Settlement Gag Clause: 'Instance of Misconduct' 2005

Bill Would End Gag Clauses That Stifle Victims Who Sue

April 19, 2005|Jordan Rau | Times Staff Writer

SACRAMENTO — Wendy Conner asked a San Diego doctor to smooth over a forehead scar in 2000. But her plastic surgeon injected fat from her abdomen into an artery in her head, permanently blinding her right eye.

Conner sued and eventually settled for what she says was a small sum. As part of that legal agreement, she promised not to turn the doctor in to state authorities. "It's a horrible thing when somebody does something so terrible to you, and then you have to cover for them for the rest of your life," she said.

For decades, negligent doctors and other professionals in California have deterred their victims from reporting them to state regulators by making silence a condition of settling lawsuits. Regulators, consumer advocates and lawmakers say these legally dubious gag clauses are among the most troublesome gaps in California's consumer protection efforts.

They are pressing to ban the stipulations, even though Gov. Arnold Schwarzenegger refused to do so last year. The governor vetoed legislation that had passed with bipartisan support, saying that eliminating gag clauses "does not further the goal of making California more business-friendly."

"The whole practice is just unconscionable, and it deprives executive branch agencies of the information they need to do their job," said Julianne D'Angelo Fellmeth, the state-appointed independent monitor for the Medical Board of California. "I don't understand how the governor didn't see that the first time around."

Conner still will not publicly identify her surgeon even though the medical board in January forced the doctor, Richard M. Escajeda, to surrender his license. Investigators charged that the year after he blinded Conner, Escajeda botched a breast implant surgery in another woman and then failed to anesthetize her properly during a subsequent surgery, causing her to experience the entire painful operation.

There are other reasons besides gag clauses that regulators never learn of lawsuits that could be evidence of professional malfeasance. Court officials and hospitals, for instance, are required by law to report criminal convictions, disciplinary actions and civil judgments against doctors, but Fellmeth's evaluation of the medical board last fall found that many do not.

The problems are not limited to the medical profession. Under state law, attorneys and automobile makers are banned from trying to stop former clients from complaining to regulators, but there are no similar prohibitions for 230 other types of licensed professionals in California.

Democratic lawmakers have resurrected last year's proposal as AB 446, sponsored by the chairwomen of the two legislative panels that oversee the state's professional regulators, Assemblywoman Gloria Negrete McCloud (D-Chino) and Sen. Liz Figueroa (D-Fremont). An Assembly hearing is set for today.

The measure would still allow secret settlements in which plaintiffs promise not to reveal the nature of the case's resolution, including the amount of money paid out. But 2.3 million California professionals -- including accountants, architects and embalmers, as well as healthcare professionals such as doctors, psychologists and nurses -- would face discipline from California's regulatory boards if they were to insert gag clauses that dissuaded plaintiffs from making complaints to authorities.

"Gag clauses in malpractice settlements present unnecessary roadblocks which impede the medical board's investigators from their sworn duty to protect the public," the board president, Mitchell Karlan, said through a spokeswoman. State regulatory boards for 10 other professions endorsed last year's effort to outlaw the provisos.

The strongest opposition has come from builders, engineers and small contractors. They fought last year's proposal and are preparing another campaign to block this year's version.

Richard Markuson, deputy executive director of Consulting Engineers and Land Surveyors of California, a Sacramento-based association, said professionals already are required to report to regulators any large civil lawsuit settlements.

"This would eliminate some of the finality that a settlement could bring to parties in a dispute," Markuson said.

Schwarzenegger agreed, writing in his veto message that "even after the resolution of a civil suit, this bill could still require a licensee to [undergo] a second adjudication before a regulatory body."

It is far from clear that the gag clauses are enforceable. The attorney general's office last year told lawmakers that it believed such clauses cannot be imposed, citing several judicial rulings.

One was a 2000 appeals court ruling that voided a settlement that prohibited customers of a securities agent from reporting misconduct. The court ruled that the inclusion of the confidentiality clause was "not only directly connected to [the agent's] misconduct, but is an instance of misconduct in itself."

Still, advocates and plaintiffs say the pressure to consent to gag clauses often is intense.

• http://articles.latimes.com/2005/apr/19/local/me-gagorders19

Implant Manufacturers Have Overwhelming Control of AAOS? Choosing Wisely!

Doctors Overlook LucrativeProcedures When Naming Unwise Treatments

By Jordan Rau

KHN Staff Writer

APR 14, 2014

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

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

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

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

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

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

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

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

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

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

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

Stenting Gets A Pass

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

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

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

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

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

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

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

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

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

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

Spinal Fusions Spared

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

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

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

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

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

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

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

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

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

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

jrau@kff.org

http://bit.ly/1t1EREe

CMS Tracks/Publishes Joint Replacement Patient Outcomes!

Medicare identifies 97 best and 95 worsthospitals for hip and knee replacements

December 18, 2013 1:52 am by Jordan Rau | MedCity News

FiDA highlight

Medicare has begun tracking the outcomes of hip and knee replacement surgeries, identifying 95 hospitals where elderly patients were more likely to suffer significant setbacks. The government also named 97 hospitals where patients tended to have the smoothest recoveries.

The analysis, which was released last week, is the latest part of the government’s push to improve quality at the nation’s hospitals instead of simply paying Medicare patients’ bills. Medicare already assesses hospital death rates, how consistently hospitals follow basic medical guidelines and how patients rate their stays.  The evaluation of hip and knee surgery outcomes is significant because for the first time, Medicare is rating hospitals’ performance on two common elective procedures.

Many patients needing joint replacements want to know a hospital’s record when choosing where to have the procedure done.  This is not usually the case for treatment of conditions Medicare has evaluated previously, such as heart attacks.

Of the 95 hospitals where knee and hip surgery patients experienced difficulties after the operation, nine were rated having both high readmissions and high complication rates. Those hospitals were: Froedtert Hospital in Milwaukee; Grant Medical Center in Columbus, Ohio; Mercy St. Anne Hospital in Toledo, Ohio; Northwestern Memorial Hospital in Chicago; the Pennsylvania Hospital of the University of Pennsylvania Health System in Philadelphia; Peterson Regional Medical Center in Kerrville, Texas; Reston Hospital Center in Reston, Va.; Shannon Medical Center in San Angelo, Texas, and Southside Regional Medical Center in Petersburg, Va.

Some of those hospitals complained Monday that Medicare’s assessments were outdated since they covered operations between July 2009 through June 2012. A spokeswoman for Shannon Medical Center said the hospital has improved since then, adding better technology and opening a clinic to follow up with patients seven days after leaving.  A spokeswoman for Southside Regional Medical Center said that hospital adopted a new treatment model in 2012 for joint and spine patients and that their outcomes have “drastically improved.”

Medicare was cautious in how it marked hospitals, only categorizing them as outliers when their records in hip and knee replacements were statistically different from the national average.

The overwhelming majority of hospitals—about 19 out of 20—were branded average, a Kaiser Health News analysis found.

Table

Hospitals Judged Best And Worst For Hip And Knee Readmissions And Complications

Out of the 97 hospitals that did better than average in avoiding either readmissions or complications, 25 were rated as being better at both measures. Those included some big hospitals such as Sutter General Hospital in Sacramento, Calif., and the Hospital for Special Surgery in Manhattan. They also included some local hospitals such Holy Cross Hospital in Fort Lauderdale, and several physician-owned hospitals that specialize in these types of surgeries, such as Arkansas Surgical Hospital in Little Rock.

About 600,000 patients in the traditional Medicare program have their hips or knees replaced each year. The growing popularity of these operations has made them a more significant expense for Medicare and private insurers. In 2010, there were 719,000 knee replacements costing nearly $12 billion and 332,000 hip replacements nearly $8 billion, according to the National Center for Health Statistics.  

Medicare published the new outcomes data on its Hospital Compare website.  While few consumers use that site, this information may reach a greater audience later on through groups and publications, such as Consumer Reports, that tap Medicare’s data in devising their own hospital ratings.

“With elective procedures, consumers like to do a lot of research to pick the right doctor and the right hospital, so this is a good first step,” said Leah Binder, CEO of the Leapfrog Group, a nonprofit funded by employers that judges hospital quality. However, she said the new ratings would be of limited use for most patients because the Centers for Medicare & Medicaid Services judged most hospitals’ performance as normal.

“We know there’s a significant variation among hospitals, but CMS reports them all as average,” Binder said.

Financial Pressure

Hospitals may soon feel a financial pinch from the evaluations. Medicare plans to add hip and knee readmission rates to the criteria it uses when deciding whether to penalize hospitals each year.

Since October, Medicare has been paying less than it normally does to 2,225 hospitals after determining their rates of rebounds for patients with pneumonia, heart attacks and heart failure were too high, even by a small amount.  Starting in the fall of 2014, when the joint replacements are to be factored into the penalty program, hospitals are at risk of losing as much as 3 percent of Medicare payments for each patient stay.

In its new evaluation of hip and knee replacement patients, Medicare used two measures. One was how often the patients ended up being readmitted to the hospital within 30 days of discharge.  The other was how often they suffered one of eight complications after the operation.  Those included a heart attack, pneumonia, sepsis or shock within seven days of admission. They also included bleeding at the site of the surgery, a blood clot in the lung or death within a month of admission. Medicare also counted mechanical complications with implants and infections of the joint or wound within 90 days of admission.

The quality of joint implants has been under scrutiny for several years. Some of the surgical devices have been plagued by quality problems, especially among artificial hips made of interlocking metal parts.  The friction created by these joints can create metal debris that damages the surrounding flesh and bone. Two manufacturers have recalled their devices since 2010.

Problems Are Declining

Nationwide, the number of readmissions following hip and knee replacement surgeries has been dropping, but not as quickly as readmission rates for heart attack, heart failure or pneumonia patients, according to a Medicare-commissioned study by the Yale New Haven Health Services Corporation Center for Outcomes Research and Evaluation.  

Dr. Eric Coleman, an expert on readmissions at the University of Colorado Anschutz Medical Campus, said some hospitals are trying to prevent joint replacement patients from returning by educating them ahead of the surgeries about how to take care of themselves and warning signs of problems. This program provides “a chance to walk you through what to expect, what your family would expect, how to arrange your home,” Coleman said. “In most of the cases of readmission reductions, we’re still very reactive.”

Hospitals’ clientele appears to play some role in how they fared after these surgeries. The outcomes for hip and knee replacements tend to be slightly worse for hospitals that serve a high proportion of Medicaid patients, according to the Yale study. The study also found that hospitals where more than one out of every five patients were African-American tended to have slightly higher complication and readmission rates than did hospitals with no black Medicare patients. However, the report noted, some of these hospitals serving large numbers of Medicaid or black patients also performed very well.

These kind of racial and economic disparities in readmissions have long troubled health policy experts. Some hospitals mostly cater to prosperous patients who have the money, resources and education to get necessary post-surgical care after discharge. But safety net hospitals often have a harder time ensuring that low-income, less educated people follow the often complex instructions about how to recover from a major surgery or hospitalization.

In Medicare’s new analysis, on average, hip and knee patients had a 5.4 percent chance of having to return to the hospital. Nationally, the average complication rate for patients after hip and knee replacement surgery was 3.4 percent. One hospital, Beaumont Health System in Royal Oak, Mich., had a mixed record: Patients there were more likely to be readmitted but less likely to suffer serious complications.

Hospital-Wide Readmissions Published

The government also last week released its first ratings of how often Medicare patients of all diagnoses returned to hospitals within 30 days. That “all cause” measure is more encompassing than Medicare’s appraisals based on heart attack, heart failure and pneumonia.  A number of prominent experts, including Congress’ Medicare Payment Advisory Commission, have been pushing for this measure to be used in setting financial penalties for hospitals.

Medicare’s analysis found that 16 percent of Medicare patients ended up returning to a hospital within 30 days between July 2011 through June 2012. Again rates varied significantly.
At 364 hospitals, or 8 percent, patients were more likely than average to return within a month, the data show. These included the Cleveland Clinic, as well as the clinic’s hospital in Weston, Fla.; both of Johns Hopkins’s hospitals in Baltimore; and New York-Presbyterian Hospital in Manhattan.

Medicare did not count cases where the patient was scheduled to return to the hospital, such as when a lung cancer patient was admitted for pneumonia and later came back for a chemotherapy treatment that had been planned. Medicare calculated that patients were less likely than average to end up back for any reason at 315 hospitals, or 7 percent of the nation’s total.

Nancy Foster, an executive with the American Hospital Association, said that tracking hospital-wide readmissions was of limited value to hospitals that wanted to do better. “Most of the interventions you would use are built and targeted around particular conditions,” she said. “You have to know what’s driving patients back into the hospital to address the problem. When you get this lump of all-cause readmissions, you don’t know what to go after.”

KHN reporters Ankita Rao and Marissa Evans contributed.

jrau@kff.org

Read more: http://medcitynews.com/2013/12/medicare-identifies-97-best-95-worst-hospitals-hip-knee-replacements/#ixzz2nqCPLGSX

Public reporting of CMS patient outcome data from joint replacement surgery has been a 'grown-up Christmas wish' for the last 5 years!  Patient harm from lax oversight of implants has cost us our humanity, needless suffering of patients and their family members, trust in our government and care providers and a substantial chunk of healthcare spending.  Simply compiling the CMS data and making that information available to researchers like Consumers Union Safe Patient Project will clarify the true risks and benefits of implanted medical devices.  The legal system unfairly entitles Pharma and the medical device industry, so preventing harm is essential to patient safety.  My blog/personal story:  http://fida-advocate.blogspot.com