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.
Please share what you have learned!
Twitter: @JjrkCh

Monday, March 11, 2013

Failed Hip Implant: $8.3 million award to plaintiff



Published: March 8, 2013
                                   
A jury in Los Angeles on Friday ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.
The 12-member panel, however, declined to issue punitive damages, saying the company’s DePuy orthopedics unit, which made and marketed the all-metal device, did not act with fraud or malice. The implant, known as the Articular Surface Replacement, or A.S.R., was recalled in mid-2010.
In a statement, the company described the verdict as “mixed” and said that it planned to appeal the damage award. It disputed the finding by the jury that the A.S.R. was defectively designed.
It was impossible to say what the verdict, which came in a Los Angeles state court, would mean for other A.S.R.-related cases. A trial on a second lawsuit is scheduled to begin Monday in Chicago, with other cases expected to proceed later this year.
In its decision, the panel ordered Johnson & Johnson to pay the case’s plaintiff, a retired Montana prison guard, Loren Kransky, $338,000 to cover his medical expenses. It also ordered him to be paid $8 million to cover his pain and emotional suffering.
Some lawyers and industry analysts have estimated that the suits ultimately would cost Johnson & Johnson billions of dollars to resolve.
Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action could provide a framework for settling the bulk of the cases and determining awards to patients.
The A.S.R. belonged to a class of once widely used hip replacements whose cup and ball components were both made of metal.
It was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use in the United States in standard hip replacements that used the same cup component as the resurfacing device.
However, the A.S.R.’s design caused the cup and ball to strike against each other as a patient moved, resulting in the shedding of metallic debris. That debris inflamed and damaged tissue and bone, causing pain and, in some cases, permanent injuries to patients.
Today, all-metal hips like the A.S.R. are rarely used by surgeons because most models suffered from similar problems. But data from orthopedic registries suggests that the A.S.R. was far worse than many competing products.
An internal Johnson & Johnson document introduced at the Los Angeles trial estimated that close to 40 percent of patients who received an A.S.R. will need to undergo a second operation within five years of the first to have the implant removed and replaced. In a recent filing with the Securities and Exchange Commission, Johnson & Johnson said that there are 10,750 A.S.R. lawsuits.
Traditional artificial hips, which are made of metal and plastic, are expected to last 15 years or more before needing to be replaced, and the normal replacement rate for early unexpected failures is about 5 percent after five years.
The lawsuit heard in Los Angeles was not originally scheduled to be the first over the A.S.R. but it was moved up because Mr. Kransky was found to have terminal cancer. Before the start of the Los Angeles trial, which began in late January, Mr. Kransky’s lawyers had not expected him to live through it.
Internal Johnson & Johnson documents that became public during the trial indicated that company executives were told by surgeons, who were also paid consultants to the device maker, that the design of A.S.R. was flawed. In addition, some surgeons also urged the device maker to slow sales of the implant or stop them completely, records show.
In the case, evidence was also presented that showed that Johnson & Johnson considered redesigning the A.S.R. to reduce its problems, but then abandoned the project because the implant’s sales did not justify the costs of the redesign. One of the DePuy executives involved in that decision was Andrew Ekdahl, who now heads Johnson & Johnson’s orthopedics division.
Johnson & Johnson executives like Mr. Ekdahl have said throughout the A.S.R. episode that they acted responsibly and moved to recall the device in 2010 when data from an orthopedic registry in Britain showed that its failure rate was higher than normal.
Before reaching its verdict Friday, the jury that heard Mr. Kransky’s case deliberated for more than five days. Mr. Kransky’s lawyers, citing what they described as the unethical behavior of DePuy executives in failing to warn doctors and patients of the device’s defects, asked jurors to punish Johnson & Johnson by awarding their client $36 million to $144 million. Jurors declined to do so.
Nonetheless, lawyers representing Mr. Kransky hailed the verdict.
This is a victory for Mr. Kransky and thousands of other badly damaged A.S.R. patients who have yet to get their day in court,” Brian Panish, one of Mr. Kransky’s lawyers, said in a statement. “Jurors across the country will return similar verdicts until J.&J. takes full responsibility.”
A DePuy spokeswoman, Lorie Gawreluk, said in the company’s statement that it planned to appeal Friday’s verdict, contending that the A.S.R.’s design was not defective.

Wednesday, February 27, 2013

Joint Replacement Survey: Consumers Union

https://stori.es/share/your-joint-replacement-experience

If you or a loved one have an implanted joint replacement, please go to the link above and fill in the survey.

Consumers Union is actively advocating for patients with implanted medical devices.  Today, CU Safe Patient Project, Senior Director, Lisa McGiffert participated by Brookings Institute webinar with FDA Jay Carney and NWHN Kate Ryan in a discussion on implementing UDI's.  Unique device identifiers are the first step in providing patients with accurate and timely information about the composition, origin and producer of their implant.  This information will be uniform and shared in the electronic health record, with the insurer and the FDA.  This will allow researchers to analyze which devices are safe and effective and provide the patient with a portal to determine which devices have been recalled.  The federal government is still working on implementation, so Consumers Union is providing this survey as a preliminary "registry" for patients until the national program is fully instituted.

Thank you!



Monday, February 25, 2013

Harmed patient not healed by $3.35M verdict.




By David Voreacos - Feb 25, 2013 11:44 AM CT  FiDA highlight
           
           
Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.
Jurors ordered J&J to pay $3.35 million to the nurse, Linda Gross, and her husband. Gross, 47, had 18 operations after the device was implanted.

J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor, the jury ruled. Jurors decided that the company failed to warn Gross’s implanting surgeon. The verdict in Atlantic City state court came in the first trial of claims Ethicon’s Gynecare Prolift injured women.
“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” Gross attorney Adam Slater said in an interview.
Slater argued to jurors that company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. Gross blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.
‘Doctors Knew’
J&J claims the Prolift is safe and effective and it warned of the risks.
“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments on Feb. 15.
Superior Court Judge Carol Higbee is considering whether to allow Gross’s attorneys to pursue punitive damages, which are intended to punish the company. If so, the same jury would hear evidence and decide whether to award such damages. New Jersey caps punitive damages at five times compensatory damages, which in this case would be $16.75 million. Jurors delivered their verdict on the fifth day of deliberations.
Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.
Difficult Removal
The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. J&J, based in New Brunswick, New Jersey, said in June that it would end sales worldwide because the products lacked commercial viability, not because of their safety and effectiveness.
Slater claimed that Gross’s chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies and was difficult for surgeons to remove.
Gross, of Watertown, South Dakota, testified on Jan. 31 that her life has changed dramatically for the worse since her mesh was implanted. She said she is in constant pain and can no longer sit comfortably, and she has prescriptions for 20 different medicines to help with her pelvic problems.
“Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.”
Little Risk
Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006 to shore up pelvic muscles, was “so gung-ho” about the Prolift that she thought she needn’t worry. She understood from talking to Benson and reading a company brochure that she faced little risk and that the mesh could be removed easily, she said. Had she known all the risks, she said, she wouldn’t have chosen the Prolift.
Gross said she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which have been “horrific.”
“I am fearful of dying because this pain is so bad,” she said.
On cross-examination, Jones sought to establish that before many of her surgeries, doctors warned that they may not help her pain. At one point, Gross shouted at Jones: “You’re trying to blame it on me, and it’s not right.”
Jurors saw the video deposition of Benson, who did three follow-up surgeries to remove portions of the mesh to help her with her pain. Other doctors also removed parts of her mesh.
During jury deliberations, the jury reheard testimony from both Gross and Benson. During the trial, which began Jan. 10, jurors also heard from 11 company witnesses and several experts on each side.
Johnson & Johnson shares fell 2 cents to $76.23 at 12:40 p.m. in New York Stock Exchange trading.
The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).
To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net




Accessing justice is a high barrier for patients who experience failed implanted medical devices. they are hurt and medically impoverished. The surgeons are not legally required to report "adverse events" to the FDA unless there is a fatality.  Registry of the devices (if there is any) is held in a proprietary silo and data of implants success/failure is obscured for patients making life-changing decisions.  The monumental failure of Johnson & Johnson both for DePuy MoM (metal on metal hips) and Ethicon surgical mesh were preventable if marketing had not led science.  Why is this not criminal?  It is defrauding the government because taxpayers absorb the expen$ive accountability that the industry does not. FiDA Failed Implant Device Allicance  Joleen Chambers

Wednesday, February 20, 2013

Women: Hip Implants 29% More Likely to Fail


By John Gever, Senior Editor, MedPage Today
Published: February 18, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Failure rates for hip implants were 29% higher for women than men in a large U.S. registry study after controlling for a variety of factors including device type, researchers said.
With a total of 35,140 patients undergoing primary total hip arthroplasty followed for a median of 3 years, the crude all-cause rate of failure (defined as subsequent revision surgery) was 2.3% for women (95% CI 2.1% to 2.5%) compared with 1.9% for men (95% CI 1.6% to 2.1%), according to Maria C.S. Inacio, MS, of the Southern California Permanente Research Group in San Diego, and colleagues.
After adjustments for age, body mass index, diabetes status, degree of presurgical symptom severity, implant fixation method, device category, and femoral head size, the authors calculated a hazard ratio (HR) for revision of 1.29 for women versus men (95% CI 1.11 to 1.51), they reported online in JAMA Internal Medicine.
The risk appeared most prominent for aseptic revision (HR 1.32, 95% CI 1.10 to 1.58) compared with septic failure (HR 1.17, 95% CI 0.81 to 1.68), the researchers found.
Larger femoral head sizes appeared especially problematic for women. For head sizes of 36 mm or more, the adjusted HR for failure in women versus men was 1.49 (95% CI 1.14 to 1.95), whereas differences in revision rates for smaller head sizes were not significant after adjustment.
Much of the increased risk for women also seemed concentrated in metal-on-metal implants, with a doubling in risk for women versus men (adjusted HR 1.97, 95% CI 1.29 to 3.00).
But that was primarily because of reduced risk of failure with metal-on-metal devices in men (adjusted HR 0.68 versus highly crosslinked polyethylene, 95% CI 0.45 to 1.02), whereas in women, the adjusted failure rates for metal-on-metal versus crosslinked polyethylene were similar, adjusted HR 1.07, 95% CI 0.72 to 1.60).
Clinical Implications?
In an accompanying commentary, Diana Zuckerman, PhD, of the National Research Center for Women and Families in Washington, D.C., suggested that the study's clinical implications were relatively trivial.
She noted that most patients considering hip replacement are already suffering pain and limited mobility and have few other options.
"Knowing that their chances of success are lower than men's is not helpful to women who are unable to perform many activities of daily living," Zuckerman argued.
Instead, she said, what is needed is "long-term comparative effectiveness research based on large sample sizes, indicating which total hip arthroplasty devices are less likely to fail in women and in men, with subgroup analyses based on age and other key patient traits, as well as key surgeon and hospital factors."
But Glenn Don Wera, MD, of UH Case Medical Center in Cleveland, told MedPage Today that the study provided valuable insights into the reasons for higher failure rates in women.
He noted that the higher rate of revision in women was already known from Medicare data. In the current study, however, "they were able to control for a number of clinical factors, including the kind of prosthesis the patient had, the experience level of the surgeon, and the different institutions and the different prostheses they were using."
That the increased risk in women was still evident despite adjusting for those factors indicates that something else, such as women's generally smaller stature, is responsible, Wera suggested.
Revision Rate: Beyond Infection
Data for the current study came from the Kaiser Permanente system's registry of total joint replacements from 2001 to 2010. Procedures were performed at 46 hospitals in California, Hawaii, Oregon, Washington, and Colorado by 319 different surgeons.
The registry is the largest of its type in the U.S., the authors said and includes data on surgeons' and hospitals' arthroplasty procedure volumes; the patients and the implants they received (cemented, uncemented, or hybrid); and implant bearing surface, such as metal on metal, metal or ceramic on highly crosslinked polyethylene, or ceramic on ceramic. The researchers put the DePuy metal-on-metal hip resurfacing monoblock device into its own category.
Only patients undergoing unilateral procedures were included in the analysis.
About 58% of the 35,140 procedures were performed in women (mean age 65.7 versus 63.8 for men). Just over 60% of both sexes had scores of 1 or 2 on the American Society of Anesthesiologists index, with nearly all of the remainder having scores of 3 or more.
The age difference between men and women was statistically significant. In addition, women in the cohort tended to be slightly more likely to be white or Asian and to have osteoarthritis, rheumatoid arthritis, or dysplasia. They were less likely to be diabetic or obese and to have osteonecrosis or post-traumatic arthritis.
Not surprisingly, women were much less likely to have implant femoral head sizes of 36 mm or more (32.8% versus 55.4% for men, P<0.001). About twice as many men as women had metal-on-metal bearings (19.4% versus 9.6%), whereas ceramic or metal on highly crosslinked polyethylene were more popular for female patients (P<0.001).
The DePuy resurfacing implant was used in 1.3% of women versus 2.6% of men (P<0.001).
Preferences for fixation types also differed between men and women, with hybrid methods more common in the women and cementless fixation more common in men.
Mean surgeon and hospital volumes did not differ between sexes.
The authors noted that with no significant increase in risk of septic failure for women, their results mean that "factors other than infection" are responsible for the higher overall revision rate.
Limitations to the analysis include its observational design, the relatively short follow-up period, lack of data on some potential confounding factors, and the use of revision surgery as the definition of implant failure. Also, the researchers used relatively broad categories of implant type, conceding that design variations within these categories could have influenced the results.
The study was funded by the FDA.
Study authors and Zuckerman declared no relationships with commercial entities. Several study authors were Kaiser Permanente employees.

Monday, February 18, 2013

NPR Diane Rehm Show: Failed Implants




New Questions About The Safety Of Hip Replacements 
The Diane Rehm Show WAMU 
Thursday, February 14, 2013 - 10:06 a.m

The Food and Drug Administration recently issued new warnings on the safety of some hip replacements. As part of our occasional series, "Mind and Body," Diane and her guests discuss what patients need to know about safety and cost of hip replacements.
Guests
Barry Meier staff reporter for "The NewYork Times" and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death."
Diana Zuckerman president of the National Research Center for Women and Families.
Dr. Henry Boucher orthopedic surgeon at Medstar Union Memorial Hospital in Baltimore, Md.
Sarah Brown CEO of The National Campaign to Prevent Teen and Unwanted Pregnancy and three-time hip replacement patient.
Kenneth Thorpe professor and chair of health policy and management at Emory University Rollins School of Public Health.

Patient/public access to implant data still missing!


Physicians face limited choice in medical device selection as hospitals push to slash supply-chain costs

 Modern Healthcare
By Jaimy Lee   FiDA highlight  
Posted: February 15, 2013 - 12:01 am ET

 Gagged by their supply contracts, some hospitals have devised a simple way to educate physicians about the cost of pricey implants: using color-coded stickers to indicate the level of a device's price.

Many of these hospitals are barred by confidentiality clauses with device manufacturers that limit, in some instances, whether hospitals in the same health system can share pricing data about the devices they purchase. Instead, they mark the devices with colored tags specifying high-, medium- or low-cost options.

The widespread use of confidentiality clauses—which limit price transparency and hospitals' ability to shop for devices based on price—and longstanding relationships between physicians and device companies are the two major factors driving costs higher on implantable devices such as artificial knees and hips or cardiovascular stents, which are among the most expensive items hospitals buy.

 They are frequently called physician preference items because orthopedic and cardiovascular surgeons traditionally make the final decisions as to which devices a hospital will use. Only over the past five years or so have some hospital administrators started to implement strategies to reduce the costs of these items.

However, mounting pressure on hospital margins, the increasing number of physicians employed by hospitals and the shift to new payment models that align the financial priorities of hospitals, physicians and a patient's cost of care indicate that the concept of a physician's preference may soon be a thing of the past.

“This will be an area where there is a lot of opportunity for cost containment because it's an area that has really run rampant in the past and has not been well controlled by many hospitals,” says Dr. Kevin Bozic, vice chairman of orthopedic surgery at the University of California at San Francisco. “There's not as much flexibility and fat in the system. They're going to have to be much more efficient and function with the same discipline as other businesses.”

At the same time, the costs of many implantable device procedures continue to rise. Orthopedic procedures accounted for most of the growth in Medicare implantable device procedures from 2004 to 2009, with spending on those procedures increasing 8.1% annually for five years, according to a Government Accountability Office report from January 2012.

There is little publicly available data showing the individual prices of implantable devices and whether those prices are rising. But the same report found examples of “substantial price variation,” with one hospital paying $4,500 for a specific primary total hip construct and another paying $8,000 for the same product.

“The cost of joint implant constructs used for knee and hip replacement vary widely and are major contributors to the variation in the cost of care for patients undergoing total joint replacement,” according to a separate study published last year in the Journal of Bone & Joint Surgery.

With hospital margins under pressure, many large health systems and integrated delivery networks have become increasingly aggressive about implementing cost-cutting initiatives that target medical devices. They usually focus on reducing prices and the number of manufacturers—which can lead to better volume discounts—as well as seeking better utilization practices.


Hospitals have introduced gain-sharing programs that allow physicians to share in cost savings. They're also creating device registries that track performance to help inform purchasing decisions and instituting bundled-payment models that may also reduce costs and improve quality.

However, there are no specific efforts under way to ban the use of confidentiality clauses.

Jeffrey Lerner, president and CEO of the ECRI Institute, an independent health technology assessment organization, says that increased awareness of the clauses, as well as the ongoing cost pressures and market changes, could lead to increased pricing transparency.

But there's more to reducing a health system's supply costs than just addressing price, says Brent Johnson, vice president of supply chain and imaging services and chief purchasing officer for Intermountain Healthcare, Salt Lake City. There is greater financial benefit when Intermountain better manages utilization and standardizes practices rather than solely focusing on price, he says.

“In this industry, we tend to tiptoe around physicians. That they are allowed preference is a huge conflict of interest most of the time,” Johnson says. “When the physician has a choice between keeping his loyalty and whatever benefit he gets from the vendor and keeping his salary whole, he'll abandon the preference in a minute.”

Many physicians develop preference for specific devices or manufacturers early in their careers. In a fee-for-service model, physicians have little incentive to choose less-expensive devices and more often than not their interests are closely aligned with those of the manufacturer rather than the hospital. This is changing.

“There have been more attempts to align the interests, financial or otherwise, of hospitals and physicians,” UCSF's Bozic says. “More physicians are employed by hospitals; more physicians are entering into joint ventures or co-management agreements with hospitals; and newer payment methodologies such as bundled payments are effectively putting both the hospital and the physicians at risk for the cost of care, (which) aligns their incentives around improving quality and reducing costs.”

The Affordable Care Act is at the center of many of these changes. Along with the introduction of new payment models, such as accountable care organizations and patient-centered medical homes, the inclusion of the Physician Payments Sunshine Act is expected to make the financial relationships between physicians and manufacturers more transparent.

Related content


Under the Sunshine Act, device companies are required to collect data about the payments, gifts and other “transfers of value” they give to physicians. That data will be posted online beginning in September 2014, which might give hospitals and physicians an incentive to reduce the appearance or prevalence of certain relationships.

“That level of disclosure may be operating to weaken the bond between the implanting surgeon and the company,” ECRI's Lerner says.

In fact, physicians are increasingly getting involved with supply chain-led initiatives to reduce costs. Dr. Richard Parker, chairman of orthopedic surgery at the Cleveland Clinic, has been working closely with the 11-hospital system's supply-chain staff since 2008. Parker, a sports medicine surgeon, was named chair of orthopedic surgery in 2009. “When I moved into that leadership role, I became much more acutely aware of costs,” he says.

With the move toward what Parker calls “value-based medicine,” physicians are becoming more engaged in supply decisions, especially in the cases where a change in device can affect patient care or when the price of a device makes up a large percentage of certain DRGs. He says there is little pushback from other physicians who may question some standardization efforts.

“We attract individuals who, quite frankly, value the brand of the organization more than their individual brand,” Parker says. “They realize that in order for this to continue we have to get our arms around these things.”

At Intermountain, the doctors who are members of physician preference committees for orthopedics, cardiovascular, neurology, trauma and surgical services items are “already more engaged, accepting of change and know this is where we're headed,” Johnson says.

The first time the supply-chain team tackled the costs of orthopedic devices was in 2007, when the 21-hospital system was spending about $32 million annually on that device category alone.

That same year, Johnson received approval from the system's administrators to share up to 30% of documented first-year savings on the costs of orthopedic devices with the system's orthopedic surgeons. By supporting Intermountain's strategy to implement standard pricing policies—physician support pressured suppliers to comply—the physicians could use the savings to purchase other equipment, supplies or training.

The approach worked, and Intermountain now re-evaluates the cost of physician preference device categories every two years. The average savings for every category assessment is about 20% each time, Johnson says.

However, he views many of the pending payment reforms as the potential forces in driving the concept of “preference” out of the industry. If a physician has to take a 20% deduction on the cost of a procedure or agree to use a limited number of suppliers, the physician will be more likely to support standardization, Johnson says.

“Healthcare reform isn't just about cost. We've got to manage utilization,” he says. “We need physicians and surgeons to not just be loyal to one supplier, we need them on board to help us manage utilization and standardization and value beyond just price.”

So while market and regulatory change may be coming, it may not be occurring as quickly as some hospitals would like. Physician preference items are usually among a hospital's most expensive supply costs. With few organizations willing to make further cuts to labor costs—an organization's highest expense—they are instead focusing on reducing their second-largest expense—supplies—with physician preference items being a key target.

“Nonlabor (cost) is now getting a lot of attention because we squeezed everything we can out of the labor side,” says Ed Hardin, vice president of supply chain management for Christus Health in Texas. “We can't afford to make those kinds of cuts, so we've got to get more efficient and more effective about how we run our supply chain.”

Physician preference items account for about 57% of total supply costs for Christus Health, Hardin says, a percentage that has increased 10% since 2008. “It's rising as a percentage of total supply expense, whereas commodity spend has gone down,” he says.

As the cost of physician preference items continues to make up a larger percentage of total supply costs, some hospital systems have looked outside of their networks in an effort to better address the costs of these devices.

Cleveland Clinic and Dignity Health, both large health systems, have formed separate joint ventures that specifically aim to address the costs of physician preference items.

San Francisco-based Dignity Health developed a for-profit company called SharedClarity with UnitedHealthcare and up to 10 additional and unnamed health systems.

“These organizations are combining data to help inform healthcare organizations about the best-performing medical devices through comparative effectiveness studies,” according to SharedClarity's website. “For the first time, these exclusive studies will enable doctors and administrators to make informed decisions based on clinical proof rather than manufacturer influence.”

When the Cleveland Clinic announced its joint venture with VHA this month, it stressed that it will focus on how it can reduce the costs of physician preference items for its hospitals. However, there are also plans to bring in VHA members, Cleveland Clinic affiliates and other organizations.

The Greater New York Hospital Association recently received approval from the U.S. Justice Department to establish a voluntary gain-sharing program for its member hospitals. UCSF's Bozic says the university is looking into the possibility of developing a similar program.

ECRI's Lerner says more hospital systems will form partnerships or other ventures to help them rein in the costs of these devices. “Change brings a lot of experimentation,” he says. “We have to see how it actually plays out.”

One of the largest concerns for executives who manage supply-chain purchasing at hospitals is how to obtain and use clinical data that allow them to choose between competing devices. The goal: improving patient outcomes and avoiding repeat operations known as revisions. As payers turn toward bundled payments, avoiding revisions can also lower costs. Kaiser Permanente and the Cleveland Clinic have each maintained system device registries that can better track how a device performs after implantation.

Government registries in Australia and the United Kingdom were the first to discover that metal-on-metal hip implants were failing at a faster rate than other hip devices. More than 93,000 metal-on-metal hip implants sold by Johnson & Johnson's DePuy Orthopaedics unit were later recalled, which led not only to revisions but also to thousands of lawsuits.

In addition, the number of recalls in recent years may have caused a splinter in the relationships between physicians and manufacturers.

“There have been disappointments for physicians,” Lerner says. “We've had high-profile recalls. You have this gigantic problem with metal-on-metal implants, which makes a huge impact. That's massive, and I think it undermines that complete trust bond between the surgeons and the companies.”

TAKEAWAY: Reducing the number of vendors and developing new ventures are among the ways hospitals are targeting supply-chain costs.