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 

jlanders@dallasnews.com

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.

Related: Calling on virtual medicine to control costs

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.

Related: Health care analyst wants to bring price transparency to North Texas

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.”

http://www.dallasnews.com/business/health-care/20150716-dmn-reporter-got-his-knees-replaced--but-was-the-stiff-price-a-good-deal.ece

"one of the worst offenders" orthopedic surgery overuse . . .

Orthopedists' Financial Conflicts Can Hurt Patients, Surgeon Says

Cheryl Clark, for HealthLeaders Media , March 17, 2015  FiDA highlight added

It is financially compelling for many doctors to do things that aren't really going to help their patients, says an orthopedist who is leading a campaign against surgical overuse.

Financial conflicts of interest often drive physicians to perform worthless surgeries, but the field of orthopedics "is one of the worst offenders," says an Indiana orthopedist who has launched a "moral persuasion" campaign to persuade his colleagues to stop.

"It's really hard for doctors to acknowledge this and change their ways," says James Rickert, MD, who years ago founded the Society for Patient Centered Orthopedic Surgery to address the problem.

It's especially tough for doctors who own related businesses that depend on surgical volume, which puts even more pressure on them to "be more like businessmen instead of doctors," he says.

A lot of orthopedic surgeons "own part of the distributorships that sell the total hip or knee implants to the hospital, and they'll make a ton of money on that. Or they own the imaging center they send their patients to. They own a piece of the surgical center. They know if they're not doing a lot of surgery, they may lose money on their overhead," Rickert says.

A series of four reports from the Government Accountability Office documents greater numbers of procedures referred by physicians who own providing businesses, compared to referrals from non-owners.

"That makes it really compelling for doctors to do things that aren't really going to help their patients. They become more like salesmen, saying things like, 'Well, it might help.' Or, 'We don't have much to lose, let's try it,' knowing full well the data shows there's very little chance the procedure will help and some evidence the patient could be hurt."

Rickert has long been aware of surgical overuse, including his own. But he didn't work hard to stop it until he himself got sick. He was diagnosed with non-Hodgkin Lymphoma at age 42, underwent chemotherapy, bone marrow, and stem cell transplants, recurrences, and foul-ups in his care. Now 54, he's been cancer free for five years. 

"I was accessing the system every day for months as a very sick person, having a lot of problems. I started to think about patient-centered care expectations and how different that is from reality."

As he got better and returned to his Bloomington practice, he founded the society to appeal to surgeons' consciences. So far, 14 fellow orthopedists have joined his effort.

Performing unnecessary surgeries, he says, "is not [necessarily] below the standard of care. For example, the doctor can usually say, 'Hey, he had a torn medial meniscus and here's an MRI that proves it,' even though it was not the right thing for a severely arthritic patient."

"I certainly have a lot of patients referred to me from nearby. And when I look at the surgery and pathology they had, I just know that there was no way that doctor really thought that was going to help them."

At the Lown Institute conference in San Diego last week Rickert described one of many sad cases. Two decades after performing a successful knee scope on a patient, the now severely arthritic patient returned, seeking another scope. Rickert advised that it would not help and could cause problems.

The patient went to another orthopedist and had the procedure. This surgeon thought the worst that would happen would be the patient wouldn't be any better, but would at least be satisfied that the doctor had tried to help. "Instead, the patient gets a deep vein thrombosis that turns into a pulmonary embolism, and two days later he's dead," Rickert says.   

For doctors, it's like an inside secret, he says. "We know about these risks, but the patients don't."

Rickert and some of his colleagues also criticize the American Academy of Orthopedic Surgeons' Choosing Wisely list of five procedures doctors and patients should avoid. None on the academy's current list is especially common or very important, Rickert says. 

Kevin Bozic, MD, chair of the AAOS Council on Research and Quality, said via email that the Choosing Wisely list was created from systematic reviews of the literature and is limited to available evidence that various treatment options for musculoskeletal conditions are effective, "which we are seeking to improve." AAOS is working to define appropriateness criteria incorporating patient preferences and values into medical decision-making, he said. Since it submitted its list of five practice guidelines in 2012, AAOS has published four more to be reviewed for possible inclusion in a second Choosing Wisely list.

At the conference, Rickert and Rob Rutherford, MD, an orthopedic surgeon from Coeur d'Alene, ID, presented what they say is a more relevant list of procedures that are frequently performed, usually unnecessary, high cost, and sometimes harmful:

1. Vertebroplasty
Cost: $10,000 

The percutaneous injection of cement into a fractured vertebra. The procedure, done in about 100,000 patients a year, is falsely marketed as relieving pain quickly. But in clinical trials, pain relief was similar to that seen in patients who underwent sham surgery. The procedure's risks include compression fractures in adjacent vertebrae, dural tears, infections, cement migration, and nerve pain that requires subsequent surgery.

2. Rotator Cuff Repairs in Elderly Patients

Cost: $15,000

About 600,000 such surgeries are performed in the U.S. each year. The number of surgeries increased by 141% between 1996 and 2006. This surgery is vastly overused on patients who are asymptomatic. Complications include infection, bleeding, re-rupture of the rotator cuff, nerve damage, blood clots, and the need for repeat surgery to correct the first procedure.

3. Clavicle fracture repair or "plating" in adolescents
Cost: $13,000
This procedure is performed in a small percentage of adolescents each year to improve function. "I don't know of any good indication, especially with conservative care being so successful" and rarely does the surgery benefit, Rickert says.  

Regardless of patient age, type of sport, and final clavicle shortening, there's no differences in pain, strength, or range of motion. But there is a risk of deep infections, pneumothorax, and other complications. 

4. Anterior Cruciate Ligament Tear Repair in Low-Risk individuals
Cost: $10,000
ACL surgeries are performed in 100,000 patients a year and carry high risks but demonstrate no difference in rates of return to pivoting-activity sports one year later than conservative rehabilitation and activity modification. Complications include infection, instability, stiffness, pain, patellar fracture and growth plate injury in children.

5. Surgical Removal of Part of a Torn Meniscus 

Cost: $6,000
Annually, this surgery is performed in 700,000 patients with knee arthritis and no mechanical symptoms. But it does not provide significant benefit compared with sham surgery in patients with degenerative meniscal tears. There's equal pain relief and functional status.

Rickert, who is on the faculty of the Indiana University School of Medicine, emphasizes that IU Health has a policy forbidding its doctors from accepting money or gifts from the pharmaceutical or medical device industries.

He says his specific orthopedic group does not own an MRI or an orthopedic surgery center. And he acknowledges that he gets "e-mails and grouchy comments from doctors [at other organizations] who want me to not do this [campaign]."  

"There's still a lot of resistance from entrenched interests. But we have to show doctors the data, studies that show this doesn't work, and then ask, 'why are we still doing this?' We have to confront them with the data."

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists. 

http://www.healthleadersmedia.com/print/QUA-314383/Orthopedists-Financial-Conflicts-Can-Hurt-Patients-Surgeon-Says

Implant Manufacturers Have Overwhelming Control of AAOS? Choosing Wisely!

Doctors Overlook LucrativeProcedures When Naming Unwise Treatments

By Jordan Rau

KHN Staff Writer

APR 14, 2014

This KHN story was produced in collaboration with the Chicago Tribune.

When America’s joint surgeons were challenged to come up with a list of unnecessary procedures in their field, their selections shared one thing: none significantly impacted their incomes.

The American Academy of Orthopaedic Surgeons discouraged patients with joint pain from taking two types of dietary supplements, wearing custom shoe inserts or overusing wrist splints after carpal tunnel surgery. The surgeons also condemned an infrequently performed procedure where doctors wash a pained knee joint with saline. 

Scott Weingarten, chief clinical transformation officer at Cedars-Sinai Health System in Los Angeles, says his hospital has embraced the Choosing Wisely recommendations by adding them to the computerized patient record system. When doctors order something on the list, they are warned by the computer about the procedure (Photo by Jeff Lewis/AP Images).

"They could have chosen many surgical procedures that are commonly done, where evidence has shown over the years that they don't work or where they're being done with no evidence," said Dr. James Rickert, an assistant professor of orthopedic surgery at Indiana University. "They chose stuff of no material consequence that nobody really does."

The medical profession has historically been reluctant to condemn unwarranted but often lucrative tests and treatments that can rack up costs to patients but not improve their health and can sometimes hurt them. But in 2012, medical specialty societies began publishing lists of at least five services that both doctors and patients should consider skeptically. So far, 54 specialty societies have each offered recommendations and distributed them to more than a half-million doctors.

Hospitals that have deployed the lists, including Cedars-Sinai Medical Center in Los Angeles, report that the frequency of superfluous procedures has dropped. Consumer Reports, AARP and Univision are some of the influential organizations that have been part of a broad campaign to educate patients about the questionable items. Dr. Donald Berwick, a former head of Medicare, heralded the "Choosing Wisely" campaign as "a game-changer" because the "advice comes not from payers or politicos, but from pedigreed physician groups."

Yet some of the largest medical associations selected rare services or ones that are done by practitioners in other fields and will not affect their earnings. "They were willing to throw someone else’s services into the arena, but not their own," said Dr. Nancy Morden, a researcher at the Dartmouth Institute for Health Policy & Clinical Practice in New Hampshire.

Some specialists did target their own money-makers. Gastroenterologists, radiologists and clinical pathologists all placed their own tests on their lists. The Society of General Internal Medicine recommended against the annual physical exam, a mainstay of American health care.

Other specialty groups said they did not include their own procedures where there are concerns of overuse, such as stents for heart patients and spine surgery, because the evidence is murky and the procedures are right for some patients. "What we did when we made up the list was to start with more straightforward situations and hopefully expand that later," said Dr. F. Todd Wetzel, a member of the board of directors of the North American Spine Society.

Those societies tended to focus on limiting testing that others do. In an article in the New England Journal of Medicine, Morden examined all the items on the first 26 Choosing Wisely lists. She found that 83 percent of the items targeted radiology, medications and cardiac and lab tests—not physician services.

Stenting Gets A Pass

The American College of Cardiology opted to list the use of cardiac testing in four circumstances. But the college did not tackle what studies suggest is the most frequent type of overtreatment in the field: inserting small mesh tubes called stents to prop open arteries of patients who are not suffering heart attacks, rather than first prescribing medicine or encouraging  a healthier lifestyle. As many as one out of eight of these stent procedures should not have been performed, according to a study in Circulation, the journal of the American Heart Association.  At hospitals where stenting was most overused, 59 percent of stents were inappropriate, the study found.

"Let's face it, angioplasty and stenting is a big business, it's highly profitable for hospitals, and it's highly remunerative for physicians," said Dr. William Boden, a New York cardiologist who oversaw the first large trials that found no advantage for stents for patients who are not in acute distress. "There's a tremendous impetus to not rock the boat and not to call attention to the fact that we do too many procedures in stable patients for whom outcomes would be the same if not even better if treated medically."

Dr. William Zoghbi, a Houston cardiologist who was president of the college when the list was announced in 2012, rejected the suggestion that stenting procedures should have been more broadly questioned, saying "the vast majority" of stents "are quite appropriate for the condition." He said cautious choices for the initial list made sense because a campaign like Choosing Wisely is unfamiliar to doctors. "You have to walk before you run," Zoghbi said.

The cardiologists did discourage one specific use of stenting, where doctors opening a clogged artery place additional stents in other places where screenings have spotted the starts of blockage. Dr. Vikas Saini, a Massachusetts cardiologist and president of the Lown Institute, which advocates for more restraint in treatments, said, "in 20 years of practice that’s not something I would have thought is standard and if people are still doing it, that’s a shame."

Stents are a profit center for the group of cardiologists who perform procedures, often known as invasive cardiologists. They earned a median salary of $488,000, according to the Medical Group Management Association. Orthopedic surgeons do even better: half earned more than $538,000 in 2012, according to the MGMA’s income survey.

The orthopedic academy defended its Choosing Wisely selections, writing in a statement that "our recommendations are limited by the existing evidence regarding the effectiveness of various treatment options for musculoskeletal conditions, which we are seeking to improve." It noted that its recommendation against the dietary supplements could save patients $750 million a year spent on these drugs.

The orthopedists' selections did not impress critics. Rickert, the Indiana orthopedist, noted that discouraging dietary supplements affects revenue for health stores and other retail outlets, not surgeons. Both he and Morden said saline injections to treat knee pain are seldom done. Morden said when she searched 2011 Medicare billing records for the procedure, "I found zero claims."

"That's how pathetic that item is," she said.

Dr. Augusto Sarmiento, a former president of the academy and retired chairman of orthopedics at the University of Miami Miller Medical School, said there were more significant overused procedures the academy omitted, including replacing hips and knees when the patient’s pain is minimal and can be managed with medicine.

In addition, Sarmiento said too many surgeons operate on simple fractured collarbones, inserting metal plates, rather than letting the injury heal with the help of a sling. "The abuse of surgery is due to the overwhelming control of the profession by the implant manufacturing companies," he said.

Spinal Fusions Spared

The median compensation of a spine surgeon is more than $730,000, according to MGMA's survey. It is unclear how many spine surgeons are still performing a procedure the North American Spine Society placed on its list: using bone growth material in spinal fusion in the neck. The Food and Drug Administration issued a safety alert against this in 2008, noting that the procedure had led to the swelling of neck tissue that compressed patients' airways, making it hard to breathe or speak.

"I think the use for that purpose has already fallen off substantially," said Dr. Richard Deyo, a professor at Oregon Health & Science University and spine researcher. "They've taken on the easy things."

The only other procedure the society mentioned was spinal injections, but it was to expand, not restrict their work: They encouraged doctors to do their injections with the help of imaging, which would tack on another expense. The group also did not address spinal fusion, which has more than doubled in frequency between 1998 and 2008, faster than most procedures, one study showed.  Other research found that patients with back pain were increasingly likely to get a physician referral, "presumably for consideration of treatments such as injections and surgery" while referrals for physical therapy stayed flat over a decade.

Wetzel, the spine society official and an orthopedic surgeon at Temple University Medical School in Philadelphia, said that since spinal fusion has been shown to be useful "under very specific circumstances," the society "didn't feel comfortable making any kind of blanket statement."

The importance of which items are included is not just an academic debate, because where the lists have been actively embraced, the rate of those services has dropped. Last year, the Cedars-Sinai Health System in Los Angeles added 120 Choosing Wisely recommendations into its computerized patient records so that they would pop up on a screen whenever a clinician tried to authorize one.

"The alerts fire about 100 times a day," said Dr. Scott Weingarten, Cedar-Sinai's chief clinical transformation officer. For example, he said, there has been a decrease in the use of benzodiazepines and other sedative-hypnotics to treat the elderly, as they result in more falls, following a recommendation from the American Geriatrics Society for Choosing Wisely.

"We've got a bunch of other countries knocking on our door," said Dr. Richard Baron, president of the ABIM Foundation, which solicited the Choosing Wisely lists from the specialties. "There's a Choosing Wisely Canada.  There are health systems using it, insurers are using it."

Dr. John Santa, medical director for Consumer Reports, said reducing tests is a worthy goal because test results often prompt patients to get procedures. He cited electrocardiograms, which are used to measure the heart’s electrical activity to diagnose heart disease.  "Some people would say, it’s a $50 test, it's harmless," Santa said. "The false positives you get from EKGs can cause significant downstream problems. You may think you may have just been brilliant in detecting some abnormality. That's how stents get put in."

In Annapolis, Md., the Anne Arundel Medical Center broadcasts "Choosing Wisely" lists on hospital television screens, places posters on the walls of doctors' offices and discusses the lists in its magazine that it mails to county residents. The lists are also embedded as links in electronic patient records so physicians can easily review them.

Dr. Barry Meisenberg, an oncologist in charge of the hospital's quality efforts, said the lists are helpful when he is trying to explain to disappointed patients why he is not ordering a particular test. "It does help that’s not just this guy’s opinion, it actually has the imprimatur of a society," he said.

jrau@kff.org

http://bit.ly/1t1EREe

Consumers Union communicates to AAOS: 50,000 patients want hip/knee warranty

 Activists Take Fight to Obtain Hip,Knee Product Warranties to AAOS. Will They Succeed?

Posted in Orthopedics by Arundhati Parmar on March 12, 2014

FiDA highlight

At AAOS, Consumers Union, through its Safe Patient Project, is asking surgeons to support their demand to obtain hip, knee warranties from device makers when implants fail early. 

A consumer advocacy group has seized upon the fairly mundane concept of product warranties to turn the heat on medical device makers.

Consumers Union, the lobbying and advocacy arm of Consumer Reports, sent letters to six top hip and knee makers last September asking them to provide product warranties for early implant failures. The letter quoted the American Academy of Orthopaedic Surgeons in saying that 10% of implants fail.

The group has now made a big push in publicizing its message by organizing a campaign outside the annual meeting of the American Academy of Orthopaedic Surgeons, which kicked off Tuesday and ends on Saturday, March 15.

Activists were handing out flyers outside the Morial Convention Center in New Orleans that urged orthopedic surgeons to text their support for manufacturer warranties. Here's what the flyer looked like:

In an interview at AAOS Wednesday, Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said that only Smith & Nephew formally responded to the letter sent to orthopedic manufacturers in September. Two others acknowledged receving the letter via email but never actually responded to the request. The others did not respond. McGiffert couldn't recall which two companies sent the acknowledgment.

What the group is asking for is not unprecedented in the medical device world, she said.

"Biomet provides a warranty for a partial knee and cardiac products have warranties," she said.

After receiving Consumers Union's letter, Smith & Nephew responded that it is a "complicated issue" because hips and knees can fail for a number of reasons, McGiffert said. It could be the caused by the patient, the surgical technique or the device, McGiffert recalled the company as saying in its response.

But McGiffert clarified that the group is focused on "when the products are the problem." In other words, Consumers Union is not looking for a blanket product warranty, but wants device makers to take responsibility and stand behind the products when device-related problems cause the joint replacement to fail.

"You get warranties for flashlights, toasters and cars, for almost everything in the U.S.," she declared. "I know they are less complicated, but this is something that is going inside people's bodies. We think they ought to stand behind their products for a certain number of years. They can decide how long."

The purpose to bring the campaign to AAOS is to win support from surgeons and get feedback from them, McGiffert said.

However, Consumers Union may not win too much sympathy from the top brass at AAOS.

In a phone interview Wednesday, outgoing AAOS president Dr. Joshua Jacobs said that the "vast majority of orthopedic implants for joint replacement perform exceedingly well - 90% of total joint replacements work 10, 15 years and beyond."

Jacobs did acknowledge that "sometimes implants fail early, " but argued that "while warranties seem like a good idea on the face of it, the issue is more complex." 

Echoing McGiffert's portrayal of Smith & Nephew's response, Jacobs said that early failures could be caused by patients, due to the manner the surgeon did the procedure or it could be because of device problems. But sometimes "a complex interaction of the three" can also lead to early implant failure. So it may not be as easy to tease out which of the three factors caused the implant to fail.

And then there is the potential for infection, which is out of everyone's control, that can contribute to a failure.

"That cannot be addressed with a warranty," Jacobs declared. 

Overactive or obese patients can also lead to implant failure, Jacobs noted. 

However, another well-known orthopedic surgeon and healthcare social media maven, Howard Luks, disagreed with that assesment. 

"I don't think it's fair to blame the patient," he contended. "Once the joint replacement is done, it's stable, it's done. They should  be ready to go. If the patient is obese, then why did you put it in? Device makers understand who these implants are going into and the implants should meet those needs. Or there should be a big red sticker on that says 'Do not put in a patient with a BMI over 30.' So I think the patients have a right to ask for a guaranty or a warranty on a product that is going in their body."

Luks said that unless surgeons push the issue, device makers wouldn't move to provide such warranties.

And it certainly appeared that way. In an interview with DePuy Synthes Joint Reconstruction at AAOS, executives punted the question of warranties to the company's spokeswoman Mindy Tinsley, who responded like this:

"We understand the position that Consumers Union has taken. We are interested in continuing to have a dialogue about this. But I think with joint replacements, it's a complex interaction of factors and revisions have sometimes to do with the implant, sometimes with the patients, sometimes with the technique. We acknowledged the letter but we haven't taken a position. This is an issue we are continuing to explore."

Stryker declined comment via email. A Zimmer spokesman at AAOS said that "it's a complex issue and has a lot of factors surrounding it." The spokesman, James Gill, also forwarded a statement from AdvaMed, the device industry association, which argued that warranties for hip and knee implants that involve complex procedures and involving many different players, involving the patient and the hospital, may not be appropriate. However, it left the decision to provide warranties to individual manufacturers.

Meanwhile, McGiffert said that Consumers Union has secured the support of 50,000 patients who have sent emails to the top orthopedics device makers asking for product warranties-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

Great Reporting

Submitted by falascoj on March 14, 2014 - 9:32am.

Great graphics and story. I believe you have only hit the surface on this story. Hopefully we will see followup stories on you asking the medical device companies to come clean on why they are fighting the idea of warranty. They are the only major industry or activity that operates that way. The arguments that Mr.Gill has mentioned and the ortho surgeon are lame and I can just see an automotive guy saying --- well be can't do bumper to bumper because an F-150 is different then a Mustang. -Not
I've forwarded this article to numerous groups as an example of a publication actually getting out in front of the biggest deception on the American public since the Warren Commission.

AAOS conference on joint repair: closed meeting to Consumers

AAOS Opens in NOLA With Joint Repair Topping Agenda

Published: Mar 10, 2014  FiDA highlight

By Sarah Wickline , Staff Writer, MedPage Today

NEW ORLEANS -- An appearance by Louisiana governor Bobby Jindal (R) is among the highlights of this year's annual meeting of the American Academy of Orthopaedic Surgeons, which begins here Tuesday and runs through Saturday.

Jindal will address the meeting on Wednesday. He is a former assistant secretary of the Department of Health and Human Services, as well as former secretary of the Louisiana Department of Health and Hospitals.

AAOS President Joshua J. Jacobs, MD, is also excited about the 825 papers, 569 posters, 217 instructional courses, and more than 88 scientific exhibits being presented at this year's meeting.

Live streaming of 13 symposia via webcasts will be available on demand through March 23.

Featured symposia to catch either in person or via webcast include "Lessons on the Outcomes of ACL Reconstruction Surgery from International Registries," "Tips, Tricks, and Technical Pearls," "Hot Topics and Controversies in Shoulder Surgery," "The Multiple Ligament Injured and Dislocated Knee," and "Complex Skeletal Reconstruction in Infection, Post Trauma, and Tumor."

A last-minute addition to the schedule, the "Health Care Reform: How Can We Adapt?" symposium, will start at 8:00 a.m. on Friday. At the same time, "Can We Improve Surgical Outcomes for Orthopaedic Patients? A Compelling Need for Change," will be moderated by James H. Herndon, MD, of Massachusetts General Hospital in Boston.

There will also be "Ask an Expert" sessions for attendees to pick the brains of leaders in hip and knee, spine, hand and elbow, trauma, shoulder, tumor, foot and ankle, hand, pediatric, and sports medicine orthopedic surgery.

A special electronic skills pavilion will provide attendees with a chance to learn about the latest technology and applications to help further their practice. Several presentations will focus on social media, managing reputations on the Internet, marketing, and privacy in the realm of medical health apps.

The AAOS tradition of hosting a Guest Nation will continue this year, with France as this year's guest.

_______________________________________________________________

Consumers Union media at New Orleans airport baggage claim

Consumers Union Safe Patient Project will be outside the convention to elicit opinions/support of orthopedic surgeons about/for warranty on implanted joint products.  Please text your thoughts to 30644 

________________________________________________________________

The text reads:  The safest, most successful surgeries happen when physicians and patients team up as active partners.  Which means plenty of candid questions and honest answers from each.  Bone up on patient safety at orthoinfo.org/patientsafety.  A public service message from American Academy of Orthopedic Surgeon, who remind patients and doctors that communication is the best medicine.

Patient advocates enlist orthopaedic surgeons' support: AAOS New Orleans

Docsfor Hip and Knee Warranties?

    

Posted by Daniela Nuñez, Consumers Union  FiDA highlight

Since last September, Consumers Union’s Safe Patient Project has been calling on the top hip and knee manufacturers to warranty their products. A warranty would cover revision surgery for patients if their implant is defective –for example, if the implant breaks, fails to adhere to the patient’s body or emits metal particles into tissue or blood. Shockingly, only one hip and knee implant part comes with a warranty, yet more and more patients are getting these implants installed in their bodies.

To help us understand what patients really need, we’ve asked thousands of people with artificial hips and knees to tell us what they expect from a good warranty. Now, we’ve started asking orthopedic surgeons who implant these hip and knee devices what they think about our warranty idea. As experts in their field, we think they’d give us some good input. A surgeon in Florida shared his thoughts on warranties in a guest blog post. Some orthopedic surgeons in Washington state had helpful comments, with several stating an interest in the idea. And a researcher who has analyzed hip and knee implants retrieved from patients over the past 30 years reached out to us with a very useful perspective on the issue.

In our newest effort to get more feedback from surgeons, our Safe Patient Project team will head to the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans March 10-14, 2014. We tried to pay the registration fee for us and several patient safety activists, but an AAOS representative told us that this is a “private meeting and not open to those outside the medical field or official exhibitors.” So, we will be outside the meeting and around New Orleans ready to talk to surgeons about why we think hip and knee manufacturers should back their products with a warranty and identifying supporters.

Unfortunately, many patients are left in the dark on how long their hip or knee implant will last — even though most people are given an estimate, there is not a solid guarantee to back that up. Patients also need a clear process to follow if their device fails unexpectedly, something that is routinely offered with warranties. And when a hip or knee implant fails, insurance companies, Medicare and patients are forced to foot the bill while the implant maker doesn’t have to pay a dime. That should change.

Surgeons play an important role in the success of a patient’s hip or knee replacement. We look forward to getting their feedback! And we hope we can enlist their support for warranties.

(If you are an orthopedic surgeon, please email us your thoughts on a warranty at safepatient@consumersunion.org. If you’ll be at the AAOS conference, let us know!)