Saturday, March 30, 2013

Hospitals Question Fairness of New Medicare Rules -

It is no longer enough for hospitals to make patients healthy enough to leave. Now, as part of the Obama administration's health care overhaul, they are spending millions of dollars to keep those patients from coming back, often acting like personal assistants to help them manage their post-hospital lives.

While federal statistics show the effort is beginning to reduce costly and unnecessary readmissions, a growing chorus of critics is asking whether the government policy, which penalizes hospitals that have high readmission rates, is unfair. They are also questioning whether hospitals should be responsible for managing the personal lives of patients once they are released — or whether they should focus on other ways to improve care.

"It's consumed a lot of resources," said Dr. J. Michael Henderson, who focuses on quality and patient safety for the Cleveland Clinic, which attributes its relatively high readmission rate to the fact that it successfully treats a high number of severely ill patients.

Under the new federal regulations, hospitals face hefty penalties for readmitting patients they have already treated, on the theory that many readmissions result from poor follow-up care.

It makes for cheaper and better care in the long run, the thinking goes, to help patients stay healthy than to be forced to readmit them for another costly hospital stay.

So hospitals call patients within 48 hours of discharge to find out how they are feeling. They arrange patients' follow-up appointments with doctors even before a patient leaves. And they have redoubled their efforts to make sure patients understand what medicines to take at home.

But hospitals have also taken on responsibilities far outside the medical realm: they are helping patients arrange transportation for follow-up doctor visits, get safe housing or even find a hot meal, all in an effort to keep them healthy.

"There's a huge opportunity to reduce the cost of medical care by addressing these other things, the social aspects," said Dr. Samuel Skootsky, chief medical officer of the U.C.L.A. Faculty Practice Group and Medical Group.

Medicare, which monitors hospitals' compliance with the new rules, says nearly two-thirds of hospitals receiving traditional Medicare payments are expected to pay penalties totaling about $300 million in 2013 because too many of their patients were readmitted within 30 days of discharge. Last month, the agency reported that readmissions had dropped to 17.8 percent by late last year from about 19 percent in 2011.

But increasingly, health policy experts and hospital executives say the penalties, which went into effect in October, unfairly target hospitals that treat the sickest patients or the patients facing the greatest socioeconomic challenges. They say a hospital's readmission rate is not a clear measure of the quality of care it provides, noting that hospitals with higher mortality rates may also have fewer returning patients.

"Dead patients can't be readmitted," Dr. Henderson said.

"We're using a proxy because it's a convenient proxy — it's just not a very accurate proxy," said Dr. Karen E. Joynt, a health policy expert and co-author of an article critical of the penalties in TheNew England Journal of Medicine this month. Large academic medical centers and so-called safety-net hospitals are bearing the brunt of the new policy, and the authors warn that the penalties could make it even harder for hospitals struggling to care for those patients with the highest needs. The current policy, the article says, "has the potential to exacerbate disparities in care and create disincentives to providing care for patients who are particularly ill or who have complex health needs."

The penalties, which apply to rates of readmission after hospitalization for heart attacks, pneumonia and heart failure, are now calculated at 1 percent of hospital payments but will increase to 3 percent by 2015. Medicare also expects to expand the targeted readmissions to include more kinds of hospitalizations, like those for chronic lung disease.

Some hospitals say they have little choice but to incur the penalties, simply because they have other demands. At Boston Medical Center, which serves a high number of low-income patients, efforts to reduce readmissions, including making follow-up appointments and writing out a simple plan of what to do after leaving the hospital, have been successful for Medicaid patients.

But the medical center chose not to immediately expand the program to all patients, including the Medicare patients who would count toward future penalties.

"We make those trade-offs," said Dr. Stanley Hochberg, the center's chief quality officer. Medicare's focus on readmissions "doesn't necessarily align with our social priorities and medical priorities," he said. Medicare officials say they have listened to hospitals' concerns but defend the policy as heading in the right direction. "It's a very traumatic event to go back to the hospital," said Jonathan Blum, a senior Medicare official. "I'm personally comfortable with some imprecision to our measures."

"The ultimate goal is to have these numbers come down," he said.

Because so many hospital readmissions are tied to social or economic factors, hospitals have a hard time predicting which patients are likely to return, said Dr. Jan Berger, the chief medical officer for Silverlink Communications, a consulting firm. When Marjorie Crear, 66, left Ronald Reagan U.C.L.A. Medical Center after a stroke, she struggled to keep track of her medications and to remember her doctor appointments. Tiffany Phan, a newly hired care manager, helped with those tasks and has also been trying to find public housing with a shower instead of a hard-to-navigate bathtub.

Making it even harder for hospitals is the number of consultants and companies springing up to offer solutions with little hard evidence about which steps are the most effective. "We don't really know very clearly how to prevent more readmissions," said Austin Frakt, a health economist at Boston University.

In some cases, such prevention may take a combination of efforts that differ from hospital to hospital, said Dr. Risa Lavizzo-Mourey, chief executive of the Robert Wood Johnson Foundation, which has been financing pilot programs aimed at reducing readmissions. "One of the key factors we keep emphasizing is that there isn't a single magic bullet to fix everything," she said.

And complicating the issue even further is the possibility of doing harm. In 2011, for example, the Department of Veterans Affairs halted a program in which patients with chronic lung disease were supposed to learn to take better care of themselves when 28 patients in the program died, in contrast to 10 deaths in the group receiving typical care.

"It was just an incredible thing," said Dr. Dennis E. Niewoehner, a researcher from the University of Minnesota who said the findings were "a warning signal" for others thinking about embarking on similar programs. The higher death rate may have been purely chance, he said, but the researchers, who published their findings last year, do not know.

Thursday, March 28, 2013

A delicate operation - Intelligent Life - The Economist

THE SCENERY WAS like nothing they had ever seen before. Last March, 47 cyclists had negotiated a 27km climb to the Puyehue Pass on the border of Chile and Argentina, passing forests and mountains, hot springs and glacial melt-water. At the summit one of them noticed a circling Andean vulture, and they joked that it might be a grim omen. Others noticed that one of their most experienced riders was looking distinctly grey. Roger Kirby, a 62-year-old professor of urology, was taking part to raise money for the Urology Foundation. He had been on similar rides in Malawi and Madagascar and prided himself on his ability to keep up with younger riders, but now he felt severely breathless. His father had died of a stroke following heart failure at the age of 49, and ever since he had been wary of the weight of genetics. So he resolved to have a cardiac check and some blood tests as soon as he returned to England.

The heart exam showed a little calcifying in the arteries, something fairly typical in men of his age, and the blood tests showed another common male attribute: a raised level of prostate-specific antigen (PSA). PSA produces the liquefying component of semen, and may ease the passage of male sperm within the uterus. It is a vital protein for conception, but when it enters the bloodstream in increasing amounts it may also indicate the growth of prostate cancer.

Roger Kirby had monitored his PSA level for more than a decade. At 50, it stood at 0.5, which was negligible. But it had risen gradually over the years, to 1.5 and then 3.3, which he regarded as a light flashing on the dashboard. Two weeks after getting back from South America, he took a second PSA test, and found it had gone down a little, which reassured him. Six months later, in September, he had another test and his PSA was 4.3, the highest it had ever been, so he underwent a high-resolution localised MRI scan.

The news wasn't good. There was a definite lesion on the right side, which his radiologist thought could be one of two things: prostatitis, an inflammation treatable with antibiotics, or a tumour. And so a biopsy was ordered, involving a local anaesthetic and a rectal probe, and the removal of 12 samples from the suspicious area.

The following day Kirby received a phone call from his pathologist. "Are you sitting down?" He was. "I'm afraid that three of the biopsies show Gleason 7." The Gleason scale is a grading system particular to prostate cancer, made up of two scores, each defining the advancement of a tumour and the risk of spread to other organs, with 10 as the worst prognosis. A combined score of 4 or 5 would prompt concern, and perhaps a policy of watchful waiting. But with a score of 7, Professor Kirby had a decision to make.

He looks boyish for his age, with a full mop of greying hair and a slightly Bunterish face, and he is not averse to wearing a rugby shirt in his leisure time. He likes to think of himself as a rather stoical, stiff-upper-lip type of Brit. But in the case of his illness his stoicism had both cause and irony: Kirby is one of the leading prostate surgeons in the world.

Prostate cancer—its prevalence and diagnosis, its virulence and treatment—has not been short of publicity recently, and Kirby is one of the reasons why. The fact that the disease is now regarded as both common and a common topic of conversation is partly thanks to Kirby's proselytising and fund-raising. He has written more than 200 research papers on the prostate and several books, including one called "The Prostate: Small Gland Big Problem". He estimates that he has removed more than 2,500 prostates since the mid-1980s.

As well as being Mr Prostate UK, Kirby has one other claim to fame: he was briefly Mr Viagra UK. As Viagra was being developed at the old Pfizer laboratories in Kent, Kirby conducted many of its safety trials (particularly on cardiovascular patients) from his base at St George's Hospital in Tooting, south London. When Viagra was announced to an excited media in 1998, Kirby was on hand as an expert, dismissing claims that it would lead to the world's adult male population spending the rest of their lives walking around like tent poles.

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Unfit for Work: The startling rise of disability in America | Planet Money - NPR

In the past three decades, the number of Americans who are on disability has skyrocketed. The rise has come even as medical advances have allowed many more people to remain on the job, and new laws have banned workplace discrimination against the disabled. Every month, 14 million people now get a disability check from the government.

The federal government spends more money each year on cash payments for disabled former workers than it spends on food stamps and welfare combined. Yet people relying on disability payments are often overlooked in discussions of the social safety net. People on federal disability do not work. Yet because they are not technically part of the labor force, they are not counted among the unemployed.

In other words, people on disability don't show up in any of the places we usually look to see how the economy is doing. But the story of these programs -- who goes on them, and why, and what happens after that -- is, to a large extent, the story of the U.S. economy. It's the story not only of an aging workforce, but also of a hidden, increasingly expensive safety net.

For the past six months, I've been reporting on the growth of federal disability programs. I've been trying to understand what disability means for American workers, and, more broadly, what it means for poor people in America nearly 20 years after we ended welfare as we knew it. Here's what I found.

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Employers Adding Incentives to Health Programs -

Employers are increasingly trying to lower health care costs by using incentives to persuade workers to make better lifestyle choices, a new survey shows, but what remains less clear is whether a reward is better than a punishment — or whether the programs work at all.

The survey, of 800 large and midsize employers conducted by the human-resources consulting firm Aon Hewitt, found that the vast majority of companies, or 79 percent, use rewards like lower insurance premiums to try to nudge employees to improve their health. But increasingly, the survey found, employers are taking the programs a step further, by penalizing employees who do not make healthy choices and linking incentives to measurable results.

"Employers are feeling the need to intensify their efforts to create an environment where people feel they are responsible for their own health," said Jim Winkler, chief innovation officer for health care at Aon Hewitt.

While a little more than half, or 56 percent, of the companies using incentives required employees to sign up for programs like health coaching or completing a questionnaire, 24 percent tied their incentives to progress on measures like a person's blood pressure or body mass index. And the survey found that more than two-thirds of companies said they were considering taking similar steps in the future.

Programs that seek to impose consequences on workers by charging them higher premiums or requiring them to pay a surcharge for failing to take steps to lose weight or quit smoking have come under criticism by those who have argued that the policies are invasive and can punish people for health problems that not are always easy to fix.

Although some employees have sought to challenge such policies in federal court, arguing that they are a violation of privacy or of the Americans with Disabilities Act, the cases have so far failed to gain traction.

The programs are likely to increase in popularity in the years ahead, in part because, as part of the new health care law, beginning in 2014 employers will be able to use as much as 30 percent of a worker's health care premiums on incentives programs, from 20 percent previously.

CVS Caremark, the large drugstore chain and pharmacy benefit manager, recently said it would require its 200,000 employees to report their weight, blood sugar and cholesterol or be forced to pay an annual penalty of $600. It also will require that smokers try to quit. Several other major employers, including PepsiCo and Wal-Mart, have also adopted such policies.

While the popularity of workplace wellness programs appears to be on the rise, there is less evidence about whether they actually lower health care costs or make employees healthier. Programs that reward people for good behavior may be singling out those who were already practicing healthy habits, while those that penalize workers for bad behavior may be unfairly singling out the very people who need lower health care costs.

"These are really hard behaviors and decisions to move the needle on," said Michelle Mello, a professor of law and public health at Harvard. She cautioned against drawing too many conclusions from the Aon Hewitt survey, because the companies that participated may have been more likely to offer workplace wellness programs than those that did not. Aon Hewitt said the survey's 20 percent response rate was typical for the industry and the companies who completed the survey were a representative sample.

One recent study of a workplace wellness program, at a hospital system in St. Louis, found that the program decreased hospitalization of its employees for some conditions, but did not actually save the system any money.

Dr. Troy Brennan, the chief medical officer at CVS Caremark, agreed that the research into whether incentive programs worked was not yet conclusive, but said his company had already seen positive results. CVS is in the third year of an ongoing incentive program: in the first year, employees were asked to answer questions about their health, and in the second they were encouraged to undergo basic tests, like blood sugar and cholesterol, or face a $180 penalty. This year, the penalty was increased to $600.

Since the program began, Dr. Brennan said, employees' overall blood sugar has decreased, as have their cholesterol levels, while their so-called good cholesterol has increased. So far, employees do not receive rewards or penalties based on their improvements on these measures, but Dr. Brennan said it was possible.

He said he understood that these policies created some discomfort, and said patients' individual data was kept private from the company. CVS contributes millions of dollars toward workers' health insurance, like most other employers, Dr. Brennan said, and thus has a stake in its employees' health. "Like it or not, in this country, employment and health insurance and health care are all intimately related," he said.

Several health groups, including the American Heart Association, have expressed concern over the growing popularity of incentive programs, saying they could be used by employers to transfer the higher costs of health care to sicker individuals.

Laurie Whitsel, director of policy research for the American Heart Association, said she was encouraged by a proposed rule by the Obama administration that would require employers to accommodate workers whose doctors concluded that certain goals, like losing weight in a short period, would be unhealthy.

Still, she said, many questions remained unanswered. "Ultimately it's really going to be a national experiment," she said.

Salesmen in the Surgical Suite -

When Fred E. Taylor arrived at Harrison Medical Center in Silverdale, Wash., for a routine prostatectomy, he expected the best medical care new technology had to offer: robotic surgery, billed as safer, less painful and easier on the body than traditional surgery.

The operation, on Sept. 9, 2008, was supposed to take five hours. But it was marred by a remarkable cascade of complications and dragged on for more than 13 hours, leaving Mr. Taylor, who had been an active 67-year-old retiree, incontinent and with a colostomy bag, and leading to kidney and lung damage, sepsis and a stroke.

Mr. Taylor survived his injuries but died last year. Now, his wife, Josette, is suing Intuitive Surgical Inc., the company that makes the equipment and trained the surgeon to use it. As it turned out, the surgeon, Dr. Scott Bildsten, had never before used the robotic equipment without supervision.

"We are the old school, where you trust the doctor," said Mrs. Taylor, who noted that her husband's life was so limited after the operation that he used to cry about being "trapped in this body."

It is not the first time patients have claimed they were harmed by Intuitive's robotic surgical equipment, called the da Vinci Surgical System. But the Taylor case, set for trial in April, is unusual. Internal company e-mails, provided to The New York Times by lawyers for the Taylor estate, offer a glimpse into the aggressive tactics used to market high-tech medical devices and raise questions about the quality of training provided to doctors before they use new equipment on patients.

Intuitive, based in Sunnyvale, Calif., declined to comment on the lawsuit but said studies showed that its robotic equipment results in better outcomes than conventional open surgery. "The most objective and therefore best measure of efficacy for all of those involved in training — from Intuitive Surgical, the hospitals, the proctors and the surgeons themselves — is represented in the comparative clinical outcomes of da Vinci surgery," said Angela Wonson, the company's vice president for communications.

According to Intuitive, 1,371 hospitals in the United States have purchased a da Vinci system, and many have purchased two. Nearly half a million procedures worldwide were performed robotically last year, including prostatectomies and hysterectomies, among other operations.

A surgeon using the da Vinci system sits at a console with a camera that provides a high-definition, three-dimensional image of the surgical site. He or she manipulates miniaturized instruments; computer and robotic technology translates and scales the surgeon's hand movements.

Hospitals are responsible for setting the credentialing standards, or training requirements, for physicians who will use the equipment on patients. But internal company e-mails suggest that Intuitive's sales representatives were intimately involved in the process, presenting themselves as experts and pressing for lower standards in order to ease the training path for busy surgeons, to increase use of the equipment and to drive sales.

In an e-mail dated May 31, 2011, a Western regional sales manager for Intuitive noted that area surgeons had used robotic equipment only five times, although the company's goal was to see 36 robotic operations performed by the end of June. He urged sales staff to persuade surgeons to switch upcoming cases to robotic ones.

"Don't let proctoring or credentialing" — shorthand for supervised surgery and hospital certification — "get in our way," the e-mail said.

In December 2009, a sales representative urged a hospital in Billings, Mont., to ease up on its credentialing requirement, saying in an e-mail that requiring surgeons to do five supervised operations using the robot before going solo was "on the high side" and could have "unintended consequences." Hospital officials replied, saying, "We will review and most likely will decrease the 5 down to 3."

Ms. Wonson, the Intuitive spokeswoman, said the company does not get involved in determining who is qualified to operate its robotic equipment, which is the responsibility of the hospitals. "We do not make recommendations," she said in an e-mail.

Dr. Bildsten was one of six doctors given free training by Intuitive, including one day of hands-on training at the company's facility in California. He also had done two practice runs on the equipment with a more experienced surgeon before operating on Mr. Taylor, he said in a legal deposition. Still, he said, no one warned him that a patient like Mr. Taylor, who weighed nearly 300 pounds, was not a good candidate for robotic surgery.

He did not respond to telephone messages requesting comment.

Company e-mails submitted in the Taylor case also suggest that members of the sales staff at Intuitive worked diligently to persuade surgeons to choose the da Vinci procedure for patients even when they were planning to use a different method.

In one e-mail on June 28, 2010, a clinical sales director urged the sales team — whose compensation was linked to filling a quarterly quota of operations — to "scrub" doctors' schedules and get procedures moved up by a few days in order to make the quarterly goal. "Let's bring it home!" she wrote. "Be sure you scrub all schedules, identify cases on Thursday and Friday that can be moved up."

On Aug. 9, 2010, a clinical sales director wrote to his team: "Be proactive in finding cases to convert. Be prepared to challenge each trained surgeon every time you see a lap or open case. Be unsatisfied with the thought of ending a day without a converted case." ("Lap" refers to laparoscopic procedures, an alternate form of minimally invasive surgery.)

The sales representatives were often in the operating rooms, where they offered advice to newly trained surgeons who were having technical difficulties with the robot, according to legal depositions in the Taylor case. The representatives also appear to have had access to the operating room schedules and were urged to "partner" with surgical teams "to review and select appropriate cases," according to court documents.

On March 3, 2011, a sales representative wrote in an e-mail to his team that he had met with a gynecologic surgeon in Utah who was trained a year earlier but had stopped doing robotic cases. The surgeon subsequently "agreed to convert the next two to da Vinci."

In depositions, some Intuitive sales representatives defended their involvement, saying that it was important for surgeons to use the robotic system frequently in order to maintain and improve their skills.

The Food and Drug Administration allowed the sale of the da Vinci system in 2000 under a controversial process called "premarket notification," often used to bring medical devices to market without the rigorous trials of safety and efficacy typically required of new drugs. Manufacturers are able to exempt devices from the rigorous trials by claiming they are similar to existing devices already on the market.

When devices are brought to market this way, the F.D.A. "cannot require training programs as a condition of clearance," said Synim Rivers, an agency spokeswoman.

Before allowing this type of market clearance, the agency twice asked Intuitive for more information about how doctors would be trained to use company equipment. Intuitive provided details of a 70-item exam for surgeons and a three-day hands-on training protocol.

By 2002, however, the company had revamped its training program, replacing the 70-item exam with a 10-question online quiz and reducing the time spent in hands-on training at Intuitive's facility to one day.

The largest study to date of robotic hysterectomies has questioned the use of robot-assisted surgery over more conventional forms of minimally invasive surgery. A study published in February in The Journal of the American Medical Association evaluated outcomes in 264,758 women who had laparoscopic or robotically assisted hysterectomy and found no overall difference in complication rates between the two groups.

But the researchers did find that robotically assisted surgery for hysterectomy costs on average about one-third more than laparoscopic surgery.

Last week, Dr. James T. Breeden, the president of the American Congress of Obstetricians and Gynecologists, publicly urged patients "to separate the marketing hype from the reality" when considering a surgical method for hysterectomy. "Just because it's newer and higher technology," he said, "doesn't mean it's better."

New Prostate Cancer Tests May Supplement P.S.A. Testing -

Sophisticated new prostate cancer tests are coming to market that might supplement the unreliable P.S.A. test, potentially saving tens of thousands of men each year from unnecessary biopsies, operations and radiation treatments.

Some of the tests are aimed at reducing the false alarms, and accompanying anxiety, caused by elevated P.S.A. readings. Others, intended for use after a definitive diagnosis, examine the genetic workings of the cancer to distinguish dangerous tumors that need treatment from slow-growing ones that might be left alone.

The tests could provide a way out of the bitter debate over whether healthy men should be screened for prostate cancer.

The problem with the P.S.A. blood test is that many of the cancers it detects are unlikely to cause harm. But there is no reliable way to identify them. So a large majority of men with positive tests undergo surgery or radiation treatment, and many suffer for years, needlessly, from complications like incontinence and erectile dysfunction.

In late 2011, the United States Preventive Services Task Force, a government advisory body, provoked a furor by recommending against screening, saying that far more men were harmed by unnecessary biopsies and treatments than were saved from dying of cancer.

But if new tests can better determine risk, screening could become more useful.

"It's not that screening doesn't work; it's that we haven't done a great job of targeting treatments for the tumors that need it," said Dr. Matthew R. Cooperberg, an assistant professor of urology at the University of California, San Francisco who has been a consultant to some of the testing companies.

Reducing unnecessary treatments could also reduce the $12 billion in estimated annual spending related to prostate cancer. Test developers hope that such savings will make their tests cost-effective, even at prices that will exceed $3,000 in some cases.

More than a dozen companies have introduced tests recently or are planning to do so in the near future. Rather than looking at a single protein like P.S.A., which stands for prostate-specific antigen, many of these tests use advanced techniques to measure multiple genes or other so-called molecular markers.

"It's the cancer for the next 18 to 24 months that will be transformed by molecular markers," said Dr. Doug Dolginow, chief executive of GenomeDx Biosciences, a start-up planning to introduce a test later this year.

Experts caution that it is too early to tell how well most of the tests will perform and whether they will make a difference. Although the tests are intended to help men make treatment decisions, the onslaught of so many could cause more confusion.

"It's a little tricky to find out which one applies to you and whether it will be paid for by insurance," said Jan Manarite, who runs the telephone help line for the Prostate Cancer Research Institute, a patient education organization.

Prostate cancer specialists say screening has declined since the task force recommended against it, but millions of men in the United States still get regular blood tests to measure P.S.A. As many as a million have biopsies each year, with about 240,000 prostate cancer cases diagnosed and 28,000 deaths from the disease.

The biggest battle among test developers could be between Genomic Health and Myriad Genetics, which are moving into the prostate cancer field after successes in breast cancer testing.

Myriad is known for its test for genetic mutations that raise a woman's risk of getting breast cancer. Genomic Health's Oncotype DX test helps determine if a woman should receive chemotherapy.

Both companies have developed prostate tests analogous to Oncotype DX. They analyze gene activity levels in the tumor sample obtained by biopsy to gauge how aggressive the cancer is, helping doctors and patients decide whether to treat it. The companies say their tests provide better information than the Gleason score, the main tool now used to assess tumor aggressiveness, which is based on how cells look under a microscope.

One study of Myriad's test looked at stored biopsy samples from 349 British men who were found to have prostate cancer from 1990 to 1996 and did not receive immediate treatment.

About 19 percent of the men with the lowest risk scores on Myriad's test died from prostate cancer within 10 years, compared with 75 percent of the men with the highest risk scores, according to results published last year in the British Journal of Cancer.

Still, some prostate cancer specialists say the test, which is called Prolaris and went on sale last year, has not been adequately validated, and sales have been very low. Noridian, the Medicarecontractor for Utah, where Myriad is based, said it would not pay for the $3,400 test.

Genomic Health says it plans to start selling its test, the Genomic Prostate Score, after releasing supporting data at the American Urological Association's annual meeting in May.

Insurers might be reluctant to pay for the new tests without evidence that men will trust the results enough to forgo treatment if so indicated. The tests still leave some uncertainty, and many men do not want to live with cancer, no matter how slight some test says the risk is.

"We already know from conventional information that there are a group of men who are very unlikely to have progression, but they still get treated," said Dr. Lee N. Newcomer, senior vice president for oncology at UnitedHealthcare.

Angel Vasquez, for example, resisted when his urologist told him that he could forgo treatment based on his low Gleason score and P.S.A. levels.

"I said, 'No, my philosophy is if there is something in my body that is not supposed to be there, I want it to come out,' " said Mr. Vasquez, 67, of Matthews, N.C.

The doctor ordered Myriad's Prolaris test. Rather than justifying a decision to watch and wait, the test showed the tumor to be more aggressive than thought, a finding later confirmed after Mr. Vasquez had surgery.

"Had I left it alone, it would have really progressed," he said.

Some experts say that even if the new tests are not perfect, they are better than what is available now.

"Even if we can only convince 15 to 20 percent of men that we have enough confidence that they don't need to be treated, that will be a big step forward," said Dr. Eric A. Klein of the Cleveland Clinic, who has worked with Genomic Health.

Another company, Bostwick Laboratories, already sells a tumor aggressiveness test called ProstaVysion, and Metamark Genetics is developing its own.

GenomeDx is focusing on a test that would be used after surgery to help determine whether additional treatment with radiation or drugs would be useful. Danaher already sells such a test.

HologicMDxHealth and Mitomics sell tests that they say can reduce the number of unnecessary second biopsies, which are often done when a first biopsy is negative but P.S.A. levels remain high.

Opko HealthBeckman Coulter and Metabolon are developing tests that would be used in conjunction with P.S.A. screening. Because P.S.A. levels can be elevated for reasons other than cancer, as many as three-quarters of biopsies do not find cancer — and the biopsies can cause pain and infections.

One published study showed that Opko's test could have reduced unnecessary biopsies by about 50 percent, though it would have missed 12 percent of high-grade cancers.

Yet another test could come from the discovery by researchers at the University of Michigan that a particular fusion of two genes is found in half of prostate cancers, and only in prostate cancer.

"You'd still miss 50 percent of the disease, but at least you know if you have it you have prostate cancer," said Dr. Arul M. Chinnaiyan, a professor of urology and pathology. He said a urine test was being developed that combines the gene fusion with PCA3, another marker.

Some experts say unnecessary procedures can be reduced simply by using the P.S.A. test less frequently, and also by improving imaging. The new tests are "singles and doubles at best," said Dr. William J. Catalona, director of the prostate program at Northwestern University, who helped bring the P.S.A. test to market in the 1990s. But, Dr. Catalona said, this is only the start. "This field is moving kind of like cellphones," he said.

Doctor for N.F.L. Says Study Overstates Effects of C.T.E. -

When a government agency prepared a workplace safety fact sheet based on a study of degenerative brain disease in retired N.F.L.players, the organization invited several people to comment on a draft.

According to a memorandum obtained by The New York Times, most of the reviewers suggested simplifying the fact sheet so that players without a scientific background could better understand the findings. But one response stood out: a doctor on the N.F.L.'s head, neck and spine committee asked that a mention of chronic traumaticencephalopathy, or C.T.E., be removed.

C.T.E. is a degenerative brain disease that is closely related to Alzheimer's disease and is believed to be caused by repeated head trauma. It has been found posthumously in dozens of football players, provoking widespread concern about the sport's potential long-term cognitive effects.

Against this backdrop of public awareness, the N.F.L. has drastically shifted its position on head injuries in recent years, introducing rule changes and promoting education. But the league has expressed skepticism about the possibility of a link between on-field head injuries and C.T.E., a sentiment captured in the league doctor's request to the federal safety agency.

The doctor, who was not named in the internal memo, said references to C.T.E. should be removed because it was "not fully understood" and because it was not listed on the death certificates of the retired players in the study and thus lacked "epidemiological validity." He suggested that traumatic brain injury, or T.B.I., be used instead because it "may accomplish what you want to say in more established medical terms."

Researchers from the National Institute for Occupational Safety and Health, which wrote the fact sheet, rejected the league doctor's proposed change. Independent medical experts said such a request was inappropriate and not in line with prevailing research.

"That's what bugged me the most," said Jeffrey Kutcher, a neurologist and the director of Michigan NeuroSport at the University of Michigan, referring to the request to use traumatic brain injury instead of C.T.E. "It's a huge jump and it goes completely away from what the Niosh study showed."

Richard Ellenbogen, the chairman of the University of Washington's neurological surgery department and a co-chairman of the N.F.L.'s head, neck and spine committee, said he did not know which doctor suggested changing the text of the fact sheet.

But he said the doctor was correct in wanting to include a reference to traumatic brain injury. T.B.I. is a clinical diagnosis that can be identified in living patients, Ellenbogen said, while C.T.E. is a pathological diagnosis that so far can be found only through autopsies.

"Whoever said that is right," Ellenbogen said. "We've got to be careful because C.T.E. is a pathological diagnosis. We know that exists. That's been proven forever. What's important about this study is, if I played sports and had concussions, what's my chance of getting these?"

Ellenbogen said there was not enough research to answer that question. "Right now, people are on the razor's edge cutting the words," he said. "The problem is, the science isn't there yet. But we have to be clear. I'm agreeing with the Niosh study, but we just have to be more careful to make clear that C.T.E. is a pathological diagnosis and T.B.I. is a clinical diagnosis."

Like Ellenbogen, independent medical experts said they agreed with the agency when it wrote that there was no known "cause-effect relationship between football-related concussions and death from these neurodegenerative disorders," as well as the agency's statement that "professional football players are at increased risk of death" fromamyotrophic lateral sclerosis, Alzheimer's disease and Parkinson's disease.

The medical experts also expressed dismay that an N.F.L. doctor would point to the death certificates of former players in the study. C.T.E. is often diagnosed months after death, when brain samples are examined.

"This is an epidemiological entity, and at this point it definitely garners this title because of the number of players we have diagnosed with it," said Alexander K. Powers, an assistant professor of neurosurgery who specializes in sports-related brain and spine injuries at Wake Forest Baptist Medical Center. "There's plenty of research that is active. It's a robust field. It's not some orphan ambition."

The fact sheet, sent to retired N.F.L. players in January, summarized research published in September in the journal Neurology that found that players "may be at a higher risk of death associated with Alzheimer's and other impairments of the brain and nervous system than the general U.S. population."

Before publishing its fact sheet, Niosh asked three former players, a representative from the N.F.L. Players Association and a representative from the N.F.L. Player Care Foundation, an independent organization that assists retired players, to review and comment on a draft. The foundation asked for advice from the doctor on the head, neck and spine committee.

Niosh researchers rejected the proposed change because C.T.E. "resonated with the players who reviewed the draft and provided feedback" and was widely acknowledged. Using T.B.I. was also inappropriate because it described an injury that might result in a disorder like C.T.E. and was therefore not equivalent, said Ann Mobley, the health communications specialist at Niosh who wrote the fact sheet.

The debate over the long-term effects of head injuries in football has engaged neurosurgeons, neurologists, neuropsychologists and other researchers and clinicians. It has also led to lawsuits. Several thousand retired players have accused the N.F.L. of deliberating playing down the dangers of head injuries.

Everett Lehman, an epidemiologist at Niosh and the principal author of the original mortality study of more than 3,400 retired players, said his department must balance accuracy and clarity in its research. He said the N.F.L. doctor's request was misguided.

"I just think they are different things, and we didn't think it was important to include T.B.I.," he said. "Maybe whoever looked at it didn't carefully look at our paper."

Sunday, March 24, 2013

A Plan To Fix Cancer Care -

This year, more than 1.6 million Americans — 0.5 percent of the population — will receive a diagnosis of cancer. Their treatment will consume at least 5 percent of the country's health care spending, at a cost that is growing faster than all other areas of medicine. Doctors and patients recognize that this is unsustainable and that we need to change the way we deliver care.
But we need help, and that is why more than 20 prominent members of the oncology community contributed to the drafting of this essay (their names appear below).
Many cancer patients, after getting a diagnosis of a terrifying disease, pursue any potentially promising therapy, regardless of the price. But the main cost driver is the fee-for-service payment system. The more doctors do for patients, the more reimbursement they receive. Surgeons earn more for every procedure. Oncologists typically make more money if they use newly approved drugs and the latest radiation treatments than if they use cheaper, older alternatives that work just as well. (This is because they get paid back the cost of the drug, in addition to an extra 6 percent of that cost — the more expensive the drug, the higher the compensation.)
Some of these new therapies are rightly heralded as substantial advances, but others provide only marginal benefit. Of the 13 anticancer drugs the Food and Drug Administration approved in 2012, only one may extend life by more than a median of six months. Two extended life for only four to six weeks. All cost more than $5,900 per month of treatment.
Significant costs also come from hospitalizations and emergency room visits that could be prevented with better management of common symptoms. Unfortunately, doctors earn more treating patients for serious problems in the hospital than they do preventing those problems from occurring in the first place.
Five major changes need to occur:
First, over the next few years, the payment system needs to move away from fee-for-service toward a system of bundled payments, in which doctors are paid one fee for all the treatments involved in caring for a cancer patient. This would remove the incentive to prescribe more expensive drugs when older generics are equally effective.
Second, insurers have to give physicians information about where they are spending money. As crazy as it sounds, most physicians have little ability to track the care they deliver, or how they compare with other physicians who care for similar patients. Costs vary wildly for patients with identical cancers. One study of patients with cancers that had spread throughout their bodies showed that the costs of four months of scans varied from $1,800 to $6,400 per patient. Doctors don't have a clear sense of whether the money is going to chemotherapy, hospitalizations or follow-up M.R.I. scans. Armed with better data, physicians can learn how to improve care at lower cost.
Third, any change in payment methods must be accompanied by rigorous quality monitoring to ensure that there is neither under- nor over-utilization of care.
Fourth, we need more "high touch" oncology practices. In these practices, nurses manage common symptoms before they escalate to the point that they require visits to the emergency room, and doctors talk with patients about palliative-care services and end-of-life preferences early on — not in the weeks before death. These services are frequently not paid for by insurers but can improve the quality of care and save significant money by averting repeated tests, hospitalizations and futile, toxic chemotherapy. Insurers need to share the resulting savings, enabling physicians to invest in providing these services.
Fifth, we need better incentives for research. Many expensive tests and treatments are introduced without evidence that they improve survival or reduce side effects, and with poor information about which patients should receive them. For instance, while more than 800,000 robotic surgeries, mostly for cancer, have been performed in the last two years, there is no reliable evidence that the robots either improve survival or reduce side effects — despite the fact that they cost more than traditional surgery. Once interventions are paid for, the incentive for research disappears.
The oncology community cannot make these changes alone. The government is deeply involved and has to help. Today, 60 percent of cancer diagnoses are made in patients who are eligible for medicare. By 2030, that number will rise to over 70 percent. Medicare and the other payers need to work with oncologists. The secretary of health and human services should organize a working group representing Medicare, private insurers, oncologists, quality experts and patients to figure out how to develop these proposals — with no increase in costs — and start implementing them by the end of 2015. Everyone engaged in cancer care needs to help improve it.
Written with:
Amy P. Abernethy, M.D., Duke UniversityJustin E. Bekelman, M.D., University of PennsylvaniaOtis W. Brawley, M.D., American Cancer SocietyRobert L. Erwin, Marti Nelson Cancer FoundationPatricia Ganz, M.D., U.C.L.A.James S. Goodwin, M.D., University of Texas Medical BranchRobert J. Green, M.D., Palm Beach Cancer InstituteJesse Gruman, President, Center for Advancing HealthJ. Russell Hoverman, M.D., Ph.D., Texas Oncology, United States OncologyJohn Mendelsohn, M.D., MD Anderson Cancer CenterLee N. Newcomer, M.D., UnitedHealth GroupJeffrey M. Peppercorn, M.D., M.P.H., Duke UniversityScott D. Ramsey, M.D., Ph.D., Fred Hutchinson Cancer Research CenterLowell E. Schnipper, M.D., Beth Israel Deaconess Medical CenterFrederick M. Schnell, M.D., Central Georgia Cancer CareDeborah Schrag, M.D., Dana-Farber Cancer InstituteYa-Chen Tina Shih, Ph.D., University of ChicagoJohn D. Sprandio, M.D., Consultants in Medical Oncology and HematologyThomas J. Smith, M.D., Johns Hopkins UniversityArthur P. Staddon, M.D., Pennsylvania Oncology Hematology AssociatesJennifer S. Temel, M.D., Massachusetts General Hospital