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E-mail Liberacion!

Thu, 05/26/2016 - 10:28

In 2011 and 2012 I wrote about the increasing problem of Business Spam – unsolicited, unconsented advertising that has grown in volume to the point that it constitutes more than half of my email .   In 2016, I’ve done an experiment – I’ve not opted in to any newsletter, any website offering notifications or any vendor offering information.   I’ve monitored my mailbox for violators of good email practices.

This month, we put a stop to it – cold turkey.   Anyone sending business spam is now blocked from the 22,000 users of Beth Israel Deaconess and its affiliates.

Here’s how we did it – using a commercially available appliance we have black listed organizations which send bulk email and companies which violate unsolicited email policies.

I realize there are many categories of activity going on here

1. Those who have my contact information for a legitimate business reason but sell that information without my consent.  Maybe there is something buried in a conference registration that suggests my information will be sold, but I’ve never found such a disclosure.

2.  Those who create mailing lists by guessing at email addresses.   John.halamka,  halamkaj, john_halamka, halamka.john are all guesses since I’ve never used such addresses on any materials.

3.  Those who facilitate bulk mailing.   I’ve had conversations with the management of companies that provide bulk mailing services such as newsletters/product updates/special deals.   Many of these bulk mailing companies have sound anti-spam policies.   However, they have to trust that organizations which use their services adhere to the policies, accepting attestation that consent/subscription has been obtained from recipients on mailing lists.   Many customers of bulk mailing outfits submit false attestations.    Remember, I’ve not opted into a single thing in 2016 and I’m receiving hundreds of bulk emails every day.

May of 2016 marks “email liberation” month at BIDMC, since  we put a stop to the electronic equivalent of garbage passing through our email gateways.   This Zero tolerance for bulk email approach may very well transform email into a once again useful medium for communication.   Sure, we’ll implement secure texting and groupware over the next year as alternatives to email, but there is a chance email could be salvaged.

My email box has gone from 1500 emails a day to 150. If everyone does this, maybe the business spammers will stop their flood of unwanted communications.

Viva the email liberation!

John Halamka is the CIO at Beth Israel Deaconess Medical Center.

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Categories: OIG Advisory Opinions

A Reality Check on Workplace Wellness

Wed, 05/25/2016 - 09:47

In 1971, President Nixon declared a war on drugs, and decades later our country’s efforts to battle drug addiction remains largely a failure. Even here on idyllic Cape Cod, we see deaths by overdose and suicide in numbers that are horrifying, particularly with our youngsters.  This epidemic shows little sign of abating as communities grapple with the scourge of runaway drug addiction and its gut-wrenching consequences.

So, it’s fair to ask: given our societal failure to stop drug abuse, should we throw in the towel because it’s, as we say here in Massachusetts, wicked hard? Is it acceptable to let drug users spiral downward with predictable ruinous consequences, because to intervene and provide programs that might help could be called invasive or ineffective?  Of course not.  Because we cannot and will not abandon people with serious health conditions who, on their own, cannot recover.

The workplace and its wellness are not so very different.  Today’s American workforce is anything but healthy.  Poor health is overwhelmingly the result of unhealthy lifestyles, and it inflicts incredible damage on employers and on employees and their families. It’s a national tragedy, and frankly, it’s a disgrace that we have not had the collective will to do more about it.    

Yet, there are those who suggest that we not only give up on trying to improve unhealthy lifestyles, but also that we give up on workplace wellness altogether. I categorically disagree.

 Just as with our drug policy’s successes and failures, the wellness industry too must learn from its successes and failures, and press forward WITHOUT ABANDONING THE ENTIRE PREMISE THAT GAVE RISE TO WORKPLACE WELLNESS IN THE FIRST PLACE.  

In this, the first of a series of articles, I will outline some fundamental Premises that compel the conclusion that we must double down on workplace wellness.  Subsequent articles will expand on those Premises, explore weaknesses and flaws of some programs, and suggest strategies that can achieve the full benefits of workplace wellness, including lowering coverage costs.

PREMISE 1:  Corporate America has a responsibility to help employees improve their health and wellbeing.  This is not about rampant paternalism. We’ve made access to quality healthcare a fundamental right of every man, woman and child legally in America.  We have compelled businesses to buy healthcare coverage for their employees.  At least 97% of today’s healthcare actually is sick-care, treating already-acquired conditions rather than preventing them.  

Is that where our obligation ends?  If so, employees will keep getting unhealthier, and even the best healthcare system can do little to stem the tide of bad health much less reduce costs.

Unfortunately, the wellness industry is under attack like never before, and an emerging sense of angst over the seeming lack of progress in workplace wellness is palpable. A recent observable trend of commentators and the workplace wellness industry in general is to give up on changing the unhealthy lifestyles of employees and reducing the cost of healthcare coverage (ROI).  “ROI” means per-employee claims expense savings that exceed the cost of a wellness program.  “VOI” (Value of Investment) means any “non-financial” improvements that result from workplace wellness activities, such as boosting productivity, morale, reducing absenteeism, etc.

Two recent articles are symptomatic of how workplace wellness is increasingly viewed as a failed concept and may represent an emerging consensus to give up on efforts to achieve ROI by improving unhealthy employee lifestyles altogether.  

Should Employers Give Up On Wellness ROI?” consists of an interview of Dee Edington, a practitioner in wellness for over 40 years.  Mr. Edington states that, “Yes, [ROI] is dying…”  He conditioned that remark with several “ifs,” but concluded that “[t]he most obvious misconception is that a wellness program will generate a positive ROI, anywhere from 1.0 to 6.0.”  He concludes by saying that corporate wellness has a bright future IF it embraces the shift of focus away from ROI to VOIs.  He was more direct in a 2009 conversation:  “Wellness programs have been focusing on behavior change, and I’ve come to the conclusion that that’s been a waste of time.”  

With respect (and with the realization that Dee has been doing this much longer than I), I emphatically disagree.  Cost of coverage MUST remain the focus.  To reduce cost, we must reduce chronic illness.  According to the US Centers for Disease Control and Prevention (CDC), chronic illness is mostly caused by unhealthy lifestyles and accounts for 75% of US healthcare expenditures.  And chronic disease is the most preventable of diseases.  The CDC states that the key to reducing chronic illness is to address unhealthy lifestyles.  To follow Mr. Edington’s  suggestion means an abandonment of attempts to reduce chronic illness, the most preventable of illnesses, and to reign in costs.

The second article is representative of an even more radical approach, namely, doing away with workplace wellness.

Playing Doctor” is written by Al Lewis, the CEO of Quizzify.com and the author of “Surviving Workplace Wellness,” a title that pretty much sums up his view of workplace wellness. Mr. Lewis’ viewpoint, characterized by militant and high visibility opposition to workplace wellness, reflects the far end of the spectrum of anti-workplace wellness sentiment.  He is oft-cited, and it seems he has not seen a wellness program or a positive ROI computation that he has liked.

“Playing Doctor” focuses on the EEOC’s final rules  regarding wellness program incentives and penalties, which Al uses as a springboard to repeat his mantra that the wellness industry hides data, misrepresents results such as ROI, and not only fails to improve employee health, but actually exposes employees to significant potential harm in order to maximize revenues. His suggestion is to steer employees to safer hospitals and educate employees how to purchase healthcare wisely, something that his company, Quizzify, purports to do.  

Educating people on how to better access our dysfunctional healthcare system should be part of any comprehensive workplace wellness program.  But if that is all we do, it perpetuates smarter purchasing of sick-care by sick people rather than well-care, prevention, and healthier lifestyles.  That, in turn, will only perpetuate an increasingly unhealthy and unproductive workforce, driving costs of coverage higher and higher.

Mr. Lewis and I have commented on each others’ articles in the past, and I commented on this one, asking “[a]re you saying we throw in the towel on changing unhealthy lifestyles…”?  His response was, “…yes, I throw in the towel until, to mix cliches, someone invents a better mousetrap.”  

I believe that commentaries such as these are leading corporate America down the wrong path.  

If followed, this will divert us from the single most important thing that must be accomplished to obtain ROI or VOIs:  healthier employee lifestyles.  We cannot be diverted from this inconvenient fact.  Without improving unhealthy lifestyles, none of these goals is accomplished.

PREMISE 2:  The workplace is not only an appropriate venue, but the best venue to facilitate wellness and wellbeing.

On the issue of appropriateness, the cost of healthcare coverage is one of corporate America’s top concerns, as is an unengaged and unproductive workforce.  It is hard to identify a more appropriate workplace activity than directly addressing those issues.  

Employee engagement is greatly affected by health and wellbeing. A 2012 Gallup State of the American Workplace study confirms how a healthier, more engaged employee population can bring huge returns. Another study by Willis, Towers, Perrin supports this finding that more employers enjoy major financial returns and competitive advantages through higher employee engagement, productivity, and workplace morale. Yet, we cannot significantly improve employee health and wellbeing without long-term improvement of unhealthy lifestyles.  It’s that simple.

As the largest aggregator of adult work-aged Americans today, the workplace is also the best venue to affect and improve employee lifestyle changes. Millions of Americans show up for work each day focused on their work and its environment.  Employers already have their attention. Messages are sent and received.  If employers can link wellness to employees’ personal and work goals, they can create the opportunity for behavior change on a scale that dwarfs any other platform.  

We cannot abandon that opportunity.  Dr. Toby Cosgrove, CEO of Cleveland Clinic said it best:  “only private business…can solve America’s epidemic of obesity, chronic disease, and runaway healthcare costs by investing in the health…of their employees.”

PREMISE 3:  Workplace wellness need not be offensive or inappropriately invasive.  We have interventions in many areas when lifestyle threatens life or good health.  Do we throw up our hands and do nothing about the opioid epidemic that we are experiencing because of some suggestion that recovery is not something you “do” to someone?  Make no mistake about it.  Most of us understand from our own experiences that to facilitate long-term lifestyle change, some method of gentle or firmer intervention is needed to change the status quo.  

Are there poorly designed programs that do more harm than good?  Unfortunately, yes.  Are there incentives that are ill-disguised stratagems to increase employee shares of health coverage costs?  Yes.  Are there examples of invasive use of employee data?   Yes.  Can there be over-testing that some describe as “bad medicine?”  Let’s assume there can be.  And have most wellness programs failed to produce a positive claims ROI ?  That is correct (Rand Study, EBRI Study, and Pepsico), and  claims of Harvard researchers of ROIs of $3.27 from traditional wellness programs have been proven suspect.

But does this imply that we get out of workplace wellness altogether? I suggest that it is quite possible to design and implement programs without being insensitive or downright stupid, nor should we be scared off by strident accusations to the contrary. Accordingly, this is not about whether we do this; it’s about how we engage employees and their families in a supportive, positive way consistent with their life goals.

PREMISE 5: While VOIs are achievable and valuable, the cost of coverage is still the single most critical issue facing corporate America today.  Wellness ROI can be achieved.

While VOIs are indeed valuable “returns” on workplace wellness programs, we are at risk of abandoning ROI. This must drive CEOs and CFOs crazy.  They are in essence being told to abandon precisely what they need most to continue to provide comprehensive employee coverage.  Ignore unhealthy lifestyles??  Other than our dysfunctional healthcare delivery system, unhealthy lifestyles are the biggest cause of our of control costs and an unsustainable trajectory.

Accordingly, it is not time to withdraw.  It is time to  double down on ROI.

America has a tradition of meeting crises head-on. There have been seemingly intractable issues that we’ve overcome by thoughtfulness, persistence, funding, and a will not to give up.  Our environmental legacy has shown that to be true.  Have we reached the finish line on the environment?  No.  We can and will always strive to do better.

I too want “a better mousetrap” for corporate America. Because while we’ve spent a bucket load of money on wellness, we haven’t put in the effort, thought, and leadership that this fundamental issue requires. It’s time to change that, and in my following articles, I will outline how we can do just that.

Categories: OIG Advisory Opinions

The Domino Effect of House v. Burwell

Tue, 05/24/2016 - 12:57

Last week, U.S. District Court of Appeals Judge Rosemary Collyer issued a ruling in House v. Burwell that could cripple the law. In her opinion, the President overstepped his Constitutional authority in granting cost sharing subsidies for those lacking insurance coverage since budgetary approval is required from Congress.

The specific constitutional question is this: Did the administration or specifically the Secretaries of Health and Human Services and Treasury violate Article I, §9, cl 7 of the U.S. Constitution when they “spent public monies that were not appropriated by the Congress.” (United States House of Representatives v. Burwell, 130 F. Supp. 3d 53, 81 D.D.C. 2015). The constitution is explicit:

No Money shall be drawn from the Treasury, but in Consequence of Appropriations made by Law; and a regular Statement and Account of the Receipts and Expenditures of all public Money shall be published from time to time. (U.S. Const. art. I, § 9, cl. 7.) The courts will have to decide if the portion of the cost sharing subsidies (ACA Sections 1401, 1402) disbursed by the federal government without Congressional authorization violates the law.


In the aftermath of the Collyer ruling, the Justice Department served notice it will appeal. Nonetheless, this decision and its pending judicial challenges is likely to have a domino effect regardless of its ultimate outcome in the courts.

Background: Along with Medicaid expansion, cost sharing subsidies are foundational to the ACA’s incentives to increase access to affordable health insurance and reduce the ranks of the uninsured. The premise is this: the majority of individuals who lack coverage simply can’t afford the premiums. So the law allows for these subsidies to be paid directly to private insurers on behalf of eligible marketplace enrollees whose incomes fall between 100% and 400% of the federal poverty level. In the first year of the marketplaces, 5.6 million enrollees had 77% of their premium, or an average of $290, paid to their plan of choice via the cost sharing element of the ACA.

Will Judge Collyer’s ruling be upheld by an Appeals court or find its way to the Supreme Court? No one knows for sure. It could take up to two years if House v. Burwell ends up being decided by SCOTUS. If it does, it’s significance in setting the future of the Affordable Care Act will rival NFIB v. Sebelius which affirmed the constitutionality of the law and King v. Burwell that upheld the availability of cost sharing subsidies for enrollees thru Healthcare.gov rather than state exchanges. And uncertainty about House v. Burwell will have immediate and significant impact regardless of the judicial process. It creates a domino effect that industry stakeholders will feel immediately:

1-Health insurers will raise premiums or exit the marketplaces altogether.

The individual insurance market for insurers is risky compared to their employer, Medicaid and Medicare Advantage lines of business. The individual market via the marketplaces is even riskier: enrollees are older, sicker and needier than ACA proponents calculated, and stringent requirements for the plans they offer make marketplace participation a tough call for insurers.  Private insurers counted on the availability of the cost sharing subsidies along with the risk-sharing pool to mitigate their financial risks. In the end, participation in the marketplace became a game-day call: for larger investor-owned and Blue Cross plans, it’s a financial call thus the recent announcements by United, Humana and others they’ll cutback their marketplace participation. For CO-OPs and plans sponsored by provider organizations, it’s more complicated. The them, the marketplaces were vehicles for expanding access to vulnerable or un-served populations. It’s safe to say that all insurers have been disappointed in the marketplaces and forced to make adjustments. Uncertainty about the fate of House v. Burwell will prompt insurers to raise premiums in their marketplace offerings while waiting on the appellate process to play out.

2-Bad debt for hospitals will increase.

In the calculations leading to the passage of the ACA in 2010, federal funding for hospitals was cut $155 Billion (2010-2019) by lawmakers on the assumption that 25 million previously uninsured would be covered through the marketplaces and Medicaid expansion would proceed in every state. And the big stick in the equation was the individual mandate requiring everyone to buy insurance or pay a penalty (in 2016, it’s the higher of 2.5% of adjusted gross income or $695 per person). None of these has worked out as planned. The Supreme Court (June 2012) made Medicaid expansion optional for states. And glitches in the Healthcare.gov rollout in the fall of 2013, higher than expected premiums for the silver plans (to which cost sharing subsidies are applied) and confusion about the exchanges depressed marketplace enrollment. Now add uncertainty about House v Burwell and the continued volatility of insurer participation and premiums. These combine to negatively impact hospitals: the ranks of the uninsured will likely swell and hospital bad debt with follow suit. Unlike insurers, hospitals can’t elect not to participate: they’re required to treat patients without considering their ability to pay their bills. And it’s not likely Congress will offer to give back hospital cuts they authorized though their calculus was faulty.

3-The politics of the ACA, and Supreme Court appointments of the next President, will become big topics in Campaign 2016. The next President will likely name one or two justices to the Supreme Court where big decisions impacting the future of the ACA will be settled. The enforcement of contraception coverage, ongoing challenges by states about the scope of the federal oversight, potentially House v. Burwell and others are foundational to the law’s implementation and compliance by all parties. To date, debate about the ACA in Campaign 2016 has been long on bravado and short on specifics: the GOP mantra has been Repeal and Replace, while the Dem retort has been Repair and Expand. An appeals court decision is unlikely before November which keeps House v. Burwell alive as a campaign issue, and Supreme Court appointments by the 45th U.S. President a major focus for both campaigns.

That’s the domino effect of House v. Burwell. As its judicial journey begins, it’s important to monitor the outcome of its deliberation, its impact across the industry and the anxiety among those most directly impacted—individuals who count on their subsidies for coverage.

 

Categories: OIG Advisory Opinions

Seven Principles For Better Information Technology

Mon, 05/23/2016 - 19:00

Physicians well know the rapid advance of information technology in medicine over the last decade.  Pushed by federal and state regulations and requirements, the adoption of electronic medical records has been swift. Today, some 90 percent of physicians in Massachusetts use some form of electronic medical records.

While health information technology (HIT) arrived with great promise and adoption has been quick, widespread acceptance has lagged, and EHRs remain a major concern among physicians of all specialties. Among the most contentious issues: interoperability, clinical workflow efficiency, and the myriad demands of reporting patient data as required by Meaningful Use and the Physician Quality Reporting System, among others.

Some physicians have embraced HIT; they see it as a way to reduce medical errors, streamline workloads, and offer a path to improved outcomes.  Others view it as an impediment to the physician-patient relationship, a huge expense, a tool that consumes too much time, and a source of immense frustration.  Some have even stopped practicing medicine because they found the rules and regulations and operations too onerous.

Health information technology has been a major focus of the Massachusetts Medical Society since the establishment of the MMS Committee on Information Technology (CIT) some 20 years ago. The Committee’s Guide to Health Information Technology has provided useful information and direction for physicians as we struggle through the obstacle courses of HIT and EHRs.

The last year has seen a renewed effort by physicians nationally and locally, to share our concerns about the impact of HIT on physician practices and how we deliver patient care.

In September, MMS hosted an AMA Break the Red Tape Town Hall, to voice concerns about Meaningful Use.  More than 100 physicians attended, and the collective message was clear: EHRs are cumbersome, time-consuming, and hurting productivity.

MMS officials have also met with CMS Acting Administrator Andrew Slavitt on multiple occasions, including a visit last fall, at our suggestion, to Massachusetts and the office of a local family physician.  The visit provided Mr. Slavitt with a first-hand, real-world look at the issues affecting physicians as they work with electronic health records and wrestle with interoperability.  The encounter influenced his thinking about Meaningful Use; Mr. Slavitt has made it clear that EHRs should be patient-centered, physician-focused, and simple.

Our most recent effort was the adoption of a new set of principles governing health information technology.  Proposed by the CIT, the principles were adopted unanimously by the House of Delegates at our May annual meeting.

The essence of the new policy is contained in seven statements. It states that information technology available to physicians should accomplish the following:

  • support the physician’s obligation to put the interests of the patient first;
  • support the patient’s autonomy by providing access to that individual’s data;
  • be safe, effective, and efficient;
  • have no institutional or administrative barriers between physicians and their patients’ health data;
  • promote the elimination of health care disparities;
  • support the integrity and autonomy of physicians; and
  • give physicians direct control over choice and management of the information technology used in their practices.

MMS members may read the complete report of the CIT on these new principles here.

Guided by these principles, MMS will continue to work on health information technology issues and how these tools can improve the practice of medicine – and that means first and foremost a focus on patient care.  HIT does indeed hold promise, but its priority should not be on data collection, but on how it can raise the level of patient care – a goal shared by each of us as physicians.

James Gessner, M.D. is the President of the Massachusetts Medical Society.

 

Categories: OIG Advisory Opinions

Annals of Decision-Making

Mon, 05/23/2016 - 09:12

Vox.com piece about decision-making caught my attention this morning.

The story was compelling.  A 12-year-old boy had intractable seizures from a leaking vascular malformation in the brain.  A first neurosurgeon would not operate and recommended radiation therapy instead.  The patient’s mother sought another opinion from a Mayo Clinic neurosurgeon who was adamant that an operation should be undertaken.  The second surgeon surgeon was undeniably right.  The patient is now a bright, fully-functional researcher at the University of California San Francisco.

So far, so good?  Not so, according to Vox.  That there should be a smart mom making a smart decision, and a smart doctor carrying out a successful surgery is apparently a problem.

Why?  Because the more cautious surgeon had a different opinion and, had the mom compliantly accepted his recommendation, the child could have been worse off.  Variability in judgment, as always, is the enemy.

Vox quotes a recent Annals of Surgery study that “supports” the concern.  When surgeons are given clinical vignettes, they vary widely in how they estimate the risks and benefits of an operation.  Consequently, the decision to operate also varies widely—at least, on vignette paper.

This variation seemed to come down to surgeons’ perceptions of risks and benefits, the researchers wrote: “Surgeons were less likely to operate as their perceptions of operative risk increased and their perceptions of nonoperative benefit increased.”

And those risk perceptions were very predictive of whether or not a surgeon would recommend an operation: “Surgeons were more likely to operate as their perceptions of operative benefit increased and their perceptions of nonoperative risk increased.”

The remedy?  Risk calculators which take “high-quality data from millions of patients” who have had similar operations to come up with estimates on the risks of surgery.

Dr. Ashish Jha, a Harvard professor of health policy concurs: “It’s clear we need to develop more resources like this to be additional input beyond personal experience for surgical decision-making.” Accordingly, had the first surgeon, truly known the actual risk of the operation, he may have acted differently, and saved the mother and her child the delay of care and any additional expense.

Imagine the conversation:

Mom: my child is not doing well.  Will you operate?

Surgeon: Too risky, I don’t want to.

Health Policy Expert: Hey, check out this cool risk calculator!

Surgeon: What was I thinking?  Of course, I’ll open the skull!

What strange minds doctors seem to have!  As it turns out, this peculiar understanding of how clinical decisions are made has been around for decades.  Quoted in the Annals‘ article is a famous JAMA paper from 1990 in which author David Eddy, a Harvard physician, mathematician, and healthcare analyst, describes clinical decision-making according to a two-step process of inputs and outputs:

From Eddy, D. Anatomy of a decision. JAMA 1990 263(3) 441-3

In other words, the doctor’s mind is a rather simple computer.  Again, from the Annals article:

According to normative decision theory, treatment decisions under uncertainty should be based on an evaluation for each available treatment option of: (i) the probabilities of possible outcomes; and (ii) the relative attractiveness or unattractiveness (ie, the utilities) of these outcomes.

Of course the computational theory of mind is not unique to the medical field.  But it has been criticized widely and, in my opinion, quite effectively, notably by John Searle and by the late Hilary Putnam.  As Robert Epstein put it just a couple of days ago: “Your brain does not process information, retrieve knowledge, or store memories.  In short, your brain is not a computer.”  But the memo, it seems, hasn’t reach the ivory towers of healthcare analysis.

I have previously pointed to the work of psychologist Gary Klein (see here and here) who studies decision-making in real life settings.  Klein shows that decision-making is clearly unlike what the computer model would lead one to believe.  In fact, excellent decisions are made, at times, on the basis of inexpressible knowledge which, to an outside objective observer, could seem like purely subjective idiosyncrasies.

Health policy experts, however, remain wedded to the computer model of the surgical mind and view the objective risk of an operation and its quantified benefit as essential “inputs” for decision-making.  Predictive analyses are then carried out with implacable logic:  Add the probability of benefit, subtract the probability of harm…Uncertainty is almost conquered.

Unfortunately, healthcare analysts seem to forget that a 5% mortality risk for resecting an aneurysm is only an average risk.  That number may be called into question when applied to a particular surgeon.  What if the doctor at hand had a drinking problem?  Or what if she or he “sensed” they had a personal technical limitation and preferred not to operate in a given case?  Should we use the average risk number to convince them otherwise?

Of course, the analysts always concede that calculation is not the end-all-be-all.  “Yes,” they say, “use your judgment along with the risk calculation.”  The risk calculator is simply offered as a tool to help “lift the bottom up,” so to speak, and should not interfere with sound judgment.

But here’s the rub about lifting the bottom up.  How does a doctor at the bottom know that his judgment is bad?  By definition, bad surgeons misjudge risk or benefit unknowingly.  If they knew they were misjudging, they would judge otherwise.  And even if bad surgeons were to agree to employ the calculator, could we still trust them to use judgment along with calculation—as if that concept had any real meaning, anyway.

Faced with the grim reality of unequal surgical talent, health policy will inevitably lean on doctors to use more and more calculation and less and less judgment.  That’s the natural history of these managerial devices.  After all, how else can we expect to have a “standard of care?” At that point, top surgeons, too, will necessarily end up making decisions rotely, and meld with the mass of undifferentiated surgical care providers.

The irony is that the boy in the story who was saved by a heroic surgeon is now a PhD student in epidemiology and seeks to develop “decision support systems…[which] can supersede the personal biases and subjectivity of physicians.”  Shouldn’t he know that getting rid of the “personal biases and subjectivity of surgeons” cuts both ways?  If variability is to be overcome, so will excellence be defeated.

Categories: OIG Advisory Opinions

Post-Palooza News: RWJF Challenge Update

Mon, 05/23/2016 - 05:00

At Health Datapalooza, we heard plenty about the importance of addressing the myriad information needs health care consumers have – when choosing plans and providers, receiving care, or trying to become more engaged in their own health.  Therefore it seems fitting to follow the ‘palooza with an update on this year’s RWJF challenge program and introduce the next for 2017. 

Although we know that consumers have many unmet information needs in the healthcare setting, our apps challenge program, which is administered by Health 2.0, has consciously focused on supporting decisions around plan choice. Our first two challenges focused on some critically important tools:  cost calculators  and provider directories.  Use of both types have soared during the third open enrollment period, and the tools of our winner, finalists, and many others have become widely used. Some have even been linked to state exchanges or healthcare.gov.

For our third challenge, we stayed with the topic of provider search, but took a slightly more ambitious path. Rather than allowing consumers to find specific known providers, this challenge aims to help consumers search for providers that are right for them.  Co-sponsored with ProPublica, the “Finding the Right Provider Challenge” aims to help consumers customize their searches based on their priorities.

Today I am pleased to announce our finalists:

Opera Solutions
Your Health Sherpa – DocFinder Sherpa
DocSpot
Locust Tech Inc.
Callout
Consumers’ Checkbook 

Finalists will submit their finished products by August 12, 2016. The judging panel will announce the winners sometime in September 2016.

This is also an opportune time to announce the kick-off of our newest challenge, which focuses on coverage and cost issues related to prescription drugs.  Access to and affordability of prescription drugs are extremely important elements of plan choice for many consumers, particularly for those who may suffer from chronic conditions. The information about drug coverage and costs that consumers need to make decisions is complex. Plans vary considerably in which drugs are covered, at what cost, and may also have other policies that  affect access (e.g.  step therapy). The increasing use of co-insurance, which requires consumers to pay a certain percent of the total cost, makes information about market prices essential to comparing the drug costs of different plans. Some plans have separate deductibles, both medical and drug, which further complicate cost comparisons.

For all these reasons, we believe that a challenge on drug coverage and cost is long overdue. We are collaborating with Vericred in this challenge, and they will make their formulary API available to entrants. 

While the solution we seek is primarily designed to address access and affordability concerns, we hope developers will consider addressing other important gaps in the information needs of consumers with respect to prescription drugs. We still lack a simple widely known information source for Rx drugs where consumers can get objective information about effectiveness and value. Adding such an informational resource to a solution can only enhance its usefulness to consumers and other insurance markets.

First round submissions are due on August 14, 2016. Developers can learn more about the challenge at the at RxCostandCoverageChallenge.com.  The collaborators will hold an introductory webinar on x date. We hope to see you there!

Katherine Hempstead is a senior advisor to the vice president at the Robert Wood Johnson Foundation.

 

Categories: OIG Advisory Opinions

How Big Is Too Big?

Fri, 05/20/2016 - 10:51

With healthcare mergers now announced seemingly every week, I’ve been giving some thought to scale:  How big can/ should health systems be?

Anecdotally, I’m struck that the most impressive healthcare companies in America are super- regional players:  Geissinger, Cleveland Clinic, UPMC, etc.  They seem to get a lot more attention than the national players with hundreds of facilities.

Leaving aside questions like strategy (e.g. is integration of payers/doctors/hospitals the key to these successes), I’ve wondered whether regional systems are simply the right size to thrive.  My suspicion is that even clever organizational structure (a topic which I wrote about last year) can’t overcome barriers that prevent large healthcare companies from innovating and thriving, particularly as companies move to risk and the business of healthcare becomes more complex. Like cellular organisms, large companies can outgrow their life support. (Interestingly, it’s actually the ratio of body volume to surface area [gas exchange, digestion, etc] that served as a constraint to organism size…)

I recently ran across a superb paper-  a doctoral thesis written by Staffan Canback.  Canback (who now leads the Economist Intelligence/ Canback predictive analytics consulting firm in Boston) wrote his thesis, called Limits of Firm Size: An Inquiry into Diseconomies of Scale in 2000, while a student in London. Canback argues, convincingly, that companies do become more efficient with scale, but reach a point where “diseconomies” begin to mitigate performance.  This may seem intuitive: (as Canback notes, if efficiency only improved with scale then we would buy everything from one company that produces everything with great levels of efficiency).  We don’t.

I’m dabbling in this complex field, but here are my takeaways:

Classic economic theory proposes that there is increasing efficiency (decreasing unit cost) with scale but that at a certain point diseconomies of scale begin to increase unit cost.

The problem with this curve is that it can’t explain why there tend to be multiple companies of various sizes competing successfully in a given industry.  The answer, according to Canback, is that there is a large “sweet spot” in most industries where the benefits of scale are reached and before structural inefficiencies develop.  There is then an inflection point, limited to large companies, where diseconomies of scale emerge.  The curve looks more like this:

What are the diseconomies of scale that Canback writes about? The ones that begin to increase unit cost at point M2?  They are ultimately bureaucratic concerns. Canback quotes the economist Herbert Simon:

“the central problem is not how to organize to produce efficiently (although this will always remain an important consideration), but how to organize to make decisions.”

The first part of this statement essentially refers to the negative derivative of the cost curve, while the second part refers to the upward slope as diseconomies of scale set in.

Here are the four main categories of scale diseconomies:

1. Communication distortion due to bounded rationality
It is impossible to expand a firm without adding hierarchical layers. As information is passed between layers it is necessarily distorted. This reduces the ability of high level executives to make decisions based on facts

2. Bureaucratic insularity
As firms increase in size the senior managers are less accountable to the lower ranks of the organisation and to the shareholders. They thus become insulated and will, given opportunism, strive to maximise their personal benefits rather than the corporate goal

3. Atmospheric consequences due to specialisation
As firms expand there will be increased specialisation, but also less moral involvement of the employees.

4. Incentive limits
Firms can not compensate their employees perfectly.
Here is the relationship between these four limiting factors and undesirable outcomes in large firms.

 

In a complex, heavily customized relationship-based industry like healthcare, I’d suspect that these difficulties would be amplified.

It would be fascinating to plot the progressive performance of the country’s largest healthcare companies as they grew over time (including not just fiscal performance, but also measures of quality and innovation).  I’d be curious to see if it they look like Canback’s charts: doing fine until the magic inflection point at M2…

Marc-David Munk, MD is a doctor and healthcare executive living in Boston. He is a fellow of the American College of Healthcare Executives and the American College of Emergency Physicians.

Categories: OIG Advisory Opinions

Beyond CQI: How Patient-Centered Care and Efficiency Go Hand-in-Hand

Fri, 05/20/2016 - 08:50

Hospital administrators are finding that true continuous quality improvement (CQI) requires a radical change in thinking.

For decades, automakers, the packaging industry and the airline industry have created better products, improved processes and greatly increased user satisfaction by adopting the principles of CQI—which, simply put, means constantly looking at our processes and asking ourselves, “Can we do it better”?

CQI principles have been applied to the delivery of healthcare with great success. Hospitals have created and employed myriad mechanisms for all staff members/personnel to continually improve existing processes. But hospital leaders and administrators know that even after decades of dutifully applying the principles of CQI to improving delivery of care, the patient’s journey from admission to discharge is still all too often filled with missed opportunities for a speedier journey through the system and better care overall.

Administrators at leading hospitals are finding that, in some cases, CQI means adopting an entirely new model of delivery.  They are also finding that the most efficient way to deliver care is also the most patient-friendly. Let me explain.

The Wisdom of Patient-Centered Care

Three decades of experience in the healthcare industry have taught me that providing exceptional, cost effective care benefits both the hospital and patient. But I’ve also learned that providing superior care starts with the patient. As we shift from fee-for-service to value-based care, we’re looking to capture savings in every imaginable nook and cranny. But ironically, the most cost-effective way to deliver care is to attend to the entire system, with a focus on the patient. When you focus on the patient, everything else falls into place; here’s why.

What Do Patients Want?

Patients want smooth, efficient care. They want a safe, friendly environment. They want to know what’s going on, to be treated as individuals, and to be treated with respect. They want staff to know who they are, and they don’t want to have to tell their story over and over. They want to be placed in the correct unit, and for that unit to have sufficient staff to attend to their needs. They want to be safe from medical errors and they want to get home as soon as possible. I am, of course, describing the perfect patient experience, but I think that experience is attainable. 

How Focusing on the Patient Improves the Bottom line

The secret to creating this Utopian patient experience lies in boosting efficiency. I’ve watched hospitals adopt changes large and small, all aimed at increasing efficiency, that also dramatically improved the patient’s experience. Some of these changes include moving from a linear to a centralized hub-and-spoke system—a bit like an air traffic control center–that is designed to monitor the activity of every patient electronically throughout the hospital. All of this is made possible by cutting-edge navigation and location sensing technology that tracks patients, beds, transport, labs and procedures, so that patients move smoothly from ED and admission to discharge, with maximum speed and efficiency.

This system might include shifting some staff into “care coordinator” roles. These staff follow the patient from ED to discharge, constantly communicating with the patient and assuring quick transition at all stages of care. These changes in process, staff roles and technology all move the patient through the system far more quickly.

Changing the Culture

Orchestrating successful travel of a patient through the entire spectrum of care requires ongoing accurate communication between departments and units, adequate staffing at all junctures, and transparency on where the patient, caregiver, beds and other resources are at all times. And making all this happen this requires a cultural shift.

Management and staff must embrace “patient first” mindset. For staff, this might mean a change in roles or it might mean embracing new technology and new ways of doing things. No one, me included, loves change. That’s human nature. So we need to first embrace change ourselves and then communicate top-down support for patient-centered care. We also need to listen to staff. What barriers are they experiencing that is impeding their ability to deliver patient-centered care? How can we help them deliver better care?

In the end, improving efficiency benefits everyone. Physicians, nurses and technicians have more time to care for patients. Length-of-stay decreases. Patients receive better care and have a better hospital experience. It’s a win-win strategy all around. OR, It’s not exactly Utopia, but it’s getting there.

About Ben Sawyer

Ben Sawyer has more than 25 years of experience in managing healthcare operations. He is currently executive vice president for Atlanta-based Care Logistics, where he leads a team of professionals passionately committed to helping hospitals achieve transformational operational results. Sawyer was formerly a service line executive for several health care systems, including St. Mary’s Health System, where he was a quality and performance improvement executive. At St. Mary’s, Sawyer personally lead many LEAN initiatives and Kaizen events, and developed a number of new approaches to healthcare delivery.

Sawyer is a frequent speaker at major healthcare industry leadership events and symposia across the country.

Categories: OIG Advisory Opinions

The Positive Impact of New Wage Protections on Home Health Agency Bottom Lines

Thu, 05/19/2016 - 19:45

In January 2016, the Department of Labor (DOL) officially extended federal wage protections to home care workers under the Fair Labor Standards Act, entitling them to the federal minimum wage, time-and-a-half pay for overtime, and pay for time spent traveling between clients. Predictably, lobbyist groups working on behalf of home care agencies have petitioned the Supreme Court to upend the new regulation. Their petition currently sits in limbo while the eight-member Court delays its’ consideration (presumably in fear of an unproductive 4-4 voting split while awaiting the confirmation of a ninth Justice). In the interim, those hoping for a review should consider the positive impacts of the new regulation and the opportunities it presents.

While on the surface this unfunded government mandate hurts home health agencies struggling to offer care within already slim Medicaid reimbursement margins, there is also a business case for increasing wages. First, increased wages will help entice new workers to the field, enabling agencies to care for more patients. Presently the median hourly wage for home care workers is $9.38[1], compared to the median for refuse collectors at $15.52 and parking enforcement workers at $16.99. While caregivers are often driven by a passion for their work, relatively low wages force many to look elsewhere. With higher pay, agencies should see an immediate impact on their ability to recruit new employees and increase revenue through improved bandwidth.

Second, better compensation will also impact the quality and scope of candidates who might consider home health work, helping agencies provide better care. Quality caregiving is a nuanced endeavor requiring technical skills and emotional intelligence; the ability to, for example, clean a patient after a bout of incontinence and then accompany them to an important meeting with their accountant. Often those with this unique pairing of skills are found outside of the traditional “system” of home care workers. Higher wages can help attract these nontraditional, but well aligned candidates onto the caregiver landscape.

Finally, better wages reduce costly turnover for agencies. While the full cost of employee turnover is difficult to measure, direct costs are conservatively estimated at $2,500 per front line employee[2]. There are also heavy indirect costs to consider. A lack of caregiver consistency is disengaging to the patient and often results in the use of another provider.

In addition to the immediate benefits of a larger, more qualified and more consistent employment base for their clients, the impact of more tenured staff and additional revenue may also allow agencies the luxury of incorporating technology platforms to help eliminate antiquated and costly operational practices, better preparing them for future increases in volume due to demographic shifts.

Each of these potential impacts of the DOL’s recent actions should contribute to the regaining of profit margins lost. While these countervailing measures may still fall short of fully insulating agencies from the pain of this regulation, they should be considered alongside any reasoned criticism of the rule.

Jeffrey Grossman and Sean Greer are managing partners of the Commonwealth Care Group, a concierge home health service provider which pays caregivers wages double the Federal minimum.

Categories: OIG Advisory Opinions

An Independent Medical Review Panel for the Candidates

Thu, 05/19/2016 - 10:55

As unusual as the 2016 presidential election has been, one obvious aspect has gone largely unnoticed: By the time the next president of the United States is inaugurated on Jan. 20, 2017, he or she will have reached or come close to reaching 70 years old.

That all the remaining major candidates are among the “young old” at this stage of the election process is unprecedented. Yet, in spite of the stakes for the American people, there is no independent source that can provide an adequate accounting of the medical condition of the next president.

Historians have examined the ways that previous administrations have been affected by the medical problems of presidents including Abraham Lincoln, William Henry Harrison, Woodrow Wilson, Franklin Roosevelt, John Kennedy, Lyndon Johnson and Ronald Reagan. The news has not always been positive.

So what have we done to help independently vet those who would lead the most powerful nation on earth? Nothing.

Currently the candidates release information produced by their own doctors, entirely at their discretion. The most amusing recent example is a letter signed by Donald Trump’s personal physician that failed to include any data and simply assured us that he “will be the healthiest individual ever elected to the presidency.” This is unlikely to prove true, considering the remarkable fitness of George W. Bush and Barack Obama, whose physical examinations while president were made public.

Hillary Clinton’s doctor’s letter was far more detailed and persuasive, including a summary of her medical history, current medications, results of routine medical tests for blood pressure and cholesterol, and her diet and exercise routine. Bernie Sanders has released a similar letter from Congress’ attending physician. But in every case the doctors were chosen by the candidates.

Aren’t voters owed an independent accounting? Even competent physicians’ judgments and recommendations can vary, especially when they know what the stakes are for their wannabe-president patients. One of the rationales for our interminable election process is that it enables the voters to get to know the views and temperaments of the candidates. What about their physical capacity for the job? We might like to think that the rigors of a lengthy and strenuous campaign can give us such insight. But the candidates’ physical capacities might be masked by medication, health management that could be a more serious liability when in office.

Our system invests so much authority in a single individual as head of state, chief executive of the federal government and commander in chief that the ways in which any medical conditions might affect performance must be explored by a process that doesn’t allow for self-censorship. An independent examination by a panel of physicians at, say, Walter Reed National Military Medical Center, would at least provide voters with some trustworthy information. The results might influence not only the voters’ thinking but also the selection of a vice president whose “heartbeat away” status might become much more intensely apparent.

Our proposal would apply to all presidential candidates, regardless of age, and to the presidents themselves while in office. We recognize that in creating a requirement for independent assessment some will call for more than the standard physical and mental clinical information. At an extreme, given the capacities of modern medical science, some may even want to see a genomic analysis. Someday a deep genetic dive might be defensible, though that day is not quite here. Today there are well-established conventions for a physical examination that have earned prognostic credibility.

With so much at stake, an independent medical assessment not controlled by the candidates seems very little to ask. All voters may not care about the health status of the candidates, but the information should be available.

Arthur Caplan is a professor of bioethics at New York University Langone Medical Center. Jonathan D. Moreno is a professor of ethics at the University of Pennsylvania.

 

Categories: OIG Advisory Opinions

The Second to Last Mile

Wed, 05/18/2016 - 19:33

Thanks to the ubiquity of cable, fiber and wireless internet, the “last mile” telecommunications gap that has long separated the consumer from the wide world web is finally being bridged. According to Pew Research, 84% of Americans now regularly use the internet, and 68% use smartphones to access increasingly available broadband services.

The impact on healthcare has been considerable. More than half of all Americans have already uploaded their vital signs, benchmarked their fitness levels, co-managed their medications, communicated with their providers or researched health-related information.  No wonder the “mHealth” market could grow to $60 billion by the end of the decade

Yet, as more and more patients have rushed into this growing ecosystem of apps, wearables, home devices and other gadgets, a considerable body of research suggests that U.S. health care providers are not keeping up.  The poor second-to-last mile fit between consumers’ personal health technology and the providers’ incumbent information systems is turning out to be an important barrier to fully realizing the full potential of mHealth.

How should mHealth leaders respond?

Everyone agrees that healthcare technology is beset by unfriendly interfaces, poor clinical fit and opaque “black-box” programming logic.  In addition to this, physicians are also well aware of the perils of inbox data overload.

Resolving these technical challenges is well within reach.  Yet, healthcare leaders who are sponsoring mHealth initiatives should also consider three lessons that address the very human dimensions of connecting the second-to-last mile:

Less is more:  While the PowerPoint allure of large and multi-faceted mHealth solutions is considerable, their real-world implementation should be easy. Before connecting the second mile, health system leaders and mHealth providers should ask 1) why any mHealth initiative should take multiple days or require the assistance of legions of “super-users”, and 2) why patients shouldn’t be able to navigate within a user interface with the “Yahoo” standard of just “two-taps.”

Additive work vs. substitutive innovation.  As that second mile is bridged with increasingly efficient mHealth technology, the inevitable additions to existing provider workloads should prompt a collaborative search for any incumbent low-value processes or tasks that can be modified or discarded.  If the result is ultimately increased work for the providers, that downside cost needs to be explicitly vetted against any tangible patient benefit.

Unintended consequences:  While there may be a natural preference to deploy mHealth for everyone who qualifies, second-mile link-ups should be initially limited to the patients who have the greatest potential for benefit.  This is not only a time-honored way to grow expertise, but allow other known and unknown dimensions of the provider-patient relationship to catch up with the technology.  Limiting the scope of a first-time mHealth initiative will also diminish the prospect of unanticipated consequences while also facilitating the disciplined measure of a limited set of key outcomes.

Categories: OIG Advisory Opinions

Why Medicine?

Wed, 05/18/2016 - 15:35

By SAURABH JHA, MD

Cross posted with Quartz.

When I was applying to med school some 20 years ago in the UK, I was advised not to say at the interview: “I want to be a doctor because I want to help people.”

The answer was considered too dull back then. And in any case, I was asked “Why medicine?” only once.

“I’m not sure, but it’s not because my parents forced me.” I hesitatingly answered.

The interview panel giggled at my honesty, and for breaking a stereotype about Indians. I was accepted. But I doubt that this answer would cut it today.

Showing a sense of altruism is practically mandatory today for would-be doctors – one wonders if functional MRI will soon be used to prove empathy. But when I was 17 (the age when we typically applied to study medicine) that wasn’t the case. My curriculum vitae had little evidence that I wanted to help people.

There was no summer volunteering in eye camps in India. No travels to Africa to be indignant about poverty. The closest thing I had done that had any semblance of medicine was a brief stint as a hospital porter to supplement my pocket money: I carried blood vials from the emergency department to the laboratory. And although I waxed lyrical about the experience in my personal statement, I can’t say it was terribly inspiring to stare at cylinders of blood.

I do not recall caring for an ill acquaintance before I became a doctor. I didn’t go out of my way to help blind men cross the road. I didn’t routinely help old women pack their groceries—I still don’t. The most altruistic thing I had ever done was rescue a budgie when I was seven. I did not put that down in my personal statement.

My father, a physician, had little influence. I hardly saw him because of his work, and when I did he hardly spoke about work. I do remember, though, as a child, that he had a full skeleton of human bones in his study. My friends and I would concoct stories that it belonged to a former serial killer.

I watched no medical dramas. There were no medical personalities I admired. I never visited a hospital to shadow a doctor. And although I did fall ill with suspected appendicitis (which turned out to be mesenteric adenitis), it was hardly a life-changing experience.

Some contend that kids do medicine because of the job security and pay. To be honest, at 17, I thought I was immortal and couldn’t have cared less about security. As for money, well I was pretty left-wing.

The reality is that there is no inspiring story I can recount about why I became a physician. If it was a calling, then I didn’t hear it. I don’t think I was the only one in my medical school with the same experience. Over the years I have seen my classmates enjoy and endure medicine. Many are now excellent physicians with impeccable work ethics and compassion. If, back when they were students, they knew that volunteering in Chad during the summer break earned five points, they would have done it just for the five points. But what would it have proven?

Understanding what truly motivates someone to choose medicine, and whether that choice is motivated by noble inclinations or not is a forlorn endeavor. As soon as “I want to help people” becomes objectified as just another criterion for medical school admissions, as it has been, it will be gamed.

I’ve seen an entire generation of medical students become excellent doctors, even though, for them, “wanting to help people” was incidental to simply wanting to be doctors. The best I can garner about why I became a doctor is that it seemed like a good idea at the time. I’m glad I did, though – I have never experienced a dull moment in this profession.

Categories: OIG Advisory Opinions

The Quality of Virtual Visits

Tue, 05/17/2016 - 12:24

Virtual visits are increasingly the rage amongst forward-thinking healthcare providers that want to jump on the telehealth band wagon.  Extending the office visit across distance, using the same technology we use to keep in touch with loved ones (videoconferencing such as Skype and FaceTime), is a safe and logical way for providers to venture into a new tech-enabled world that may still be scary for some.

One way to think of this trend is to consider virtual visits an extension of the brick and mortar care model made famous a decade ago by companies like Minute Clinic.  Offer convenient access to a care provider for a limited number of conditions.

Virtual visits can take place by either video or voice connection.  These interactions are most often for indications that are non-life threatening, acute problems such as sore throat, ear ache, urinary tract infection and the like.  There is also a role for this technology in follow up care for conditions such as diabetes and hypertension, but for this post we’ll focus on acute care.

Employers and health plans are interested in this mode of care delivery too.  In a relatively short period of time, virtual visits have gone from a curiosity to a ‘table stakes’ offering in the world of employee health.  Several companies now offer services in the space, most notably Teladoc (now publically traded) and American Well.  These companies are interesting in that they can offer a complete service (i.e., software platform for access and a network of physicians who are waiting by the (video)phone for your call) or pieces of the service (for instance, just the software platform).  This has led to some confusion in the marketplace.  A consumer can now get a virtual visit from Walgreens or CVS (using the complete approach noted above).  Blue Cross of MA offers its fully insured members access to virtual visits through American Well’s software and network.

You can see why provider organizations would sit up and take notice, with concerns about loss of revenue in the very important segment of primary care, as well as fragmented care. Hence, providers are looking very carefully at how they can offer these services themselves, before they are disrupted by the likes of CVS, Walgreens and their local health plan.

With this backdrop, I read two interesting journal articles this month.  The first, published in JAMA Internal Medicine, employed individuals trained to act as patients with the following acute illnesses:  ankle pain, strep throat, common cold, low back pain and urinary tract infection.  These were chosen because there are recognized quality measures (which go by the acronym HEDIS) for how they are to be handled in an outpatient setting.

These fake patients performed 599 virtual visits across a number of different vendor scenarios.  The findings revealed that quality of care delivered by this method is variable.  For instance, the correct diagnosis was arrived at in 458/599 visits.  Rates of guideline-adherent care ranged from 206 visits to 396 across eight different vendors.  The big challenge with this —  and something we have trouble talking about — is lack of comparison to the face-to-face office visit.  For example, in traditional office-based circumstances, doctors misdiagnose and sometimes do not follow established guidelines.

The second paper was published in the Journal of Telemedicine and eHealth.  The authors specifically targeted virtual visits from Teladoc and they did the comparison with office visits.  The approach was different, however, in that it involved a retrospective insurance claims analysis from a specific organization, the California Public Employees Retirement System.

The first interesting data point is that of 233,000 eligible individuals, 3,000 took advantage of virtual visits, accounting for just over 4,600 visits.  Utilization of just 1.3% is worth noting for those of us preparing to offer these services in the near future.  We probably don’t need to anticipate an avalanche of demand.

The punch line from this study: Teladoc doctors performed worse on a number of indicators than office-based practitioners.  Specifically, they did not order strep tests as much as office providers and they ordered antibiotics for bronchitis more often.  This makes some intuitive sense, as it is additional work and bother for the virtual doctor to insist the patient get a strep test. (The patient will also be thinking, “Why did I bother to do this virtually and why do they offer this service if I have to travel for a strep test?”)  In the case of antibiotics, the virtual provider may be more cautious without the person in the same room and err on the side of treating with antibiotics.

Both of these papers highlight how early we still are in the widespread adoption of virtual visits.  Though there is lots of pressure to move, and we should do so, we have some time to get it right.  We can take comfort in the low utilization, and work on educating providers on the pitfalls of the virtual environment.  We can also educate our patients up front that even though their entry into the healthcare system will be virtual, they may need to travel to get additional diagnostic services, etc.

It seems that anytime a new tool or technology is introduced, we inevitably apply it broadly, learning as we go that the tool has ideal applications.  Think about how we reflexively use text messaging, email, voice calls and in-person meetings in the context of our work lives.  With time and a thoughtful approach, we’ll get there with virtual visits as well.

Of course there will come a time when that strep test can be done in-home, at the time of the virtual visit (or even before).  We’ll have better tools for determining which cases of bronchitis should be treated with antibiotics.  Who knows, we might even be able to do some sort of portable imaging for your low back pain.

Until then, we’ll be well served to educate both providers and consumers regarding both the excitement and the limitations of virtual visits.

Categories: OIG Advisory Opinions

Slavitt’s “Data Paradox”

Mon, 05/16/2016 - 19:08

Andy Slavitt began his statement at the Datapalooza conference with encouraging words for those of us who believe that the measurement craze has been a disaster and that MACRA will make it worse.  

Slavitt claimed to be in favor of electronic medical record “reform” that “works with doctors, not against them.” He seemed to say he understood MACRA could aggravate the damage that “meaningful use” and the pay-for-performance fad have already inflicted on doctors.

He even accurately summarized the lousy results to date of the measurement craze. He said doctors feel all the data entry “took time away from patients and provided nothing or little back in return.” “[P]hysicians are baffled by what feels like the ‘physician data paradox,’” he said. “They are overloaded on data entry and yet rampantly under-informed.”

But the rest of Slavitt’s statement reveals he has no idea how to solve the “data paradox.” He asserted that “technology that works for doctors and patients” is the solution. I have no idea what this means and Slavitt did not indicate that he has a clue either. What I’m sure of is that “technology” is not the solution to the “data paradox.”

The “Paradox” is not fixable with EMRs

The “data paradox” as Slavitt described it is not fixable with changes in “technology.” It’s the mindset of people like Slavitt that has to change. The “data paradox” will be fixed only when Andy Slavitt and other proponents of the measurement craze terminate the craze or, at minimum, drastically reduce measurement activities. That in turn will require that Slavitt et al. concede that they have vastly oversold what measurement and “data feedback” can accomplish and have vastly underestimated the cost of chronic measurement.

There is no “data paradox.” Physician hostility to being turned into data entry clerks so they can receive mountains of data back from CMS and other insurers can be explained very simply: The data they get back is either worthless or at best useful for generating hypotheses that physicians have neither the time, money nor training to prove or disprove. The data is not, as CMS likes to say, “actionable” by the physicians who receive it.

The data is not actionable because it is inaccurate or, at best, too abstract. Usually the data is both – grossly inaccurate and uselessly abstract. The inaccuracy is caused by two problems: The inability of CMS and other insurers to “attribute” patients accurately to the clinics that treat them (the “attribution problem”); and the inability of CMS et al. to adjust cost and quality scores to reflect factors outside physician control (the “risk adjustment problem”). Technology cannot solve any of these problems. It cannot solve the attribution and risk-adjustment problems, and it cannot make the data less abstract without making it more inaccurate.

Andy Slavitt and his allies in the managed care movement need to be deprogrammed. The deprogramming has to occur in two steps. First, Slavitt et al. must be disabused of the illusion that the data that CMS collects and throws back at doctors is “actionable,” or in the Mother Tongue, useful. Once this is achieved, the “data paradox” will disappear. Next Slavitt and his allies must be persuaded that improvements in technology (slicker EMRs, more interoperability, whatever) cannot solve the problems created by the measurement craze. During this phase of the deprogramming, Slavitt et al. must be persuaded that the problem is sloppy thinking by those who promote the measurement craze.

Conversely, they must be persuaded the problem does not lie anywhere else. The problem is not “resistance” by doctors. It is not stupid patients. It is not “bad technology.” It is cult-like, mulish, sloppy thinking on the part of people who have the power to inflict bad policy on the rest of us.

CMS’s “aerial view” of the Earthlings

The best evidence that CMS’s “data feedback” is almost totally useless is the inability of CMS and the researchers who evaluate CMS demonstrations to articulate what the feedback is good for. For the last three or four years, CMS has been giving “data feedback” to physicians who participate in the Medicare ACO programs (Pioneer and MSSP) and all three of the “medical home” demonstrations. CMS has hired researchers to evaluate these demos (it appears CMS does not intend to evaluate the MSSP demo). You can read published evaluations of these experiments from cover to cover and find no useful information on what function the data served.

The single best characterization of CMS’s data I have found is this one by an unidentified doctor quoted in the latest evaluation of the Comprehensive Primary Care Initiative, one of the three “home” experiments CMS has conducted: “[The report] leaves it up to us to try to figure out how to study that [the cause of high costs]. So it gives you an aerial view of what is going on but does not help you know where to attack the problem.” (P. 32. Bracketed language in the original) The “report” referred to by this doctor is the quarterly “feedback” report that CMS makes available for downloading.

I urge readers to memorize the “aerial view” metaphor used by this doctor. It perfectly illustrates the sloppy thinking at CMS. CMS and its allies in the managed care movement develop evidence-free policy at 80,000 feet and then wonder why Earthlings have so much trouble executing their brilliant policies. When the behavior of the Earthlings fails to improve, CMS refuses to get out of its hovercraft and investigate what happened. Instead they invent fact-free diagnoses like “data paradox.”

CMS’s worthless “tips”

Let us examine the contents of the reports CMS hatched in its hovercraft. I call your attention to a document CMS posted last September entitled “Medicare FFS Physician Feedback/Value Based Payment Modifier: 2014 QRUR and 2016 Value Modifier” 

This document contains the latest Quality and Resource Use Reports (QRURs) published by CMS. According to CMS, these reports are prepared for every doctor who treats Medicare patients. Doctors and their clinics are identified by their Taxpayer Identification Number (TIN). These are the reports CMS expects doctors involved in the ACO and “home” demonstrations to download. It is these reports that CMS and its cheerleaders think will lead doctors to practice “smarter” medicine.

The cost data contained in the QRURs includes CMS’s estimate of the doctor’s or group’s expenditures per attributed patient as well as per attributed patient with one of four diseases (diabetes etc.) The “quality” measures include, among others, 30-day hospital readmission rates. [1]

If you scroll about half way down the page that opens at the address above, you will come upon a document with the encouraging title, “How to Understand Your 2014 Annual QRUR and Supplementary Exhibits.” https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2014-UnderstandingYourQRUR.pdf CMS says you should read this document because it “provides tips on how groups and solo practitioners can use the QRUR … to understand their performance and identify opportunities for improvement.” That word “tips” is your first hint that CMS doesn’t have a clue how doctors should make sense of their QRUR. The waffle words “opportunities for improvement” constitute your second hint.

Here are two examples of the “tips” we encounter in this “How to understand your … QRUR” document.

Example 1: Exhibit 3 of the QRUR presents “the average number of primary care services provided to [Medicare] beneficiaries attributed to your TIN.” Here is CMS’s tip: “If you observe that a large percentage of primary care services provided to your TIN’s attributed beneficiaries is provided by eligible professionals outside your TIN, you may wish to coordinate with these eligible professionals to ensure that your TIN’s attributed beneficiaries are receiving efficient, effective care.”(p. 3)

That’s it. You “may wish to coordinate,” whatever that means. “Coordinate” is one of those all-purpose managed-care buzzwords. You’re supposed to know what it means even though the word is used incessantly, rarely defined, and never defined with anything resembling precision. And don’t ask what “efficient, effective care” means. That’s for CMS to know and the doctor to figure out.

Example 2: Exhibit 10 presents “per episode” costs for four diseases. CMS’s tip (I have italicized waffle words): “The information … allows you to determine specific groups of beneficiaries for which your TIN’s costs are higher than your peers. For example, if your TIN’s Per Capita Costs for Beneficiaries with Diabetes are higher than your peers, then you could consider developing a strategy to improve the efficiency of the care of these beneficiaries, perhaps by adopting care management practices or by educating beneficiaries on self-management techniques.” (p. 7)

I quote two more examples in the footnote below. [2]

All the “tips” are like this. They are vague, and they never hint at the possibility that CMS’s data could be inaccurate. The possibility that CMS’s data might be far to inaccurate to help anyone figure out why their “performance” is above or below average is beneath discussion.

Researchers cannot identify meaningful use of CMS’s data

Since CMS cannot offer any useful advice on how to use its data, it is not surprising that researchers who write papers about CMS’s ACO and “medical home” experiments have been unable to offer any evidence demonstrating that CMS’s data is helpful. The best these researchers can do is report that “some” doctors say the feedback is useful and offer an anecdote. For example, Mathematica, the author of the second-year evaluation of the Comprehensive Primary Care Initiative, tells a story about a clinic that said it began to investigate why its ER costs were “above average.” Mathematica did not report any effort to determine what truths the clinic unearthed as a result of its investigation, what actions it took as a result of its investigation, what these actions cost the clinic, and what the results were. We’re simply left with the claim that one clinic told a researcher they took some time to look at the ER use of their patients.

On the other hand, researchers frequently report evidence that doctors find the reports to be not worth reading. Here is a typical example from Mathematica’s evaluation  of the Comprehensive Primary Care Initiative: “Some practices considered [CMS’s] data feedback useful, but many found it challenging to understand how to use it in their improvement efforts.” (p. xviii) Based on interviews with 21 of the “home” clinics, Mathematica stated that “many … practices … indicated the Medicare FFS data feedback reports lack actionable information from which to draw conclusions. Some practice leadership described the Medicare FFS reports as complicated and did not know how to reconcile the costs being reported with the clinical issues they face in their practice. Moreover, practices noted that the feedback reports do not differentiate between unnecessary and appropriate costs for care consistent with standards of care.” (pp. 32-33)

Wrong diagnosis, wrong prescription

Slavitt’s diagnosis of the problem is half right: Doctors justifiably feel they’ve been forced to take time away from patients to enter data for CMS. But it is incorrect to say doctors feel “rampantly under-informed.” They feel rampantly pestered. They feel the bumptious staff at CMS are forcing them to engage in many hours of busywork and all they’re getting in return is abstract and inaccurate data on their “performance.” This problem will get much worse under MACRA.

Slavitt’s urgent plea to the IT buffs at the Datapalooza conference to “think bigger” and come up with a technological solution to this problem is wildly misguided. Slavitt should have instead promised his audience that he will use his remaining months in office to eliminate the fire-aim-ready approach to policy-making CMS has promoted for decades and replace it with evidence-based health policy. The first policies he should subject to an evidence-based examination are CMS’s measurement and pay-for-performance policies.

[1] Here is how CMS describes the contents of the QRURs: “The cost measures included in this report, and calculated using administrative claims, are Per Capita Costs for All Attributed Beneficiaries, Per Capita Costs for Beneficiaries with Specific Conditions (Diabetes, Chronic Obstructive Pulmonary Disease (COPD), Coronary Artery Disease (CAD), and Heart Failure), and Medicare Spending per Beneficiary (MSPB). The claims-based quality outcome measures included in this report are the 30-day All Cause Hospital Readmission, Acute Ambulatory Care-Sensitive Condition (ACSC) Composite, and Chronic ACSC Composite measures. PQRS and CAHPS measures are also included, if your TIN reported these measures.”

[2] Here are two more examples of useless “tips” from CMS.

Example 3: Exhibit 6 tells doctors their “quality” scores on what Berenson and Kaye  have described as a “vanishingly small part” of the services doctors provide to patients. CMS’s tip:

“A low Quality Domain Score may alert you to opportunities for improvement; review Exhibit 6 to determine the quality domains of weakest performance and to identify the quality measures on which you may wish to focus your quality improvement efforts.” (p. 4) That’s it. Let us count the waffle words in this single sentence: “Opportunities,” “weakest performance,” “focus,” and “efforts.”

Example 4: “Exhibit 7 identifies the hospitals that provided at least 5 percent of your TIN’s attributed beneficiaries’ inpatient stays over the performance period. This exhibit includes only the beneficiaries attributed to your TIN for the three claims-based outcome measures and the five per capita cost measures.” CMS’s tip (I have italicized the waffle words): “Use the data presented in the last column to better understand which hospitals most frequently admitted your TIN’s attributed beneficiaries. This information can help you target care coordination efforts more appropriately.” (p 5)

[3] Mathematica reported an odd discrepancy in its data that suggests that the clinics that claimed to find CMS’s data useful were just brownnosing. In response to one survey question about CMS’s data feedback, 90 percent of the “home” clinics (or perhaps the hospital-clinic cartels that own the clinics) said the data was useful. But in response to another survey, 64 percent said they had never seen the reports. (See discussion pp. 30-31.) Mathematica promised to investigate this discrepancy.

Categories: OIG Advisory Opinions

Playing Doctor

Mon, 05/16/2016 - 14:06

In a deep dark recess of today’s Federal Register, large corporations just quietly received permission to “play doctor” with their employees. They can now impose even more draconian and counterproductive wellness schemes on their workers than they already do. Their hope is to claw back a big chunk of the insurance premiums paid on behalf of employees who refuse to submit to these programs, or who can’t lose weight.

A Bit of Background on Wellness

The Affordable Care Act (ACA) allowed employers to force employees to submit to wellness under threat of fines. Specifically, the ACA’s “Safeway Amendment” — named after the supermarket chain whose wellness program was highlighted as a shining example of how corporations could help employees become healthier — encouraged corporations to tie 30% to 50% of the total health insurance premium to employee health behaviors and outcomes. (As was revealed while ACA was being debated, Safeway didn’t have a wellness program. The fictional Safeway success was a smokescreen for corporate lobbyists to shoehorn this withhold into the ACA.)

Once this 30% to 50% windfall became apparent, many corporations figured out what this vendor (Bravo Wellness) advertised: there is much more money to be made in clawing back large sums of money from employees who refuse to submit to these programs than in improving the health of employees enough to allegedly reduce spending many years from now. “Allegedly” because–unlike simply collecting fines or withholding incentive payments–improving employee health turns out to be remarkably hard and ridiculously expensive to do, so hard and expensive that:

Most importantly, the complete lack of regulation has allowed the wellness industry and health plans to expose employees to significant potential harms, in order to maximize revenues.

The Federal Government Green-Lights “Wellness-or-Else” Programs

There are no regulations, licensure requirements or oversight boards constraining the conduct of wellness vendors, and only one agency — the Equal Employment Opportunity Commission (EEOC) — providing any employee recourse. The Business Roundtable has taken on the latter at every opportunity. First they threatened President Obama that it would withdraw its support for ACA unless he declawed the EEOC. Then they held sham Senate hearings entitled: “Employer Wellness Programs: Better Health Outcomes and Lower Costs.” Finally, they threatened to push the“Preserving Employee Wellness Programs Act” to eviscerate the EEOC’s protections legislatively.

But it turns out the legislative end-around wasn’t necessary. The EEOC has now caved in. These programs are defined as “voluntary,” and yet as of now, employees can be forced to hand over genetic and family history information, or pay penalties. So, as in 1984, where “war” means “peace,” employees can be required to voluntarily hand over this information.

Let’s be clear. This isn’t about employee wellness programs, which don’t work. It’s all about the penalties. Genetic information is worthless in the prevention of heart disease and diabetes, as Aetna just showed in a failed experiment on its own employees.

Knowing family history does have some predictive value, but it is unclear how employees are going to benefit from employers collecting it. Self-insured employers could either fire the employee or do nothing. Neither is useful for the employee. If the employer is fully insured, this information is akin to a “pre-existing condition” in the old days. The employer’s premiums will increase as long as employees with bad family histories remain on their payroll.

The Good News, Part 1: Corporations Wising Up

The Business Roundtable, and their friends at the US Chamber of Commerce, might want to connect their computers to the internet. It turns out that many companies are finally realizing that compelling employees to submit to medical screens just to claw back some insurance money isn’t worth the morale hit.

Increasingly, employers are learning that what the national data shows is also true for themselves: these programs simply do not work. For example:

And the morale hit? A formerly obscure faculty member who led the successful employee revolt against the Penn State wellness program just got elected president of the Penn State Faculty Senate–largely because employees were so grateful to him for his leadership in that revolt.

The Good News, Part 2: Wellness For Employees

As a result, many companies are deciding that clawing back some insurance money isn’t worth the damage done to their workforces. They are replacing “wellness done to employees” with “wellness done for employees.” These companies are improving the built environment, upgrading their foodservice, encouraging fitness, or simply adding features to the health benefit like paternal leave or financial counseling. They might still hold a “health fair” every now and then, but their medical tests are conducted infrequently–according to actual clinical guidelines–instead of allowing vendors to screen the stuffing out of their employees to find diseases that don’t exist.

Or they are actually focusing efforts where they can make a difference, like steering employees to safer hospitals or educating employees on how to purchase healthcare services wisely. (Disclosure: my own company, Quizzify, is in the business of teaching employees how to do the latter.)

Notwithstanding this disruption and regardless of the harms it has caused, the $7-billion wellness industry has excelled in perpetuating its own existence. Industry “thought leaders” recently proposed a scheme to encourage companies to disclose how fat their employees are –and have even managed to get a few large employers to sign on to it.

The sheer audacity of that scheme and complete disregard for its consequences on overweight employees means the war on “voluntary” wellness-or-else programs is by no means over. Like every other industry threatened by reality but supported by deep-pocketed allies like the Business Roundtable, the wellness industry can rely on the government to delay the inevitable.

Consequently, it might be quite some time before the inevitable course of reality overcomes the wellness-or-else pox on the healthcare system.

Al Lewis is the CEO of Quizzify.com and the author of “Surviving Workplace Wellness”

Categories: OIG Advisory Opinions

Rethinking MACRA Part II

Sun, 05/15/2016 - 21:40

In my blog posts, I speak from the heart without a specific political or economic motivation. Although I’ve not written about highly controversial subjects such as religion, gun control, or reproductive policy, some of the topics in my posts can be polarizing.   Such as was the case with MACRA.

Some agreed with my initial analysis that clinicians will have a hard time translating complex MACRA payment processes into altered clinical behavior.   Others felt I was overharsh, negative and inappropriate.  It’s never my intent to criticize people, instead I want encourage dialog about ideas.  In that spirit, here’s my opinion on how we should evolve from fee for service to pay for value/outcomes.

1.  Humans can never really focus on more than 3 things at a time.  Although we sometimes believe multi-tasking is efficient, in reality we do work faster with less quality.    Instead of 6 or 8 dimensions of Meaningful Use performance combined with a large number of quality indicators, why not delegate each medical specialty the task of choosing 3 highly desirable outcomes to focus on each year, then reward those outcomes?  For example, I have glaucoma.   Asking my opthalmologist to record my smoking status or engage in secure messaging with me is probably less important than ensuring my intraocular pressures are measured, appropriate medications are given, and my visual field does not significantly worsen.    The cost to society of my blindness would be significant.    Keeping my sight intact represents value.   Care Management software could ensure I’m scheduled for pressure check appointments, given medications, and have my visual field checked once per year.   Some percentage of reimbursement could be withheld until those outcomes are achieved. How  software does that is not important and innovative workflow would be left to the marketplace where clinicians will choose applications based on usability, cost, and time savings instead of regulatory oversight.

2.  Care coordination is important and there is a role for government to drive consensus around standards selection.   Certification could be limited to an application’s ability to perform a few key interoperability functions such as

a.  Look up a recipient address from a national provider directory and send a clinical summary of care (transition, referral request, consult note) to that address securely

b.  Query a record locator service/master patient index and retrieve a list of electronic addresses where patient data is stored, then be able to retrieve a small common data set from those locations (problems, meds, allergies, labs, notes)

c.  Be able to send a clinical summary of care to a patient provided electronic address.

d.  Be able to send a small number of data elements to a relevant registry

e.  Be able to participate in a prescription drug monitoring program

Each of these functions would use a single standards implementation guide without significant optionality,  tested in the marketplace and deemed mature enough for use.  How these transactions are implemented in workflow would be up to each vendor.    Certification would test nothing more than successful transactions against a publicly available test bed.

3.  All other Meaningful Use criteria and quality measures would be eliminated so that clinicians can focus on just the three goals per year relevant to their specialty while  working in an environment that thrives on the simple information exchanges listed above.

We need to avoid unnecessary burden for clinicians, hospitals and software developers.   Think about all the effort (and dollars) spent during the Meaningful Use Stage 1 and 2 processes to report quality measurements, which were never used for anything.   Think about all the certification done that was not related to health policy goals or outcomes.  Think of all the data entry required which resulted in clinicians  spending time practicing below the top of their licenses.

Focusing on 3 outcomes per specialty which are easily measurable, while radically focusing certfication on a few key interoperability transactions is likely to be acceptable to provider and developer stakeholders.   The big question – would it satisfy CMS goals for MACRA based on Congressional mandates?  I hope to have that dialog in several forums over the next few weeks.

Categories: OIG Advisory Opinions

Independent Decision Support at the Point-of-Care for Both Patients and Physicians

Fri, 05/13/2016 - 17:07

“We did not spend $35 Billion to create 5 data silos.” This was said by Vice President Biden at the beginning of Datapalooza on Monday and repeated by CMS’s Andy Slavitt on Tuesday. On Wednesday, at the Privacy and Security Datapalooza at HHS, I proposed a very simple definition of electronic health record (EHR) interoperability as the ability for patients and physicians to access independent decision support at the point of care regardless of what EHR system was being used.

Over the three days of Datapalooza, I talked to both advocates and officials about data blocking. In my opinion, current work on FHIR and HEART is not going to make a big dent in data blocking and would not enable independent decision support at the point of care. The reasons are:

  • Digital signatures are not supported for patient-authorized release of information directly to third parties. This would require a mechanism for the patient to register a signing key via the EHR View, Download, Transmit (VDT) portal so that from then on the EHR could accept Release of Information (ROI) requests digitally signed by the patient. Lacking this automation feature, the patient would have to sign-in to the EHR VDT portal for each ROI request that directed access to a new destination.

  • There is no provision for the EHR to notify or warn the patient when an ROI request is made unless the patient is signed-in to the VDT portal. HIPAA allows the patient to specify any destination for the ROI but HIPAA also allows a warning to be issued by the hospital if they don’t like the destination. Lacking a means to issue this warning in a convenient way that is specified or controlled by the patient, the scope of automation is limited and interoperability becomes less practical.

  • There is no standardized provision for notification of the patient whenever a release of information is made via the FHIR API. In finance and most of web commerce, we expect an email whenever our account is accessed externally, but HIPAA does not require, and EHR vendors do not provide, this kind of accounting for disclosures. This delays discovery of security breaches and contributes to inappropriate snooping in health systems and HIEs that now each provide access to millions of patients by tens of thousands of staff.

  • There is no provision for alerting the patient’s caregivers, AI, or medical home technology that a change has been made to her record in the EHR. This key feature of the now abandoned Blue Button Plus, has no equivalent in FHIR. This makes decision support at the point of care entirely dependent on the EHR vendor and hospital organization. Lacking this feature, an ROI request would have to be issued and re-issued blindly to check if anything has changed. EHR vendors and hospitals will be able to claim that will overload their systems and refuse to provide access for independent decision support at the point of care.

Any one of these four missing standards can be used to continue data blocking even as FHIR and HEART are released. All of these four standards would be consistent with HIPAA and the oft-cited goal of interoperability to facilitate health reform and the Precision Medicine Initiative.

Also around Datapalooza, CMS is promoting Blue Button on FHIR and ONC announced the first initiatives that involve both FHIR and HEART. They say: “The goal of this Challenge is to incentivize participants to create a Solution that utilizes the HEART implementation specifications to enable individuals to securely authorize the movement of their health data to destinations they choose.” … “Engaging individuals is a requirement of the Challenge. Participants are expected to engage individuals to test implementation of the Solution and enable processes that require individuals to authorize the release of their health data to a destination they choose.”

Lacking adequate standards support by FHIR and HEART, data blockers will find all sorts of excuses for their actions. They say “it’s too hard”, “too expensive”, “the standards don’t exist”, and invoke the HIPAA Security Rule. We have seen this with health information exchanges, Blue Button, Blue Button Plus, Direct messaging, and Meaningful Use View, Download, Transmit. On the current path, MACRA and the EHR regulators will not have the tools they need to promote practical interoperability and to execute on the vision of VP Biden and Andy Slavitt.

Categories: OIG Advisory Opinions

A Free Market Repudiation of Evidence-Based Medicine

Fri, 05/13/2016 - 13:29

In a recent article entitled “A Hayekian Defense of Evidence-Based Medicine” Andrew Foy makes a thoughtful attempt to rebut my article on “The Devolution of Evidence-Based Medicine.”  I am grateful for his interest in my work and for the the kind compliment that he extended in his article.  Having also become familiar with his fine writing, I return it with all sincerity.  I am also grateful to the THCB staff for allowing me to respond to Andrew’s article.

Andrew views EBM as a positive development away from the era of anecdotal, and often misleading medical practices:  “Arguing for a return to small data and physician judgment based on personal experience is, in my opinion, the worst thing we could be promoting.”  Andrew’s main concern is that my views may amount to “throwing the baby with the bath water.”

On those counts, I must plead guilty as charged.  I have been trying to sink that baby for a number of years now, attacking it from a variety of angles.  I have made a special plea in favor of small data and I have even questioned the intellectual sanity of EBM.  On the question of the coexistence between EBM and clinical judgment, I have been decidedly intolerant, relegating EBM to second class citizen status.  In other words, I’m an unapologetic EBM-denialist which, as I found out yesterday on Twitter, puts me in the same category as climate change skeptics.

My main concern today, however, is to address the relationship between EBM and the free-market, and to reject Andrew’s point that EBM is somehow compatible with it.  First, though, let me say that in no way do I deny the notion that American medicine has, for decades, harbored practices of highly doubtful benefit to benefit to patients, and that many such practices may, in fact, have been dangerous or harmful.  I am fully on board with any effort to eradicate “eminence-based medicine.”

But before we reach out for an EBM solution to that problem, perhaps we should first wonder about causes.  What keeps the errors of eminence-based medicine persisting for so long?  Why do patients and doctors remain so wedded to a course of therapy as to blithely engage in unbeneficial or even harmful care?

If I read Andrew correctly, he seems to believe that these errors persist because outcome uncertainties are inherent to clinical care, hence the need for EBM. But that cannot be the fundamental reason.  Why would patients continue to pursue a treatment for which they have neither objective nor subjective tangible benefit?  Why wouldn’t they refuse to go along?  After all, many of them do exercise their ability to be non-compliant in the case of treatments deemed beneficial to them according to the truths of EBM!

Outcome uncertainty, then cannot be the reason why futile or harmful treatments persist, and if outcome uncertainty is not the reason, reducing it by way of EBM may not be the answer either.

What eludes Andrews is that eminence-based medicine is not simply the result of individual doctors exercising judgment with limited knowledge. Rather, eminence-based medicine happens when doctors apply their own pet theories and disregard the needs and wants of the patient at hand.

By missing that point, Andrew misses that eminence-based medicine is precisely minimized by the free-market and, on the contrary, encouraged by government intervention.  The history of American medicine provides ample examples to make that point.

In the late nineteenth century, healthcare in the United States was uniquely unregulated.  Yet, contrary to common belief or fabricated myths, care was improving by leaps and bounds, getting at once better, cheaper—and more scientific.  It is during that time that some of the finest medical institutions emerged, including the Mayo Clinic and the Johns Hopkins Hospital.  Sure, there were snake oil salesmen, but these were by-and-large being driven out of business by a growing community of serious, well-trained, and effective physicians.  And competition among these practitioners kept them humble and at the service of patients.

All of this changed in the 1910’s when, following the Flexner reforms, state licensing laws were enacted.  It is in the heels of these laws that medical paternalism emerged.

As an illustration, consider this passage excerpted from an official report published soon after the enactment of licensing laws:

The physician is the outstanding practitioner of medicine.  The need and the value of his service sets him above all others.  He alone, of all types of medical practitioners in the United States, is permitted by law to diagnose and treat all diseases and conditions and to use (with certain minor exceptions) any form of diagnostic or therapeutic technique which he considers necessary, desirable, and within his professional skill.  (Report of the Committee on the Cost of Medical Care, 1928, p. 195)

From that point onward, medical abuses of privilege became much more widespread than they had been.

Furthermore, as Kenneth Ludmerer has pointed out, this elevation of the physician to the status of demi-God by government fiat went hand-in-hand with the rise of the academic ivory tower, since academic medical schools were producing the “cream of the crop” among doctors.  Academic ivory towers, naturally, become common sources of practices founded on eminence.

Of course, licensing laws and the emergence of the ivory towers are not the only factors to consider.  Other government interventions soon followed to bring about systems of third-party payment for medical care—health insurance.  Without these government interventions, and without the existence of licensing laws, it is unlikely that health insurance would have emerged from the free market.  By unmooring medical decisions from any financial constraints, health insurance contributes immensely to the perpetuation of eminence-based practice.

It is this regulatory context, then, that is at the root of eminence-based medicine, and not the uncertainties of clinical care which, in a profound way, are inherent to the medical encounter.

Andrew believes that EBM discovery is akin to price setting on the free market.  I strongly disagree with that analogy.  As Andrew himself has noted, prices set in the free market convey consumer values and are the end results of myriad decisions made on the basis of dispersed knowledge.

EBM results, on the other hand, are statistical relationships between interventions and outcomes which are carefully selected by investigators in highly contrived experimental settings.  In these settings, the choices and preferences of doctors and patients are ignored or neutered by design in order to isolate the relationship of interest.  Any value obtained as a result of an EBM experiment is primarily imputable to the investigators or sponsors, and only secondarily (and statistically) of benefit to patients.

EBM is no free market phenomenon.  EBM is an academic invention incubated in Canada, a country with a single-payer healthcare system!  As I described in my article, this invention has spun out of control and has turned EBM into a weapon wielded with equal vigor by the pharmaceutical industry, by regulators, and by those who aim to equalize the historical excesses of eminence-based medicine through the dubious doctrine of “Less-Is-More.”  None of these movements, it seems, are motivated by a desire to advance a genuine human science that is meaningful to individual patients.  In fact, to the extent that is a pet theory which standardizes care for entire populations, EBM is eminence-based medicine on steroids.

But if EBM is by no means a product of the free market, can the free market address our need to improve therapeutic predictions or will it set us back to a clinical stone age?

So long as narrowing clinical outcome expectations is truly desired by doctors and patients—and there is no reason to doubt that it is—then the free market is demonstrably the optimal environment that can allow human ingenuity to devise clever ways and methods to achieve that goal.  But what shape or form would those methods take and how closely would they resemble what we now take to be evidence-based science, I have no idea.  If I believed I held that knowledge, I would be repudiating Hayek.

Michel Accad is a cardiologist who practices in San Francisco.  He blogs at Alert and Oriented and can be followed on Twitter @michelaccad

Categories: OIG Advisory Opinions

Hillary’s Pivot Left on Healthcare

Fri, 05/13/2016 - 11:41

Is Hillary Clinton really moving to the left on healthcare, as the NY Times and many others have asserted, pushed by continued pressure from Bernie Sanders to endorse the public option? It is a strange claim. First of all, her campaign’s explicit support of the Public Option goes back to at least February, when her site was updated with language backing it, and which seems essentially identical to the language the campaign uses today.  She hasn’t moved left in the last three months due to the lingering strength of the Sanders campaign. Has she changed at all from previous years? There isn’t any indication of that, either. If anything, her plans today are scaled back from her 2008 presidential campaign, in which the public option, based on Medicare, figured prominently. Her support of the public option in 2016 is cautious, burned by past failures and acutely conscious of the need for a sympathetic Congress to pass meaningful legislation. She does not say today that she would seek new legislation to enable a public option, leaving it implicit that with a Democratic congress she would test the waters and jump if the opportunity arises. Instead, what she does promise is that she will “work with interested governors, using current flexibility under the Affordable Care Act, to empower states to establish a public option choice.” In other words, leave it up to the states to decide under existing law. So a state like Vermont would be likely to adopt it, but a state like Alabama wouldn’t. In other words, the states that would benefit most would be least likely to take advantage of the opportunity, if history is any guide. This does not sound like a move to the left under pressure, but an acknowledgement of desires long present. This is a more subdued, perhaps wiser, expression of the ideal of universal coverage within the the constraints of political reality, and Bernie has little or nothing to do with it.

 

 

Categories: OIG Advisory Opinions