affecting his eyesight and his kidneys, he is overweight and cannot exercise because of chronic gouty arthritis. He has high blood pressure and cares for his wife who has schizophrenia, doesn’t speak any English and is frequently admitted to hospital.

Henry is 91, he has had a series of strokes and moderately severe Dementia – a mix of Alzheimer’s disease and stroke disease. He has metastatic prostate cancer and pain in his back from where the cancer has spread. He cannot speak and needs nursing assistance for all his needs.

Doreen, Ahmed and Henry are not the kinds of patients who are going to object when the doctor they know and trust, or even the expert they have never met before, changes their medication to include Atorvastatin 80mg. Dozens of people like them are my patients. I have no desire to impose an unnecessary burden of treatment upon them. I have every desire to practice with wisdom and compassion, to understand what matters most to them, what they want to get out of their treatment, to know how much is enough and how much is too much, to know which risks are worth taking and which are not. I want to know, in the context of their lives and their complex multiple conditions how much, and in what ways they are likely to benefit from changing their medication to include Atorvastatin 80mg. It is almost impossible to answer these questions without time. Guidelines do not, and cannot possibly take into account the characteristics of every patient. They generalise and we attempt to contextualise. Guidelines are rarely ever put together with or even for, patients. They rarely ever have any shared-decision making support and are not written in a way that is easily accessible to patients. Guidelines recommend that we are patient-centred, but they are not.

I am not sure that shared-decision making tools aren’t heading down a blind alley. They assume that people making decisions are rational and interested in abstractions like statistical tools and flow-charts, when the way my patients usually talk about healthcare is in personal narratives with significant events, characters, aspirations and moral negotiations. Compare Richard Lehman’s description of a shared decision making process or Paul Haidet’s description of a consultation with the NHS shared decision making website.

There is another, perhaps more important issue that this case highlights. GP appointments are a valuable and scarce resource. If the agenda for discussion is to be determined by neither the patient nor the doctor, but by the guideline, then there is less time to discuss other issues that may be of far greater importance and potential benefit. One important question to ask before administering any guideline is, “are there more important issues or interventions to discuss with your patient?”

Thousands of doctors and nurses struggle all day, every day to share difficult decisions with their patients. Making the right decision in the face of the natural complexity of medical practice and our patients’ lives, requires ‘phronesis’ or practical wisdom, informed by guidelines, but not led by them. Thousands more clinicians, caught in a trap with too little time and too much pressure to prescribe will skip the deliberation and simply default to the bit of the guideline that tells them what to prescribe.

When our patients look at the league tables and the accountants look at our books, will they be able to tell us apart?

Tomlinson is a physician in the UK. He blogs at A Better NHS , where this post first appeared.

Categories: OIG Advisory Opinions

Employer Sponsored Insurance: Unfair and Unaffordable

The Healthcare Blog - Thu, 01/28/2016 - 18:29

For all those Americans faced with higher health insurance premiums or less coverage (that’s most of us), the temptation is to blame the Affordable Care Act. Maybe instead we should be blaming the one thing the ACA didn’t significantly change: employer sponsored insurance—the norm for most working Americans.

Although the ACA imposed some new standards for coverage, ESI employers remain free to dictate most insurance details, the tax-exclusion of ESI benefits is largely unchanged, ESI premiums are still generally independent of income, and small employers can still offer ESI or not.

Unfortunately for millions of workers, it’s a model that’s increasingly neither affordable nor equitable. What seemed a reasonable approach fifty or sixty years ago when healthcare costs were far lower is now one of the most regressive health insurance systems in the industrialized world.

The Kaiser Family Foundation’s most recent employee benefits report demonstrates the problem.

Average ESI premiums are now $6,250 for an individual and $17,500 for a family. Most workers must pay part of the premium, with contributions averaging rather more than $1,000 for individuals and around $5,000 for family coverage. Most employees are also faced when they need care with substantial deductibles, averaging $1,300 for an individual and two or three times that for a family. (These figures are averages; in many cases, especially for smaller firms, the numbers are much higher.)

The out-of-pocket costs for premium contributions and deductibles may be tolerable for a manager earning $200,000 annually but can be a catastrophe for a$55,000 median income worker with a family. A look at the numbers for two typical employees shows just how unfair ESI has become.

The $200,000 manager with a family receives a tax-free benefit worth $22,400 in after-tax dollars, while the $55,000 worker gets only a $20,100 benefit. While both pay a $5,000premium contribution, it’s just2.5 percent of the manager’s salary,but almost four times this percentage of the worker’s pay. An even biggerinequity comes with the deductibles: incurring a typical $4,000 family deductible may be unwelcome for the manager, but it’s a crisis for the worker facing a choice between forgoing urgently needed care and financial disaster.

And it’s getting worse.

Each annual rise in healthcare costs requires employers to decide between increasing their share of premium costs and passing more of the burden onto their workers. Arecent survey of projected 2016 employer benefits illustrates what’s occurring. Faced with average 6 percent premium increases over 2015 levels (assuming no change in coverage), the typical employer is choosing to bear just a third of the increase, while dealing with the other two-thirds by simultaneously raising employee contributions and reducing coverage (usually by increasing deductibles).

Based oncurrent trends,in ten years’ time ESI premiums will average around $10,000for individuals, with employees paying close to $2,000, and some $30,000 for family coverage, with employee contributions near $9,000. Deductibles are expected to rise even more steeply, as employers try to control costs andalso avoid the Affordable Care Act’s delayed “Cadillac tax,” intended to curb overly generous coverage, but now likely to hit many more workers than originally expected.

If recent years’ pattern of close-to-inflation wage increases continues over the next decade, the well-paid manager (at $250,000 a year by 2025) will be able to afford the $9,000 family premium contribution and a potential deductible of $5,000 or more, but the average worker (at a projected $69,000) may find these costs impossible to bear. Two comparisons shows the unfairness.The manager will receive a benefit worth $38,500 and the worker one worth $4,000 less. Meanwhile, the manager will pay 3.6 percent of income as premium contribution and the average worker a big13 percent. (For lower-paid workers, the percentage will be even greater.)

Simple arithmetic shows thatby 2025, the combination of premium contributions and deductibles is likely to result inmany workers having to spend up to a quarter of their income to get any care at all.

The Affordable Care Act may have made healthcare available to more Americans, but in its attempt to minimize disruption for the majority of employees, it perpetuated a system that is increasingly unfair and unaffordable for those same workers and their families. (It’s also a system that healthcare economists have criticized for hurting smaller employers, reducing employment flexibility, damaging the overall economy, and doing far too little to encourage insurer competition.)

A fundamental re-think is needed. If we want employee health insurance to be fair and affordable, we must abandon the ESI system’s one-size-fits-all approach to premiums and deductibles. As in virtually every other industrialized nation, the cost of health insurance should be tied in some way to income.

Better yet, we should eliminate the employer role entirely. Replacing ESI and its unfair tax subsidies with coverage selected by individuals – not employers — would have several advantages. Insurance would no longer be tied to employment or be dependent on employer decisions, the true costs of healthcare would be more apparent, the bias against small businesses would be eliminated, employees would have more choices, insurer competition would be enhanced, and – most important of all – coverage costs could fairly reflect family income.

Roger Collier is the founder of the Campaign for a Rational Healthcare System (www.rational-healthcare.com). He was formerly CEO of a national healthcare consulting firm.

Categories: OIG Advisory Opinions

Enduring Effects of Trauma in Newtown and Beyond

The Healthcare Blog - Thu, 01/28/2016 - 07:46

This month’s Sundance Film Festival, a 10-day salute to movies that are often hailed as tapping into the national zeitgeist, have two films this year on gun violence: Katie Couric’s “Under the Gun” and Kim Snyder’s “Newtown.” Both will be screened by influential audiences this week with a plan for larger distribution over the year. And both will no doubt question what we as Americans should do to prevent mass shootings and to heal afterward.

The ripple effects of mass shootings are immense. Earlier this month school leaders in Newtown testified to Connecticut’s state board of education about the ongoing mental health difficulties that children in Newtown are having three years after the massacre at Sandy Hook. As a trauma psychologist and a pediatrician, we were saddened, but not surprised, by this report. Working in New Haven, just 20 miles from Newtown, we both have colleagues and patients who are in those concentric circles of Sandy Hook and have felt the effects in our professional and personal lives. As health care professionals, mothers, and neighbors of Newtown, we wondered what we as a nation have learned about long-term healing ­in places like Columbine and Virginia Tech.

We wondered about long-term healing for children and adults. We wondered about long-term healing for those closest to the tragedy and for those a degree or two or three away. As it turns out, we still have plenty to understand.

Residents of traumatized communities have strong, complex, and enduring feelings, including fear, rage, guilt, sadness, and anxiety. They have changes to the way they think about themselves, other people and the world. Their sense of security may never return to what it was. And how can it when their trust in a just world was stolen?

We know that early interventions right after the trauma accelerate recovery and prevent long-term mental health problems. One key early intervention is psychological first aid. In psychological first aid, health care providers gather information on current needs and concerns: Is the survivor currently displaced from their home? Are they separated from or concerned about the welfare of a loved one? Psychological first aid includes offering practical assistance to address essential matters, advocating for survivors to connect to social support systems, and providing information on healthy coping strategies including the basic do’s and don’ts of good mental health: Do get adequate rest and meals. Don’t use drugs or alcohol to cope.

In the first few months after the trauma, some survivors warrant a diagnoses of depression, anxiety or PTSD. For survivors with these diagnoses, mental health providers can reduce suffering through proven techniques that enhance the survivor’s capacity to manage emotional responses and challenge unhelpful thinking. But for survivors who are suffering with sadness or issues of trust and hope, and don’t warrant a specific diagnosis, we don’t have evidence-based interventions for healing.Most of the research on medium and long-term healing comes from survivors of natural (earthquakes, hurricanes) or man-made (oil spills, bridge collapses) disasters. We don’t know as much about the effectiveness of treatments in survivors of mass violence. We don’t yet know how to reduce traumatic grief for whole communities.

In some ways, this speaks to the good fortune of Americans until Oklahoma and 9/11–community-wide violence—in places where people felt safe and secure only the day before—used to happen only to children and families who lived elsewhere so we were not faced with how to facilitate long-term community-wide healing. Yet even in the international literature, there are only expert opinions and not evidence for what to do for long term healing after a community-wide mass shooting. Promoting a sense of safety and connectedness and instilling hope are important health care intervention principles, for sure. But they clearly are not enough: over three years after the Newtown massacre the wounds are still gaping.For all of these communities of vulnerable mourners, where losses were sudden, violent, and of human malice, maybe out-of-the-box interventions need to be designed and tested? Restorative retelling where mourners give voice to the most painful particulars of traumatic loss might prove effective. But we don’t know.

If we want to build national capacity for addressing the long term mental health needs of traumatized communities that have experienced mass violence, we need more research and we need more federal funding committed to research — to indicate if and how healing is possible, what it looks like, and how to get there, for Newtown, Charleston, San Bernardino, and—unfortunately–so many other communities.

Categories: OIG Advisory Opinions

Data Socialism

The Healthcare Blog - Tue, 01/26/2016 - 07:20

In an unusually candid editorial in the NEJM, Longo and Drazen say that data sharing may be problematic because some researchers fear that the data could be used to by others to disprove their results. The editors predicted a new class of researchers who use data created by other researchers without ever taking the trouble to generate data themselves – research parasites.

With this editorial, the NEJM has firmly established itself as descriptive (the way the world is), rather than normative (the way the world ought to be). I, for one, find this move rather refreshing. I have been pumped to a diabetic state by the saccharine naivety of the hopey-changey, “we need this and that” brigade. The editors merely said what some researchers secretly think, and how many actually behave.

Once, I asked the PI of an RCT a specific question about outcomes. I received a reply within seconds. The PI sent me a pdf of the data. The email ended with that banal academic signature “Best, MD.”

I was flattered by the promptness of her response – many PIs who publish in high impact journals don’t bother replying. Then I discovered she sent me the supplementary appendix, which was also available online. Unsurprisingly, my question was not answered. But it was not supposed to be answered. The unpublished data, which included the answer to my question, was going to be used by the PI for more papers in high impact journals, as it should be.

Another time I asked an economist to share an economic model of a technology, which I did not believe was as cost-effective as he said it was. After a few evasive responses, when it became apparent that I was not getting the message through my thick skull, he replied, “sorry I can’t show you my model. I spent my PhD developing it.” If he thought that I was a data parasite gagging to prove him wrong he was, to put it plainly, spot on.


Karl Popper, the philosopher of science, said that what tells science apart from astrology is that science is falsifiable – if it can’t be disproven it’s not science. Replication, the key to progress in physical sciences, is medical science’s Achilles’ heel.

We should dwell a bit longer on the hard sciences because they are instructive. No body had to do a meta-analysis of experimental evidence of the presence of ether (the mysterious substance believed to conduct gravity). Why? Because ether either exists or doesn’t exist, and it doesn’t exist. Since Michelson-Morley’s famous failed attempt to show the presence of ether, several physicists have tried, and failed.

There is no meta-analysis of experiments of possible curvature of space-time with I2 to measure the heterogeneity of sample size. Arthur Eddington showed that gravity bent space-time, during a solar eclipse, and several others have, since, verified Einstein’s theories. Publication bias is not an issue in physics.

While physicists seek truth which uncovers the mysteries of the universe, the objective truth in medical sciences is settling petty quibbles probabilistically, such as:

Should we give 150 mg or 75 mg of aspirin after a myocardial infarction?

Do patient-centered ward rounds improve outcomes?

Is cardiac CT superior to SPECT in the diagnosis of obstructive coronary artery disease?

A bunch of studies root for cardiac CT. Another set root for SPECT. Then we have a meta-analysis. Then an RCT. Then more RCTs. Then a meta-analysis of RCTs. Then finally an analysis of an administrative database with dodgy risk adjustment renders all previous research obsolete.

To which one is tempted to yell – FFS it doesn’t matter, use either or neither. But it does matter. It matters because we’re rational optimizers. We cannot ever, ever, not be doing the best we can, even if the best is like adding a gnome on top of Everest and celebrating the total height.

Optimization is endless quibbling because the differences are so small. Optimization like is a train which departs on a lengthy journey but never leaves the platform. Optimization makes careers. Optimization leads to lots of publications. Lots. There is an infinite number of ethers and space-times to prove and disprove in healthcare sciences.

But optimization is a methodological nightmare. Because when you’re dealing with such small differences, to make sure those Lilliputian differences are real, the measuring instrument has to be precise. And one cause of an imprecise instrument, other than inherent imprecision, is sloppy research.

If you tell physicists that facts have changed they’ll say “welcome to science and have a nice day.” If you tell physicians that facts change they’ll scream “research fraud.” If Einstein and Newton were doctors, Einstein would have asked Newton to retract his theory of gravity.

One reason why there is no culture of replication in the biomedical sciences is that falsification is suffused with moral outrage. Retraction should be a normal clearing house for biomedical sciences – like shedding hair or clipping nails. It has become a consumer watchdog.

I wonder if the illiteracy most urgently in need of redress in doctors is philosophy of science, rather than evidence-based medicine or statistics. Science is a provisional assumption. Facts are supposed to change. Changing facts doesn’t mean that science is broken. It means that science is happening.

Much angst against the NEJM editorial, mostly hilarious on Twitter, is a common misunderstanding of the ought-is dilemma – confusing the description of the way the world is with endorsement of the way the world is.

I stand with the detractors though. Data ought to be shared. But, as I have learnt painfully, there is a way to ask for it. You must endear yourself to the researchers – a few complimentary emails followed by a chance encounter at a national meeting where you prostrate with reverie of the PI. Parasites must be charming.

It takes a lot of effort to generate data in biomedical sciences. To expect researchers to surrender the data for the greater good is fuzzy, and lamentably boring, adolescent naivety. If we do not recognize the self-interest of researchers, data socialism, like other forms of socialism, is condemned to failure. This is what I think Longo and Drazen are warning us in their editorial.

Saurabh Jha is a radiologist based in Philadelphia and a contributing editor for THCB.

Categories: OIG Advisory Opinions