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Coronary Stent Price Control in India: Two Years and Counting

By SOMALARAM VENKATESH MD

With a stated intent of bringing social justice and financial relief to hundreds of thousands of patients undergoing coronary angioplasty in the country every year, the Government of India capped the sale price of coronary stents in Feb 2017. Stent prices fell by as much as 80% with this populist move, seen as anti-trade within the industry circles. It is tempting for a practising interventional cardiologist to look at two years of this government control on medical device prices in a market economy.

Before price-capping, angioplasty patients were indeed getting a raw deal. There was no uniformity in price among stents of similar class/generation made by different manufacturers. The cost of the only bioabsorbable stent then available in India, to the patient, was 200,000 Indian Rupees (a little under USD 3000), whereas the US or European-manufactured (“Imported”) drug eluting stents (DES) would cost anywhere between INR 85,000 to 160,000. Stents manufactured within India (“Indigenous”) were cheaper. The real cost of manufacture or import was hidden from public view. It was left to the eventual vendor, with alleged involvement of the user hospitals, to determine the Maximum Retail Price (MRP). It was speculated that a huge margin was worked into it, and the profit was split between manufacturers, distributors, and hospitals. Allegedly, some unscrupulous physicians received kickbacks for implanting these devices. Even in government-run hospitals, foul play was suspected.

By a single stroke of the pen, Prime Minister Narendra Modi government slashed stent prices substantially. The bioabsorbable stent cost, to the patient, was capped at INR 60,000 (< USD 1000). Bare metal stents (BMS) and Drug-eluting stents (DES) were capped at INR 7500 and 30,000, respectively. The government seemed to have done its homework: these figures were arrived at from industry-supplied figures on manufacturing or import costs. The cosy network of coronary stent food chain was set on fire with this move: with sudden diminution of profit margins, it was feared that multinational companies would cut Indian workforce; stent distributors & vendors (especially small vendors) were expected to be wiped out or cut in size; doctors worried that with low profitability, multinational stent manufacturers would exit the country or at least, stop importing newer technologies; and hospitals feared revenue loss.

Following this, Industry and Hospital-chain representatives are said to have had series of discussions with the government. Rumours were that the Central Government was arm-twisting traders and that it would relent and raise price limits after these ‘talks.’ The National Pharmaceutical Pricing Authority (NPPA) promised a price revision, one year after the price cap. Meanwhile, some multinationals informed the government that they would withdraw some of their ‘top-end products’ from the Indian market, citing financial nonviability, obviously to put pressure on the government. The Bioresorbable Scaffold from Abbott actually disappeared from Cath lab shelves.

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Orbiting ORBITA

I’m sitting amidst a number of cardiologists to go over the most recent trials presented at the interventional cardiology conference in Denver.  The cardiology fellow presenting goes quickly through the hors de oeuvres until finally getting to the main course – ORBITA.

ORBITA sought to test the very foundations interventional cardiology was built on – the simple idea that opening a stenosed coronary artery was good for patients.  The trial was a double blind randomized control trial of patients with tightly stenosed arteries who either had a stent placed or had a sham procedure.  Before the results are presented, the lay media headlines from cardiobrief, the New York Times, and the Atlantic are presented to guffaws from the audience.  The indignant smirks are audible as the accompanying editorial remarks from Rita Redberg and David Brown are displayed :

”The results of ORBITA show unequivocally that there are no benefits for PCI compared with medical therapy for stable angina, even when angina is refractory to medical therapy.”

The trial results follow – no statistically significant difference in the primary outcome of exercise time increment between sham and stent, and no difference in angina between the two groups.  The meat of the presentation involves the limitations of the trial that make the trial inapplicable – 200 patients total, 6 week follow up, the underlying heterogeneity of the patient angiograms that were randomized, and the wide confidence intervals of the primary outcome that swallowed the actual effect size.  Two different angiograms were shown to the audience from the ORBITA appendix.

The images demonstrate two ‘blockages’.  To the eye, at least, one appears tighter than the other.  The audience was polled on each image – everyone voted to stent the tighter blockage and medically manage the lesser of the blockages.  It could be all perception but I could feel the relief in the room as ORBITA was being made irrelevant.  The implication clearly was that some angiograms used to show the lack of benefit from stents would not have needed stenting in the first place.

There was no real challenge to the presenter save for one:

“One of the authors – Rita Redberg – is very sharp – why do you think she wrote that editorial?”

There was no good answer – the presenter shrugged and muttered something about an anti-interventional cardiology bias.

It was at that moment that I realized why cardiologists were having such trouble with  ORBITA – we were arguing like puritans.   Everyone in the room already ‘knew’ stents worked.  This was an exercise in bias confirmation when what was needed was an examination of the source of bias.  Faced with the ultimate epistemological challenge we were resorting to authority to dismiss findings we didn’t like.  Now I think cardiologists have authority with good reason, and certainly ORBITA may have limitations inherent in any small randomized control trial that’s performed, but we can do a better job answering the fundamental question raised here that relates to the primary evidence opening a narrowed artery actually can relieve angina.

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Death and Readmissions

Eugene’s wife is on the phone.  She has been taking care of Eugene for 41 years.  I supposedly take care of his heart, weakened by two prior heart attacks.  I say supposedly because his wife does all the heavy lifting.  She makes sure he takes his medications when he should.  She watches his weight every day and occasionally administers an extra dose of diuretic when his weight climbs more than a few pounds in a day.  And perhaps most importantly, she calls me when Eugene’s in the hospital and things seem wrong to her.  This is one of those phone calls.  They were in the ER, Eugene hadn’t been responding to his diuretic as he normally does, and his breathing seemed more labored to her.  The ER physician wanted to send them home – she was hoping I would weigh in.  Not surprisingly, she was right, Eugene needed to come into the hospital.  I used to be surprised when the ER wouldn’t call me for complex cardiac patient having an acute cardiac problem.  Not any more.

There is a clear culture shift that is obvious to those who have spent any time in the ER over the past ten years.  Low risk patients used to be managed and discharged from the ER, and higher risk patients were quickly admitted to the hospital for management by specialists.  This used to be a source of tremendous friction with the ER in my younger years, as I would try to explain to ER physicians that every single chest pain in a patient with known coronary disease did not deserve admission.  I seldom have this conversation with the ER anymore.  What changed?

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How Mayo Clinic Is Using iPads to Empower Patients

Throughout the world, companies are embracing mobile devices to set customer expectations, enlist them in satisfying their own needs, and get workers to adhere to best practices. An effort under way at the Mayo Clinic shows how such technology can be used to improve outcomes and lower costs in health care.

Defining the care a patient can expect to receive and what the road to recovery will look like is crucial. When care expectations are not well defined or communicated, the process of care may drift, leading to unwarranted variation, reduced predictability, longer hospital stays, higher costs, poorer outcomes, and patient and provider dissatisfaction.

With all this in mind, a group at the Mayo Clinic led by the four of us developed and implemented a standardized practice model over a three-year period (2010-2012) that significantly reduced variation and improved predictability of care in adult cardiac surgery.

One of the developments that germinated in that effort was the interactive Mayo myCare program, which uses an iPad to provide patients with detailed descriptions of their treatment plans and clinical milestones, educational materials, and a daily “To Do” list, and to report their progress and identify problems to their providers.

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Why Your A-fib Diagnosis May Not Be as Bad as You Think It Is

With breathtaking speed, atrial fibrillation has gone from “Huh?” to parlance.

“A-fib”, a common cardiac cause of palpitations, is now in the front ranks of evils lurking to smite our well-being. There is no mystery to this transformation. In 2013, the Food and Drug Administration licensed three new drugs to prevent a stroke, the fearful complication of A-fib: apixaban (Eliquis), rivaroxaban (Xarelto) and dibatigatran (Pradaxa).

This unleashed the full might of pharmaceutical marketing: the scientific data for efficacy that convinced the FDA is tortured till it convinced “thought leaders” whose opinions convinced influential journalists. Sales pitches populate print, broadcast and social media. A-fib is now more than a worrisome disease; it is a product line.

Nonetheless, A-fib can be scary for those afflicted. There are lots of choices to make and a lot of confusing, conflictual and counter-intuitive advice to deal with. Troubled by this situation, Mr. X recently sought me out to have a dialogue about his situation.

Mr. X is a 70-year-old business executive who has enjoyed robust good health and is on no prescription drugs. He exercises vigorously and is a consumer of various over the counter treatments purveyed as salutary. Like many “health-wise” Americans, he also takes 80mg of aspirin a day unaware that the benefit is minimal at best and is counterbalanced by a similar magnitude of risk.

A month earlier he had the sudden onset of palpitations, a fluttering in his chest that made him exceedingly anxious and somewhat breathless. He waited an hour before asking his wife to drive him to the local emergency room. By the time he was first seen, another hour passed. The diagnosis of A-fib followed. Another hour passed to find the consulting cardiologists debating whether to convert the A-fib to a normal rhythm by using drugs or an electrical shock.

Before they could decide, Mr X’s heart decided to behave again; he was back in a normal rhythm. It was a frightening experience for Mr. and Mrs. X. He left the ED shaken and shaky.

He also left with a follow-up appointment with a cardiologist who specialized in rhythm disorders and a prescription for a drug that slowed the conduction of electrical impulses initiating in one heart chamber, the right atrium, and traversing the heart. The normal “pacemaker” is a specialized cluster of muscle cells in the right atrium that discharges at regular intervals, initiating a current that causes the heart to contract in the synchronized fashion termed Normal Sinus Rhythm.

In A-fib, for reasons that are poorly understood, multiple pacemakers form in the right atrium leading to chaotic discharging and circular currents in the right atrium. How many of these impulses manage to exit the atrium to traverse the heart depends on the capacity of the conducting tissues; most just stay confined to the atrium causing it to quiver ineffectively.

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The Great Coronary Angioplasty Debate: Giving Patients the Right to Speak

Earlier this month, the editors of THCB saw fit to post my essay, “The End of the Era of Coronary Angioplasty.”

The comments posted on THCB in response to the essay, and those the editors and I have directly received, have been most gratifying. The essay is an exercise in informing medical decisions, which is my creed as a clinician and perspective as a clinical investigator.

I use the recent British federal guideline document as my object lesson. This Guideline examines the science that speaks to the efficacy of the last consensus indication for angioplasty, the setting of an acute ST-elevation myocardial infarction (STEMI). Clinical science has rendered all other indications, by consensus, relative at best. But in the case of STEMI, the British guideline panel supports the consensus and concludes that angioplasty should be “offered” in a timely fashion.

I will not repeat my original essay here since it is only a click away. The exercise I display is how I would take this last consensus statement into a trusting, empathic patient-physician discourse. This is a hypothetical exercise to the extent that little in the way of clear thinking can be expected of a patient in the throes of a STEMI, and not much more of the patient’s caring community.

So all of us, we the people regardless of our credentials, need to consider and value the putative efficacy of angioplasty (with or without stenting) a priori. For me, personally, there is no value to be had rushing me from the “door to the balloon” regardless of the speed. You may not share this value for yourself, but my essay speaks to the upper limits of benefit you are seeking in the race to the putative cure by dissecting and displaying the data upon which the British guideline is based.

There is an informative science, most of which cannot deduce any benefit and that which deduces benefit finds the likelihood too remote for me to consider it worth my attempt. A hundred or more patients with STEMI would have to be rushed to the catheterization lab to perhaps benefit one (and to harm more than one).

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The End of the Era of Coronary Angioplasty

In a single generation, the evidentiary basis for the practice of medicine has grown from a dream to a massif. No longer need physicians rely solely on experience and opinion in formulating diagnostic and therapeutic approaches to the care of the patient.

However, for any given clinical challenge, the available science is never flawless, monolithic or comprehensive, nor is it likely to be durable in the face of newer studies.

The international medical community has mounted two approaches to sorting the wheat from the chaff: One targets the doctor in convening committees to formulate guidelines for patient care. The other targets the patient for evaluating options, so-called informed medical decision making. Both approaches are now sizable undertakings clothed in organizational imprimaturs and girded by self-promotion.

But they are largely parallel undertakings with work products that can cause considerable cognitive dissonance on the part of the patient and the physician. In a recent article in the British Medical Journal [1] the Guideline Development Group convened by the National Institute for Health and Clinical Excellence (NICE) summarized the thinking behind the guidance it was offering regarding the management of STEMI. This is an object lesson in such cognitive dissonance.

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How Misplaced Reimbursement Incentives Drive Healthcare Costs Up

For all of those out there anticipating the 2014 official role out of Obamacare, also known as the ACA (Affordable Care Act), here is a cautionary tale.

Many years ago, as I was growing my cardiology practice, it became evident that diagnostic services for my specialty, like stress tests, echocardiograms, etc., were done less efficiently and cost more at the local hospital, then in the office. This stimulated many groups in the 1980s and 90s to install their own “ancillary” diagnostic services. Patients loved not having to deal with the long waits and higher copay prices at the hospitals. And yes, the cardiologists did increase their revenues with these tests. However, lower costs to patients, insurance companies, Medicare, and improved patient satisfaction were just as powerful a stimulus to the explosive growth of these diagnostic tests, and later even cardiac catheterization labs, when integrated into the physicians’ offices.

As the growth in testing spiraled upward, the hospital industry saw their slice of the outpatient revenue pie nosedive. Hospital lobbyists and policy-makers cried foul and complained of greed and self-referral, which they said was spiking the rapid rise in healthcare costs.

Studies laying blame on self-referrals being the major culprit for escalating healthcare costs, have been inconclusive. However, after years of lobbying and the passage of ACA, the hospital industry finally had the weight of the Federal government on their side. It did not take long for Medicare to start dialing back the reimbursements for in-office ancillary tests and procedures, and outpatient cardiac catheterization labs were one of their main targets. Hospitals had lost millions of dollars to the burgeoning growth of these labs inside the cardiologist’s office.

Our twelve-man group had a safe and successful lab for about ten years. Then after the ACA was passed, Medicare began to cut the reimbursements for global and technical fees in this area. The cuts were so Draconian that it became impossible financially to continue the service. Never mind that we could provide the same service as the hospital more efficiently, with better patient satisfaction, and at a third of the cost.

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My Grand, Sweeping Cardiovascular Predictions for 2013

Cardiovascular predictions for next year are always fun to contemplate this time of year.  So much is happening to the practice of medicine as we’ve known it that it can be helpful to highlight some of those changes, both good and bad, as our medical world continues to evolve.  While these predictions contain pure guesses, they also contain one doctor’s observations of our new evolving medical world.  Many of these changes will profoundly shape how doctors interact with their patients.

So grab some coffee and strap in.  Here are my 2013 predictions of life as a cardiologist in 2013.  (Please feel free to add your own predictions in the comments section.)

Valvular Heart Disease

  • TAVR for critical aortic stenosis will be applied to progressively younger and healthier patients.
  • As smaller delivery systems for percutaneous heart valves gain widespread acceptance, government payers will look for new and inventive techniques to restrict patient access to these devices.  No heart valve will remain untouched as creative uses of the approved devices are attempted in non-surgical patients.
  • Innovations valve design will improve the safety and effectiveness of this therapy.

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The Unheard Heart: A Metaphor For Medicine In the Digital Age

A few months ago, a young cardiologist told me that he rarely listens to hearts anymore. In a strange way, I was not surprised.

He went on to tell me that he gets all the information he needs from echocardiograms, EKGs, MRIs, and catherizations. In the ICU, he can even measure cardiac output within seconds. He told me that these devices tell him vastly more than listening to out-of-date sounds via a long rubber tube attached to his ear.

There was even an element of disdain. He said, “There is absolutely nothing that listening to hearts can tell me that I don’t already know from technology. I have no need to listen. So I don’t do it much anymore.”

I began to wonder. I called my longtime friend and colleague, also a cardiologist. I knew him to be one of the best heart listeners. I asked him if he still listens to hearts. He answered, “Of course I do. I could not practice medicine if I didn’t. But you know every week, several patients tell me when I listen to their hearts that I am the first doctor ever to do that. Can you imagine that?”

Playing the devil’s advocate, I challenged my friend to tell me what he learned from listening to hearts.

He answered, “How could anyone not want to hear those murmurs, sometimes ever so soft, like whispers? Murmurs from the heart, even very faint ones, are trying to tell us significant things. Some sounds are very localized, even hidden or obscured by layers of air. And then there is the rhythm and the beat and the cadence that you cannot hear on the paper strip of the EKG. Also, careful listening is the only way to appreciate the rubs of friction if there are any. The devices are important, but the heart has its own spoken and unspoken language if you know how to listen.

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