Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Showing posts with label Jim Landers. Show all posts
Showing posts with label Jim Landers. Show all posts

Monday, July 20, 2015

Patients and surgeons select implants blind to effectiveness, safety and cost.



DMN reporter got his knees replaced — but was the stiff price a good deal?

By JIM LANDERS 
Staff Writer
16 July 2015 

Getting your knees replaced can be an education in much of what’s wrong with health care — as I learned last year from personal experience.
My insurer offered guidance on which hospitals were in network, and how much they’d be reimbursed. My doctor referred me to a surgery group that practiced at only one of those hospitals.
I didn’t know which companies make artificial knee joints, or which ones are best.
Luckily, I came out of it with mechanical knees that greatly improve my quality of life. I remember the times I couldn’t run across the street before the light turned red because running meant bone-on-bone pain. I remember the photos my wife took where I was as bow-legged as a cowboy cliche — my knee cartilage was so far gone.
But the choices I made with limited information about surgeons, hospitals and medical devices probably wound up hitting my employer, The Dallas Morning News, with $10,000 in extra insurance charges.
It was a surprise, though, when one of the nation’s top orthopedic surgeons told me he is almost equally in the dark as he tries to determine where to go to replace one of his own knees.
“There should be a process where I can seek information about quality, outcomes and cost,” said Dr. Kevin Bozic, chairman of surgery at the University of Texas at Austin’s Dell Medical Center. “If you’re in D.C. or Dallas and you’re trying to figure out where you can get that, it’s a joke.”
Market peculiarities
Bozic recently came to Austin from San Francisco, where he was part of an orthopedic surgical team and was on the faculty of the University of California at San Francisco. He has a master’s degree in business administration to go along with his medical credentials.
He’s studied and written about the peculiarities of the joint replacement market for several years.
“If you look this up online,” he said, “you’re going to get a bunch of advertisements saying this one uses robots, or this one has the latest technology, and then you’ll find information on Yelp about the surgeon’s bedside manner, and that’s important.
“But the things you really care about — will it improve my health, reduce my pain, will I have a quality outcome — you’re going to find nothing.
“That needs to change,” Bozic said. “The consumer wants the best outcome at the lowest cost.”
He hopes a more rational way of doing business is on the horizon.

The hope, which is beginning to emerge in Dallas and elsewhere, is that medical devices will have a searchable track record of success — or failure.
It’s a hope that consumers can learn which hospitals and surgeons do the best work — and which surgeons are paid huge sums by the device makers. It’s a hope that patients will be out of bed and able to start physical therapy within a day of surgery, rather than two or three or even four days later.
And it’s a hope that insurers will someday pay one bundled price for joint replacements — and hospitals, surgeons, anesthesiologists, physical therapists and medical device makers will have to work within that budget.
Some device manufacturers are taking cost out of their products. Prices have fallen between 8 percent and 13 percent over the last year for key knee and hip replacement components.

The 4-year-old American Joint Replacement Registry (Bozic is its vice chairman) has data on nearly 300,000 joint replacements. The group is watching to see how long the replacements last, which surgery techniques and technologies work best, and which ones don’t.
This month, Medicare announced a bundled payment initiative for joint replacements. And for two years, it has released data on medical device and pharmaceutical company payments to physicians and hospitals.
The big remaining question is: Value for whom? The consumer, or the hospital? In Dallas, at least, the hospitals are the ones coming out ahead.
Oblivious to cost
The way it’s worked until now is pretty strange.
Most orthopedic surgeons are oblivious to the cost of medical devices. They choose what they’ll use based on a buddy system with a sales representative. Many surgeons get consulting fees or design royalties from those device makers.
Hospitals that want the surgeon’s business buy the joint replacements the surgeon wants. They are contractually forbidden from telling the surgeons or anyone else what price they pay. The hospitals bill patients for the device (often including a big, hidden markup), for the operating room and for their care during a typical two-night stay.
“In most places, physicians are not employees of hospitals and don’t care what things cost, and that shifts a lot of power to the manufacturers,” said Pete Allen, executive vice president for sales and marketing with Novation, an Irving-based company that buys supplies for more than 1,500 hospitals across the country.
The sales reps stick with their surgeons. They go to all the surgeon’s operations with suitcases full of tools and parts for artificial joints. They use laser pointers to tell nurses and other members of the operating team what to use.

Sometimes they upsell, Allen said, recommending a new component to the surgeon while the patient is on the operating table.
When a patient has multiple fractures, the operating room can get crowded. “A trauma case may have four or five reps in the operating room,” Allen said. “That’s a lot of expense, and it’s not free.”

Artificial knees are made of cobalt, stainless steel or titanium that covers the ends of the thigh and shin bones. A hard plastic disc absorbs the friction between the metal pieces. A sliding button on the back of the knee cap keeps it moving.
Hips are made from similar materials and ceramics, with a long stem embedded in the femur and a ball-and-socket placed into the pelvis.
Hospitals pay anywhere from $3,300 to nearly $11,000 for the parts in one standard artificial hip or knee, according to the ECRI Institute, a Pennsylvania group that tracks medical supply pricing for hospitals.
U.S. surgeons are expected to replace more than 1.3 million hips and knees this year. By 2020, the number is expected to hit 2 million, with 3 million by 2030.
In 2012, Truven Health Analytics determined that medical devices were the single-biggest driver of hospital inflation between 2001 and 2006.
Medical device prices doubled between 1997 and 2008, and the number of joint replacements grew even faster. Hospitals complained that they were getting squeezed between what Medicare was prepared to reimburse and what device makers were demanding as payment.
A bill was unsuccessfully introduced in Congress to compel device manufacturers to reveal their selling prices.
The gross margins on joint replacement sales are as much as three times greater than the costs of manufacturing. Relatively little of those margins are invested in research and development. Most of it goes back to the sales reps, who account for 40 percent to 45 percent of the price of a joint replacement.
Steve Lichtenthal, vice president of business development with the Orthopaedic Implant Company of Reno, Nev., argues those margins are too big.
“Thirty-five years ago, orthopedic implant sales operated like any other industry. The sales rep would come around every so often with lunch for the staff and to shake the doctor’s hand,” he said. “Then every few years there’d be new technology; anatomically shaped plates, different screws, or a different material used in spacers for a vertebral fusion case, for a few examples. Hospitals couldn’t keep up with the changes, and the industry did a wonderful job embedding their sales reps to manage the entire implant supply chain for the hospital while upselling physicians in the operating room while attending surgical cases.”
“It’s going to be very, very tough to undo that,” he said. “But if you eliminate that sales rep and modify the supply chain, you halve your implant costs. The magnitude of savings is into the billions.

Lichtenthal’s company is just getting started, and specializes in trauma plates rather than joint replacements. But another device maker is experimenting with a lower-cost, “rep-less” approach.
Smith & Nephew, Britain’s largest joint replacement maker and one of the top four sellers in the U.S. market, recently launched a line of hips and knees called Syncera using last year’s components, training software — and no sales reps. The company hasn’t said how well it’s doing, but promises more information later this month.
Other device makers are watching but haven’t followed.
David Floyd, group president for orthopedics with Michigan-based Stryker Corp., was asked by analysts in May what impact Syncera was having on his firm. “None,” he replied.

Bob Marshall, a vice president with Indiana-based Zimmer Holdings, told another group that the competition was healthy.
“If we can’t prove out the value for the premium technology, those prices won’t be held,” he said. But he warned that value-based joint implants could be costly for hospitals if they lead to liability problems.
And yet, the pricing of joint replacements has dropped.
Tim Browne, ECRI Institute’s price guide director, said prices for a key knee component are down 8.3 percent from a year ago. With hips, the key component price has fallen 13.4 percent.
“Of late, hospitals have really gotten engaged with physicians, working collectively, to drive that down,” Browne said.
Some insurers are also pushing back. CalPERS, the California state employee retirement system, notified members in 2011 that their health insurance would cover a hospital’s knee replacement charges up to $30,000.
If the procedure cost more, the consumer would pay the difference.
In response, California hospitals left out by CalPERS’ reference price lowered their prices by 38 percent — from an average of $43,308 to $28,465.
The Blue Cross Blue Shield Association reported in January that joint replacement charges can double or even triple among hospitals within the same metro area. Between 2011 and 2013, hospitals in Dallas got as little as $16,772 and as much as $69,654 for a knee replacement.
The current average knee replacement reimbursement in Dallas, according to insurance claims sifted by the Health Care Cost Institute, is $45,436. The national average is $33,560.
Dallas hospital administrators say they’re squeezed by low Medicare reimbursements and have to recover by charging more to insured patients.
Big markups
Whether needed or not, the markups are big.
Baylor Scott & White Health System hospitals in the Dallas area performed almost 2,400 hip and knee replacements last year. The hospital chain’s supply managers and surgeons meet to discuss which devices to use. They try to limit the number of suppliers as much as they can to drive a better bargain.
A similar approach with cardiologists led to savings of between 18 percent and 20 percent on $40 million worth of stents, pacemakers and other heart surgery devices, said Pam Bryant, Baylor’s supply manager.
Bryant said the hospital chain spends about $30 million a year on knee and hip replacements. She said she pays between $3,800 and $6,900 each for artificial knees.
Insurers and patients never see those bills. Instead, their line-item hospital bills include component pricing that covers both the negotiated device price and the hospital’s markup.
David Toomey, a health care consultant with Dallas-based Compass Professional Health Services, said area insurers are paying between $7,860 and $12,800 for knee replacement components — almost twice as much as the average cost of the device.
Asked about these markups, Baylor responded with this statement: “Our charges for devices utilize a markup on the raw cost of the device, which is in line with industry standards. Baylor Scott & White Health engages a third party to conduct an annual review of our device markup formula, which is proprietary, to ensure its reasonableness and alignment with device pricing by other leading health care providers.
“Baylor is reimbursed less than 100 percent of the actual cost of treating more than half of its patients, as roughly 60 percent of the patient base we serve is uninsured or underinsured.”
My knees
For my knees, my surgeon chose standard components made by DePuy Synthes, an Indiana firm owned by health care conglomerate Johnson & Johnson.j
So far, they’re working fine. The pain is gone. I can stand a little taller these days.
The hospital where I had them replaced charged $16,097.05 for each artificial knee. My insurance paid $10,982.72 each.
When I studied the bill, I thought it meant my surgeon had used some fancier components that provide the knees with rotation.
Not so. They’re fixed, standard knees.
ECRI Institute’s Tim Browne says the current average price paid by U.S. hospitals for the components of a standard knee replacement last year (when I had my surgery) was $5,081 — half the price paid by my health insurance.

“It’s a very inefficient marketplace,” UT’s Bozic said. “Even [for] me, an orthopedic surgeon who needs a knee replaced — I have no information on value.”

Wednesday, May 14, 2014

If my knees were a car, my mechanic would choose my next automobile!




Jim Landers

Published: 12 May 2014 09:15 PM
Updated: 12 May 2014 09:44 PM  FiDA highlight

WASHINGTON — This winter, I had my knees replaced. I used a surgeon and a hospital in my neighborhood of Alexandria, Va., not far from where I work. The surgery and rehab are going fine. The lessons in health care economics are becoming strange.
For each knee, the bills (hospital, surgeon, anesthesiologist) came to roughly $32,000. Michael Toomey, president of Compass Care Engineering in Dallas, says the average in the Dallas area is between $42,000 and $43,000.
My new mechanical knees were the most expensive items in the bills. The hospital wanted $16,097.05 for each of them. My insurance agreed to pay $10,982.72 apiece.
These are Sigma System knees, size 5, made by DePuy Orthopaedics of Warsaw, Ind. DePuy is part of Johnson & Johnson.
The knees are made of cobalt, chrome and polyethylene. There’s a buckle-like piece that fits over the knee tip of my thigh bone. There’s a piece that looks like a peg with a circle on it drilled into my shin bone. Between them is a plastic disc. On the back of the knee cap, there’s a metal dome.
My surgeon chose these knees. The hospital bought them. Insurance (and my out-of-pocket max of $3,000) paid for them.
So, let’s see, if my knees were a car, my mechanic would choose my next automobile. A garage would buy it, and add its own markup. My employer (which is where I get health insurance) would pay for most of it, using an insurance administrator to bargain over the price.
Survey of surgeons
This is standard practice in the medical world. Device manufacturers will pitch their products to surgeons, but the surgeons are often in the dark or heedless of the cost. A survey cited in the January issue of Health Affairs found that 81 percent of orthopedic surgeons could not accurately guess the cost of these devices. And American surgeons replace about 720,000 knees a year.
Baylor Scott & White Health is using a different approach. The surgeons and the supply people meet to talk openly about prices and quality. They agree on a price the hospital system will pay. Medical device makers are then invited to meet or beat that price.
“Everybody can play, but you have to meet this capitated [maximum] price,” said Pam Bryant, Baylor Scott & White’s senior vice president for supply chain services.
Surgeons can choose among four or five key types, Bryant said.
Texas Health Resources also negotiates as a chain for its joint replacements. But here, the surgeons can choose what they like.
“While there is a great deal of similarity between devices, surgeons have definite preferences based upon training and their individual style of surgery — as well as the individual patient needs, including age, activity and other factors,” said John Gaida, THR’s senior vice president for supply chain management.
“Texas Health strives to make virtually all brands of hip and knee implants available to our surgeons so that the patient needs are always the primary consideration,” he said.
Across the country, surgeons are not clued in on the cost of medical devices often because the hospital can’t share that information. They typically sign a contract with the medical device company that forbids disclosure.
Doctors order
I know little about mechanical knees. My surgeon implants them all the time, so it makes sense to follow his guidance on what would suit me best and last longest.
But we didn’t go over a list of knees and manufacturers. My surgeon asked about my lifestyle, looked at my age and weight, and chose for me.
The hospital did the negotiating with DePuy. Did they get a good deal?
A 2012 Government Accountability Office report covering a small sample of hospitals found that one paid $5,200 for a knee replacement while another paid $9,500 for the same device.
There are several types of knees on the market. There’s a standard, fixed-bearing knee; a rotational knee that can handle more twists and turns; and a rotational/full flexion knee that allows for deep squats.
Prices seem to run between $2,000 and $16,000 for the device. So it turns out that my new knees (rotational) are pretty high-end. I hope they last a long time.

Follow Jim Landers on Twitter at @landersjim.

Tuesday, January 28, 2014

Costs vary wildly for knee replacements! Patients and doctors are in the dark.



Jim Landers

Published: 27 January 2014 09:37 PM
Dallas Morning News

WASHINGTON — I often write about the cost of health care, guided by the perception that Americans pay too much and get too little in return.
On Wednesday, it gets personal.
I am about to have knee replacement surgery at a hospital in Alexandria, Va., just across the Potomac River.
Both knees are shot. I played too much football, had two surgeries for torn cartilage and ran for too many years on unforgiving concrete sidewalks. An orthopedist told me in 2004 that I could keep on running and soon face knee replacements or quit running and postpone the inevitable.
Nine years later, it’s hard to dance or even walk the supermarket aisles with my wife. Running is out of the question. At my last physical, I explained this to Dr. Bilal Desai, my physician. She gave me a referral to an orthopedic group.
“You need total knee replacements — both knees,” said Dr. Daniel Weingold, the surgeon who explained my X-rays to me.
We discussed alternatives — Ibuprofen, weight loss, intense exercise — but none of those would repair the damage. Weingold said he could do the surgery at Inova Alexandria Hospital.

More expensive
Inova owns several hospitals in Northern Virginia, as well as the outpatient clinic where Dr. Desai practices.
I remembered reading that a knee replacement at Inova Alexandria Hospital would cost as much as $5,000 more than at Inova Mount Vernon Hospital, a few miles away.
I asked Weingold. He doubted there could be such a difference between two Inova hospitals. Well, what are the charges, I asked. He did not know. None of the surgeons in his group practices at Mount Vernon, he said, but if I wanted to go there, we could stop now and I could go to another orthopedic group.
I said I wanted to talk with my insurance company.
I emailed BlueCross BlueShield of Texas, which administers our health plan here at The Dallas Morning News. I asked: Do you have any information about which hospital does a better job? What the costs are? Does it make a difference to you if one is cheaper than the other?

High-deductible plan
I was told that both hospitals are in our health plan’s PPO, or preferred provider network, as is Dr. Weingold. Since the hospitals are in Virginia rather than Dallas, I was told, BlueCross Blue-Shield of Texas doesn’t have much information to go on in terms of a recommendation.
Like a lot of people working for Dallas companies, we have a high-deductible health plan designed to make employees better health care shoppers. My deductible is $1,500, and my out-of-pocket maximum is $3,000. I knew I would blow through that, regardless of which hospital I chose.
I’m not eligible for Medicare, but I looked at the Medicare charge information for 3,000-plus hospitals in the country. In 2011, Inova Alexandria Hospital charged $32,051 for a total knee replacement. Inova Mount Vernon Hospital charged $27,549.
I looked at the charges for Dallas hospitals. Medical City Dallas charged $117,616. Baylor University Medical Center charged $43,852. Texas Health Presbyterian charged $58,854.
None of the hospitals in Dallas charged less than $32,938, which was nearly $900 more than the Alexandria hospital.
‘Medicine in America’
I went back to Dr. Desai and told her she’d referred me to an orthopedic practice and hospital where the charges were $5,000 more.
“That’s a lot of money,” she said. “Go to Mount Vernon.”
“But I don’t know a surgeon at Mount Vernon. I went where you referred me,” I said.
“I can write you a blank referral and you can find a surgeon and fill it in,” she suggested.
“Well, why don’t you know about the difference in these hospital charges?” I asked.
“We don’t know about that,” she said. “That’s just medicine in America.”

I’m having the surgery on my right knee at Inova Alexandria. I’ll see how it goes but expect Mount Vernon Hospital will get my left knee.

Wednesday, October 23, 2013

Patient harm escalates: patient safety is elusive.


By JIM LANDERS
Washington Bureau
Published: 22 October 2013 08:14 PM
Updated: 23 October 2013 12:47 AM





Parkland Memorial Hospital, which has a new facility under construction, saw its grade drop in the most recent Leapfrog safety ratings from A to C.
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WASHINGTON — Sixteen of 41 Dallas-area hospitals slipped in safety ratings issued Wednesday by the nation’s largest self-insured employers.
Parkland Memorial Hospital and Baylor Medical Center at Carrollton fell two marks from A to C grades, while Texas Regional Medical Center in Sunnyvale fell from a B to a D.
Medical Center of Plano, meanwhile, went from a C to an A.
The grades, compiled by the Washington-based Leapfrog Group, are summations of 28 safety indicators and correspond to the letter grades most kids get in school.
Nine hospitals including Medical Center of Plano improved their grades from May’s evaluation. Another 16 hospitals stayed the same.
The middling showing for Dallas-area hospitals was reflected nationwide among 2,539 hospitals that were judged on the incidence of medical and medication errors, infections and injuries.
Two new types of hospital-acquired infections — for colon surgeries and urinary-tract catheters — were added to the latest report card. But a review of the data did not show they were responsible for the lower scores at some hospitals.
John T. James, a Houston toxicologist and head of an advocacy group called Patient Safety America, estimates that as many as 440,000 Americans die each year as a result of preventable harm while hospitalized.
The Leapfrog Group is made up of hundreds of large companies and includes the Dallas-Fort Worth Business Group on Health. It cited James’ findings in its latest report.
“We are burying a population the size of Miami every year from medical errors that can be prevented. A number of hospitals have improved by one or even two grades, indicating hospitals are taking steps toward safer practices, but these efforts aren’t enough,” said Leah Binder, president and CEO of the Leapfrog Group.
Parkland’s slump was “a disappointment,” said interim senior vice president Mike Malaise. The hospital had pulled itself up from a C to an A in Leapfrog’s May evaluation.
“We remain focused on sustaining the many improvements we have recently made. There is no question that Parkland is a much better health care provider than it was two years ago, but we must remain focused on continual improvement,” Malaise said in a statement.
No surprise
Medical Center of Plano’s jump from a C to an A was no surprise, said chief nursing officer Sandy Haire.
“We embrace public reporting of quality and safety data, and we work hard every day to improve the care we deliver. We fully anticipated our most recent score would accurately reflect our ongoing commitment to provide the highest level of quality patient care,” she said.
Baylor Health Care System saw grades fall at five of its nine Dallas-area hospitals, while one — Baylor Medical Center at Irving — improved from a B to an A.
Baylor chief quality officer Dr. Donald Kennerly said the hospital group supports Leapfrog and other evaluators, but he said it has improved by its own measures.
“Since there is no nationally accepted yardstick to judge patient safety, we use a variety of measures to evaluate our performance monthly, many of which are not available to Leapfrog,” he said.
“By constantly measuring and working to improve patient safety at all of our facilities, we have seen a more than 40 percent reduction in preventable adverse events over the past five years,” Kennerly said.
Texas Regional Medical Center and Dallas Medical Center (formerly Texas Hospital for Advanced Medicine) were the only area hospitals to get a D grade.
Texas Regional argued it would do better once more recent results become available.
First few years
“Much of the data Leapfrog used for this year’s assessment is based on the hospital’s first few years of business. Since Texas Regional Medical Center at Sunnyvale opened in September 2009, we are always improving,” said Dani Morales, the hospital’s director of quality.
Even though this is the second report card issued in 2013, Leapfrog officials said they were basing their latest results largely on data submitted a year or two ago by the hospitals to the federal government.
Hospitals are required to report information on medication errors, surgical site infections, bedsores, falls and other maladies that occur while patients are hospitalized. The information is summarized for consumers at medicare.gov/hospitalcompare.
Those results plus information on electronic health records, staffing and training are sifted by Leapfrog analysts and reviewed by a panel of hospital safety experts.
Leapfrog analysts say they work with the latest data and invite hospitals to update information as it becomes available.
The Leapfrog grades are available at www.hospitalsafetyscore.org.
Follow Jim Landers on Twitter at @landersjim.