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A Warning Label For Healthcare E-mail?

The Healthcare Blog - Fri, 08/26/2016 - 12:11

Eric Jones, the CEO of a large hospital, is at the end of a long day.  It’s 10 PM, he’s very tired, and has had his maximum of three drinks.  He’s checking his emails and sees one from Ralph Smith, CEO of a small community hospital, rejecting Jones’ offer to joint venture hips and knees.  The small hospital has rated tops in those categories, and Jones had hoped to achieve a quality and marketing coup by joining forces, perhaps as a prelude to acquisition.  This rejection was the last straw, particularly since Smith and Jones never had gotten on very well.  Immediately, Jones whipped off an email excoriating and libeling Smith and his hospital, misrepresenting what happened in negotiations, and threatening to “go to war” and “destroy” him and his hospital if they don’t “play ball.”

Think that far-fetched?  Nope.  Things worse than that have happened with astonishing regularity.  Assume that when Smith opens and reads that email the next morning, he then forwards it to his senior staff and the hospital’s litigation lawyer.  The lawyer confirms that it’s not only actionable for libel, but could constitute a violation of antitrust law, where damages can be trebled and attorneys’ fees recovered.

Then one of the small hospital’s senior staff decides to forward the email “without attribution” to one of his friends who is a local investigative reporter.  Two mornings later, the email, in its entirety with only obscenities deleted, appears above the fold on page one of the local newspaper, and a summary, with several choice quoted sentences, are run on local TV and radio news, just below a terribly unflattering photo of Eric Jones.

At that point, would you like to be Eric Jones?  Would you like to face his board of directors?  And the coming lawsuits, talk show commentary, blogs, etc.? Dust off the resume Eric.

We all use email.  Some 90% of Americans do today.  Some misuse it famously, as we see in the election cycle press every day, and with predictable results.  Because email IS different.  It’s not the same as a face to face discussion, or even a phone call.

Clearly, the ubiquitous use of email has blinded many of us to its dangers.  Accordingly, the purpose of this piece is to discuss some of those dangers via do’s and don’ts.  And for sure, healthcare is particularly apt for caution given that unauthorized disclosure of personally identifiable confidential healthcare information brings with it an avalanche of very nasty consequences.

Let’s first consider everyday business use of emails.  We start with the “10PM Rule.”  The 10PM Rule says: “Never, ever, send a confrontational or angry email after 10PM.  Ever.”   If it’s a really bad one, they’ll assume you were drinking or worse.  At best, you exercised poor judgment because you were tired and cranky, not exactly inspiring confidence either.  It even has a name:  “email flaming.”

Truth is you should try to avoid sending any confrontational emails.  Yet so many people avoid confrontations by using confrontational email as a substitute.  Face to face is so much better for more reasons than we have space to write. And once the email is sent, the recipient feels she MUST respond, usually in kind, to “set the record straight.”  And there is now a “record” for the world to see if it really wants to.

The temptation to copy others must be avoided.  Don’t make more of a spectacle out of yourself than you just did.  You’ve just turned what should have been a private discussion into a public washing of the dirty laundry.  Don’t make it worse.  Moreover, emails too often get missent, or miscopied; and those who were erroneously copied just love forwarding something juicy to their 50 best friends, and it becomes, how do we say, viral.  All a bad email needs is a single recipient who wants to do you harm by forwarding it to your regulator, your enemy, your competitor, your boss, or your spouse.

Arguments by email are the height of inefficiency.  Write, respond, write, respond, claim, counterclaim, and never resolve.  Tit for tat.  And, email is decidedly NOT the medium for extended discussion of complex issues.

And extremely important:  email causes misunderstanding all too often.  One does not see the sender’s face, expressions, and gestures, nor hear the tone of voice which is so important.  Tone, emphasis, and meaning count for much in communication.  A surprisingly high percentage of face to face communication comes from nonverbal, well over 50%.

And what about labelling it “confidential” or some such?  Meh.  That almost ensures it will catch someone’s eye or end up in the absolutely wrong person’s in box.  It also is one of the best ways to unintentionally waive the attorney client privilege if sent to the wrong person.

Emails never die and can always be retrieved, even if you’ve deleted them and your history, and crushed your computer with a sledgehammer.  Never die, get that?  Servers somehow retain them, despite best efforts to make them go away.  We also are reading all about that in the news during this election year.

So what do you do?  Try the following:

Avoid using email for:

  • Confrontations
  • Slurs or socially unacceptable commentary
  • Judgmental commentary
  • Jokes of any kind (I really mean this one)
  • Confidential or sensitive business information, or privileged information, unless as advised by your attorney
  • Write your emails with minimum use of adjectives and adverbs—stay factual
  • Never, never use military or sports terms to juice up your point (in my organization, that was a CLM (Career Limiting Move)
  • Write your email as if it WILL IN FACT somehow end up in the hands of your competitor, enemy, or the local newspaper, or Facebook
  • Oh, speaking of Facebook, avoid business or sensitive personal communications there at all costs

If you have any doubts after drafting an email:

Keep it in draft and wait a day to reread it.  Your judgment might have improved.

Triple check that it is going to the right person and only that person.  Those chain emails have a nasty way of going to everyone despite your best effort to limit it to just one person.  I’ve been embarrassed in exactly that way.

Physician use of email can enhance communication with patients AND improve care.  After all, almost all Americans use and rely on email today as their primary communication tool.  But it’s tricky.  Many payors do not yet reimburse physicians for emails, so it’s not exactly a revenue driver, yet. But leave that aside.  If physicians decide they will use email because it enhances the relationship and the level of communication, they should consider the various legal and other risks and take the necessary steps to lessen those risks.

Patients who wish to communicate with their physician via email should be informed of the risks and sign a document whereby they assume risks inherent in email.  It would be well to seek legal advice for particular federal or state legal requirements or prohibitions.  State statutes on confidential healthcare information protection vary widely.  And there are HIPAA and HITECH, etc.

Note also that under HITECH, physicians are required to provide patients access to their information in the form and format requested by the patient.  That may well be electronically by email.  “Reasonable safeguards” must be in place to protect electronic transmission of such information.  So emails probably cannot be completely avoided.

As we’ve seen, it is impossible to absolutely guarantee the security and privacy of email.  Thus, all you can do is minimize the risks as much as you can.  Check for applicable guidelines (e.g., AMA).  Internal process should be adopted incorporating such guidelines.  If the practice has its own website, a secure website portal should be considered as the way to email.  Encryption also helps, but both parties must be able to use the encryption.

To summarize:  electronic communications can be wonderfully efficient, speedy, and practical in all sorts of contexts, including healthcare.  But please understand the risks inherent in its use, and take the common sense steps to protect yourself and others.


Categories: OIG Advisory Opinions

Hold on. Ready For It? EpiPen May Actually Still Be Too Cheap!!!

The Healthcare Blog - Fri, 08/26/2016 - 00:26

Pick up a newspaper or surf the web and you’ll find story after story taking Mylan to task for EpiPen pricing practices. The list price of a 2-pack has soared from about $100 to $600 over the past decade. The price is deemed too high and the rate of increase is considered particularly unconscionable.

Let me offer a brief counterargument:

EpiPen is worth the price. A $300 pen regularly rescues children from anaphylactic shock that would otherwise be fatal, offering them the chance to live to 100 instead of dying at 10. (About 20% of patients need a second dose, which is why these devices are sold in 2-packs.) Meanwhile drug makers charge hundreds of thousands of dollars per year per hemophiliac, tens of thousands or more to give a cancer patient a shot at a couple or few more months of life, and thousands per year to modestly lower the chance of a heart attack. Within that context, and in absolute terms, EpiPen is indeed a bargain.

People are complaining that they pay hundreds of dollars per year –or more if they have multiple packs– for something they hope never to use. But they should acknowledge that they are actually using EpiPen even when they never dispense the drug. EpiPen is what lets them send their children on playdates and be comfortable with them away at school and summer camp, go out to restaurants, and take hikes in the woods.

EpiPen is worth a lot more than its current and former competitors. According to the Washington Post, Twinject left the market in 2012 and was considered clumsy and unappealing compared to EpiPen. Auvi-Q was recalled last year because it could administer the wrong dose. Teva’s autoinjector was rejected by FDA this year for “major deficiencies.” How many parents would be willing to trade down to save a few dollars on these? Anybody?

The failure of Adrenaclick to catch on despite a lower price, distribution through Walmart and a good review from Consumer Reports demonstrates that Mylan has done a lot with EpiPen over the past decade to earn its price premium and high market share. In particular, EpiPens are now close to ubiquitous in schools thanks to clever marketing, effective lobbying, and public health campaigns. School nurses know how to use them, babysitters know how, and so do siblings. When an emergency strikes and seconds count, the familiar tools are at hand, and people are ready to act. It doesn’t really feel like the moment to learn about Adrenaclick for the first time!

In effect, Mylan has created a public health support system around EpiPen. I’ll go ahead and make myself even more unpopular by saying that this system justifies the big price increases. When you buy EpiPen in 2016 you’re not just getting the product like you were in 2007, you’re benefiting from the whole system. Although the product itself hasn’t changed, EpiPen is more valuable now than it used to be, and Mylan has justifiably reaped the rewards.

EpiPen is far from perfect. For example, it needs to be stored within a tight temperature range and protected from light.  The pens have to be replaced annually. Other companies are working on EpiPen alternatives, and I’d like them to have a financial incentive to do so. A cheaper EpiPen could be nice, but I’d rather see something that’s better (easier to use, more effective, more stable), even if the price is higher. The current attacks on EpiPen are unfortunate because they discourage investment in these types of innovation.

Before you dismiss these arguments and call me an industry hack, I’ll point out that I have advocated for drug price regulation since 2006. But EpiPen is not the place for the government to intervene.

David E. Williams is a health care consultant and blogs at The Health Business Blog.

Categories: OIG Advisory Opinions

EpiPen Shock

The Healthcare Blog - Thu, 08/25/2016 - 16:37

The white hot EpiPen controversy is the latest signal—and it should be loud and clear at this point—that the pharmaceutical marketplace is dysfunctional.

To be sure, drug companies make medicines that save and prolong lives and ease suffering. And many drugs save money compared to alternative treatments, and yield productivity gains by keeping people alive, well, and working.

But over the past two decades, the industry has become the poster child for poor business ethics, flaunting the law, and profiteering. Just one example: Since 1990 drug companies have paid $15 billion in civil and criminal fines to the federal government for promoting the use of their products “off-label” – that is, for unapproved uses.

They have also been caught red-handed (a) testing drugs in illegal and unethical ways in third world countries, and (b) hiding study results from authorities worldwide that undermine claims for their drugs’ effectiveness and/or safety.

Most recently, they have been vilified for startling increases in the prices of both brand-name and generic drugs.

EpiPen, made by Mylan Pharmaceuticals, is the latest. Thanks go to analysts at Well Fargo who brought to light the product’s steady year-over-year price rise (for a two-pack) from $165 in May 2011 to $608 in May 2016.

Mylan’s CEO Heather Bresch has reacted aggressively to tamp down the public and media uproar, and in fairness she’s not another Martin Shkreli, the infamous former head of Turing Pharmaceuticals who smirked his way through a congressional hearing on the companies 5000% increase of a generic drug that cost pennies to make. Nor does she seem to be in the mode of pharma villain Michael Pearson, former head of Valeant Pharmaceuticals. According to a revealing and detailed piece in Vanity Fair (June 2016) by Bethany McLean, Pearson pioneered a new form of “drug dealing” and made a high art form out of price gouging before he was forced out.

No, Bresch and Mylan are more in the main stream, and that’s the problem. In recent days she has justified the EpiPen price increases by arguing that: (1) she had to do it to recoup legitimate investment costs; (2) Mylan gets only $274 of that $608 list price with the rest going to insurers, pharmacy benefit managers, and other middlemen, because of (her words) “an outdated, inefficient system;” and (3) “It was never intended that a consumer — the patient — would be paying this price” (as she told CNBC) and they are paying more, Bresch said, because insurers have hiked insurance deductibles and drug co-pays so significantly in recent years.

Bresch makes some valid points. But much of her explanation and response is disingenuous and spotlights the problems with the pharma industry as well as the way we price and pay for drugs in the U.S.

First, what’s the justification for even doubling the price? There can be none other than the desire for more profit. The drug (epinephrine/adrenalin) as well as the type of delivery mechanism EpiPen uses has been on the market for decades. Mylan acquired EpiPen in 2007 when sales were $170 million. EpiPen sales in 2015 were $1.7 billion.

The real explanation, which Bresch didn’t acknowledge, is that her product has a near monopoly (more on that below). So Mylan could raise the price without fear of market share loss. In fact, Mylan has a quasi state-sanctioned monopoly since 11 states require schools to have injectable epinephrine products on hand, in part as a result of Mylan’s lobbying. And a 2013 federal law—the School Access to Emergency Epinephrine Act—gives financial incentives to states to enact mandates for schools to stock epinephrine autoinjectors and train personnel to administer them.

That’s actually a good law because the need is justified, but the problem is there’s only one viable product now. In fairness, according to a Washington Post story, Mylan gives EpiPen free to many schools.

Not incidental to its market lock and profitability (and the cumulative cost to buyers over time), EpiPens have a shelf life of just 1 year.

Second, Bresch’s statement that “the consumer was never meant to pay” for EpiPens betrays a broad pharma approach to the marketplace. Since the consumer is insulated from out-of-pocket costs, let’s get what we can from insurers and government.   Well, everybody is doing that so what’s the problem? The problem is that Bresch and every other pharma CEO (and healthcare CEO in general) knows that in the end, WE PAY. In higher premiums, taxes, deductibles, co-pays etc. It’s that simple.

Bresch says she know that, believes “the system is broken,” and is ready to work with Congress to fix it.

She could have started by immediately lowering EpiPen’s price. She declined to do so. Instead, she adopted the tried and true pharma approach of reducing consumer’s out-of-pocket costs for EpiPen. Mylan will increase the amount of money on a copay assistance card from $100 to $300 and will widen eligibility for that assistance program. Per the above explanation, that’s not in any way a savings to the system or in the long run, consumers.

As for Bresch’s explanation that Mylan gets only $274 of that $608 list price with the rest going to insurers, pharmacy benefit managers, and other middlemen, there’s no way to know if those numbers are correct. Why? Because the system is opaque, and she knows that. Knowing a bit about this marketplace, I doubt seriously that PBMs are pocketing $200 or more per EpiPen two-pack.

The system is also broken is ways Bresche didn’t directly address this past week.  EpiPen has a monopoly in large part because the FDA did not help competitors stay in the market or get to market to compete with it.

As reported by Dana Goldman, a professor at the University of Southern California, in the online news service STAT, FDA failed to work with Sanofi Pharmaceuticals in 2015 and this year to get a competitor to EpiPen back on the market after it was recalled in 2015 because of 26 adverse event reports. The device in those cases was found to be delivering too much or too little drug. But Goldman says no one died and the failure rate, based on sales of 2.8 million units, was just 0.01 percent.

Instead of working with Sanofi to keep it in the game, FDA dawdled as Mylan’s market grew rapidly, Goldman says. In addition, this past spring FDA rejected an EpiPen copycat made by Teva. Five senators wrote the FDA on August 25 expressing concerns the agency may have stifled competition.

This is consistent with complaints by lawmakers, consumer advocates and others over the last few years that the FDA does not approve generics fast enough, nor pay enough attention to situations in which a single product—brand or generic—lacks viable competition and starts to become excessively expensive. The FDA defends itself, claiming its only job is to make sure drugs are effective and safe, not affordably priced. Consumer advocate pooh-pooh that, arguing that FDA has a long-standing mandate from Congress to approve competing brands and generics quickly.

Two final notes:

(1) Mylan’s price hike for EpiPen is not an aberration. It just garnered the most attention. The company has made price hikes on dozens of medications.

(2) Bresch’s compensation has risen at the same rate as EpiPen’s price, roughly six fold since 2007, to $19 million in 2015.

Categories: OIG Advisory Opinions

The Self-Care Rx

The Healthcare Blog - Thu, 08/25/2016 - 15:33

“The system only changes if we empower the one person who cares about their health the most – the patient. Over the next decade, I believe people will become the CEOs of their own health.” Vinod Khosla

Self care is the future for the simple reason that nobody wants to be a patient. Of course we want care when we need it. We want to be well. We want a good life. We want independence. We want control, and we certainly don’t want to need care nor to lose control.

And becoming a patient, for better or for worse, implies giving up control. Being a patient implies there are gatekeepers, there are limits, there are constraints, there are decisions we can’t make for ourselves. We can’t always get the access we want. Talk to patient advocates and you’ll find people fed up with the lack of control, lack of ownership and the lack of help from the health care system.

While we won’t ever get all the care we need from patient groups and new digital self care tools, we’ll always need professionals to make decisions that are deeply complex and require a deep understanding, there’s still a great deal we can get from our peers and our new tools and the list is growing every day. Many conditions simply don’t need deep expertise, they only need to answer “what do I do next?” around a condition.

The desire for action and control drives our internal motivation, but, along with them, there are now also strong technological and societal forces driving an emerging self care movement.

Here are the major forces at work:

1. Internet of Things (IoT): Sensor costs are becoming very inexpensive. They will become commoditized. Telemedicine is growing, and, as payment aligns with outcomes, it will be routine. In 5 or 10 years, in a non-emergency situation, why will we need to go to a “bricks and mortar clinic”?

You may need to get a scan, or you may need a real physical exam, but less so every year. The world of medicine become more and more digital every day as measurements are enabled for the consumer. Philips recently made the move in the wearable marketplace from fitness to chronic disease, with a $600 system including a watch, scale, BP monitor and thermometer.  This is a big step, and foreshadows a self-tracking future for healthcare. More sensors are surely on their way to the home and mobile.

2. Shifting Risk: Patients and self-insured employers are looking for new ways to minimize their financial risks as plans move toward high deductibles and employers are looking for new ways to keep employees healthy and happy and looking for new measurements. It’s historically been very expensive to get data on populations, and even more difficult for data around individuals. For individuals and employers, to bend the cost curve, they need the best information available on what costs will be and how behavior affects costs and disease risk.

Say someone is diagnosed with pre-Diabetes. How much will will he have to pay for those Diabetes meds if he gets full-blown diabetes? Will he have to get daily insulin injections? When risk is personal, we can start to change outcomes and drive engagement. While some health is measured and influenced at the population level, including social determinants, health is still driven by individual decisions on a daily basis. We are driving toward individual risks as we get better at measuring. This will have big implications for insurers in the not-to distant future, and for individual rights as well. As we gather more information, when we get to very accurate predictions of risk for an individual. What will population-based insurance look like with all this information? We all need the right information to make our own decision on our financial and health futures. Laws governing individual risk will likely change as well.

3. Interoperability around the individual. It’s been a long time coming, but the recognition that patients must be the means by which health data is transferred is coming into the mainstream.

CIOs have indicated that relying on institutions, institutions that have neither the rights nor the incentives, to share health data might not be the right approach.

According to Dr. David Kibbe of DirectTrust,

“The real issue involves who owns the health information that is created by you and me, and about you and me, and who has the rights to view it, access it, use it, download it and move it around.”

Kibbe went on to say, ““We need a new and different national, maybe international, dialogue about how health data and information are centralized and de-centralized, about how to assure its privacy, about the use of encryption for security and about identity assurance,” Kibbe added. “Some of this is policy and some of this is social science.”

Kibbe gets it right on decentralization: decentralized technologies are allowing individuals the ability to track the information about themselves without a third party. Blockchain is being hailed as user-centric data store. Just as bitcoin is showing the promise of de-institutionalizing banks to protocols and distributed data stores, blockchain shows promise for other kinds of individual-centric data.

Don and Alex Tapscott have written “The Blockchain Revolution” which details how blockchain and related technologies will weave their way into many industries, driving decentralization of many currently centralized processes.This could be a core part of moving health data exchange to a truly individual-centric system. Bruce Boussard, the CEO of Humana recently confirmed this perspective, saying: “The promise of Blockchain is about putting the consumer at the center of health care, instead of the other way around.”

While Kibbe’s comments above were on the care delivery side of health care, big changes will be impacted on the research side of things as well. Eric Topol and John Wilbanks highlight in a recent Nature article that, even if we have easily given up personal data rights around commerce, we need to draw the line on the privatization of personal data around health data. Just as we control our own bodies, so must we control data about our bodies and minds.

4. Precision medicine. Precision medicine is information science, population health, value-based care and patient experience driven to the level of the individual. Although we tend to think of individual and population health as opposite sides of the same spectrum, precision medicine is the path we’ll follow to get to all the others. Take a look at the recent award for Scripps to understand Precision Medicine:

“This range of information at the scale of 1 million people from all walks of life will be an unprecedented resource for researchers working to understand all of the factors that influence health and disease,” NIH Director Dr. Francis Collins said in a statement. “Over time, data provided by participants will help us answer important health questions, such as why some people with elevated genetic and environmental risk factors for disease still manage to maintain good health, and how people suffering from a chronic illness can maintain the highest possible quality of life. The more we understand about individual differences, the better able we will be to effectively prevent and treat illness.”

Providing the right care to the right individual requires a complete picture of that individual. Precision medicine is the the nexus of the combining forces of medicine becoming and information science while being directed to the unique contexts of a person’s lifestyle and genomics.

In June, Healthcare IT News and HIMSS released a study and the headline, “Hospitals rank population health, value-based care, patient experience as top strategic drivers of precision medicine.” The first part is perhaps not that surprising, but what’s been missing is how tightly related population health, value-based care and patient experience are to each other, and they are all going to be accelerated with precision medicine. Precision medicine has the ability to become the medical science of how to do better care at lower cost and create a better experience for each individual. It has the potential to become the science of value-based care. The more we customize treatments, the better we can manage populations, it’s not unlike the idea of mass customization in retail.

5. Volume to value is becoming ingrained in the health system. By this time, just about every pharma company either has or is thinking about putting together a patient engagement strategy. Part of this is driven by the success of Direct to Consumer Advertising and a desire to extend it, but the other part is that patients are a wealth of valuable information that can now be accessed for research and insight into disease and patients’ experience with their disease.. There’s a lot to learn at every step of the pharma value chain. Payers and providers are a bit slower to change, but, with value-based payments forcing movement, it’s coming.

6. Self care is what people want. Finally, as discussed in the beginning. Nobody wants to be a patient. We want independence. The horrible experiences and the overall lack of access, all driven by the insane economics of health care, are driving people away from the current health system and towards personal choice and self care with new tools and new communities. People want to be well far more than they care how they get there. There will always be a role for the professionals, be we have to offload as much as possible. The core unit of value in healthcare is the right decision. It doesn’t matter how the decision is made as long as it is correct.

7. It’s the right thing to do. Patient engagement and personal empowerment with information means better outcomes. People actively engaged do better. It’s simple, but powerful. When people have data they feel better, errors can be found, and outcomes improve. Self care is the natural end game.

Independence in care is  a huge improvement to care. It’s not a cure, it’s not a fix all, but ask any patient what they hate the most about the health system, and they’ll often mention a loss of control. When we can feel like we are in control of our illness and recovery without a forced dependency for many simple conditions, it’s a big part of the battle.

Quick plug on self care: Interested in exploring self care further? There will be a panel hosted by Dell Medical School and a workshop I’ll be hosting with Self Care Catalysts (where I’m a Senior Advisor).  Please vote early and often!

Categories: OIG Advisory Opinions

Open Letter to President Obama About His JAMA Paper

The Healthcare Blog - Wed, 08/24/2016 - 09:29

Dear President Obama,

If I were to tell you that alligators and southern accents are correlated and that alligators cause southern accents, what would you say? You’d say, “Yes, Kip, there is a correlation, but it’s weak. But more importantly, even if the correlation were strong, there is no plausible mechanism by which alligators could influence accents. Therefore I reject your conclusion.”

I offer the same rejoinder to your argument in your August 2 JAMA article  that the Affordable Care Act has reduced health care inflation. In that paper, you claimed the ACA has “contributed to a sustained period of slow growth in per-enrollee health care spending,” and you cited the low average inflation rate of the five-year period 2010 to 2014. But that period correlates only loosely with the period of very low inflation that began in 2008 and ended in 2014. The fit is even worse if we define the “sustained period of slow growth” as 2004 or 2005 to 2014 as some do. To give you the benefit of the doubt, I’ll assume you were referring to the 2008-2013 inflation lull.

Of far more importance, even if the correlation were strong, there is no plausible mechanism in the ACA that could have caused more than a tiny fraction of the 2008-2013 slowdown.

Your post-presidency sabbatical

The purpose of this letter is to urge you to find the time after you leave office to discover for yourself there is no cost containment in the ACA for the non-Medicare population and very little for the Medicare program, and the net effect of the ACA on national health spending is inflationary, not deflationary. If the ACA’s so-called cost-containment provisions don’t cut costs (or even raise costs when all costs are measured), but the ACA raises inflation by expanding coverage, its net effect has to be inflationary.

You of all people need to acknowledge that fact and do something about it. Your name will forever be tied with the ACA. The ACA has never been on a solid footing, and now that inflation is resuming, it should be clear even to you and other diehard ACA supporters the ACA is in trouble. If nothing changes, the ACA could become what Henry Aaron predicted in 2010 it might become – “zombie legislation, a program that lives on but works badly.”

Just because you’re leaving office doesn’t mean you must sit on the sidelines and watch the ACA take a slow nose dive. If you set aside some time after you leave office to immerse yourself in health policy, and if you give high priority to finding the truth and low priority to making the ACA look good, you will conclude as I have that the ACA has little cost containment in it. You’ll conclude, as I have, that Peter Orszag, Zeke Emanuel, Jeanne Lambrew and the other advisors who told you “accountable care organizations” and other pay-for-performance fads could cut costs were merely regurgitating groupthink developed over the last half-century by the managed care movement.

And once you have determined that ACOs and the other cost-containment nostrums in the ACA are not lowering inflation and some (notably ACOs and “medical homes”) may actually be inflationary, you can then use your influence to educate Congress and the health policy elite about why the ACA is aggravating inflation and what should be done about it.

In this letter and two comments I’ll post shortly, I will offer a quick tutorial on where you went wrong in claiming the ACA is anti-inflationary. Obviously I don’t have the space here to teach a graduate course in health policy. But I do believe that in three essays I can make you suspicious of the groupthink you were exposed to in the White House, and I believe I can whet your appetite for the antidote to groupthink – evidence-based health policy.

It’s the economy, stupid!

There is near-universal consensus that the 2008-2013 inflation lull began in 2008 because that was the first full year of the Great Recession, and the lull ended in 2014 because the recession’s worst effects were over by then and because the most inflationary provisions of the ACA – the coverage expansion provisions – kicked in that year. Other factors contributed to the lull, but the recession was far and away the most important.

The latest report on the National Health Expenditure Accounts, a document you cited four times in your paper, makes it crystal clear the inflation lull came to a halt in 2014. Here is the very first sentence in the summary of that report:

“In 2014, U.S. health care spending increased 5.3 percent following growth of 2.9 percent in 2013 to reach $3.0 trillion…. The faster growth experienced in 2014 was primarily due to the major coverage expansions under the Affordable Care Act, particularly for Medicaid and private health insurance.” [1]

How did you miss that statement? Inflation almost doubled in 2014 primarily because of the ACA. Inflation is projected to rise gradually to 6 percent by 2020

Why did you fail to tell us the “sustained period of slow growth” ended two years ago?

There is widespread agreement that the enormous loss of income and wealth caused by the 2007-2009 Great Recession is the most important reason why the inflation lull began and ended when it did. The reason for that is the existence of a well-documented correlation you neglected to mention – a consistent correlation over time, over space, and over income classes between income and health care spending. Richer nations spend more on health care than poorer nations; upper-income Americans spend more on health care than lower-income Americans; and Americans as a group spend more on health care during good times and less in bad times.

To put that last point more precisely, we spend less during periods that include recessions and recovery from recessions, and we spend more during periods following recovery from recessions. Because the Great Recession was brutal (it was the worst recession since the Great Depression), its effect on medical spending was immediate and its effect lasted beyond 2009.

Perhaps the single best paper documenting the tight link between the recession and the inflation lull is one by Dranove et al.  entitled, “Health spending slowdown is mostly due to economic factors, not structural change in the health care sector.” Your former advisor Peter Orszag cited that paper in his editorial commenting on your paper.

Alligators don’t cause accents

The correlation between recessions and health care inflation is not only consistent over many years and reasonably tight, but it has a plausible explanation. Conversely, the correlation you asked us to accept (the 2008-2013 inflation lull and the short lifespan of the ACA) is loose and, with one possible exception that I will discuss and dismiss below, has no plausible explanation.

The explanation for the correlation between recessions and health care inflation is not just plausible, it is obvious. Medical care is expensive (it accounts for a sixth of our Gross Domestic Product) and much of it can and will be put off when more basic needs like food and shelter become harder to pay for. Conversely, when most households have recovered from recessions, national spending on health care returns to levels approximating pre-recession levels. By contrast, with one remotely possible exception (the cuts to Medicare), your claim that there is something in the ACA that would explain the last four years of the inflation lull (2010-2013) defies commonsense.

I urge you to read the annual reports on national health spending during the post-2010 portion of the inflation lull by CMS’s Office of the Actuary (OACT). You’ll see that OACT gave the ACA virtually no credit for the inflation lull and instead attributed the lull to the Great Recession. For example, in a paper  on national health expenditures for 2011, OACT stated: “Although some provisions of the Patient Protection and Affordable Care Act … were in effect in 2010 and 2011, the impact on aggregate health spending growth was minimal in these years. The most prominent provisions of the act will not be implemented until 2014.”

In its report on national expenditures for 2013 ,OACT again attributed the continued low inflation to the recession. OACT mentioned the ACA only in passing, and then merely to say that the ACA contained inflationary and deflationary provisions. [2] Of the four deflationary provisions OACT mentioned, only two – the cuts in Medicare’s FFS program and in the Medicare Advantage program – constitute remotely plausible mechanisms by which the ACA could have made a dent in inflation during the 2010-2013 period. But upon examination, those cuts do not constitute a plausible mechanism because they did not take effect until 2012, and they did not become substantial until 2014. [3] To repeat, by 2014 the inflation lull was over.

To your credit, you did not attempt to argue in your JAMA paper that ACOs and other “alternative payment model” (APM) programs authorized for Medicare by the ACA should take any credit for the inflation lull. That would have been foolish for two reasons. First, like the cuts to Medicare, the APM demonstrations weren’t implemented till late in the 2008-2013 period. Second, those demos are saving little or no money and may be raising costs when all costs incurred by all payers (doctors, hospitals, foundations, and public and private insurers) are taken into account.

For the record, the Medicare inflation lull ended in 2014 as abruptly as the system-wide inflation lull ended. [4] Medicare inflation resumed in 2014 despite the big cuts inflicted on Medicare by the ACA and the 2011 sequestration legislation.

Electronic medical records: An overlooked cause of inflation

Oddly, you made no mention of electronic medical records (EMRs) as a mechanism that deserves credit for the inflation lull. You have been a huge fan of EMRs. You believed the folklore promoted by the Institute of Medicine and the computer industry that EMRs would cut medical costs by more than the EMRs cost to install and maintain. Because you believed that folklore, you enthusiastically supported legislation (the HITECH Act, the ACA, and MACRA) that put financial pressure on doctors and hospitals to buy EMRs.

The evidence indicates that the campaign to induce doctors and hospitals to buy EMRs (which began under Bush II) has raised total health care spending. A paper published in 2005 concluded that the cost of installing EMRs in all hospitals and clinics will raise national health expenditures by 2 percent. [5] Not every clinic and hospital has purchased one of the clunky EMRs available for sale these days, so we can’t say the cost of buying and maintaining EMRs has reached 2 percent of our $3 trillion health care bill yet. But we’re getting there. By 2013, according to the CDC, eight in ten clinics and six in ten hospitals had purchased an EMR. Meanwhile, the evidence indicates EMRs are not cutting costs. We may conclude, therefore, that the ACA has contributed to health care inflation by putting pressure on doctors and hospitals to buy EMRs.

Please note I do not dispute those portions of your JAMA paper which argued that the uninsured rate has fallen and that millions of Americans have access to medical care they didn’t have before. I have focused on your cost-containment claims in order to make it clear to you the ACA will never “bend the cost curve.” If it can’t reduce health care inflation, it is unlikely any Congress, even a Congress consisting of 100 percent Democrats, will ever raise taxes high enough to maintain the lower uninsured rate the ACA has achieved to date. I want you to understand the ACA is headed toward “zombie-law” status unless ACA proponents get it through your heads that the ACA’s faddish “value-based purchasing” nostrums will have little or no effect on health care inflation and might even make it worse.

Analyzing the bad advice you got

I believe you cling to the myth that the ACA deserves substantial credit for the inflation lull, and you cling to the hope that the ACA will lower health care inflation in the future, because you bought the wrong diagnosis of the US health care crisis. You bought the diagnosis peddled by the managed care movement since 1970, namely, that US health care costs are high because patients get too much medical care, and this alleged overuse problem is in turn caused by the fee-for-service method of payment. Having bought this diagnosis, you naturally bought the “solution” proposed by the managed care movement – the fee-for-service incentive must be turned upside down by exposing doctors and hospitals to insurance risk, and doctors must be micro-managed. That diagnosis is wrong, and so is the solution.

In my next two posts I will criticize both the managed care diagnosis (overuse) and the managed care solution (risk-shifting and micro-management). I will do so by focusing on three managed care proponents who influenced you deeply: Atul Gawande, Elliot Fisher and his colleagues at the Dartmouth Atlas, and Peter Orszag. If I can show you how they misled you, I believe you’ll be more open to my argument that the ACA is inflationary.

As you can tell, I really don’t like your health policy. But I want you to know I voted for you twice, and I have great respect for you. Thank you for being our president in such tumultuous times.

[1] Here are the inflation figures (increase in national health expenditures) for 2007 through 2014, beginning with 2007: 6.5 percent, 4.6, 3.9, 4.0, 3.9, 3.8, 2.9, and in 2014, 5.3. (Source: National Health Expenditure Accounts )

[2] Here are the inflationary and deflationary factors OACT mentioned in its report on 2013 spending: “A few key provisions [of the ACA] exerted downward pressure on health spending growth in 2013, including the productivity adjustments to Medicare fee-for-service payments, reduced Medicare Advantage base payment rates, increased Medicaid prescription drug rebates, and the medical loss ratio requirement for private insurers. At the same time, other provisions – such as early Medicaid expansion initiatives, a temporary increase in Medicaid primary care provider payments, reducing the size of the Medicare Part D doughnut hole, and the implementation of drug industry fees – exerted upward pressure on health spending growth.”


[3] The Congressional Budget Office projected ACA-authorized Medicare cuts would total $9 billion in 2012, $14 billion in 2013, and $40 billion in 2014 (see Table 2 of this 2011 CBO report ). The $40 billion cut equaled about 1 percent of national spending in 2014, a significant amount. But by 2014, the inflationary coverage expansion provisions swamped the Medicare cuts.


[4] Medicare inflation rose from 3.0 percent in 2013 to 5.5 percent in 2014 (see Exhibit 3 in this paper behind a paywall) , and is projected to remain in the 5 to 7 percent range over the next decade (see Exhibit 2 in this paper, also behind a paywall).

[5] Here is a quote from that paper: “To achieve an NHIN (national health information network) would cost $156 billion in capital investment over 5 years and $48 billion in annual operating costs. … $156 billion is equivalent to 2 percent of annual health care spending for 5 years.” (Rainu Kaushal et al., “The costs of a National Health Information Network,” Annals of Internal Medicine 2005;143:165-173, 165.)

Categories: OIG Advisory Opinions

My Ideal EHR

The Healthcare Blog - Tue, 08/23/2016 - 13:39

Give me technology which improves my life and that of my patients, or give me death.  Medical records must be informative, efficient, and flexible; like the physicians they serve.  For me, a medical record does not contain just a collection of problem lists, prescribed medications, and immunizations; it is a noteworthy account of the health care provided to another human being over a lifetime.

Recently, I attended a baby shower of a patient who is now an adult.  (I am a pediatrician.) I brought her medical chart wrapped with a satin bow as one of her gifts.  I was her physician for many years; my father had taken care of both her and her mother as children.  Her growth, development, immunizations, and illnesses were all recorded; but so were 25 years of life experiences, trials, triumphs, and tribulations.  The back section contains drawings she had given me, newspaper articles of her achievements, graduation announcements, and her wedding invitation.  Obviously, medical records register growth parameters, vital signs, and sick visits; but they also encompass my relationship with my patients.

New technology must be better than what I already use; otherwise there is no reason to change.  In 2009, the Department of Health and Human Services led many to believe (incorrectly) “using electronic health records will reduce administrative burdens, cut costs, reduce medical errors and most importantly, improve the quality of care.”  Few, if any, of these goals have materialized.  IT experts are tinkering with the grand design of a documentation method that has satisfactorily served physicians for hundreds, if not thousands, of years.  It is no small undertaking; a certain degree of diligence is required for conversion to experience success.

Administrators, MBA’s, and CEO’s know nothing of providing patient care, yet they spend obscene amounts of money on fancy automated systems which are grossly incompetent at facilitating our workflow.  Electronically generated notes take up to six faxed pages instead of the requisite one, yet provide little in the way of useful information.   How is that an improvement on what we had before?  Non-physician health leaders are missing the forest for the trees as they search for innovative ways to enhance data collection while overlooking the accumulation of critical information to support proper medical decision making.

Electronic records need to be user friendly, free or low cost for physicians, and reduce the workload, but current systems are far too cumbersome to accomplish this task.  The more complicated and structured the program; the less likely it appears to improve patient care while increasing the physician burden at the same time. Few primary care physicians have weighed in on technology needs because we are busy seeing 20-40 patients per day.   We do not need computers to do the thinking; we need them to do the documenting with speed and accuracy.

To improve care quality, adaptability is also imperative in any electronic system.   Using a simple, basic, and more customizable interface would allow each specialty to tailor the structure to fit their individualized needs.    Clicking pre-defined boxes on a computer screen does not capture the essence of each patient nor adequately describe the distinctive features of various medical conditions.

Visually, my ideal EHR would be a “paper chart” on a computer screen.  The first page would be a standard intake form providing the general health background, birth history, past medical and surgical histories, allergies, immunizations, medication list, and pertinent family history.  The second page is the problem list and other necessary details depending on medical specialty.  The third and fourth pages would be growth charts and then the immunization record follows.  Those pages could be accessible by tabs on the left hand side of the screen to review or update when necessary.

Pressing the edge of the screen would allow review of previous notes with one touch.   There would be tabs on that right side to review labs, radiology reports, and “one-page” notes from consulting physicians with the impression and plan succinctly summarized at the top.  The last tab in the bottom right corner of the screen would contain scanned newspaper articles, pictures, notes, and cards from my patients; I call that my “friendship” section. It is a “custom” add-on that should be offered to primary care physicians like me.

The structure for each note would be SOAP in format; it would take 60 seconds to record an office visit by dictation. A program would convert the dictation to a word processing document in the SOAP layout.   Auto-fill would be unnecessary with such a swift and efficient system.  It must be resistant to crashing and have an auxiliary back-up to store new notes if glitches arise so as not to negatively impact patient care.  Our office has been open during earthquakes, a flash flood, when the power is out, in a windstorm, and when there is snow, sleet or hail (just like the post office.)  Our paper records have never been inaccessible or unusable.

Do not forget the fundamental purpose of medical records in the first place.  They are a chronicle of diagnoses, treatments, and follow up for myriad of medical conditions. Systems attempting to be “one size fits all” lead to over collection of redundant information in the name of comprehensiveness. Unfortunately, no single system has yet achieved the Holy Grail of being cheap, efficient, and accessible while improving the quality of patient care.  Only technology that enhances the practice of medicine for physicians should make the final cut.

It is vital that new technology benefits both patients and physicians, enriching our non-judgmental, empathetic, and long-term relationships.   Seven years ago, I lost a college-aged patient in a car accident.  Placing the final dictation in her chart a week later gave me the opportunity to reflect on our relationship and her assorted illnesses, injuries, and well visits over almost two decades.  What a treasure to behold after years of friendship and medical care.  Her paper chart was tangible proof of a life well-lived.

I recently contacted her mother to inquire if she wanted her daughters’ medical chart.  She said it was a gift to see her daughter through the eyes of her physician, who was there every step of the way.  Medical records are more than metadata on a computer screen; they are a sacred chronicle of our enduring connection with our patients in life, and even in death.   When an EMR can do that, I will be thrilled to embark on a digital journey.  Until then, give me paper or give me death.

Niran Al-Agba, MD is a pediatrician in private practice in Washington State.

Categories: OIG Advisory Opinions

Ten Things About Oct. 1 That You Need To Know Now!

Medical Coding News - Tue, 08/23/2016 - 08:34

The 2017 Inpatient Prospective Payment System (IPPS) final rule brings with it a number of changes that are likely to have an even bigger impact on documentation, coding, and revenue than ICD-10 itself. An unprecedented number of dramatic changes will go into effect on Oct. 1. I knew that things were going to be interesting […]

The post Ten Things About Oct. 1 That You Need To Know Now! appeared first on MedicalCodingNews.Org.

Categories: Healthcare News

Self-Driving Health

The Healthcare Blog - Mon, 08/22/2016 - 12:44

Lots of news about this recently.  Five years ago, you would shake your head and say “no way – not in my lifetime.”  Now you know that this is our future.  It will be safer, will save billions of dollars, and will be have positive consequences we can barely imagine.  The kids need to go to soccer practice?  Send them.  Get the dog to the vet for his check-up?  Plop him in the car and off he goes. It’s real. It will happen.  Soon.

So why is it so hard for us to imagine self-driving health?  Do we have a crisis of under-supply of primary care?  Yes.  Today we do .  But I wonder if that’s because we’re asking the wrong question.

Not long ago, I heard that we would need 60,000 additional primary care visits in our community to reduce the demand for non-urgent visits in our emergency departments.  If a primary care provider can see 25 patients a day – then we need ten additional providers in our community (250/day = 1250/week = 5000/month = 60,000/year).   But what if those 25 visits that didn’t need an ED visit ALSO didn’t require a primary care visit?  What if “visits” in 8 x 10 exam rooms with white-coated professionals weren’t the solution?  Let’s play the “five why” exercise:

Donald Duck went to the Emergency Department

  1. Why did he go to the emergency department?   Because he didn’t feel well and wanted to feel better.
  2. Why didn’t he feel well?  Because he had a fever and cough and the medicine he bought at CVS didn’t help.
  3. Why did he have a fever?  Why didn’t the medicine he bought help?  Because he had a bad cold – maybe even the flu (didn’t get a flu shot) and wasn’t sure what to buy at CVS.  He bought some kombucha and aspirin.
  4. Why didn’t he get a flu shot?  Because he doesn’t like going to the doctor.  Only goes (to the ED) when he feels sick.
  5. Why doesn’t he like going to the doctor?  Because they never seem to listen to him – and doctors are for sick people anyway.  Why bother?

So what’s going to prevent Donald – and 24 of his friends – from going to the ED?  Is it another doctor with an open appointment?  No.  Education, empathy, caring people – who can help Donald understand what’s available to him to prevent illness, and what’s available to him when he is ill:  a phone call, some good trustworthy advice, and (yes) if necessary – a visit with a care provider. But I’d argue that this is much less frequent than we assume.  Adding 60,000 visits is a short sighted (and impractical) way to solve this problem.  We need to help Donald to find self-driving health:  tools that help navigate, understand his goals, and get him from were he is to where he needs to be.

Categories: OIG Advisory Opinions

Aetna’s Obamacare Surprise

The Healthcare Blog - Sun, 08/21/2016 - 12:39

Did Aetna just pull a nasty, Trump-like move and up the ante on the Obamacare debate in advance of the election and exchange open enrollment for 2017?

The allegation is that the company withdrew from 11 state insurance exchange marketplaces for 2017 after the Justice Department failed to heed Aetna’s warning that it would do so if Justice didn’t approve its $37 billion purchase of Humana.  The Justice Department announced last month that it was challenging that deal and Anthem’s proposed merger with Cigna, saying both deals threaten to sharply reduce competition in the health insurance marketplace.

A July 2016 letter from Aetna to Justice, unearthed by Huffington Post, contains the threat.   But in announcing its exchange pullback this past week, Aetna made no mention of the letter and insisted its action was prompted by existing and expected future financial losses in the exchanges.

Even if there was no quid pro quo with respect to the Humana purchase, was Aetna’s move justified by the losses, and forecast of future losses?

You could argue that’s their business and their decision.  But in April, according to news reports, Aetna’s CEO, Mark Bertolini, said the company was committed to staying in the exchanges and making them work.   Indeed, he told analysts that it would have cost the company around $1 billion to acquire the million or so new customers it had signed up on the Obamacare exchanges.

Moreover, the company booked $200 million in ACA-related pretax losses in the second quarter of 2016—not insignificant but far from an existential threat to the company.

In addition, there’s every indication at this point that state regulators are going to approve fairly substantial premium increases for 2017.

Said Bertolini this week: “As a strong supporter of public exchanges as a means to meet the needs of the uninsured, we regret having to make this decision.”

News reports implied heavily that what Bertolini and Aetna started to really worry about was the possible $1 billion breakup fee they’ll have to pay Humana if the purchase deal is blocked.  And thus, there’s the future implication in Aetna’s move that it is losing faith it will prevail in its merger battle with the government.

Aetna’s withdrawal from the exchanges is just the latest.  UnitedHealth said it’ll depart all but a few of exchanges in 2017 and Humana is dropping out of many exchanges, too.

So, here’s question 1:  Do these large, powerful, and rich insurers have a social responsibility to hang in the exchanges for at least a few more years to help address what was an awful 40 year social problem (too many uninsured) and market failure that was largely of their making?

Question 2:  Are the mergers among four of the largest health insurers a good or bad idea?  Is the Justice Dept. right or wrong to try and block them?

Question 3:  Is Obamacare imploding, with proposed premiums soaring and stable insurers dropping out?  Or is this just an expected period of turmoil in a new and highly competitive marketplace in which consumers have turned out to be very price sensitive (about 40% of returning exchange enrollees switched plans last year and the vast majority went to cheaper coverage) and in which there will be winners and losers?  (The co-ops were clearly big losers.)

Question 4:  Is the adverse selection issue in the exchanges—too many old, sick people and too few young healthy ones—a potentially long-term problem that’s unlikely to change without major remedy.  Or is that a short-term problem likely to correct itself over time, especially as the tax penalties get larger?  Could 2017 be the turning point year when young people start to flood into the exchanges, due to the higher tax penalties, marketing, and social forces?

Question 5:  What can and should be done to control premium increases in the exchanges?  Should benefit designs be more flexible?  Do the subsidies need to be increased to make coverage more affordable, or is that caving into insurers and providers failure to control costs?

Let the dialogue begin?

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

Categories: OIG Advisory Opinions

More Than a Lollipop: Helping Kids Get Through the Hospital Experience

The Healthcare Blog - Sun, 08/21/2016 - 11:55

In the latest installment of the Who Cares: Hospital Talk podcast we chat with Kristin Colby, a specialist with Children’s Hospital of Atlanta about the challenges of preparing kids for the uncertainty and trauma of hospital care. Could working with kids just maybe teach something to the rest of us? Maybe. Just maybe ..

Categories: OIG Advisory Opinions

The Exchanges Part II

The Healthcare Blog - Sun, 08/21/2016 - 06:57

I wrote earlier here about the exchanges, how they are failing, and why.  It is unsurprising that what I wrote is coming true, not because I am some clairvoyant, but because I’ve lived in the insurance world and understand it.  The causes are very, very obvious.

The most recent whipping boy is Aetna, which announced that it is exiting most of its exchange markets, citing losses of $200 Million in the second quarter. From correspondence, it is clear that Aetna was willing to be a good citizen and accept such losses if its proposed acquisition of Humana were not opposed by the feds.  Well, the feds are opposing.  And predictably, Aetna is sending back a message that it’s willing to be a good citizen, but only up to a point.

Might we wonder what the Obama Administration is thinking regarding the exchanges?  All of this is so predictable.  The exchanges were designed to fail economically.  Fundamentally, insurance is a financial matter.  Money in, money out.  If the exchanges were designed to be something else (a socially-conscious program to afford (so to speak) coverage to everyone that would require tax subsidies), it might be time to admit to that.

The Administration’s view of private health insurers is reflected in the rather snotty recent comment by Kevin Counihan, Chief Executive of the US government-run individual marketplace, that:

“It’s no surprise that companies are adapting at different rates to a market where they compete for business on cost and quality rather than by denying coverage to people with preexisting conditions.”

That was totally uncalled for and simply does not advance the discussion.  Pre-existing condition clauses were a perfectly acceptable (financially) underwriting technique.  The truth is that if the administration (which is decidedly NOT business savvy) is going to play in the rough and tumble sandbox of health insurance, it needs a reality check, which it appears it is now getting, whether it admits it or not.

One wonders if anyone with true insurance cred was involved in the design of the exchanges.  Steven Brill’s book, America’s Bitter Pill, describes in exhausting detail how Obamacare came about.  At the risk of over generalizing, there were two camps.  One was focused on expanding coverage AND reducing costs.  The other was focused only on expanding coverage.  The latter group “won.”  It was all about getting a win, getting something on the books, and worrying about the costs later.  Well,that later is now.

As the WSJ’s Reporter Greg Ip noted on Thursday, “Selling mispriced insurance is a precarious business model.”  In his article he noted that the average 64 year old consumes six times as much health care as the average 21 year old.  To force insurers to adhere to a 3:1 maximum ratio, an insurer would have to charge the 21 year old 75% more than his actual cost and the 64 year old 13% less.  Go figure.  I know this is about spreading risk, but let’s be clear about the results.

And therefore is it any surprise that young healthy Americans are avoiding exchanges?

So what is going on here?  What is happening is that a fundamentally financial transaction (insurance) has been politicized.  Once that happens, normal actuarial and underwriting rules are out the window.  This is all about “doing the right thing” by the lights of politicians, something that is difficult to oppose in principle, but more difficult to finance.

I’ve never met Aetna’s CEO Mark Bertolini.  Yet, he seems like a forward thinking guy who is the sort of person you’d want as the CEO of one of the major health insurers in the US.  Yet, we’re now vilifying him and his company.  Of course there is a quid pro quo in the willingness to accept losses in the exchanges and the merger.  That shouldn’t shock anyone.

And this isn’t about the insurers mispricing because they were negligent.  Jumping into the exchanges, they had NO DATA on which to price, so they guessed.  Then, as experience progressed, the adverse selection that occurred caused the price spiral to continue.  As Alissa Fox of the Blue Cross Association noted, “We’ve just seen the costs of people increasing.”

It’s all about dollars in, and dollars out.  We unfortunately seem to have a government that legislates based on wishes rather than reality.  Might we please have an administration that undertakes a financial obligation using honest, financial bases?

Jim Purcell is the former CEO of BCBS of Rhode Island and before that a trial lawyer. Today he arbitrates and mediates complex disputes.

Categories: OIG Advisory Opinions

The Iora Health Fellowship: A Call For Applicants

The Healthcare Blog - Sun, 08/21/2016 - 06:00

As physicians, we pride ourselves on our clinical wins – nailing the diagnosis of a rare disorder or helping a patient achieve control of their long-standing diabetes. However, we commonly face intense frustration and high rates of burnout due to socioeconomic, political, and bureaucratic forces that prevent us from delivering impactful patient care. This frustration is compounded by the constant proliferation of changes in healthcare policy and care delivery to address alarming increases in healthcare cost and waste. Between the deluge of paperwork, regulations, and resource constraints, we often ask ourselves: Why does the system often hinder rather than enhance the physician-patient relationship?

The truth is that physicians can no longer sit on the sidelines. The questionable value of so many clinical procedures and the immense cost baked into the system are clearly unsustainable. Given that physicians – with their patients – ultimately make decisions regarding care plans, they are uniquely positioned to move the healthcare system to one that rewards doing only what is best for the patient. Yet, current physician training rarely incorporates curriculum designed to create systems thinkers capable of leading multi-discplinary care teams.

Enter Iora Health and its unique fellowship in primary care innovation and leadership. Iora is an innovative primary care delivery startup that is committed to restoring humanity to healthcare. It advances a high-impact, relationship based primary care model that is backed by talented health coaches, robust technology, and payment that is focused on patient outcomes.

The Iora fellowship, now taking applications for its fourth cohort, is designed to train the next generation of leaders that are focused on doing rather than talking about how to fix primary care. Iora fellows are enthusiastic clinician innovators that are committed to improving the primary care system while practicing medicine in an Iora clinic – the goal here is to develop leaders with deep appreciation for how interdisciplinary, collaborative care works. Besides superb clinical skills and deep-seated compassion, Iora fellows gain advanced systems thinking and management expertise. In part, this is accomplished through rigorous mentorship from Iora’s executive team, including frequent involvement from nationally recognized health innovation leader and Iora’s CEO/Co-Founder, Rushika Fernandopulle. Additionally, fellows complete a Masters in Healthcare Delivery Science at Dartmouth’s Tuck School of Business. Innovation projects round out the experience.

The fellows like to think of this program as an intense and multifaceted study of innovation as it happens on the frontlines. The regular mentorship from top-level physician and operations executives is genuine and heartfelt. The Masters at Dartmouth is one of the premier programs in the country committed to creating a legion of healthcare leaders committed to system transformation. It does this by placing key stakeholders in healthcare – providers, policy experts, payers, administrators, and industry executives – in the same classroom to learn from and challenge each other. Our individual projects have included the design of a primary care hospital visit program; leadership of a cross-functional team tackling medication reconciliation; buildout of a screening and referral tool for patients’ unmet social needs; and the creation of “Jumpstart” visits to creatively engage patients when they first join our clinics. Besides these projects, fellows take on a very real leadership role in helping run their respective clinics – they lead initiatives in population health management, analyze performance data, design clinic strategy, and act as cultural ambassadors. Perhaps most importantly, fellows are clinicians that see patients everyday – this ensures that their innovation work and learning is directly tied to the patient. The breadth of these experiences ensure that fellows are ready to take on a real leadership challenge upon completing the program.

Major changes in healthcare are afoot, and it is up to us to ensure that we have the skill set necessary to thrive in this dynamic environment. Change is rarely easy, but it does provide ample opportunity to rethink how care can be engineered to meet the needs of patients and their providers. The Iora fellowship in primary care leadership and innovation is a unique and fantastic opportunity to learn by doing the work necessary to create the change agents that American healthcare so desperately needs.

We are currently accepting applications for our fellowship class of 2019.

An Iora Fellow is a board-certified/eligible physician who has completed (or will soon complete) an accredited residency program in one of the following disciplines: internal medicine, family medicine and medicine-pediatrics. The two year fellowship provides a full-time, competitive fellowship-level salary, benefits and full Dartmouth tuition, contingent on admission to Dartmouth’s MHCDS program. All MHCDS coursework will take place in an executive education format, with both off- and on-campus coursework interspersed throughout the  program. Iora Fellows may be placed at any of our practice sites nationwide, both existing and new.

Please note the application deadline of September 30th, 2016.

If you’re intrigued, please visit our Web site at or contact Stephen Gordon, MD, MBA, Director of Fellowship at

Categories: OIG Advisory Opinions

Value-Based Government (GACRA)

The Healthcare Blog - Sat, 08/20/2016 - 05:07

We decided that if MACRA is good for physicians, then the same thinking is probably a pretty good idea for the US government. We need Value-Based Government. It’s clear that past methods of paying for US Government services have been terribly inefficient. Costs keep going up. Quality keeps going down. We thought about doing this nationwide, with all US government personnel, but we will just do CMS leaders for now. Let’s call it a demonstration, we’re calling it  GACRA, Government Access and CMS Revaluation Act.

Eventually we want all US government employees to be value- based, no more salaries. This is an obvious improvement on how we will pay you,  The way you are paid now does not seem to work. Everyone agrees our government is too expensive to run and nothing gets done.

Here’s how value-based government works:

Every CMS leader will send in a code for every 10 or so minutes of work and exactly what they did. Yes, Andy Slavitt and Sylvia Burwell, you will not be paid as you were previously.

You will now be paid for value.

With GACRA, you will need to document every thing you do, but we will only pay for meetings and rules you make.

You will be paid for each meeting in this manner: You need to document the history of the meeting, what you discussed, how complicated the problem is, did you review any prior documentation, did you do an adequate review of the pertinent materials?  You will document a level 1,2,3,4, or 5 depending on the complexity, history etc. Don’t document a 4 if it was really a 3, thats fraud, so pay attention, its a complicated formula, but you have time to figure it out.

Now also you will need to code the meeting, there are 70,000 codes to chose from…like “Meeting to Discuss the Burden of MACRA on Physicians, While Riding on Waterski’s that are on Fire”. Be specific, if you want to be paid. Remember, we do not pay for scribes, Andy and Sylvia, you must do all this data entry and documenting. Don’t forget, you cannot bill us until you finish you documentation and sign it.

You will be paid for every rule you produce. If you go back to the rule within 90 days to work on it, you cannot charge us for the rule. Every rule has a specific code, be sure it matches the codes for the meetings that you used to make the rule, if they do not match to our liking, you will not be paid. Remember you will need to create an electronic claim to file with a clearinghouse all your meeting and rule codes.

Remember, you do not get paid for phone calls, emails, text, Twitter, vacation, only when doing what we think is measurable work.

For EVERY meeting and rule, you will now with GACRA, have to answer at least 6 Quality Questions about the meeting or rule. This is a big improvement from 9, so be thankful. We will give you a list to pick from. You will need to select at least one cross cutting measure and one outcome measure.

This is the Quality portion of GACRA we changed the way we pay you and give you financial incentives for providing high value government or penalties for half of you.

We want to be sure you are using the computer correctly, to document all this. So we’re introducing a new program that will called Advancing Government Information. There are at least 6 objectives with multiple measures in each that you will need to report on for MU/AGI. It used to be more objectives and measures, so be thankful its just 6 with multiple measures in each. For instance, your work on your computer needs be shared securely and your records can easily be exchanged with the DOD and VA (not 5 years from now), and physicians and citizens can access through a portal the work done you claim you did on meetings and rules, all within a day or so, etc.

Again, there will be at least 6 other Advancing Government Information objectives with multiple measures in each objective we want to monitor. This will be reported separately, but it will affect your pay, just wanted to let you know. Also if ANY of this information exchanging gets lost or a cyber criminal takes it, we fine you. You may call that victim blaming, but we need to make an example of you. But keep sharing all your data, but don’t lose one byte. You have to sign a form that you are NOT in anyway trying to block any information in anyway, even if you don’t totally understand what that means nor can you control the software, we want you to sign that.

I also want the CMS leaders to tell me what Government Improvement Activity they are participating in. This is a separate and new part of GACRA. You have to get a score of 60, so you will have to do at least several activities of high or medium weights. Look at our list, for instance, you, yes you, will need to be available 24/7 for your answering questions about your meetings and rules, you offer same day meetings for concerned physicians/citizens, employ shared decision making with physicians. Good stuff. This too will be added to the equation to see if they are penalized. You are not doing enough already, we want you to do more. We want value and these are laudable goals.

Among all this, if we as citizens and physicians feel they are not satisfied with your rules or meetings or you did not listen to them, the citizen can “rate” the CMS leader less than 5 stars, this will probably cause you to be penalized, so be sure to do whatever the citizen or physician wants, as you need 5 stars for each one. Citizen and physician satisfaction is a top priority now.

In the end, we will then do some calculations on all this and its possible the CMS leader may get a bonus or a penalty depending on other leaders at CMS, if they are doing a good job or not. You could be penalized even if you think you are doing a good job. Too bad, you are all competing against each other, we have to balance the bonuses with the penalties. I mean you all can’t be doing a good job, half of you are worse than the others. Isn’t this great, budget neutral! Half of you will get a bonus, the other half will get a penalty. And those bonuses and penalties will keep increasing every year up to at least 9 % of you fee schedule payment.

To document all this, you must use the software that we certify, you cannot use your own. No customized software. We know better on what you need, not you. You may think you have a better way, but forget it. We don’t want innovation or new ideas, we want you to use old, one-size-fits-none software, that they will charge you a lot of money to buy and support. Sorry that its pricey and it doesn’t work well, it is what it is, don’t whine about it.

As for how you get paid again, you will need to file these claims of work electronically with a clearinghouse, obviously use ANSI X12/5010 specifications, and we will decide if we want to pay you, it will take at least 14 days for every claim, maybe longer. You can call us if we decide not to pay you, and if we feel we didn’t want to pay, even if you did the service, we may or may not answer or help, or just tell you to refile, and then re-deny it because you already filed it. We may also send a company that we pay if they can find a reason to clawback your payment for work from years ago, they get paid to determine that you did not document your interaction to our liking. Sorry about that, those are the rules.

Now for those pesky quality indicators and such, you will need to use a fancy add-on section of your software or a separate registry or something similar for the value based measurements, like Quality and Advancing Government Information and Government Improvement Activities. Finding a registry and signing up, well, that is for you to pay for and figure out how to send the data.

We will also audit your attestations with GACRA. We want to be sure we are paying you correctly. We know these GACRA rules are complex and they will probably change every year (or less), get new names, new measures, lots of fun stuff, big long 1000 page rules, so much fun. Don’t let it stress you out, worst case, you will just have to pay us all your money back.

As a fun idea, we decided there is also an Advanced Leader Model that will allow leaders to create a fancy group, but you will have to use a software that we certify and the CMS leaders will must take some financial risk and their are lots of extra complex rules for this, most won’t want to do this. We know taking risks is usually for insurance companies, but hey we want you to get in the risk game, since its so complicated, we will most likely always win! Don’t be sad.  We never showed that this Advanced Leader Model stuff works, ever, but still, we think its neat. We are thinking of other untested, fun things too, like giving you a bundled payment for a rule with lots of problems, if they have more problems within a few weeks or months after you do the rule, you will be penalized or if we go outside your fancy Advanced Leader Model for help on rules you made, you may get penalized and have to pay us back. But you could make 5% more than normal if you are really quality leaders.

If we feel you were negligent, like implemented a rule without testing it or proving it works, or if it has always failed and you keep making us do it, or the rule did not get the desired outcome, we can sue you, so get malpractice insurance too, you don’t want to lose your house or savings.

Finally, we will also factor in if you cost a lot of money to do all these meetings and rule writings. If you cost more than we think you should have or used more resources that we feel you should have used, we will penalize you, there is no real way to measure this, but wanted to add that in too.

The final rules will come out in November 2016. This will be implemented January 1, 2017. Your pay will be affected in 2019. There is no way to check how you are doing. It will magically happen. You will not be paid to implement any of this. You have no recourse. Good luck. More hurdles to come. You should not feel burdened, this is such an improvement! Don’t you agree, we all want value based government, along with butterflies and rainbows. This streamlines all your work into one program, we listened to you. We want a better, smarter Government. Government meetings and rules made for physicians and citizens need to be open flexible and user centric.

#GACRA is Great!!

Categories: OIG Advisory Opinions

The American Medical Association Takes a Step In the Right Direction

The Healthcare Blog - Sat, 08/20/2016 - 02:47

I am very glad the AMA is studying the issue of aid in dying. Opponents to the legalization of aid in dying put quotes around the term, apparently to indicate that it is a euphemism for what they believe is physician-assisted suicide. But aid in dying is not suicide.

On 9/11 witnesses saw a number of people trapped in the World Trade Center intentionally jump to their deaths. None of those deaths were ruled suicides by the medical examiner. The death certificates for the jumpers list the cause of death as homicide.

Similarly, in the states in which aid in dying is legal, the death certificates do not list “suicide” as the cause of death; instead, they list the underlying terminal disease as the cause. Just as the 9/11 jumpers chose death by falling over death by burning, those terminally ill people fortunate enough to live in an aid in dying state can choose a peaceful, quick death at the time and place of their choosing over a drawn-out, miserable death that may end alone, intubated in an ICU rather than at home with loved ones present.

Doctors have traditionally been associated with saving lives and the Hippocratic oath rejects doing harm. However, doctors have also been traditionally associated with preventing suffering; and giving a mentally competent, terminally ill patient a prescription to end his or her life does not seem like “doing harm” to me. I see it as an act of compassion supporting a patient’s right to choose how he or she wants to die. The patient is not choosing whether or not to die; that is a given for the terminally ill. The patient is choosing how to die, just as the jumpers did on 9/11.

The author is executive director for Life Choices New York.

Categories: OIG Advisory Opinions

Capping Co-Pays Doesn’t Lower Drug Costs

The Healthcare Blog - Thu, 08/18/2016 - 17:00

Politicians are concerned about your drug costs. Unfortunately, their proposals could actually raise drug prices and force you to pay more, albeit indirectly. For instance, presidential candidate Hillary Clinton proposes to cap your prescription drug co-pays at no more than $250 per month. Rising drug costs are now a political issue because the number of diseases and conditions that can be treated using drug therapy has grown tremendously over the past 25 years. Arguably, one of the main reasons patients visit their doctors is to obtain or renew prescriptions. When they visit their doctors’ offices, Americans leave with a prescription in hand about three-fourths of the time. This is hardly a travesty; and few patients are drowning under the cost of prescriptions drugs. Most prescription costs are paid for by prescription drug plans sponsored by insurers and health plans.

Insurers and health plans use multiple techniques to make drugs affordable. One of the ways employers, insurers and pharmacy benefit managers (PBMs) hold down costs is through drug formularies with multiple tiers. The purpose of tiered formularies is to steer enrollees to lower-cost alternatives when appropriate, using differing levels of cost-sharing and co-pays. Drug plans typically encourage generic use by requiring little if any cost-sharing when a generic drug is dispensed. Prescriptions are dispensed in generic form about 88 percent of the time. Generic drugs are cheap compared to brand drugs — accounting for less than three percent of national health care expenditures.

However, drug plan formularies usually require higher cost-sharing (and co-pays) for patients who prefer to take more costly brand drugs — especially brand drugs for which cheap, effective substitutes exist. Some drug plans also have specialty tiers for costly “specialty drugs.” Specialty drugs are used to treat serious health conditions like cancer, hepatitis C, rheumatoid arthritis and some rare diseases. Specialty drugs are sometimes administered in hospitals and clinics, and are more expensive than typical brand drugs. These newer therapies are often derived from living substances and expensive to produce. Only about 1 percent of drugs fall into the unofficial category known as specialty drugs, while about 11 percent fall into the category of brand drugs. Specialty drugs tend to have the highest cost-sharing and would be most affected by a cap on co-pays.

Health plans carefully manage these drugs due to their high cost.
For the most part, drugs are a bargain. Yet Hillary Clinton wants to pass legislation that would allow these high-priced drugs to rise even higher in price. She is not alone. At the federal level, Oregon Senator Ron Wyden has championed bills that seek to cap prescription drug cost-sharing for Medicare beneficiaries. At the state level, one-third of states have either passed legislation or have introduced bills that seek to limit cost-sharing. So far seven states have laws limiting cost-sharing for drug therapies. An eighth state, California, passed a law due to take effect in January 2017.

The forthcoming law in California would limit copays to $250 for a 30-day outpatient prescription ($500 for people with high-deductible plans). A law in Louisiana limits copays to $150 per prescription, while laws in Delaware and Maryland limit cost sharing to no more than $150 a month. A law in Vermont limits copays to no more than $1,000 per year. In Maine, copays cannot exceed $3,500 per year.

What’s wrong with these laws? Plenty! Increasingly, health care has become a gold rush with some health care industry stakeholders looking for ways to swindle employers, insurers and taxpayers into reimbursing outrageous prices. About a year ago, drug maker Valeant Pharmaceuticals was accused of using various strategies to aggressively raise drug prices, most of which was passed on to insurers, employers and health plans. One strategy was to partner with a pharmacy that would not substitute generic drugs for brand drugs costing a multiple of the cheaper drugs’ price. Another strategy was to waive expensive co-pays so patients would not request a generic substitute. About the same time another drug company, Turing Pharmaceuticals, carefully sought out and acquired old generic drugs that had little competition, and then raised prices aggressively — in one instance by 5,000 percent.

Valeant and Turing developed these elaborate strategies because the firms know there are limits to what consumers are willing to pay for drugs. But if consumers can be insulated from high prices and discouraged (or limited) from selecting lower-priced options, the sky is the limit to the prices that could be charged for drugs.
Patients benefit enormously from safe and effective drug therapies. Drug therapy is the most efficient method to treat most ailments — often substituting for more expensive hospital and surgical treatments. Campaign rhetoric about unaffordable drug costs is much ado about nothing. The proportion of drug costs Americans pay out of their own pocket has been falling for decades. Around 1960, Americans paid for nearly all of their prescription drugs. By 1980, that figure was down to about 75 percent. By 1995, the figure was 50 percent. Today, Americans pay for only about 16 percent of their prescription drug costs. Moreover, an estimated 70 percent of Americans belong to a drug plan that manages drug benefits on patients’ behalf. According to industry data, nearly one-fourth of retail prescriptions are fully covered by insurers and require no copayment by the patient. An additional one-third cost the patient $5 or less. Just over three-fourths cost the patient $10 or less.

Cost-sharing is a method employers, insurers and drug plans use to hold down drug spending and keep premiums affordable by giving enrollees an incentive to ask for generic drugs. Cost-sharing also provides drug makers with an incentive to limit excessive price hikes. If Hillary Clinton and others are successful in their attempts to limit cost-sharing, you can bet there will be even more drugs with prices that reach the stratosphere.

Devon M. Herrick, PhD is a health economist and senior fellow at the National Center for Policy Analysis.


Categories: OIG Advisory Opinions

Patients Without Borders

The Healthcare Blog - Thu, 08/18/2016 - 12:04

More about Jess Jacobs, who died on Saturday–also known as #UnicornJess. (That link will take you to the twitter memorial on Sunday night, but also check out remembrances from Ted Eytan & Carly Medosch). Today I’m re-running a beautiful, and very personal piece (on Medium) from her friend Whitney Bowman-Zatzkin who was a key patient advocate for Jess in Washington DC–Matthew Holt

I attended a walking tour once where the guide was going on about Von Gogh’s quest to paint yellow in the most yellowy of yellow ways. Even NIH articles talk about it. Theories abound.

As we walked, I gained an appreciation for the lengths this guy went to on his quest for a single portrait of yellowy yellowness. I remember the guide saying something like:

“Van Gogh sought his whole career to paint in a way that demonstrated how yellow made him feel.”

The tour was years ago but that line stuck with me. Has anything ever trapped you like that? Like a quest to craft a brushstroke for how something made you feel?

My treasured friend Jess Jacobs died this weekend. She flooded my life with laughter and jokes, expanding what I knew in what it is to love a friend in the very best of ways.

Jess and I met in a classroom at Georgetown where she swiftly passed out in front of me when I returned for the final pitches of my first-ever code-a-thon. Later she’d tell of waking up to a blur of people and a certain bow tie being in focus.

Shortly thereafter, she fainted in front of me again and I soon learned how to trust a new friend and be there for her more than I ever had before. That pattern continued throughout my whole friendship with Jess. She gifted me a new definition of trust and capability.

Some of the scariest words I’ve ever known in health care existed in Jess’ medical profile, yet she was always the outlier redefining what it meant to have those diagnoses.

In the easiest of moments, we’d bandage a knee and make a few jokes about how her wardrobe encapsulated the very best of falling-down-worthy attire. We’d hand her salted sodas or ice packs and sanitizing lotion or rubbing alcohol swabs.

I’ve used geolocation on a phone to find Jess and pick her up and take her home. I’ve played a hands-shaking medical assistant for her as we set up IV drips, performed heparin flushes to a port, and sorted through an intimidating inventory of medical supplies in her apartment. I’ve called more than one stranger (or rather, friend-to-be) to get a set of updates and hand-off details as we “changed shifts” for visiting her in a hospital. I was there to soften the blow of threatening letters from clinicians refusing her care as they faced their own fears, calming or distracting Jess while an incredible force of others would make calls and demands for action. I’ve stood there while clinicians, including some I deeply admired, all checked a mental box for triage and passed her to a never-named “someone else.”

Jess and I were ferocious FaceTime users. When she was going through a spell of bizarre fevers and infections we created an “isolation period” for when I was home from work travel. I couldn’t visit her for three days after flying so we could make sure all the germs “fell off.” It wasn’t evidence based, but it made us feel like we were doing something to help stop the mystery infections. We’d FaceTime together and share a tour of her meal tray or grand accommodations.

In the best of moments, Jess and I swapped internet memes and daydreamed about our futures and families-to-be. We made pinky-promises on secret pranks. We’d debate just how much we’d rabble rouse for the next bit, celebrate our recent victories, swap stories about our must-meet mentor list, dream massively for the things we’d fix if given the opportunity, and then toodle off to our next set of shenanigans.

When a tweeting artist first surfaced with an idea for something called the Walking Gallery of Healthcare — we dove in and recruited others, swiftly embracing Regina as fully as possible. Walking together that first night as the Gallery solidified our friendship.

Years later, when a colleague left a post at HHS, we swapped texts about how it was the end of an era and how just like our mentors chatting about the “last time we passed health reform in the 90s,” Jess and I would one day be the older generation of folks in DC and we’d be talking about “that time in 2011” when we all met.

In the toughest of moments, we’d cry together on the phone and I would beg her to never give up fighting. Relentlessly, we’d stay on the line until one of us would crack a joke that demanded a belly laugh. Instantly, we’d both be back to desperately searching the internet, scouring every published journal and data set and design workshop for another path in the choose-your-own adventure novel that was “care coordination” for dear Jess.

As things were advancing for Jess, my spouse, Jake, and I were soon in her “first responder unit” — a small team of friends in DC that sought to catch her when she fell, or maybe it was more to make sure she had a gentle landing. We’d keep her company during hospital stays and, eventually, help advocate and fight for her basic rights in the health system. We’d coordinate her care when no clinician would — with the resourcefulness of our MSF-Doctors without Borders friends abroad. We didn’t have to go abroad to a remote nation state to serve where most needed, we just had to look about a block into DC.

We became a bonus-family because of Jess.

I became an expert at pulling up medical notes and records on cell phones (that she had at the ready at all times), honored her requests to not call an ambulance, and eventually got quite good at firmly telling venues from the Kennedy Center to the White House to trust me that the person on the ground was actually “fine” and did not need security to call 9–1–1. I learned how to recite the names of her conditions to medical teams and I often kept a little “notes” file on my phone of her latest, just in case. I carried Disney-themed band-aids and salt packets and gatorade mixes quietly in my bag at events we attended together as well as extra charging cables I could leave with her if needed. And, as I came to know more of them, I’d mention to event hosts before we were onsite to reach out if something happened to Jess and give them my cell phone.

I was never the only one doing these things. We all just hoped to one day be enough.

I’d watch for any of her symptoms before she might fall whenever I saw her, carefully balancing my own worry against her love of “free-range Jess” status.

These small moments, these tweaks or hacks to the norm, they gave Jess the ability to live her life as an enriching part of ours.

Occasionally I was scared, I’d debate the ethics of where we stood trying to be the right thing for Jess vs. the reality of those able to do the right thing, but refusing to stand.

Though strangled into accepting repeat inaction, our crew was purpose-driven. This was for Jess.

We invented the best protocols to follow because we had to.

We created the Jess model of care delivery and set quality goals for how Jess wanted to live.

We’d push her when we needed to and we’d comfort her when we had to.

We worked within the lines and eventually grew fluid to stand outside them.

We never looked back or questioned that we should do it, we always just asked how, and we became very careful to make sure we supported one another when we needed our own breaks. Jess never took a break.

We functioned in this strange place in health care — we were present, but not accounted for.

As friends, our little team knew a secret type of life-resilience and love for one another through our communal heartbeat, Jess.


Much like Van Gogh’s quest for yellow, I may never have the ability to write how these years having Jess as my friend truly made me feel.

I was blessed by her friendship. I’m so deeply thankful her family let us borrow her for a while out here in DC.

She altered the DNA of our community. That’s perhaps the toughest thing to attempt to describe. She changed who we are and how we approach life and our expectations for it.

Jess was the brightest light, the deepest laugh, and the spunkiest of people. She was magic.

Thank you for being in my life. I love you, Jess.

  Visiting during one of many hospital stays. We got a little punchy in trouble shooting an IV-line-clip idea and thanks to a local pharmacy, solved it with…lip clips.


Whitney Bowman-Zatzkin runs the Flip the Clinic project for RWJF and is obviously a great friend

Categories: OIG Advisory Opinions

The American Medical Association Goes Wobbly on Physician-Assisted Suicide

The Healthcare Blog - Thu, 08/18/2016 - 08:50

Physician-assisted suicide. Physician-assisted dying. Physician Aid in Dying. All these terms have been used to describe a terminally ill patient’s use of a lethal, prescribed medication. Sometimes the medication is used to end the patient’s life; sometimes, it is held “in reserve” to provide a sense of control over the timing of death. Historically, the American Medical Association has stood squarely against physician-assisted suicide (PAS). But recently, in approving “Resolution 015”, the organization has resolved to study the issue of “aid in dying”, with an eye toward reconsidering the AMA’s longstanding policy. As a medical ethicist, I find this resolution deeply troubling.

Consider this scenario from an ethical perspective. Your loved one is facing a terminal illness, and is expected to live only another month or two. He is sitting in his doctor’s office, and knows that the doctor owns a gun, which she keeps locked up and loaded in her office. The patient, who is mentally competent, requests use of the physician’s gun, in order to end his life. Would it be ethical for the physician to grant the patient’s request? I suspect most of us would be horrified at the thought. Indeed, most U.S. states have laws that prohibit someone from “knowingly and willfully assisting” another person in the commission of suicide.

Yet four states (California, Vermont, Washington and Oregon) have passed legislation that allows physicians to prescribe a lethal drug to terminally ill patients who wish to end their lives. (In Montana, the state’s Supreme Court ruled, in 2009, that terminally ill patients may avail themselves of a physician’s aid in ending their lives, without deciding the constitutionality of that practice).

From the ethicist’s point of view, the question is: what is the ethical and moral difference between handing a terminally ill, suicidal patient a loaded gun, and handing him a lethal prescription? In both instances, the physician acts with the knowledge that, if “correctly” used, the lethal means will almost certainly kill the patient. Indeed, I believe the apparent differences between the scenarios are mostly cosmetic and psychological: we associate physicians with writing out prescriptions, not with handing out loaded guns.

I don’t mean to argue that the procedures and safeguards in place for PAS are ethically equivalent to handing the patient a loaded gun. In all four states where PAS is legal, there are safeguards to ensure that the patient is acting voluntarily and not, for example, suffering from a psychiatric disorder that impairs judgment. However, there continues to be controversy regarding the adequacy of these supposed safeguards, and research studies have yielded mixed results. My point is simply that the mere act of prescribing a lethal drug to one’s own patient is comparable, in ethical terms, to handing the patient a loaded gun.

To be sure, guns are widely available to almost anyone in the U.S., whereas medication is dispensed almost entirely under the aegis of a physician or other health care professional. This has led some to argue that, if PAS is prohibited, there ought to be some legally approved mechanism for terminally ill patients to acquire lethal medication, without involving physicians. This is certainly an issue worthy of debate and discussion, and I might conceivably support such a mechanism. But, in my view, the absence of this option does not legitimize the use of physicians as indirect agents of the patient’s death. Indeed, beneath the comforting euphemisms of “death with dignity” and “physician assisted dying”, we find a stark truth: in states where PAS is legal, some physicians—albeit with humane intentions– are deliberately facilitating the self-induced death of their patients. I do not condemn the benign motives of these physicians, but neither do I condone their actions.

To be clear: the U.S. Supreme Court, in its 1990 Cruzan case, supported a mentally competent patient’s right to refuse medical treatment or to stop intrusive medical care, even if that decision is expected to be life-ending. However, in two 1997 cases (Washington v. Glucksberg and Vacco v. Quill), the U.S. Supreme Court essentially rejected a constitutional “right to assisted suicide.” Even the famously libertarian psychiatrist, the late Dr. Thomas Szasz, did not recognize a “right to suicide”–much less to physician-assisted suicide–though he believed that persons ought to be “at liberty” to end their own lives. This is a crucial distinction: a right ordinarily imposes obligations on others to ensure that the right can be exercised–a liberty does not. But even if we posit a “right” to use another person’s assistance in committing suicide—e.g., a friend or family member–it does not follow that physicians ought to be among the permitted agents of the patient’s self-inflicted death.

Finally, it must be said that orthodox medicine has not adequately addressed the physical and emotional needs of terminally ill patients–especially with respect to providing adequate relief of pain. The medical profession needs to do much more to ensure that dying patients receive the best available palliative care, including emotional support for patients and their families. But “assisting” patients to kill themselves is simply a bridge too far—and radically undermines the traditional role of the physician as trusted teacher and healer.

Acknowledgment : The author thanks James L. Knoll IV, MD, for his comments on an earlier draft of this piece; however, the views presented here are my own.

For further reading:

Pies R:

Pies R: Physician-Assisted Suicide and the Rise of the Consumer Movement.

Starks H, Dudzinski D, White N. Physician aid-in-dying. Ethics in Medicine. Accessed June 28, 2016.

Lewis P. Assisted dying: what does the law in different countries say? BBC. Accessed June 28, 2016.

Harper T. Call for assisted dying for our young will prove most emotional, contentious. The Accessed June 28, 2016.

Massachusetts Medical Society. Physicians reaffirm opposition to physician-assisted suicide. December 3, 2011. Accessed June 28, 2016.

Battin MP, van der Heide A, Ganzini L, et al. Legal physician-assisted dying in Oregon and the Netherlands: evidence concerning the impact on patients in “vulnerable” groups. J Med Ethics. 2007;33:591-597.

Finlay IG, George R. Legal physician-assisted suicide in Oregon and The Netherlands: evidence concerning the impact on patients in vulnerable groups—another perspective on Oregon’s data. J Med Ethics. 2011;37:171-174.

Ganzini L, Goy ER, Miller LL, et al. Nurses’ experiences with hospice patients who refuse food and fluids to hasten death. N Engl J Med. 2003;349:359-365.

Categories: OIG Advisory Opinions

Community Health Centers Are Essential to a Safety Net

The Healthcare Blog - Thu, 08/18/2016 - 08:06

Since we are in a political season, I’ll begin with one of the candidate’s positions on a facet of healthcare: Hillary wants to double funding for Community Health Centers (CHCs) over the next decade.

Is that a good or bad thing?  If you’re inclined to think that’s good, please read on; I’ll reinforce your views.  If your impulses are in the opposite direction….well, I hope you’ll still read on; I’ll hope to convince you.

By the way, I could find no mention by Trump of CHCs—no surprise there.

The role CHCs play in healthcare has gone largely unheralded for years, eclipsed by sexier health policy topics and debates.  But that role has expanded in recent years and become more important than you might think.  And not incidentally, CHCs have had broad bipartisan support for many years.

The National Institute for Health Care Management is out with a policy brief on CHCs, authored by Peter Shin.    Shin is an associate professor of health policy and management at George Washington University in Washington, D.C.  The brief, just a couple pages, presents results from a nationwide survey of CHCs Shin and his colleagues recently conducted.

Shin’s main argument is that CHC’s are not only a critical component of the nation’s healthcare safety net but also have become one main path by which millions of low-income people are gaining insurance coverage under the Affordable Care Act.

The CHC program was launched in the mid-1960s to provide care for the medically underserved and low-income populations, in both urban and rural communities.  Today, some 1,400 CHCs serve 24.3 million people nationwide.  In 2014, 92 percent of CHC patients had incomes below 200 percent of the federal poverty level and 28 percent were uninsured.  CHCs provide a comprehensive set of services, including dental, vision, prescription drugs, and mental health counseling.

Studies consistently show that CHCs improve the health status of communities and patients, and have been linked to reduced emergency room use and hospitalizations, enhanced preventive and chronic care management, and more use of less expensive providers.

Shin found that in 2013-14 about 80 percent of CHCs provided Medicaid application assistance and 90 percent helped people enroll in the ACA health exchanges.  And, he says, recent federal data indicate that CHCs have provided such assistance to some 17 million people since ACA enrollments began in 2013.

That means it’s feasible that a sizable number of people who have enrolled in Medicaid or an exchange under the ACA since 2014 did so with help at a CHC.

The Medicaid connection is especially strong since millions of Medicaid beneficiaries already get their primary care at CHCs.  Indeed, Shin found that in the first year of Medicaid expansion (in the states that did so) the share of all CHC patients with Medicaid coverage increased from 44 to 53 percent.  Not surprisingly, no increase occurred in the 19 states that didn’t expand Medicaid.

So what’s the problem?

It’s this:  CHCs don’t have stable or adequate funding, and some must scramble for money to meet the growing demand for their services.

By design, CHCs are not federally funded clinics.  They rely on a mix of revenue, including reimbursement from Medicare, Medicaid, and private insurers.  But federal grants do account for an important 22 percent of their revenue.

The ACA funded CHCs to the tune of $11 billion from 2011 to 2015, which paid for an increase in the capacity of existing CHCs and dozens of new ones.  In 2015, Congress extended funding, but only through 2017.
Shin says that the growth in the number of patients will require CHCs to recruit additional staff and expand their capacity significantly in the years ahead.  That’ll especially be the case if some or all of the 19 states that have not yet expanded Medicaid decide to do so in the next few years.

Shin says the CHCs in states that have expanded Medicaid are already feeling the pinch, largely because those were the states with less generous Medicaid coverage for childless adults to begin with.

In addition, the ACA requires private health plans sold in the exchanges to offer a contract to at least one CHC in every county where a CHC exists.  As exchange enrollment increases over time, CHC capacity will have to grow.

Despite bipartisan support for CHCs and the additional funding they got in 2015, funding beyond 2017 is no slam dunk, however.  And there’s no way to know now how the politics of that will go.  A Hillary Clinton White House is certain to support more funding for CHCs but if Congress remains in Republican hands, there’ll likely be a fight.  If Trump becomes president—as with almost every area of policy—all bets are off.

Bottom line: 29 million Americans remain uninsured.  CHCs are an essential component of the health care safety net that meets their medical needs, as well as the needs of millions of low-income insured people.   And CHCs are increasingly helping people gain coverage.

In 2017, Congress must not fail to adequately fund CHCs, and it should provide stable funding for at least five years.

Read the brief.  Here’s the link again.

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

Categories: OIG Advisory Opinions

European and American Efforts to Tackle AMR: Great Minds Think Alike (Almost Always)

The Healthcare Blog - Wed, 08/17/2016 - 10:21

Antimicrobial resistance (AMR) is a major threat to public health and the global economy. Indeed, a RAND Europe study found that failure to address AMR could result in worldwide economic losses of $3 trillion and annual population decreases of 10 million people every year until 2050.

In May 2016, the UK’s Review on AMR, headed by economist Jim O’Neill, delivered its final report, which stressed the need to find global and cooperative international solutions. It is good news then that the United States and European Union (EU) are among the most important international actors in this area committed to making an effort to tackle AMR, both domestically and in collaboration with their international partners.

The United States adopted a National Action Plan to tackle AMR in 2015, and the Obama administration nearly doubled federal funding for 2016 to more than $1.2 billion. Similarly, the EU’s activities in the area are guided by an EU Action Plan on AMR, which RAND Europe is evaluating, with the EU dedicating substantial resources to AMR-related efforts, including about €2 billion on AMR-related research from 2012-2015.

Efforts to tackle AMR on both sides of the Atlantic share common objectives around key areas for improvement, such as the stewardship of existing antimicrobials, surveillance of their use and development of new antimicrobials. Importantly, both the United States and the EU explicitly recognize the importance of adopting a “one health” approach, which acknowledges that efforts to tackle AMR need to incorporate all relevant perspectives, including human medicine, agriculture and the environment. Together the United States and the EU have formed the Transatlantic Taskforce on Antimicrobial Resistance, which began in 2009 and last year was extended until 2020.

As part of their approach to addressing AMR, the United States and EU share a common commitment to stimulating new drug discovery. The EU, through its flagship Innovative Medicines Initiative, is funding a research project DRIVE-AB, which aims to develop new economic models for the discovery and production of antimicrobials.

The United States has passed similar initiatives to improve the incentives for potential new drug developers. The Generating Antibiotics Incentives Now Act, signed into law in 2012, increased the period of market exclusivity for pharmaceutical companies and offered companies early engagement with the Food and Drug Administration (FDA) and access to priority review procedures. Other proposals still to be considered include the Reinvigorating Antibiotic and Diagnostic Innovation Act, proposed in 2015 and modeled after previous legislation on orphan drugs, would provide transferrable tax credits to companies for rapid development of new antibiotics. Finally, the U.S. House of Representatives’ Antibiotic Development to Advance Patient Treatment Act and the Senate’s counterpart Promise for Antibiotics and Therapeutics for Health Act would permit the FDA to approve antibiotics that treat a serious condition or unmet need for a narrow patient population.

Despite common declared objectives and the existence of collaborative platforms, one notable point of divergence persists between the EU and the United States. In 2006, an EU ban on the use of antibiotics in livestock as a growth-promoting agent went into effect (although the use of antibiotics in animals continues to be permitted in the EU for therapeutic reasons).

In the United States, despite previous efforts by the FDA, no such ban has been passed. Instead, the FDA has issued a series of voluntary guidelines regarding antimicrobial use in farming. These guidelines have led to some results; for instance, every company producing antibiotics for livestock feed has opted to adhere to the FDA’s request not to use medically important drugs for production purposes. However, participation in this arrangement is not mandatory and entire classes of antibiotics remain outside of its scope. Monitoring and follow-up is necessary to assess the implementation and effects of the voluntary guidelines to determine whether, as the FDA suggests, they are “the fastest, most efficient way” to achieve changes in antimicrobial use or whether a ban more in line with the European approach may be needed.

Although there are similarities between U.S. and European approaches to tackling the threat of AMR, the EU has arguably taken a more holistic approach to dealing with the threat, not only looking at human health, but also mandating practices and policies in agriculture to manage AMR more stringently. Regardless, the United States and Europe have made important and significant moves in addressing the threat, with further action expected on both sides of the Atlantic in the near future.

Jirka Taylor is an analyst at the nonprofit, nonpartisan RAND Corporation and Elta Smith is a research leader at RAND Europe. Both are involved in RAND’s work on AMR. 

Categories: OIG Advisory Opinions

Building Better Metrics: Invest in “Good” Primary Care and Get What You Pay For

The Healthcare Blog - Tue, 08/16/2016 - 10:59

In 1978, the Institute of Medicine published A Manpower Policy for Primary Health Care: Report of a Study (IOM, 1978) where they defined primary care as “integrated, accessible services by clinicians accountable for addressing a majority of heath care needs, developing a sustained partnership with patients, and practicing in the context of family and community.” The four main features of “good” primary care based on this definition are: 1. First-contact access for new medical issues, 2. Long-term and patient (not disease)-focused care, 3. Comprehensive in scope for most medical issues, and 4. Care coordination when specialty referral is required.  These metrics ring as true today as they did many years ago.

Estimates suggest that a primary care physician would spend 21.7 hours per day to provide all recommended acute, chronic, and preventive care for a panel of 2,500 patients.  An average workday of 8 hours extrapolates to an ideal panel of 909 patients; let us make it an even 1000 to simplify.  A primary care physician could easily meet acute, chronic, and preventative needs of 1000 patients, thereby improving access.  Our panels are much larger due to the shortage of available primary care physicians and poor reimbursement which keeps us enslaved.  Pay us what we are worth and then utilize this “first-access” metric to judge our “quality.”

Hippocrates said “It is more important to know what sort of person has a disease than to know what sort of disease a person has.” Primary care physicians excel at knowing their patients. Continuity of care and long-standing treatment of families within the larger context of the community is our raison d’etre. Numerous studies have confirmed accessible, comprehensive, and integrated primary care is associated with better clinical outcomes and lower costs.  Track how long our patients have been with us as yet another reimbursable measure.

The significance of enduring patient relationships at small practices cannot be overemphasized; our practice has had more than 3 dozen families for 46 years, which is older than one of the physicians (me) at my two-physician practice.  The Commonwealth Fund in 2014 found an inverse relationship between practice size and preventable hospital admission rates, precisely because we know our patients better. Practices with one or two physicians had preventable hospital admission rates that were 33% lower than practices with 10-19 physicians, and practices with 3-9 physicians had a reduction of 27% comparatively.  CMS plans to bonus large practices with more than 100 physicians because they believe “bigger is better.”  What on earth do you think their preventable hospital admission rates will be?  Likely more than twice the rate when compared to small, but mighty solo or two-physician practices.

A third worthwhile metric would be evaluating whether primary care physicians are able to provide comprehensive care to meet the majority of medical needs.  A study by the Robert Graham Center evaluated 3,652 physicians and 555,165 Medicare patients and found that patients of physicians who provided a wider range of services experienced fewer hospitalizations and incurred lower health care costs.  Costs were reduced by 10-15% and patients were 35% less likely to be admitted to the hospital when physicians could provide comprehensive care.  Dr. Kevin Grumback, who wrote a commentary accompanying the study, said “This probably trumps any other innovation in terms of reducing Medicare costs.”  Increasing health care costs have far outpaced economic growth for many reasons; relying on specialists to meet a wider scope of health needs has undoubtedly contributed to increasing expenditures.  As a pediatrician, Obamacare plans refused to reimburse me for cauterizing an umbilical granuloma because the procedure was considered too specialized.  Any mammal with opposable thumbs can treat an umbilical granuloma. What is the purpose of this narrow-minded short-sightedness?
Studies have demonstrated preventive services are delivered more efficiently and cost-effectively by primary care physicians.    Primary care physicians order fewer tests than specialists and help protect their patients from inappropriate and unnecessary care resulting in significant reductions in health care expenditures. Even when costs are calculated for treating common conditions, such as pneumonia, specialty care is more expensive compared to primary care and patient outcomes are no different.  Metrics should reward us for utilizing the full breadth of our skillset.

Finally, primary care physicians should coordinate care when specialty referral is required.  This is one of the largest drivers of redundant evaluations and testing.  Records without critical interoperability, specialists are starting fresh with each new patient and often repeat testing unknowingly due to inept communication.  Physician to physician conversation is paramount; primary care physicians need sufficient reimbursement for the work and time involved.  This would allow for a more focused, efficient evaluation by the specialist and reduce spending.

If primary care physicians were paid what they are essentially worth, there would be more of us to go around and health expenditures would decrease substantially.  The physician workforce in the United States is currently 80% specialty, 20% primary care.  Over a 40-year medical career, the income gap is 3.5 million, on average, between a primary care physician and a specialist.  Increasing by one primary care physician per 10,000 people, decreases mortality by 5.3% thereby avoiding 127,617 deaths per year in the U.S.  Payment methods must better reflect the value of services provided by primary care physicians especially in small practice settings. Reimbursement for conversation and less for testing and procedures results in the right kind of care.

Building better metrics is about incentivizing delivery of superior quality health care.  Small practices are the first point of access for many underserved populations.  Increasing the number of primary care physicians compared to specialists would control escalating costs, but our income must reflect our work.  The physician-patient relationship is a tremendous therapeutic force.  Business entities must recognize that power of relationships built over decades in small practice settings and harness it.  We are clearly worth our weight in gold; isn’t it time for those in power to recognize our value?

Niran al-Agba, MD is a physician in Washington State.

Categories: OIG Advisory Opinions