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Guidelines vs. Personalized Medicine: the Battle for the Future of Healthcare

As we grapple with provider shortages, the surge in chronic illness and the quality to price (QPR as they say in the wine business) challenge in US healthcare delivery, it’s hard to imagine a future that does not include some sort of guideline or algorithm-driven care.  As providers take on more financial risk, one common strategy involves team-based care, and the attendant increase in decision-making and care delivery by non-physician clinicians.  If the je ne sais quoi feature of a quintessentially great doctor is clinical judgment and instinct, one of the challenges of this transition to team-based care is how to harness that trait and use it efficiently.

Care decisions that are unassailable at a population level (e.g., women should have regular, routine PAP smears or smoking is bad for your health) or are algorithmic in nature (e.g., titration of treatment for uncomplicated hypertension or therapy for mild to moderate teenage acne) can all be effectively reduced to guidelines.  This, in turn, allows a physician to delegate certain therapeutic decisions to non-physician providers while maintaining a high degree of care quality.  It is also thought that this type of uniformity of care delivery will improve the QPR too, by decreasing variability.

How do we come up with guidelines?  Typically they are based on large-scale, randomized, controlled clinical studies.  As is nicely articulated in a recent JAMA opinion piece by Drs. Jeffrey Goldberg and Alfred Buxton (JAMA, June 26, 2013—Vol 309, No. 24, pg 2559), guidelines are formulated based on the inclusion criteria for these trials.  This process gives us comfort that guidelines are based on rigorous science — and that is a good thing.  The challenge arises when we realize that individuals do not reflect populations exactly.  Clinical research is much more complex than wet lab work because people are complex and indeed unique.  Every clinician has had the experience of prescribing a therapy to a patient who fit guideline criteria exactly and having the opposite outcome of what the guideline predicts.

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Can Medicare Reach Its 65th Birthday?

Every day, 10,000 people in the U.S. celebrate their 65th birthday, making each one of these seniors eligible for Medicare. The very program that gives America’s seniors access to affordable health care will turn a youngish 48 on July 30, but in a biting irony, it could go bankrupt before reaching its 65th birthday.

We cannot wish away or ignore the reality that Medicare’s Part A trust fund — the portion that pays hospital claims — is currently projected to run out of money by 2026. The good news, however, is that it is possible to put Medicare on a sustainable path if we can surmount current political hurdles.

It is no secret that Washington is better known for what it is not doing than what it is doing these days. Partisan gridlock has proved to be an insurmountable impasse for potentially worthy legislative efforts. This is especially true when it comes to making the changes needed to sustain Medicare’s future, where Washington is truly making things much harder than they need to be.

Much of the current debate has focused on reforms that would only slightly defer Medicare’s pending insolvency, with the potential for mere cost-shifting. With many of those recommendations, political disagreement is so strong that an extremely limited chance exists to pass a compromise version. However, even if enacted, these reforms would only address the symptoms of Medicare’s condition rather than the underlying problem. The result would only help Medicare limp to its 65th birthday at best.

There is a much more meaningful reform out there that addresses the underlying problem, and, surprisingly, bipartisan consensus exists around the need to end the fee-for-service system in Medicare.

The current fee-for-service payment system compensates physicians and other health care providers for each service they deliver, such as an office visit, test or other procedure. While it is critical that providers be fairly compensated, Medicare’s fee-for-service structure contributes to inefficient care that is often disconnected with actual patient outcomes. It has accelerated the program’s financial imbalance with inflationary spending that has little or no connection to helping beneficiaries get healthier.
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The Merit of Merit Affidavits in Malpractice Lawsuits

Similar to many other states, Oklahoma has a statute prescribing that suits alleging medical malpractice must be verified by an affidavit from a qualified medical expert. Suits unaccompanied by a proper affidavit must be stricken out. This statute is part of what I call – and commend – as a procedural tort reform: it allows courts to get rid of unmeritorious suits against doctors and hospitals early in the process.

The statute, however, recently became a dead letter after being pronounced unconstitutional by Oklahoma’s Supreme Court for the second time in a row (Wall v. Marouk, — P.3d —-, 2013 WL 2407160 (Okla. 2013)). Evidently, this Court does not view merit affidavits as favorably as I do.  Let’s see why.

The previous version of Oklahoma’s affidavit-of-merit requirement, limited to medical malpractice suits, was found unconstitutional as a “special law” and “monetary barrier to the access to courts” (Zeier v. Zimmer, Inc., 152 P. 3d 861 (Okla. 2006)). The current version extended to all suits asserting professional negligence, which makes it less “special.” This version was nonetheless challenged by a patient whose suit against a physician was not accompanied by a merit affidavit from a qualified expert.

The plaintiff alleged that the physician caused him permanent injury during surgery (loss of feeling in right fingers) by negligently cutting the median nerve in his right arm.  The trial court ruled that the plaintiff must submit the required affidavit within twenty days or face dismissal.

The Oklahoma Supreme Court voided this requirement for being as unconstitutional as the previous one.  The Court ruled that the requirement arbitrarily separates suits that allege professional negligence from other civil actions, in which plaintiffs do not bear the costly burden of obtaining expert review prior to proceeding. This disparate treatment, explained the Court, discriminates against victims of professional misconduct.

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Physician Collaboration Isn’t Collusion to Increase Costs

“This GAO report sheds new light on the behavior of physicians reaping personal gain by referring patients to services at locations where they have an ownership interest. The analysis suggests that financial incentives for self-referring providers is likely a major factor driving the increase in referrals for these services. As Congress looks to reign in unnecessary spending, my colleagues and I should explore this area in greater depth,” Rep. Waxman said.

Explore you should, Representative Waxman. For if you look beyond the GAO’s conclusions, you will find that what we really need are bundled payments and a regulatory environment that supports, not inhibits, innovation to improve high-value health care.

Just because physicians have come together to manage their own futures doesn’t mean that their intent is to collude and increase costs. Could it not also indicate that health-care professionals have joined together to provide better care in a more efficient manner that reduces waste and unnecessary services to save the system money?
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The Affordable Care Act Will Fail Without Patient Engagement

What’s behind the recent EHR public relations blitz and our passionate debate in The Health Care Blog? It’s fear for the Affordable Care Act’s future. Oh, the ACA can weather political challenge in the short term, but in the long run, only health cost containment will matter. EHRs are the ship that institutions are counting on to navigate payment reform and, from the institutional perspective, physicians and patients are just along for the ride. From the citizen perspective however, cost containment will be seen as rationing unless patients and physicians are appropriately engaged in the most costly decisions.

The impact of yet more regulations, such as Stage 3 Meaningful Use, could be too late to save the ACA. For now, the administration and those of us that hope the ACA succeeds must work to shift EHR vendors and their institutional customers toward patient engagement using the tools of policy guidance, public relations and federal procurement.

First, a crash course in health economics. If you have a few minutes, read Accountable Care Organizations: Can We Have Our Cake and Eat It Too? by Jessica L. Mantel. Otherwise, just struggle through the next two paragraphs summarizing why EHRs are the lynchpin of health reform via the ACA.

Cost containment requires either cost controls or a shift away from fee-for-service payment. The ACA is based on accountable care as an alternative to fee-for-service. Accountable Care Organization (ACO) is shorthand for the new health care payments regime. By paying ACO institutions instead of individual service providers, health insurance companies and Medicare provide direct economic incentives to reduce waste, lower costs and, if we’re not careful, withhold needed care. An ACO is by definition an organization or institutional construct.

The EHR is is not the Jedi knight’s lightsaber, it is an institutional tool designed to bind the individual service providers into the Federation’s collective. Not surprisingly, patient engagement is an afterthought.

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The Office Visit Revisited

A patient calls or emails me with a problem. I talk with them over the course of a few days, using whatever form of communication works best.  Eventually, they need to come to the office to be seen – either for something needing to be done in-person (examination, procedure, or lab test), or because of the advantages of face-to-face communication.  At the visit, I not only deal with one problem, but there are other issues needing to be addressed.  Finally, after the visit, follow-up on the problem continues until it is either resolved, or at least is not causing much trouble.

So how do I document that?

In the past I would’ve had a clear structure for the “office visit” and separate “encounters” for the documentation of the communication done outside of the office.  The latter would be done largely with narrative of the conversation, and some direct quotes from the patient.  The former, the “office visit” would include:

  • A re-telling of the story of the “chief complaint” and what’s been happening that caused this encounter to be necessary.
  • A sifting through other symptoms and past-problems to see if there is any information hidden there that may be useful.
  • A documentation of past problems (already in the record) to support the thought process documented later in the visit.
  • An overview of the physical exam, again to support the  decisions made as a result of the visit.
  • A discussion of my thoughts on what I think is going on.
  • A telling of my plan on how to deal with this.
  • A list of any advice given, tests ordered, medications changed, prescriptions written, and follow-up as the details of that plan.
  • A signature at the end, attesting to the validity of what is contained in the note.

But here’s the problem: it’s not real.  I don’t make all of my decisions based on the visit, and the patient’s story is not limited to what they tell me.  Details may be left out because they are forgotten, questions aren’t asked, or things just haven’t happened yet.  This signed and sealed unit of care, represented as a full story, actually represents only fragments of the story, of many stories actually, and only as a moment on the continuum of the patient’s care.
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Blood Pressure Monitoring, Telemedicine, and Automated Hovering: A Future Model for Disease Management?

Use of an at-home telemonitoring blood pressure device significantly reduced out-of-control high blood pressure, according to a recent study in the Journal of the American Medical Association. It’s another data point showing the potential of telemedicine to have a profound effect on American medicine, by positively modifying health behaviors, providing real-time data to clinicians through “automated hovering,” and helping Americans get and stay healthy – all of which holds the promise of bending the cost curve.

Led by Karen Margolis, MD, MPH, a Senior Investigator at Health Partners Institute for Education and Research, the cluster-randomized study investigated whether using a cloud-connected, at-home blood pressure monitor paired with pharmacist and case manager support would lead to controlled blood pressure more than typical care, which involved check-ups with a physician.

Those using the telemonitoring device were 90% more likely to have controlled blood pressure at both the six and twelve-month checkups than the control group (57.2% and 30%, respectively), and had, on average, statistically significant lower systolic and diastolic readings.
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What Happens In New York Stays In New York

While sitting in the crowded waiting room of a medical specialist’s office I was forced to listen to the television set directly over my head. Cranked up so that everyone could listen above the din of conversation, Wolf Blitzer introduced a video clip of the President hailing the latest news from New York about health insurance exchanges.

Speaking as if he was still on the campaign trail, the President’s words came through loud and clear over the television: thanks to his health reform, premiums in the New York exchange would be half that of premiums in the individual market. This was a model the entire nation should embrace.

No one heard me mutter under my breath that this was a model for New York and a small handful of other states that previously regulated their individual insurance markets effectively out of existence.

What the President undoubtedly knows, but dared not say, is that New York’s individual insurance market is unlike any other state. In New York, insurers cannot charge higher premiums to high risk enrollees.

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As a result of this aggressive community rating, high risk individuals are disproportionately represented in New York’s individual policy risk pools. This drives up premiums, which drives away low risks, driving premiums even higher. Insurers in New York are counting on the purchase mandate, combined with purchase subsidies, to lure low risks into the pool.

This is why they have lowered premiums.

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The EHR Debate: Fighting the Last War?

Right now there’s a fierce debate going on for the hearts and minds of health IT. Finally American health care (well, half of it anyway) is using electronic medical records. But it’s not the panacea we were lead to believe. Costs haven’t gone down, health hasn’t markedly improved and the taxpayer/Chinese government is poorer. So too are many doctors and hospitals, and the main beneficiaries appear to be construction companies in Madison, Wisconsin.

Worse, those who promote the impact and importance of EMRs (Farzad MostashariAshish Jha) are being attacked by Ross Koppel, Steve SoumeraiScott SIlverstein and others who essentially say that EMRs are more dangerous and inefficient than paper.

This reminds me of the World War One British Army preparing to fight in the mud of Flanders with cavalry charges suited to the Boer War, the French Army in 1939 retreating to their WWI style trenches while the Germans flew over them, and (dare I say it) today’s TSA strip searching grandmothers looking for boxcutters.

Yes, we’re having the wrong fight by focusing on old problems. The EMRs that are producing the studies we’re fighting about are the current equivalent of 1990s EPR implementations. In general they’re hard to use and require lots of money and training to produce halfway decent results. The real improvements from IT came when user-centered tools came to consumers and then to business with Web 2.0 and new devices like the iPhone.

It may take months of training on Epic or Cerner to get a doctor or nurse to be three-quarters as productive as they used to be, but my two-year-old daughter can fire up an iPad and play games and watch videos with no training.What we’re seeing every day at Health 2.0 is a whole new generation of data-driven applications and devices that are going to make the health care user experience much more like the one my daughter has.

When we get there, the real improvements in both productivity and safety, as well as in quality and even cost, will emerge and we’ll wonder why we ever were having this fight.

More Work Is Needed on the Safety and Efficacy of Healthcare Information Technology

If one were writing about the improvement of gastronomy in America, one would probably not celebrate “over 300 billion hamburgers served.”  But that’s very much the type of success Dr. Ashish Jha is celebrating in last week’s piece on recent US healthcare IT sales. Unfortunately, the proliferation of Big Macs does not reflect superior cuisine, and healthcare IT (HIT) sales do not equate with better healthcare or with better health. Quantity does not equal quality of care.

To be sure, Dr. Jha acknowledges the challenges of rolling out HIT throughout US hospitals. And he should be strongly commended for his admission that HIT doesn’t capture care by many specialists and doesn’t save money. In addition, Dr. Jha points to the general inability of hospitals, outpatient physicians and laboratories to transfer data among themselves as a reason for HIT’s meager results.

But this is a circular argument and not an excuse. It is the vendors’ insistence on isolated proprietary systems (and the government’s acquiescence to the vendors) that created this lack of communication (non-interoperability) which so limits one of HIT’s most valuable benefits.

In our opinion, the major concern is that the blog post fails to answer the question we ask our PhD students:

So what? What is the outcome?

This entire effort is fueled by $29 billion in government subsidies and incentives, and by trillions of dollars spent and to be spent by hospitals, doctors and others [1].

So where is the evidence to back up the government’s and industry’s promises of lower mortality, improved health and lower health care costs?

Single studies tell us little. Sadly, as many as 90% of health IT studies fail the minimal criteria of the respected international literature syntheses conducted by the Cochrane Collaboration.

In other words, studies with weak methodology or sweetheart evaluation arrangements just don’t count as evidence.
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