The Health Care Blog – Page 293 – Everything you always wanted to know about the Health Care system. But were afraid to ask.

Above the Fold

12 Seconds of Placebo – An Outsider’s View of ORBITA

Nov 7, 2017• 3

By SAURABH JHA, MD

The reactions of physicians to ORBITA, a blinded, randomized controlled trial (RCT) from Britain, with a sham arm, comparing percutaneous coronary intervention (PCI) to placebo, in patients with stable angina, are as fascinating as the cardiac cycle. There were murmurs, kicks, and pulsating jugulars. Though many claimed to be surprised, and many unsurprised, by the null results of the trial, the responses were predictably predictable. Some basked in playful schadenfreude, and some became defensive and bisferious.

No shame in sham

The coverage of the trial in the NY Times was predictably jejune and hyperbolic. Predictably, the most nuanced and divergent viewpoints were curated by Larry Husten. Predictably, medical Twitter was set alight. The trial vindicated Vinay Prasad and Adam Cifu who predicted that PCI for stable angina will get placeboed, in their popular book, Ending Medical Reversal. Prasad and Cifu are tireless advocates for using sham control trials to judge the true efficacy of procedures, such as PCI, in relieving symptoms, and reject the notion that invasive placebos are unethical. There’s no shame in sham, they say. They were right.

The Objective Randomized Blinded Investigation With Optimal Medical Therapy in Stable Angina (ORBITA) is an impressive trial, which enrolled 230 patients with stable angina and single vessel stenosis greater than 70 %. The vast majority had class 2 (59 %) and class 3 (39 %) angina. Majority of the patients, 70 %, had LAD lesions. If you look in the appendix, which has pictures of catheter angiograms of all patients, you’ll see scary tight proximal LAD stenosis – yes, even these patients had 50 % chance of getting sham. This takes balls. The trialists deserve applause, as do the Brits who volunteered. These were no snowflakes.

The DNA Tool That You Must See

Nov 7, 2017• 1

BY HEALTH 2.0 SPONSORED POST

Most people have no way of accessing DNA-powered insights about themselves, and no way to store and use their genome in ways that they control. Technology for Precision Health Summit demoer Helix solves that by providing the world’s first online store for DNA-powered products where people can explore diverse and uniquely personalized products developed by high-quality partners. After being sequenced once with true next-generation sequencing, the user can query their data on-demand at any time for a large variety of uses.

The costs of DNA sequencing have dropped rapidly, and our understanding of how DNA influences our lives has increased. For partners in the Helix marketplace, DNA now becomes a software problem, not a hardware problem, where a full clinical-grade exome is accessible through an API. Helix handles sample collection, DNA sequencing, and secure data storage so that our partners can integrate DNA insights into products across a range of categories, including ancestry, entertainment, family, fitness, health and nutrition.

Check out a live demo of Helix’s DNA-powered tool from its co-founder Justin Kao during the New Diagnostic and Screening Tools panel session at the Technology for Precision Health Summit. Hear perspectives about the value of personalization, and lessons learned from being at the forefront of an emerging and exciting new consumer market.

Right to Know: Why the FDA Should Not Be Cut Out of Expanded Access Requests

Nov 6, 2017• 2

By CHAPMAN, KLEIN and McFADYEN

Over the past three years, the libertarian Goldwater Institute–led right to try (RTT) movement has had wind in its sails, propelling the passage of RTT laws in 38 states and counting. The movement, which aims to cut the FDA out of the process by which patients with serious or immediately life-threatening diseases without available therapies access investigational drugs and biologics, hit some choppier waters at the hearing held October 3rd by the Health Subcommittee of the House Energy & Commerce Committee. The House is considering passage of a federal RTT bill, and two potential options were presented at the hearing. S. 204, sponsored by Sen. Ron Johnson (R-Wis.), was passed by unanimous consent in the Senate on August 3. Another RTT bill, H.R. 1020, introduced by Representatives Morgan Griffith (R-Va.) and Dave Brat (R-Va.) in February, was also under consideration. Rep. Andy Biggs (R-Arizona), who in February introduced a third version of a federal RTT bill, H.R. 878, testified at the hearing. Senators Joe Donnelly (D-Ill.) and Johnson have urged the House to pass S.204 “as soon as possible” and “without amendment.” Making any changes to S.204 would require reconsideration of the new version by the Senate.

A Tale of Two Doctors

Nov 3, 2017• 10

By ROBERT MCNUTT, MD

Data is not always the path to identifying good medicine. Quality and cost measures should not be perceived as “scores,” because the health care process is neither simplistic nor deterministic; it involves as much art and perception as science—and never is this more the case than in the first step of that process, making a diagnosis.

I share the following story to illustrate this lesson: we should stop behaving as if good quality can be delineated by data alone. Instead, we should be using that data to ask questions. We need to know more about exactly what we are measuring, how we can capture both the physician and patient inputs to care decisions, and how and why there are variations among different physicians.

A Tale of Two Doctors

“As soon as I start swimming, my chest feels heavy and I have trouble breathing. It is a dull pain. It is scary. I swim about a lap of the pool, and, thankfully, the pain goes away. This is happening every time I go to work out in the pool”.

Her primary physician listened intently. With more than 40 years of experience, the physician, a stalwart in the medical community, loved by all, who scored high on the “physician compare” web site listing, stopped the interview after the description and announced, with concern, that she needed to have a cardiac stress test. The stress test would require walking on a “treadmill” to monitor her heart and would include, additionally, an echocardiogram test to see if her heart was being compromised from a lack of blood flow.

“But, I have had three echocardiogram tests in the last year as part of my treatment for breast cancer and each was normal. Why would I need another”?

“Well, I understand your concern about more tests, but the echocardiograms were done without having your heart stressed by exercise. The echo tests may be normal under those circumstances, but be abnormal when you are on the treadmill. You still need the test, unfortunately. I want to order the test today and you should get it done in the next week”.

The Dunning-Kruger Effect, Or the Real Reason Why the Guys Trying to “Fix” Health Care Are Driving You Crazy

Nov 3, 2017• 2

By HANS DUVEFELT, MD

“The fool doth think he is wise, but the wise man knows himself to be a fool.”
– Willam Shakespeare

I learned about the Dunning-Kruger effect at a medical conference recently. It certainly seems to apply in medicine. So often, a novice thinks he or she has mastered a new skill or achieved full understanding of something complicated, but as time goes on, we all begin to see how little we actually know. Over time, we may regain some or most of our initial confidence, but never all of it. Experience brings at least a measure of humility.

Just the other day I finished a manuscript for an article in a Swedish medical journal with the statement that, 38 years after my medical school graduation, I’m starting to “get warm in my clothes”, as we say in Swedish.

I think the Dunning-Kruger effect applies not only to people who are in the beginning of a career in medicine, but also to people who learn about it for purposes of judging its quality or efficiency or of regulating or managing it from a governmental or administrative point of view.

I think many people outside medicine think “how hard can it be” and then proceed to imagine ways to change how trained medical professionals do their work.

But the Dunning-Kruger effect is also a particular problem in rural primary care. Newly trained physicians, PA’s and Nurse Practitioners are asked to work in relative professional isolation with full responsibility for sizeable patient populations. Unlike the hospital environment, primary care practices seldom have time earmarked for teaching and supervision, and there is little feedback given to such new providers. There is also very seldom collaboration and communication about specific patients or cases. We probably get more feedback from our specialist consultants than we do from the providers in our own clinics, because we are all busy with our own patients.

So, how does a new clinician avoid the newbie hubris Dunning and Kruger describe? Seek out potential mentors and ask them to be yours, start a case conference at your clinic, read the leading journals, NEJM, JAMA, BMJ, The Lancet and ones like them, and read about the history of medicine and the old masters.

Evaluating ACO Performance, 2016 Edition

Nov 2, 2017• 1

By DAVID INTROCASO

(A review of 2015 ACO results appeared on The Health Care Blog on October 1, 2016.)

The Medicare Shared Savings Program (MSSP), or Accountable Care Organizations (ACOs), continue to be CMS’ flagship pay for performance (P4P) model delivering care via 432 MSSP ACOs located in every state to over nine million, or 16%, of Medicare beneficiaries. This year the agency did not announce 2016 performance year results. Instead, CMS posted without notice in late October a Public Use File (PUF) or spread sheet summarizing 2016 performance. What analysis CMS did provide was by CMS’ vendor, the Research Triangle Institute (RTI), several weeks ago to ACO participants via webinar. RTI’s slides are not made publicly available.

Like performance year one (2013), two (2014), and three (2015), performance year four (2016) once again produced limited positive results. As stated last year, CMS does not evaluate the ACO program, therefore, ACO participants and Medicare policy analysts are left to decipher how success was achieved, what performance results mean for the MSSP program and in context of the agency’s overall efforts to reduce Medicare spending growth.

2016 ACO Financial Performance Results

Here is a bulleted summary of 2016 financial performance based on the PUF and RTI’s slides.

In 2016 there were 432 ACOs that had their performance year results reconciled.
Of these, 410 were Track 1, six were Track 2 and 16 were Track 3.
Of the 432, 134 earned shared savings or 119 out of 410 Track 1s, six out of six Track 2s earned shared savings and nine out of 16 Track 3s earned shared savings. Four Track 3 ACOs owed $9.33 million in shared losses. Only 129 actually received shared savings checks because five of the 134 owed CMS for advanced ACO payments.
Physician only ACOs once again were more successful than ACOs that included a hospital, or 41% versus 23% respectively.
Also again longer tenured ACOs were more successful. Among the 2012-2013 ACO class 42% were successful compared to 18% of the 2016 starters.
The 134 2016 ACOs earned in sum slightly more than $700 million in shared savings. Actual savings paid out was close to $650 million because imperfect quality caused ACOs to leave money on the table and because of Medicare reimbursement or sequestration cuts required the 2011 Budget Control Act.
For 2016 30% of participation MSSP ACOs will receive a shared savings check compared to 29% in 2016, 26% in 2015 and 27% in 2014.
Earned shared savings were again highly concentrated. The 15 highest performing ACOs received $265 million total in shared savings as compared to the 15 lowest performing shared savings ACOs that received $20 million in total. An August DHHS Office of Inspector General (OIG) report made note of this dynamic, i.e., about half of the spending reductions during the first three years of the program, or $1.7 billion, were generated by 36 ACOs and three ACOs in that group generated a quarter of the amount.
Of the remaining 294 2016 ACOs, 107 fell within their positive Minimum Loss Ratio (MLR) corridor, 105 fell within their negative MLR corridor and 82 fell outside their negative MLR corridor. This last group, the worst performing ACOs, was 19% of all 2016 ACOs, significantly less than the 24% of the worse performing 2015 ACOs.
Again, success was largely determined by an ACO’s financial benchmark. ACOs that earned shared savings in 2016 had a reconciled benchmark 10% higher than all other ACOs, or respectively $11,614 per beneficiary versus $10,563 per beneficiary, or a benchmark 7% higher than those within their positive MLR corridor and 12% higher than those that fell below their negative MLR. The OIG report reached the same conclusion. During the first three years of the program, ACOs that received shared savings had a $11,748 per beneficiary benchmark compared to a $10,284 per beneficiary for ACOs that did not receive shared savings, a 12% difference. As noted last year, because of this successful ACOs only had to comparatively spend a trivial amount less than their financial benchmark to be successful.

Reducing Opioid Abuse, A Quick Guide to Internet Resources

Nov 1, 2017• 9

By DAVID HARLOW, MD

The opioid crisis has been upon us for years now, and we are now seeing the problem become more pervasive, with more than 90 deaths per day in the U.S. due to this scourge. The president recently said he would be declaring a public health emergency (which would free up some funds) but has not done so as of this writing. The public health threat is so persistent that it calls for responses on many levels, and those responses are coming. Some have been in place for a while, some are more recent. These responses may be broken down into a number of different categories:

Broader availability of naloxone (antidote) and related training to first responders, health care providers and the general public (though of course in our litigious society, applicability of Good Samaritan laws to naloxone use by laypersons is a consideration)
Medication-assisted treatment following acute episodes (emergency room visits)
States imposing limits on prescribing and dispensing, mandating education and other innovations (for example, Massachusetts’ first-in-the nation opioids law (including the first state law limiting most opioid prescriptions to a seven-day supply), enacted in 2015, with a follow-up law enacted in 2016 that among other things offers a system for recording and communicating a voluntary opiate “opt-out” for individuals); and limiting pharma payments to physicians in order to discourage incentives for high-prescriber status (current proposal in New Jersey)
Licensure and certification bodies imposing limits on prescribing and dispensing (state boards of registration in medicine, e.g., Ohio) and articulating management and operations frameworks for implementing those limits (Joint Commission)
PBMs establishing limits for dispensing (Express Scripts, CVS Caremark)
Payors imposing limits on payment (see, e.g., Cigna‘s opioid abuse detection and prevention program)
The FDA mandating prescriber training (it is also being urged to ban high-dose formulations)
Providers developing programs to limit the use of opioids in pain management along with specific targets on reduction in use (e.g., Intermountain)
Professional and industry associations providing training of clinicians in pain management without opioids, or with limited opioid use (e.g., Massachusetts Medical Society, Colorado Hospital Association)

The overarching goal is to eliminate the use of opiates for all but the most critical short-term needs (limiting prescriptions to a seven-day supply) and medically-appropriate chronic and palliative pain management. There are alternative pain relief drugs — and a wide variety of other treatments for pain, ranging from TENS to meditation to VR. Taken together, the initiatives highlighted and linked to above represent a good start. Of course, we need more than a good start, as the US consumes a wildly disproportionate share of opiates compared to other countries — follow link for some facts and figures — for predictable reasons of economics, politics and culture, and we are paying a staggering price in excess morbidity and mortality and in secondary effects (the effects on family and community).

Why the Potential CVS Acquisition of Aetna is Brilliant, The Law of Unintended Consequences

Oct 30, 2017• 6

By FRED GOLDSTEIN

Many people have been surprised by the announcement that CVS is interested in purchasing Aetna. Why would a PBM want to own a health plan? There has been speculation that the move by Amazon to get into the pharmacy space may be a reason. But there is another more rationale reason and its based upon a flaw in the Affordable Care Act.

The flaw is known as the Medical Loss Ratio requirement and it reads like this from the CMS website

The Affordable Care Act requires insurance companies to spend at least 80% or 85% of premium dollars on medical care, with the rate review provisions imposing tighter limits on health insurance rate increases. If an issuer fails to meet the applicable MLR standard in any given year, as of 2012, the issuer is required to provide a rebate to its customers.

This requirement was put in place as a way to ensure that health plans did not make money by underutilizing medical care. But it had the unintended consequence of insuring that costs never went down and here’s why.

“Mouths Full of Gold.” Private Practice in Britain’s National Health System

Oct 29, 2017• 8

By SAURABH JHA, MD

When Aneurin Bevan was asked how he convinced doctors to come on board the National Health Service (NHS) he allegedly replied, “I stuffed their mouths full of gold.” Bevan recognized that to conscript doctors to the largest socialist experiment in healthcare in the world he had to appeal not so much to their morals, but pockets.

There is much piety about the NHS. It is the envy of the world, though oddly Saudi oil barons still favor Cleveland Clinic and Texas Heart Institute over quaint little hospitals in rural Scotland. The NHS featured in Britain’s 2012 Olympic parade along with Mr. Bean and the human right activist, Shami Chakrabarti – only one of them was there for parody. Brits aren’t ones to posture self-righteously, except when it is about the NHS, when the violins come out full mast, and we’re treated to a spectacular display of sanctimony and disingenuity. The NHS is a religion which keeps its prophets happy.

Bevan, an arch socialist, Labour to the bones, and founder of the NHS, was no social justice warrior. He recognized that berating doctors into doing the right thing wasn’t going to work. Nor was selling them a utopian paradise. Remember, this was post Second World War Britain, when socialism was in fashion, and sympathies towards communist Soviet Union was an intellectual fad. Selling the concept of the NHS should have been a cake walk, most of all to doctors. But Bevan was a pragmatist, not sentimentalist. He knew that he needed more than ethos, logos and pathos.

So, in a stroke of everlasting genius Bevan allowed doctors to see private patients in NHS hospitals, a small quirk with considerable consequences. In essence, Bevan legitimized a two-tier system, in which the rich could jump queues, and doctors could serve the rich and the poor, though the rich a little faster, and with more personal touch. The NHS is living embodiment of George Orwell’s famous quip: everybody is equal, but some are more equal than others.

If the NHS isn’t the envy of the world it should be the intrigue of the world. Its survival wasn’t probabilistic. There are two reasons why the NHS hasn’t imploded – foreign-trained doctors and private medicine. The contribution of the private sector to the longevity of the NHS isn’t immediately apparent. Both tiers support each other. The parallel private track allows doctors in Britain to earn more than their NHS salaries, with only a little extra effort. Private insurance in Britain compensates handsomely.

To Achieve Its Goals, Population Health Needs More Specialists

Oct 28, 2017• 15

By VIKRAM REDDY, MD

I attended a Population Health conference this summer where a number of representatives from large health systems and physician organizations convened to discuss common challenges. Many of my healthcare colleagues assume that anything that carries the label “Population Health” must relate to health disparities and food deserts. While we do address these topics, the vast majority of sessions and conversations had one underlying theme: lowering the total cost of care.

In rebuttal to any charges that our group is far too corporate to be considered a fair example of Population Health advocates, even the Institute for Healthcare Improvement addresses the importance of managing costs with the third part of the Triple Aim stated as “reducing the per capita cost of health care”.

Whether it is from Medicare or commercial ACOs, the Efficiency metric in CMS’s Value-Based Purchasing program, or the continued push from commercial payors for bundled payment programs, health systems and provider groups are beset by demands regarding cost. Unfortunately, at this conference, and in most groups trying to meet the demands of Population Health, one key stakeholder group is often absent: Specialists.

If cardiologists, spine surgeons, and hospitalists cannot become engaged with Population Health principles, moving the cost needle will be very challenging, if not impossible. I believe there are ways, however, to engage specialists in providing efficient care.