Medicare reimbursement incentivizes risky outpatient medical procedure

Investment Analysis Clubs Macro Economic Trends and Risks
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It’s a pretty universal rule: Incentivize something by paying money and you are guaranteed to get more of it.

They Lost Their Legs. Doctors and Health Care Giants Profited.

Medical device makers have bankrolled a cottage industry of doctors and clinics that perform artery-clearing procedures that can lead to amputations.

Robert Gebeloff

By Katie Thomas, Jessica Silver-Greenberg and Robert Gebeloff, The New York Times, July 15, 2023

…
With the financial backing of medical device manufacturers, a booming cottage industry that peddles risky artery-opening procedures to millions of Americans — enriching doctors and device companies and sometimes costing patients their limbs.

The industry targets the roughly 12 million Americans with peripheral artery disease, in which plaque, a sticky slurry of fat, calcium and other materials, accumulates in the arteries of the legs. For a tiny portion of patients, the plaque can choke off blood flow, leading to amputations or death…

Some doctors insert metal stents or nylon balloons to push plaque to the sides of arteries. Others perform atherectomies, in which a wire armed with a tiny blade or laser is deployed inside arteries to blast away plaque. Rigorous medical research has found that atherectomies are especially risky: Patients with peripheral artery disease who undergo the procedures are more likely to have amputations than those who do not…

The volume of these vascular procedures has been surging. The use of atherectomies, in particular, has soared — by one measure, more than doubling in the past decade.

There are two reasons. First, the government changed how it pays doctors for these procedures. In 2008, Medicare created incentives for doctors to perform all sorts of procedures outside of hospitals, part of an effort to curb medical costs. A few years later, it began paying doctors for outpatient atherectomies, transforming the procedure into a surefire moneymaker. Doctors rushed to capitalize on the opportunity by opening their own outpatient clinics, where by 2021 they were billing $10,000 or more per atherectomy.

The second reason: Companies that make equipment for vascular procedures pumped resources into a fledgling field of medicine to build a lucrative market…

Medicare’s decision to reimburse doctors for procedures performed outside hospitals led to a proliferation of outpatient clinics specializing in everything from orthopedics to dermatology.

The policy also motivated doctors to perform more procedures, in part because private insurers tend to follow the federal agency’s lead…[end quote]

From Medicare’s standpoint, it makes sense to encourage outpatient instead of expensive inpatient treatments. Doctors like this arrangement because they pocket the entire fee instead of splitting it with a hospital.

Unfortunately, the FDA does not regulate the safety and effectiveness of medical devices closely. To get approval, a new device only needs to be “substantially similar” to an already approved device.

A wide body of scientific research has found that for about 90 percent of people with peripheral artery disease — including those who experience the most common symptom, pain while walking, or have no symptoms — the recommended treatments are blood-thinning medications and lifestyle changes like getting more exercise or quitting smoking. But the FDA doesn’t effectively track doctors who recommend profitable procedures to patients who don’t need them. The clinics are not subject to the same safety regulations as hospitals.

The device manufacturers lend money to the clinics to buy the machinery. Of course they later sell the consumable devices.

This is a long and sickening article.

As investors, we can buy stock in medical device manufacturers.

As potential patients, we must be diligent about researching any procedure recommended to us by a doctor.

Wendy

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UGLY. This is neo-liberalism in advanced decay catastrophe.

david fb

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Interesting article…with my usual (for now) caveat …that peripheral vascular disease and ASCVD in general isn’t automatically and inevitably confined to overeaters, smokers and Sedentarians. For sure, these lifestyles are commonly represented among those who receive stent placement…but need can arise in true Good Custodians of their bodies. Indeed, demonstrated Good Custodianship such as evidence of healthy eating habits, exercise and no smoking (no stench of an ashtray) can act as a smokescreen to mask early warnings such as “mildly elevated LDL-C” and miss the window of opportunity for primary prevention.

I’ve found myself pondering the notion that the cholesterol denialism and statin phobia that is so prevalent along with squawks that doctors are in the pocket of Big Pharma is somehow linked to the influence weilded by Big Device. After all, it’s the stent manufacturers who gain the most when primary prevention fails.

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I’m not a rocket surgeon. I don’t even play one on TV. But the idea of “removing” built up plaque inside a blocked artery by doing ANYTHING to “shave away” that plaque sounds like an inherently dumb idea. Essentially roto-rootering the plaque doesn’t make that plaque go away, it simply grinds it up, making it possible to be carried away by blood flow to even narrower arteries elsewhere in the body - like the brain. I wonder how many subjected to this atherectomy procedure wind up in only months experiencing strokes. Not just the obvious strokes that cause immediate paralysis or speech problems, but dozens of silent TIAs (transient ischaemic attack) that individually are often unnoticed but collectively over time drastically affect brain health and cognitive function.

Is the entire medical community this stupid / greedy? Is the entire patient community this ignorant of biology and basic human mechanics to think this is a good idea for a corrective procedure?

WTH

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VeeEnn, I do not know if you have heard of ShockWave? They do business in this space and insert a tool into the artery that provides a shockwave to break up plaque. I assumed the plaque was small enough that it was either expelled or absorbed by the body. Is that incorrect? So does that type of surgery have no use in the Medical field? I assumed it was helping, not hurting people. Your help to better understand this would be helpful.

Andy

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This is a long and sickening article

Well, it’s designed to be that way, no? The authors present data in an emotive fashion that’s designed to encourage the reader to believe that doctors etc are actually deliberately finding excuses to perform risky and unnecessary procedures on patients. Whereas, careful reading and thinking about the primary documents the authors have chosen to validate their suggestions shows a whiff of faulty reasoning…or a stench of deliberate misrepresentation.

Now, like most folk here I’m not a cardiologist so can’t truly speak on clinical decision mak8ng. However, I’ve found to my shock and surprise and that do I have a dog in this fight and, as a consequence, have acquired something of a take.

I can certainly attest to the merits of ceasing smoking and exercise providing for symptomatic relief with, say, claudication from peripheral vascular disease. This is how my mother’s ASCVD manifested itself in her very early 60s. Vascular surgeon (unwilling to accept that she was now a non smoker…having given up an over 40 year habit the day before!) prescribed no smoking and attempt to walk a few steps through the pain…which came on within 50 yds or so by then. On 3 months follow-up, he was almost unbelieving that she and my dad had walked the 4 miles from home to hospital. Unbelieving because of the rarity of patients who follow such prescriptions. This is the reality of delivering medical care in the Real World.

Given the basic facts…i.e. changes in Medicare reimbursement such that performing these potentially risky procedures in a hospital setting became less and less feasible…this could have been a worthwhile discussion of relative safety of hospital vs outpatient treatment for the same conditions. This would’ve given potential patients (which might include more of us than are aware) a better framework for decision making than the low hanging fruit of scare mongering.

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I’ve “heard” of a good many of the revascularization procedures around…but know enough on the topic to be aware that I don’t know enough to be due an opinion. I’ll give one anyway. I’m reasonably sure that, if the morbidity/mortality were as high as these journalists imply(none of whom appear to have background in cardiology, BTW) it’d be so obvious that the practice would fizzle out.

Given the degree of blockage in my coronary arteries, I’d assumed that I was all set for stent placement in spite of no symptoms…until my intervention cardiologist intervened. In the right population…i.e people like me (and his wife, it transpires) who haven’t “lifestyled” their way to ASCVD via the eating, smoking and sitting route but have been gifted with an unfavorable genetic profile, it’s possible to achieve an actual regression of the plaque deposits with aggressive lipid lowering therapy. That’s what I’m doing right now.

Interestingly, I stumbled upon my potential for risk whilst listening to a few podcasts on the topic while doing high volume/low-moderate intensity treadmill training. I now call it my Z2/MAF/ASCVD mitigation training because of the potential for producing a compensatory collateral circulation. Whilst, I doubt my long track record of this type of training would prevent Sudden Cardiac Death in the even of a sudden, dramatic blockage, it’s surely helped in preventing, say, angina, high BP or other issues with peripheral vascular disease.

P.S. The first reported example of exercise relieving symptoms of angina pectoris was a paper by William Heberden back in 1772 in the Medical Transactions of the Royal College of Physicians, apparently (couldn’t find it on PubMed etc) Seems a patient with chest pain on exertion set about a regimen of extended periods of wood sawing…and it worked.

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Yep. In the US version of “for profit” health care you’re a “billing opportunity” not “a patient”. And the system is optimized to produce excessive Executive Compensation rather than patient health.

intercst

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Are folk with no background in intervention cardiology so credulous that they can imagine an understanding of a complex procedure from an article designed to promote misunderstanding?

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This is the future, not just this procedure, but more stuff on an outpatient basis. The upcoming trend before I retired, sending people home the same day they had a knee or hip replacement surgery.

Of course you have to be choosey with your patients, but the slippery slope argument easily applies and I dealt with it my entire career. Surgeons arguing we did X to Y patient and they did fine. Well this is patient Z and the story is different.

FWIW, my wife had a hysterectomy and went home the same day. Of course it was the ideal situation from the patient to the home care giver.

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I have a story-in-reverse in this vein. Prior to my retirement, a heck of a lot of oral surgery procedures were done on an out-patient basis. Some I would never have imagined back when I was a resident. Back then…in the UK in the 1970s…pretty much all but the most straightforward third molar extractions were done in hospital with general anaesthia. A 3 day stay. Admission the afternoon before. Seen by the anaesthesiologist the evening before, day of surgery and discharge the day after…if all was smooth sailing. It seemed perfectly normal at the time. How else could you guarantee npo for the procedure or that patients would comply with post op instructions? How times have changed. Kind of hard to justify it in retrospect.

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Here’s a summary of risks from the Cleveland Clinic:

Atherectomy: Procedure Details & Purpose Sometimes a piece of plaque can break off and become lodged or stuck in a smaller downstream blood vessel as healthcare providers cut or scrape away plaque. The atherectomy procedure can also cut too deep and create a tear or hole in your blood vessel.

Here is a document from 1993 citing the same issues seen with the procedure:

https://www.ajconline.org/article/0002-9149(93)91038-J/pdf The procedural mortality rate for coronary atherectomy has been reported to be O-3% and is similar to the 1.0% rate reported in the second National Heart, Lung, and Blood Institute PTCA Registry.2 Of 14 deaths reported in the original 1,648 patient DVI Multicenter Registry, only 8 were directly attributable to atherectomy, and virtually all deaths occurred in patients who had predictors of mortality following balloon angioplasty. The occurrence of acute vessel closure after atherectomy increases the mortality risk substantially (from 0.3% to 5%).

One can find studies from roughly 2000 citing similar or better results with atherectomy versus balloons / stents

Atherectomy vs. Angioplasty with Stent Placement | AAFP The authors conclude that directional coronary atherectomy provides better clinical and angiographic outcomes in patients with coronary artery disease than primary stenting during angioplasty. They also emphasize that relatively large vessels are most suitable for directional coronary atherectomy.

but newer studies in the last three years or so show worse results for atherectomy:

Comparison of Atherectomy to Balloon Angioplasty and Stenting for Isolated Femoropopliteal Revascularization - PubMed Atherectomy does not seem to confer any significant additional clinical benefit compared with balloon angioplasty or stenting. Further research is needed to justify its additional cost over other endovascular modalities.

I don’t claim to understand all of the pros and cons of the procedure but if I HAD a condition exhibiting this problem and had the options of stent versus atherectomy explained to me, I would be more comfortable having a stent inserted which doesn’t attempt to dislodge or remove a plaque versus an atherectomy. Mortality rates 1-5 years after the procedure seem to be within 1% for both approaches but I’ve never heard of anyone having a stent placed (on a planned or emergency basis) and ever later having a limb amputated resulting from the placement of the stent.

WTH

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Well, there you have it…trawling the literature doesn’t give one insight WRT the merits of either procedure…or any revascularization procedure come to that…in the varying clinical situations that might crop up. I certainly don’t have any…but I have a shrewd idea that, for the most part, it’s unlikely to be a direct choice between one or the other and not one that a person could make ahead of time, when they have no idea whether or not they even have any vascular issues (and what they might be) and with speculation based on what they’ve read online

That’s just me, mind…and I’m setting my stall out to avoid the need for either in a way that most folk probably aren’t willing to do.

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I wonder if this might be the beginning of a campaign against risky medical procedures. What next? An article opposing heart transplants because 10+% of the patients die?

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Hopefully, transplant services as outpatient procedures. Cuts in reimbursement for hospital based procedures have been/are being made across the board, not just those mentioned thus far … so it’s not as facetious a remark as might appear on first blush.

However, as proof that any topic of discussion can be a stimulus for growth, my response has been to add another 15 minutes to my Z2/MAF/ASCVD mitigation training. 3×hour plus sessions done and dusted/3 podcasts caught up on since this thread began. Good ROI for my cardiac collateral circulation.