After initially resisting their disclosure, the Bush administration on Tuesday published the names of 131 nursing homes with poor inspection records and said some were already showing signs of improvement.

The list released by the Centers for Medicare and Medicaid Services represents troubled facilities cited as a "special focus facility," a designation used to identify those that merit more oversight. For these homes, states conduct inspections at six-month intervals rather than annually.

Last November, the government released a partial list of 54 nursing homes that ranked among the worst in their states, balking at releasing the full list of homes with the "special focus" designation. After a group of Democratic lawmakers began pushing for full disclosure, CMS said Tuesday it was publishing the names after cross-checking information to ensure the release of the most accurate data.

CMS will update its list of troubled nursing homes on a quarterly basis, with its next release scheduled for April.

Within the space of two weeks late last year, Michael and Hedy Cohen, who happen to be experts on medical errors, each encountered what they saw as a disturbing development in the modern doctor-patient relationship.

They were asked by two groups of suburban doctors to sign away their right to a jury trial in the interest of reducing malpractice costs.

Legal experts say such attempts to channel potentially unhappy patients away from the court system and into arbitration are becoming increasingly common in health care. Agreements to settle future disputes with binding arbitration, in which an appointed individual or small panel decides the case instead of a judge or jury, are now pervasive in contracts involving many other things we buy, including credit cards, cell phones and cars.

Proponents say arbitration is faster, cheaper and fairer than trials, but critics say the secretive system can be weighted against consumers and makes it harder to track complaints or build legal precedents.

Eugene Rosov, who runs two malpractice-insurance companies that advise doctors to use arbitration agreements, said he thought they ultimately would reduce the cost of insurance and defensive medicine - tests ordered primarily to protect against lawsuits. "This agreement is better for doctors and for patients," said Rosov, whose companies have 35 subscribers in New Jersey and Pennsylvania. "The only person it's bad for is the plaintiffs attorneys."

But Temple University law professor Bill Woodward thinks the growth of a private judicial system "is a pretty nasty legal development, I think, and it's just crying out for correction from Congress."

A bill introduced last year by Sen. Russ Feingold (D., Wis.) aims to do that. It would prohibit pre-dispute arbitration clauses involving employment, consumer, franchise and civil rights disputes.

Michael Cohen was handed an arbitration agreement when he visited his longtime primary-care doctor in Bucks County. Cohen said he was not the suing kind, but the thought of being asked to give up his right to sue "stopped me in my tracks."

He said no, and his doctor saw him anyway.

Then Hedy Cohen, who has had a kidney transplant, was mailed a similar form by a group of kidney specialists she planned to see for the first time. The form from Hypertension-Nephrology Associates in Willow Grove insisted on binding arbitration and said she would have to pay the doctors' legal fees if she filed a complaint and lost.

Hedy Cohen said no and was told to find another nephrologist.

That was fine with Cohen, a nurse with a master's degree in health-care administration. "I couldn't have a relationship with this person because they had already set the tone," she said. "We're adversaries before we even know each other."

Jerry Dolchin, the nephrologists' attorney, said the doctors began using the forms at the height of Pennsylvania's malpractice crisis in 2003, when doctors, he said, were being "hit pretty hard by overzealous plaintiffs' lawyers." Since then, he said, "hundreds and hundreds and hundreds" of patients have signed the form.

Ruth Schulze, a North Jersey gynecologist, started asking patients to sign an arbitration agreement last year after she bought malpractice protection from Obstetricians & Gynecologists Risk Retention Group of America Inc., one of Rosov's companies. She gave up obstetrics two years ago after she was told she would have to pay more than $120,000 for insurance.

Schulze said she won each of the three times she was sued, but left the trials disenchanted. "It is not really a trial of your peers," she said. "It's theater."

Her patients have largely embraced the new approach, she said. She will not do surgery on anyone who refuses to sign the form, which limits pain and suffering payments.

For her, the arbitration agreement sets the groundwork for a more trusting doctor-patient relationship. Patients need to understand that bad things happen in spite of doctors' best efforts. "Medicine is not guaranteed perfection," she said.

Steven Barrer, a Montgomery County neurosurgeon, says he thinks he was the first in his area to start using an arbitration agreement around 2003. Barrer wanted to "somehow create malpractice reform for myself since it wasn't coming from the courts and it wasn't coming from the legislature."

He got the idea for an arbitration agreement from his cell phone contract. "I figured if they can do it, why can't I?" he said.

Out of thousands of new patients, only about 10 have refused to sign the form. He does not ask patients with emergencies.

No one knows how many doctors here use such agreements, but the practice does not appear widespread. It is common on the West Coast, and legal experts say it is spreading nationally. Many nursing homes ask residents to sign arbitration agreements, experts said. Golden Living, a national chain that operates 40 nursing homes in Pennsylvania, says about half of its residents agree to arbitration.

A Superior Court jury in Stamford has ordered a city obstetrician to pay $38.5 million to the family of a boy born with cerebral palsy in 2003.

The verdict is believed to be among the largest medical malpractice awards in the state, surpassing a $36.5 million award in 2005 against Hartford Hospital and an obstetrician.

The Stamford jury ruled Friday that Dr. Corinne De Cholnoky should have performed a Caesarean section more quickly during the 2003 delivery of Spencer Oram, whose umbilical cord was impeding blood flow to his brain.

The boy now has cerebral palsy, although his twin sister was born 27 minutes earlier is healthy, said Richard Silver, an attorney for the Oram family. The case was filed almost three years ago.

The family is "incredibly emotionally drained," Silver said.

Two years ago, Tony Grier received a pair of diseased lungs during a lung transplant at the Hospital of the University of Pennsylvania. Now, HUP must respond to questions raised in a lawsuit filed by Grier's estate.

Grier, 43, had pulmonary sarcoidosis - a rare disease that in its chronic form thickens lung tissue to the point at which it can no longer transmit oxygen into the bloodstream - and believed he was exchanging his own lungs for those of a healthy 18-year-old.

Instead, Grier received the cancerous lungs of a 31-year-old smoker. He died six months after the operation.

Last October, his mother, Emma Grier, filed a lawsuit against HUP, four of its physicians and Gift of Life - the organ-donor program through which the lungs were allocated to Tony Grier. She is suing each defendant for $750,000 on seven counts, including medical malpractice, wrongful death and common law fraud.

No date has yet been set for a hearing, and all lawyers involved declined to speak about the case or were unavailable for comment.

According to the complaint filed by Emma Grier in December, HUP doctors misrepresented the identity of his lung donor "with the knowledge that the misrepresentations were false when made."

One month after the surgery, Tony Grier began to complain about pain and coughing. His doctors at HUP examined the lungs and found a spot, but did not recognize it as a cancerous tumor.

They treated the spot with antibiotics which, the complaint alleges, "served as a fertilizer for the cancer-filled tumor to grow and spread throughout Mr. Grier's body." By the time the tumor was recognized, the cancer was untreatable, and Tony Grier "continued under great pain and suffering fully aware that he was going to die."

Saul Langsam, an attorney with the Philadelphia medical malpractice firm Silvers, Langsam and Weitzman who is not affiliated with the Grier case, said he has never come across a case like it.

On the basis of the facts presented in Emma Grier's complaint, he said the episode seemed "outrageous." But, Langsam said, "you never see the full picture until the defense files its answer."
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North Texan files suit over transplanted tissue By JAN JARVIS Star-Telegram Staff Writer A stolen bone fragment was implanted in Jim Livingston's neck during a surgery to relieve the pain of a ruptured disk. X-RAY COURTESY OF JIM LIVINGSTON A stolen bone fragment was implanted in Jim Livingston's neck during a surgery to relieve the pain of a ruptured disk. JIM LIVINGSTON Jim Livingston never gave much thought to the bone transplanted in his neck until that Sunday afternoon when his doctor called to tell him about the recall. "Do they want it back?" he asked, half-jokingly. Quickly it became clear that this was no laughing matter. Bone allegedly stolen from a corpse had been used in Livingston's neck to relieve the pain of a ruptured disk. With that bit of news, the 44-year-old Weatherford father joined hundreds of others nationwide who are living with the knowledge that they carry bones and tissue taken illegally from cadavers in what has become a bizarre tale of selling body parts for profit. The experience has left Livingston, an insurance inspector, yearning for answers. Fed up with wondering what will happen to his wife and three children if he became seriously ill, he filed a lawsuit last month in New York claiming fraud and negligence against the parties involved in the scandal. He is not seeking a specific amount. "How can you sell parts out of a body, just like parts from a stolen car?" he said. New York authorities investigating the case believe Biomedical Tissue Services owner Michael Mastromarino started by striking deals with funeral directors to remove body parts from corpses without notifying their families or screening for disease. Then, in a secret room in a Brooklyn funeral home, he removed bones, tendons and heart valves, according to a spokesman for the Kings County district attorney's office in New York. The charges include a Class B felony punishable by up to 25 years in prison. Mastromarino is accused of doctoring death certificates and forging consent forms, according to the Kings County district attorney's office. Then, investigators believe, he replaced the bones with PVC pipe and sewed the incision so it would not be noticed at the funeral. From there, the body parts were shipped to processing firms across the country. Once sterilized, they were implanted in patients from early 2004 to September 2005. Fear of disease Just how many patients received stolen tissue or bone, no one seems to know. Tissue from a single human body can be used for more than 100 tissue transplants. A body can bring more than $250,000 for harvesting, according to a spokesman for the Kings County district attorney's office. Although it is illegal to sell body parts, the law allows tissue banks to recover transportation and processing costs. Livingston's lawyer, John David Hart of Fort Worth, said he knows of no other related lawsuits in Dallas-Fort Worth, though there have been others around the country. After New York investigators started to unravel the case involving Mastromarino, five tissue processors that received human parts from Biomedical Tissue Services in Brooklyn issued voluntarily recalls. Medtronic, a Minneapolis distributor that received the parts, also issued a voluntary recall. When Baylor All Saints Medical Center at Fort Worth -- the hospital where Livingston had surgery -- learned of the recall, it immediately pulled the tissue from its stock. Physicians who had implanted the suspect material contacted their patients, said Wendy Walker, a spokeswoman for Baylor Health Care System. Five Baylor patients were notified, she said. When Livingston found out that the bone used in his Sept. 1, 2005, surgery was from Biomedical Tissue Services, he panicked. Then he got a blood test. Although there is no evidence of disease, Livingston worries that future tests will bring bad news. It's that fear and the lack of proof that he's not a risk that gnaws at him most. "Nobody can medically tell you that you don't have anything to worry about," he said. "For all I know, this guy died of bone cancer and I've got his bones." Medtronic, which is named in Livingston's lawsuit, has said he has nothing to worry about. The company has voluntarily recalled about 16,000 bones nationwide, said Medtronic spokesman Bert Kelly. "As of this date we have tested 12,000 to 13,000 people, and none have shown up with an infectious disease that is traceable to the recalled tissue," Kelly said. "A few patients have shown up with infectious diseases of some sort, but none have been linked to the tissue in their surgery." Once someone tests negative for an infectious disease "they should be cleared from here to eternity," Kelly said. An infectious disease cannot survive the sterilization process, he said. But Livingston, a one-time professional roper on the rodeo circuit who now works for State Farm's Premiere Service Program, said there's no guarantee that he won't get sick years from now. "It's a situation where I put it on the back burner, but it has just kept eating away at me," he said. "I want to believe that I got nothing to worry about, but it is the kind of thing you think about in the middle of the night and wonder, 'What if?'" More meaningful oversight of tissue harvesting is needed to protect people such as Livingston, Hart said. "There has to be some sort of process in place so these companies that obtain donor tissue and bone make sure that the product is safe," he said. "Patient safety is being compromised by an industry's greed and the failure of the government to provide adequate oversight." Sterilized parts About 1.5 million pieces of tissue are used in transplants each year, according to the American Association of Tissue Banks. The transplants are used to replace tissue or bones damaged by trauma, tumors and other conditions. Regulations require consent of the donor's family before the tissue can be removed. After the tissue is removed, it is disinfected using anti-microbial chemicals, irradiation or both. The process eliminates HIV, hepatitis, bacteria, mold, fungi and spores and removes 99.9 percent of blood, lipids and marrow, according to Regeneration Technologies, a Florida-based processing company that is also named in the lawsuit. By the time the tissue fragments reach a distributor such as Medtronic, they are hardly recognizable. Bone is crafted into different shapes, some as small as dice. Over time, the transplant fuses with natural bone to form a solid piece. Knowing that the bone he received went through a sterilization process is of little comfort to Livingston. He tried to trace the donor but was blocked by privacy laws. Now he worries about getting HIV, hepatitis, even mad cow disease. "My biggest concern is, nobody really knows," he said. "And there's a part of me that really does want to give that bone back." Medtronic After recalling the bone used in orthopedic procedures, the company set up a hot line to respond to patients' concerns. Call the toll-free hot line at 866-825-6158 A nurse is available to answer questions from 7 a.m. to 7 p.m. Mondays through Thursdays. For more information go to www.medtronicspinal.com Timeline 1993 -- FDA begins regulating human tissue for transplantation. 2000 -- Former oral surgeon Michael Mastromarino and embalmer Joseph Nicelli enter into an agreement to open Biomedical Tissue Services. Early 2004 to September 2005 -- Questionable tissue implanted in thousands of patients nationwide. October 2005 -- The Centers for Disease Control and Prevention and the FDA recommend that recipients of tissue recovered by Biomedical Tissue Services be tested for HIV, hepatitis B, hepatitis C and syphilis. Five processors issue a voluntary recall, including the Austin-based Blood and Tissue Center of Central Texas. January 2006 -- FDA orders Biomedical Tissue Services to cease manufacturing and retain existing inventory of human cells, tissue and products. February 2006 -- Mastromarino, Nicelli and two others are charged in a 122-count criminal indictment. They are accused of orchestrating a large-scale enterprise in which tissue was harvested from dead people and sold for use in surgery. Charges including corruption, a Class B felony punishable by up to 25 years in prison. Mastromarino is free on $150,000 bail. October 2006 -- Indictment is expanded to include criminal operations in Rochester, the Bronx and Manhattan. It charges that three additional funeral homes provided corpses. Seven licensed funeral home directors have pleaded guilty and have agreed to cooperate in the ongoing investigation. Source: Kings County district attorney's office Safe tissue transplants There have been more than 10 million tissue transplants in the past two decades. The last reported case of disease transmission in a tissue recipient was in 2002. There have been no transmissions of Chagas' disease, rabies or West Nile virus from tissue transplants. The only reported cases of tuberculosis and hepatitis B in tissue recipients occurred more than 50 years ago. The only reported transmission of HIV occurred 20 years ago, before more sensitive testing was required. A few hepatitis C cases were transmitted in the early 1990s. Source: American Association of Tissue Banks Alistair Cooke Alistair Cooke, the dignified British broadcaster who hosted the PBS series Masterpiece Theater for 22 seasons, wanted to be cremated. Most of him was. Cooke's body -- along with hundreds of others taken from funeral homes -- was cut up and his bones illegally harvested. The stolen tissue and bones were then sold to processors for a profit and eventually ended up in patients throughout the country, according to the district attorney's office in Kings County, New York. Cooke's face is perhaps the most famous in this body-snatching story, but many families have learned that their loved ones' body parts were sold. Others have been on the other side of this story and learned that they received those illegally harvested parts. Susan Cooke Kittredge -- who wrote about the loss in a New York Times editorial -- learned what happened to her father's bones 10 days before Christmas in 2005. His family had never agreed to donate his bones. Cooke died from lung cancer that had spread to his bones; he was frail and 95 years old. Using cancerous bone for transplantation is a Food and Drug Administration violation, as is using bone from the elderly. But New York investigators told Kittredge that the people who stole her father's bones changed his age to 85 and the cause of death to a heart attack in their paperwork. Source: The Associated Press - 56 - 60

Ruling may unlock key data on doctors template_bas template_bas An order to release Medicare files might help patients choose physicians. Medical experts say the records don't tell the whole story. By Ricardo Alonso-Zaldivar, Los Angeles Times Staff Writer August 30, 2007 WASHINGTON -- Whether it's a hernia repair or heart bypass, doctors with a lot of experience performing a given operation tend to have better results. The problem for patients in choosing a physician has been finding out which ones have the know-how. Now a court ruling appears to open the way for consumer access to such information for the first time, potentially transforming the relationship between doctors and patients, as well as the business of healthcare. In a little-noticed decision last week, a federal judge in Washington, D.C., ruled in favor of a consumer group that sued the Health and Human Services Department to allow disclosure of specific data about doctors from the Medicare claims database. U.S. District Judge Emmet G. Sullivan concluded that releasing the data would be "a significant public benefit," and ordered the department to turn it over by Sept. 21. With information on more than 40 million patients and 700,000 doctors, the Medicare database is far richer than any private insurer's. Though it does not have information on some doctors, such as pediatricians, who don't treat Medicare patients, it is considered the mother lode for data on those who treat adults, because Medicare recipients are a mainstay of most practices. The database's usefulness has been limited by a decades-old government policy that protects the privacy of doctors, who fear the information could be used to micromanage the practice of medicine. But as the cost of medical care has skyrocketed, employers, insurers and consumer groups have pressured the government to open up Medicare's files on individual doctors. Those files could reveal far more than how many times a year a surgeon performs a hip replacement operation. The data could also be analyzed to determine how a doctor makes crucial decisions on tests and procedures that determine both quality and costs. They would show which doctors fail to order prudent preventive tests. And they could indicate which ones order duplicative tests or unnecessary hospitalizations. "These data will make it possible to develop measures that will be very helpful to consumers," said Robert Krughoff, president of Consumers' Checkbook, the nonprofit group that sued for the information. "Someone who is thinking they need a knee replacement -- or a prostatectomy -- will be able to go on our website and see how many of these procedures their physician has done for Medicare patients," he added. His organization -- which compiles ratings of a wide range of service providers -- sells its information to individual subscribers. But Krughoff said it intended to make the Medicare data available free of charge. The lawsuit did not seek any identifying information on patients. Some business groups said the ruling could be a turning point in the quest for the elusive balance between costs and quality, setting a precedent for the release of more detailed data. "We're very excited that the court has ruled in this direction," said Helen Darling, president of the National Business Group on Health, which represents big companies. "Large employers have been trying to make information available on performance to consumers and to those who make purchasing decisions on which providers might be in a preferred network." The Department of Health and Human Services has not decided whether to appeal the ruling. "We're in the process of reviewing the court's decision and evaluating our response," spokeswoman Christina Pearson said. An appeal could be politically embarrassing for the administration, because President Bush and Health and Human Services Secretary Mike Leavitt have both campaigned for greater openness and consumer empowerment in healthcare. "Not supporting this ruling would certainly be inconsistent with administration initiatives that favor price and quality transparency in healthcare," said Paul Ginsburg, president of the Center for Studying Health System Change, a research group. "This represents transparency on the quality side." Moreover, support for opening up the Medicare database is building in Congress. Two unlikely allies, Sen. Hillary Rodham Clinton (D-N.Y.) and Sen. Judd Gregg (R-N.H.), a conservative budget hawk, introduced legislation in June to make the data available to research organizations around the country. Under current policies, researchers who use Medicare information cannot identify individual doctors. In the past, the American Medical Assn. has voiced strong reservations about releasing the Medicare files. Spokeswoman Katherine Hatwell said the organization was closely reviewing the ruling and its implications. Doctors are worried that Medicare files do not account for the severity of the cases that individual physicians may handle. Medicare files might show a higher-than-average number of patient deaths for a particular doctor's office. But that could be because the physician takes on the sickest patients. As for the issue of how frequently doctors perform a given medical procedure, they point out there's a first time for every physician. "Physicians are concerned that they will look bad, not because of their own shortcomings, but because their patients are difficult," Ginsburg said. "There are issues about using this type of information responsibly, and not using it unless you can do some significant adjustment for the difference in patients." Krughoff acknowledges that such issues will have to be resolved as the use of the Medicare data becomes more sophisticated. In the lawsuit, Consumers' Checkbook sought access to data on procedures performed by doctors in Washington, D.C., Illinois, Maryland, Virginia and Washington state. But Krughoff said the group has filed a Freedom of Information Act request for the same information from the remaining states. "I think there's no question but that the judge's decision settles the matter," he said. "They'll have to give us all 50 states." He estimated it would take a month or two after receiving the information to post it online. - 57 - 60