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, August 26, 2013

Sunshine Act exemption is a missed opportunity to fund/include patients at medical conferences.



New Health Law Calls for Increased Disclosures

            By PETER LOFTUS CONNECT  Wall Street Journal
FiDA highlight added
U.S. doctors are bracing for increased public scrutiny of the payments and gifts they receive from pharmaceutical and medical-device companies as a result of the new health law.
Starting this month, companies must record nearly every transaction with doctors—from sales reps bearing pizza to compensation for expert advice on research—to comply with the so-called Sunshine Act provision of the U.S. health-care overhaul. The companies must report data on individual doctors and how much they received to a federal health agency, which will post it on a searchable, public website beginning September 2014.
Many doctors say the increased disclosures are making them rethink their relationships with industry, citing concerns about privacy and accuracy, and worry that the public will misinterpret the information. Some fear patients will view the payments as tainting their medical decisions, and will lump together compensation for research-related services with payments of a more promotional nature.
Drug companies collectively pay hundreds of millions of dollars in fees and gifts to doctors every year. In 2012, Pfizer Inc., PFE +0.64% the biggest drug maker by sales, paid $173.2 million to U.S. health-care professionals. Some companies including Pfizer have decreased these payments in recent years; Pfizer's total was $195.4 million for 2011.
Consulting and speaking fees are an important source of income for some physicians, who can be paid tens of thousands of dollars a year for such services. But now physicians say they will be much more selective about the work they do and what they will accept from industry representatives. Some are even restricting access to their offices by sales reps, or requiring forms that document the value of anything brought to the office, according to medical societies.
John Mandrola, a cardiologist in Louisville, Ky., said he has been paid a total of $1,500 to $2,000 this year by medical-device makers for speaking engagements. Knowing that such transactions will become public has caused him to be more cautious about what fees to accept, he said. He avoids industry reps visiting his office, believing he can get information on new drugs elsewhere.
"I'll continue to weigh the benefits and the negatives, and I think the Sunshine Act and the public reporting of all this stuff makes us think about that," said Dr. Mandrola. "And I think that's a good thing."
A benefit of transparency, Dr. Mandrola said, is that it will help doctors evaluate medical research from peers if they know whether the researchers receive payments from certain companies. Still, he worries that the disclosures could squelch legitimate interactions—for example, when doctors receive consulting fees to help companies develop drugs and determine their best use.
"I don't think all physician-industry interaction is bad," he said.
The push for greater transparency was driven by concerns that doctors' prescribing decisions are tainted by the payments and gifts, as well as allegations that drug companies have used payments to induce doctors to prescribe drugs for unapproved, "off-label" uses. Several drug companies have paid large penalties to settle government allegations of off-label marketing, and were required to disclose physician-payment data as conditions of the settlements.
"The idea is that transparency will encourage doctors to evaluate whether these are appropriate relationships with companies or not," said Daniel Carlat, a psychiatrist and director of the prescription project at the Pew Charitable Trusts, which supported the Sunshine Act. He expects patients won't have much of a problem if their doctors receive $200 worth of company-provided lunches, but may question doctors who receive tens or hundreds of thousands of dollars from the industry annually.
Several drug and device makers—including Pfizer and Eli Lilly LLY +0.30% & Co.—have been posting physician-payment data online for the past few years. Some U.S. states already require companies to report such information. But the Sunshine Act will significantly widen the scope because it applies to most companies—any company whose products are covered by Medicare—and the government's launch of the database could draw greater public attention.
Richard B. Aguilar, a diabetes-care specialist, received a total of $42,339 from Lilly for the first three months of 2013, according to Lilly's online payment database. Dr. Aguilar, who has a private practice in Downey, Calif., said he speaks about Lilly drugs at programs to teach other doctors, and the information is consistent with the FDA-approved prescribing labels. He says the payments are fair compensation for his expertise and travel.
Dr. Aguilar plans to continue serving as a paid speaker, but he says other doctors are increasingly opting out of attending or speaking at such programs for fear of what the public will think about the payment disclosures.
Dr. Aguilar said he hopes the public would see the value of physicians learning new information about drugs from an expert at speaker programs, rather than having to rely upon their own educational resources to keep current. "This, in essence, is reducing the number of valuable expert educational speakers who might otherwise have provided teaching and experience to many health-care providers," he said.
Some doctors fear the payment data will be inaccurate and could mislead the public about the nature of their relationships with the industry. Gary M. Cowan, an ophthalmologist in Fort Worth, Texas, said he has occasionally attended company-sponsored dinners to hear a lecture from an expert in his field. He plans to monitor the payments that companies report in his name.
"I think it behooves every physician to look and see what's said about him," he said.
Drug makers said they've been preparing for the new reporting requirements and have implemented technology systems to collect the data, but they will continue to work with physicians because the interactions improve science and medicine.
The Centers for Medicare & Medicaid Services, which is implementing the Sunshine Act, is advising doctors to keep records of all payments and transfers of value received from industry. Once the agency receives payment data from manufacturers, it will give doctors about two months to review the data and work with companies to make any corrections before it is made public.
CMS also will break down the payment data into more than a dozen categories—such as meals, travel, research or speaking fees—to give a clearer idea of the nature of a doctor's relationship with industry.
One key exemption: Companies won't have to report compensation to doctors who speak at certain accredited events where physicians receive continuing medical education—as long the sponsoring company doesn't select or directly pay the speaker, but rather delegates those duties to a third-party organization. CMS initially proposed to require that such payments be reported, but granted the exemption in its final rule issued earlier this year, saying industry support for accredited or certified continuing medical education is a "unique relationship." Continuing-medical education providers pushed for the exemption, arguing that industry support would dwindle if the payments had to be reported.
Stefanie A. Doebler, an attorney with Covington & Burling LLP who represents health-care companies, said the exemption for indirect payments to speakers at continuing-medical education events could help sustain industry support for such programs. However, companies will be required to report certain other expenses for these programs, such as meals provided to physician attendees if the cost of each meal is separately identifiable. Some companies have decided not to fund such meals, she said, which could cause program providers to charge attendees for the meals.
To ensure accuracy, CMS is required to conduct audits of the data submitted and levy civil monetary penalties against companies for failing to submit data, or for submitting inaccurate data. Companies that fail to report information in a timely, accurate or complete manner face penalties of at least $1,000 per transaction, with a total maximum annual penalty of up to $1.15 million per company, according to CMS.
CMS plans to publish the data each year on a public website starting in the fall of 2014. CMS says patients will be able to look up their doctors and see if they have any financial relationships with companies, which types of payments they receive and how much.
Some companies are taking steps to prepare the doctors with whom they do business. Later this year, Roche AG's RHHBY -0.06% Genentech unit, which sells the cancer drug Avastin, will launch an online portal called "Sunshine Track," which will allow doctors to review payment data before it is reported to CMS. "We have implemented extensive processes to validate all payment information we collect," said a spokeswoman.
Genentech also allows physicians to opt out of receiving meals from the company at speaker programs or during office visits by sales reps. Doctors opting out of meals at speaker programs must certify this on a sign-in sheet and can either pay for the meal themselves or not partake, the spokeswoman said.
Write to Peter Loftus at peter.loftus@dowjones.com

Joleen Chambers comment:
More empty talk about being patient-centered:  with the exemption allowing industry to support medical education through a third party, the legislation FAILS to include a % of the funding to go to consumer organization scholarships making participation in the conferences possible.  Treatment decision makers and healthcare system designers are notorious for ignoring the patient stakeholder!   Engaged patient advocates are otherwise unfunded and pay a big price to compete for conference slots competing with those with professional credentials and a sponsoring organization.

Friday, August 23, 2013

Insidious medical device marketing to physicians



Georgetown University - Department of Strategy/Economics/Ethics/Public Policy; Harvard University - Edmond J. Safra Center for Ethics

Georgetown University Medical Center

April 30, 2013  FiDA highlight

Journal of Law, Medicine and Ethics, Volume 14, No. 3, August 2013, Forthcoming
Edmond J. Safra Working Papers, Forthcoming

Abstract:     
Pharmaceutical and medical device companies apply social psychology to influence physicians’ prescribing behavior and decision-making. Physicians fail to recognize their vulnerability to commercial influences; due to self-serving bias, rationalization, and cognitive dissonance. Professionalism offers little protection; even the most conscious and genuine commitment to ethical behavior cannot eliminate unintentional, subconscious bias. Six principles of influence — reciprocation, commitment, social proof, liking, authority, and scarcity — are key to the industry’s routine marketing strategies, which rely on the illusion that the industry is a generous avuncular partner to physicians. In order to resist industry influence, physicians must accept that they are vulnerable to subconscious bias, and have both the motivation and means to resist industry influence. A culture in which accepting industry gifts engenders shame, rather than gratitude, will reduce conflicts of interest. If greater academic prestige accrues to distant, rather than close relationships with industry, a new social norm may emerge that promotes patient care and scientific integrity. In addition to educating faculty and students about the social psychology underlying sophisticated, but potentially manipulative marketing and about how to resist it, academic medical institutions should develop strong organizational policies to counteract the medical profession’s improper dependence on industry.

Number of Pages in PDF File: 27

Thursday, August 22, 2013

$3B on failed hips offset by Celebrity Shill?

 To object to direct-to-consumer marketing of implanted medical devices:
Deborah A. Wolf, JD
Regulatory Counsel-Office of Compliance, CDRH
U.S. Food and Drug Administration
301.796.5732   deborah.wolf@fda.hhs.gov
10903 New Hampshire Avenue
Silver Spring, MD 20993





9/18/2013 Norman, OK
"Coach Barry Switzer talks about his personal touchdown in the game against hip pain and his innovative hip replacement surgery."     click on link to see flyer for invitation



J&J Said to Weigh $3 BillionSettlement of Its Hip Implant Cases

By Jef Feeley & David Voreacos - Aug 20, 2013 11:00 PM CT  Bloomberg
FiDA highlight added
Johnson & Johnson (JNJ), the world’s biggest seller of health-care products, has discussed paying more than $3 billion to settle lawsuits over its recalled hip implants, according to five people familiar with the matter.
J&J seeks to resolve as many as 11,500 lawsuits in the U.S. and has considered paying more than $300,000 per case, according to the people. Such a settlement would exceed $3 billion if most plaintiffs accept the terms, an amount 50 percent larger than that proposed in previous discussions.

Michael Kelly, attorney for plaintiff Loren Kransky, holds up an ASR XL hip implant made by Johnson & Johnson during his opening statement to the jury at the trial of Kransky v. DePuy, at the California Superior Court in Los Angeles, on Jan. 25, 2013. Photographer: Patrick T. Fallon/Bloomberg
A $3 billion settlement would dwarf a 2001 accord Sulzer (SUN) AG reached with patients who claimed that company’s hip and knee implants were defective. Sulzer, a Winterthur, Switzerland-based pump maker, agreed to pay $1 billion to resolve those suits, then the largest settlement involving hip implants.
Any accord would be affected by the outcome of seven product-liability trials between September and January, according to the people, who aren’t authorized to make the negotiations public.
“It’s going to be a fascinating case to watch settle because of the level of complexity of the injuries and the amount of money that will be involved,” said Bruce Cranner, a medical device defense lawyer not involved in the case. “You don’t see a lot of mass-tort implant cases settle for a substantial amount of money.”
Replacement Surgeries
The company is pushing to resolve U.S. cases by early next year, according to the people. J&J’s DePuy unit recalled 93,000 implants in 2010, including 37,000 in the U.S., after more than 12 percent failed within five years. That rate is climbing, along with suits by patients blaming the chromium and cobalt devices for pain, metal debris and replacement surgeries.
J&J, based in New Brunswick, New Jersey, has spent about $993 million on medical costs and informing patients and surgeons about the ASR recall, Lorie Gawreluk, a spokeswoman for DePuy, said in an e-mail. J&J set aside an undisclosed amount for litigation, which it increased before June 30, she said.
“The company also continues to support ASR patients with a reimbursement program to address recall-related testing and treatment costs,” she said. “Reports about a possible resolution of the litigation are premature and speculative, including any estimates of resolution amounts.”
Steven Skikos, a plaintiffs’ lawyer leading efforts to prepare lawsuits against DePuy, said his group is preparing for jury trials, which include the first case in federal court.
‘Dangerous Guess’
“With the trials rapidly approaching, and our continuing efforts to obtain more information and data about the patients, it’s easy to speculate about settlement,” Skikos said in an e-mail. “However, any comment relating to settlement that does not come from the plaintiff’s leadership, the court, or from the company itself remains premature, uninformed and a dangerous guess.”
J&J lost an $8.3 million verdict in the first trial over the ASR device and won the second. In the first case, a California jury in March awarded damages to a retired Montana prison guard. The panel also ruled the device was defectively designed, that DePuy properly warned of the risks, and that the company didn’t owe punitive damages. DePuy is appealing.
A Chicago jury ruled six weeks later for DePuy in rejecting a defective design claim by an Illinois nurse.
Other Trials
Seven other trials of lawsuits by plaintiffs blaming the ASR hips for injuries will help lawyers for both sides frame questions over liability and damages. The first is scheduled to begin Sept. 9 in federal court in Cleveland. U.S. District Judge David Katz is overseeing that lawsuit by Ann McCracken, 58, a resident of Rochester, New York, who needed two replacement surgeries known as revisions after her ASR implant.
Katz is overseeing about 8,000 federal cases consolidated before him for the pre-trial collection of evidence. About 2,000 cases are pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco.
Trials also are scheduled in state courts in San Francisco in October; in Hackensack, New Jersey, in October and January; in West Palm Beach, Florida, in November; in Chicago in December; and in Los Angeles in January.
“DePuy believes the evidence to be presented at trial will show the company acted appropriately and responsibly,” Gawreluk said. “The ASR hip system was properly designed, physicians were properly informed of the product’s risks, and DePuy’s actions concerning the product were appropriate.”
Broad Outline
Lawyers for hip recipients are still reviewing more than 50 million pages of J&J documents and conducting pre-trial interviews of company officials and experts to prepare for those cases, Skikos said.
While settlement talks continue, J&J and lawyers for hip claimants have agreed on the broad outline of a so-called “global settlement” covering all U.S. cases, the people said.
In January, five people familiar with the talks had said J&J officials were willing to pay about $2 billion to resolve the cases. Lawyers for plaintiffs rejected that amount as too little, the people said.
Any overall accord would compensate patients based on such factors as age, extent of injuries and whether they had one or more surgeries to replace defective implants, according to the people. Negotiators would likely rank those and other factors on a matrix or grid, the people said.
“J&J’s strategy will be to find a way to negotiate a grid to settle each of the claims based on five or six variables that could be plugged in and changed up or down to determine the value of any claim,” said Cranner, a lawyer with the New Orleans-based law firm of Frilot LLC. He is past chairman of the Medical Liability and Health Care Law Committee of DRI, an organization of lawyers who represent corporations and insurers.
Obstacles Remain
Several obstacles to a final settlement still must be overcome, the people said. One includes the number of years that J&J may potentially have to pay future claims. Another is whether the settlement would include reimbursing Medicare for claims paid. A third is the amount of compensation for extreme medical cases, which include dual hip surgeries or cases where infection prompted long hospital stays, the people added.
“There are a significant subset of clients who got very badly hurt by the device, and their injuries are much more than a simple revision,” said Matthew Davis, a lawyer at Walkup Melodia Kelly & Schoenberger in San Francisco whose firm represents 270 ASR clients.
“If those cases went to trial and there was a finding of liability, a jury would award them general damages in the seven figures,” said Davis, who isn’t involved in the negotiations.
Alloy Used
The J&J hips were made from a cobalt-and-chromium alloy used in two related models -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revisions, and 12 percent of the ASR Hip Resurfacing System failed.
At the first trial in Los Angeles, lawyers for plaintiff Loren Kransky argued DePuy failed to test the device adequately before selling it in the U.S. in 2005, buried surgeon complaints of mounting failures, and studied a redesign of the ASR before scrapping that effort in 2008.
Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels.
J&J set up a help line for patients that is “available in dozens of countries and has served tens of thousands of callers,” Gawreluk said. J&J runs a worldwide reimbursement program resulting in “thousands of payments to patients for testing and treatment of other out-of-pocket expenses.”
The McCracken DePuy case is McCracken v. DePuy, 11-dp-20485, U.S. District Court, Northern District of Ohio (Toledo). The consolidated federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).
To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net.
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Tuesday, August 20, 2013

Is there proven value in high cost hip/knee implants?



Hospitals set supply cost-cutting targets, push physicians to change behavior

Posted: August 17, 2013 - 12:01 am ET

Patients with a new cardiac pacemaker have an advantage over patients who have received standard pacemakers: they can undergo MRI scans as a part of their care without the risk of adverse events.

But the new device costs hospitals $1,300 to $3,000 more than a traditional pacemaker and could cut into a hospital's margin because Medicare and other insurers pay the same rate for implanting MRI-compatible pacemakers as they pay for the standard pacemakers. From a clinical perspective, physicians are put in the position of having to predict which patients are likely to need an MRI and should receive the new pacemaker.
It's one of many supply-chain decisions hospital administrators have to make where they must weigh the benefits of a new technology—such as the fact that the new pacemaker doesn't improve immediate outcomes for the patient but may have additional benefits in the long term—against its higher costs.

These executives face similarly difficult decisions to slash millions of dollars in supply expenses each year. In the case of the MRI-compatible pacemaker, one executive says his system likely will pay more for the new pacemaker when appropriate and seek offsetting cost reductions elsewhere in the supply chain.

“It's one of those things where to make the quality of life better for our patients, we're going to incur new costs,” says William Mosser, vice president of materials management at Franciscan Missionaries of Our Lady Health System in Baton Rouge, La.

Facing declining revenue and reimbursement, hospital systems across the U.S. are making it a priority to sharply reduce spending on supplies including gloves, syringes and hip implants. Supplies typically make up hospitals' second-largest expense, after labor costs. Hospitals spent about $255 billion on supplies and nonlabor services in 2011.

Budget pressure has led to increased scrutiny of the costs, clinical outcomes and utilization of products. Many hospitals are setting cost-reduction targets, evaluating the effectiveness of their group purchasing organizations, and pushing for better data and analytics on products to persuade physicians to accept changes to the types of devices or supplies being purchased.

More than 60% of the hospital supply-chain executives who participated in Modern Healthcare's 2013 Survey of Executive Opinions on Purchasing said they were very satisfied or satisfied with their primary GPO. About 40% were somewhat satisfied or not satisfied. Meanwhile, 59% of respondents said their primary GPO was very effective or effective in controlling costs; the remaining 41% said their main GPO was somewhat effective or not effective.

Cost reduction, clinical integration
“Everyone that we deal with at the hospital level today is focused on cost reduction and clinical integration and managing patients to outcomes with a bent toward resource reduction,” says John Bardis, chairman, president and CEO of MedAssets, one of the nation's largest GPOs.
But many hospital executives say there are cultural and operational challenges that can slow these kinds of cost-cutting initiatives.

One major factor is that physicians often have relationships with particular medical device manufacturers or have used certain devices for a long time and are resistant to changing to other devices. Another is that the higher costs of new technologies touted as improving quality of care can set back savings efforts. And in many cases, there is a lack of validated clinical data that can definitively prove whether a particular product yields better results for patients.

“The biggest hurdle we have is there is not a consistent and large enough base of validated evidence,” Mosser says.

Like many other hospitals, Franciscan is undertaking an initiative to cut millions of dollars in annual supply expenses as it faces the prospect of significantly lower reimbursement rates in the coming years. The program, which it calls Healthy 2016, aims to cut $165 million in operating expenses, including $31 million in medical and surgical supplies and purchased services, over the next three years.

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Other hospital systems have implemented cost-cutting initiatives similar to the one at Franciscan. Over five years, Lahey Health, based in Burlington, Mass., plans to cut

$40 million out of the $300 million it spends each year on medical and surgical supplies. BJC HealthCare, a 12-hospital system based in St. Louis, plans to reduce its $850 million in annual supply spending by $54 million this year, and it's seeking to cut out an additional $150 million over the next three years.

“This is a primary focus across the system, from the CEO down,” says Nancy LeMaster, BJC's vice president of supply chain. “In the last three years, as the reimbursement pressures have been getting tighter and tighter, people have really started to see how this could impact us. We call (supply chain) a sustainable advantage rather than just a back-office function.”

Hospitals are undertaking a number of strategies, including standardizing the types of products clinicians use, optimizing appropriate utilization by physicians, nurses and other staff, and continuing to negotiate lower prices for supplies. Many but not all hospitals have value-analysis teams in place.

Focus on physician preference
A big area of focus is usually physician preference items, such as hip or knee implants as well as stents and other cardiac rhythm management devices. These are some of the costliest purchases hospitals make.

BJC is focused this year on reducing costs associated with spine implants. “This is an area of focus where the pricing does not appear correlated to the cost to manufacture and sell the product, but rather has historically been based on what the market would bear,” LeMaster says in an e-mail. “The market can no longer bear this level of pricing.”

The system's strategy focuses on first achieving market-competitive pricing with the spine vendors, and then taking on utilization management and possibly standardization.

Franciscan is supporting a clinical variation project led by chief medical officers at its five hospitals in Louisiana that seeks to better align the clinical protocols of spine surgeons. That could reduce the number of vendors of spine surgery products the system works with, from about 20 now.

“Spine surgeons across our health system do things differently,” Mosser says. “Some might overutilize. Some might underutilize. Some might use generic products, and others are using different types of techniques. Our chief medical officers are working down a path of aligning both the protocols and the practices from a clinical perspective that will allow us to minimize (the) number of those vendors.”

GPOs say their core business is still supply contracts, but the other services and technologies they offer to hospitals to help address a number of financial pressures are increasingly becoming of interest to their members.

You've got to look at best demonstrated practices,” says Ed Jones, president and CEO of HealthTrust, a Brentwood, Tenn.-based GPO that is part of HCA's Parallon Business Solutions. “You've got to look at reducing clinical variability. You've got to look at streamlining your sourcing decisions.”

Nearly half of the hospital supply-chain executives who participated in Modern Healthcare's purchasing survey said they planned to increase their use of GPO contracts in 2013. Only 7.6% said they planned to decrease their use of GPO contracts.

“If a big system feels like their GPO can give them access to scale and aligns that scale to drive better value than they can do on their own, they will tend to work more with the GPO,” Jones says. “If the larger systems are in a position where their GPO is not as effective in that regard, they're probably going to do it on their own.”

Smaller health systems and hospitals are generally more inclined to work with GPOs and increase their spending with them to gain the scale and volume that they provide, Jones says. In other instances, contracts with higher commitment levels also are generating more interest because they often deliver better pricing, he adds.

Lahey Health says it plans to review its current GPO relationships with Novation, a GPO based in Irving, Texas, and MedAssets and then sign a contract in October with a single GPO that will handle at least $180 million of spending.

“It's a partner to help us meet our margin targets as we worry about declining reimbursements,” says Eric Berger, Lahey's vice president of supply chain. “We really need to look at expenses, so having a GPO partner will help us do that.”

Looking at the data
As hospitals dive deeper into the supply chain searching for ways to reduce spending, new areas of focus are emerging. Not only are some hospital systems bringing distribution in-house, but they are also hiring new talent, investing further in data and analytics tools, and some are even forming their own GPOs.

While many hospitals report that they have met cost-reduction targets ahead of schedule, the cost of high-priced implants remains a big barrier. Hospital and GPO executives bemoan that the implantables market has not become more like the markets for other commodities.

“These innovations in total knee and total hip have been around a long time but they've had a strong hold on high prices compared to the rest of the world, in large part because of physician relationships, MedAssets' Bardis says.

On the other hand, teaching hospitals and physician-owned hospitals are more likely to continue to allow preference among physicians. “We will tend to give them what they want, regardless of what the cost is, in order for them to want to practice there,” says Bruce Kizzier, director of materials management at seven-bed Lincoln (Neb.) Surgical Hospital, a physician-owned hospital.

He believes his hospital has gotten the best prices, noting that the hospital's physicians have participated in meetings with vendors to ensure that the hospital was receiving competitive pricing.

“More organizations are having these conversations with surgeons,” says Dr. Peggy Naas, an orthopedic surgeon and vice president of physician strategies for VHA, the parent organization of Novation. “More surgeons, seeing the pressure to add value, are asking questions.”

Other supply-chain executives say that while hospitals have done a poor job in the past in educating their physicians about the costs of preference items and keeping supply costs under control, that's changing and doctors increasingly are facing up to the problem.

“They've seen the impact of the sequestration, the federal law changes and reimbursement drops have been very dramatic across the country for every system,” BJC's LeMaster says. “They're really seeing that if we don't get it out of supplies, then we've got to look at labor.”


?trk=tynt 

Thursday, August 15, 2013

Failed Surgical Mesh producer C.R. Bard guilty.



By Jef Feeley & Phil Milford - Aug 15, 2013 2:51 PM CT
            C.R. Bard Inc. (BCR) should pay $250,000 to a woman who sued saying she suffered injuries from the company’s vaginal-mesh implant, a jury found.
The first federal-court trial of more than 5,000 claims over the devices now moves to the punitive-damages phase in Charleston, West Virginia.
Jurors deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable today for injuries that Donna Cisson blamed on its Avaulta line of devices.
Patients claim the implants cause organ damage and make sexual intercourse painful when they erode. Johnson & Johnson (JNJ), Endo Health Solutions Inc. (ENDP)-formerly American Medical Systems- and Boston Scientific Corp. (BSX) face similar claims that their implants, threaded in place through incisions, degrade and shrink over time.
Cisson’s first trial, in July, ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. U.S. District Judge Joseph Goodwin ruled earlier that plaintiffs couldn’t mention that Bard had withdrawn the products.
Scott Lowry, a Bard spokesman, wasn’t immediately available at his New Jersey office to comment on the verdict.
The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).
To contact the reporters on this story: Jef Feeley in federal court in Charleston, West Virginia, at jfeeley@bloomberg.net; Phil Milford in Wilmington, Delaware, at pmilford@bloomberg.net.
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.

Wednesday, August 14, 2013

Medical Device Implants lead national hospital costs data.










Celeste M. Torio, Ph.D., M.P.H. and Roxanne M. Andrews, Ph.D. 
Statistical Brief #160, August 2013         
     

Introduction
Health care costs continue to grow faster than the economy, and the health share of the Gross Domestic Product (GDP) has maintained its upward trend, reaching 17.9 percent in 2011.  


   The top five conditions—septicemia; osteoarthritis; complication of device, implant or graft; liveborn (newborn) infants; and acute myocardial infarction—accounted for nearly one-fifth of the total aggregate cost for hospitalizations.

Complication of device, implant or graft
#3 most expensive condition treated in U.S. hospitals, all payers 2011
#3 most expensive condition billed to Medicaid
#4 most expensive condition billed to Medicare






Osteoarthritis was ranked the second most expensive condition only for Medicare ($8.0 billion) and private insurance ($5.7 billion). Over 90 percent of the hospitalizations for osteoarthritis involved a knee or hip replacement




About HCUP

HCUP is a family of powerful health care databases, software tools, and products for advancing research. Sponsored by the Agency for Healthcare Research and Quality (AHRQ), HCUP includes the largest all-payer encounter-level collection of longitudinal health care data (inpatient, ambulatory surgery, and emergency department) in the United States, beginning in 1988. HCUP is a Federal-State—Industry Partnership that brings together the data collection efforts of many organizations—such as State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource.