Terry Waddell knew that her 87-year-old mother did not have long to live. The woman’s organs were shutting down because of old age, she said, and her arthritic body had withered to 80 pounds.
So, when Waddell received a call about her mother’s health, it was not what she expected. A visiting nurse had noticed a bit of blood between the frail woman’s legs and wanted her screened for cervical cancer.
Waddell, of Houston, regrets that she took her mother for the test. She refused to let doctor’s aides weigh her, she said, protesting that getting her mother out of her wheelchair was too arduous a process. Then came the actual exam, which she said “was painful to watch.” Her mother struggled to open her legs wide enough for the procedure and then lay there, quietly crying.
“I blame myself for not stopping this,” said Waddell, whose mother died two months later.“It was totally unnecessary.” Unnecessary, perhaps, but surprisingly common.
Cancer screening tests are vastly overused in the United States, with about 40 percent of Medicare spending on common preventive screenings regarded as medically unnecessary, an iWatch News investigation reveals. Millions of Americans get such tests more frequently than medically recommended or at times when they cannot gain any proven medical benefit, extracting an enormous financial toll on the nation’s health care system. Doctors disregard scientific guidelines out of ignorance, fear of malpractice suits or for financial gain, as patients inundated by medical advertising clamor for extra tests.
In the frenzied hunt for cancer, the risks of the screenings also get overlooked. Besides producing anxiety, screening people for cancer can itself cause injuries — even death — or set off a cascade of expensive tests and treatments that can waste more money and create more problems.
The U.S. Preventive Services Task Force, a panel of independent medical experts, determines which screening tests offer more benefits than risks — and who should get them. But even though the group’s guidelines are considered the gold standard for medical care, its detailed recommendations are largely ignored, an iWatch News’ probe found, and the fiscal consequences are profound.
Medicare spent about $1.9 billion on common cancer screenings for people who were older than government-recommended age limits between 2003 and 2008, according to iWatch News’ examination of a six-year sample of Medicare billing records obtained by iWatch News and The Wall Street Journal. That’s about 40 percent of everything that Medicare spent on breast, colon, prostate and cervical cancer screenings in that time period.
More than $31 million of that money was spent screening people who were in their 90s, the investigation showed.
Breast cancer screening guidelines were disregarded most frequently during this period, according to the iWatch News analysis. More than 22 million mammogram claims were submitted for women at or over the recommended limit of 75, the age when the task force says “evidence of benefits of mammography is lacking.” (The number of claims cited for each test is greater than the number of procedures as hospitals and doctors both sometimes bill separately for each procedure. See methodology for more details.) Health care providers, meanwhile, billed Medicare for more than 10 million colon cancer screening claims and more than 6 million prostate cancer screening claims for people at or over the suggested upper age limit of 75.The task force gave these prostate screenings its strongest negative rating, actually discouraging their use.
For cervical cancer screenings, which the government panel says can usually stop at 65, over 80 percent of Medicare claims — more than 13 million — were for women who were 65 or older.
“This is a very bad way to expend money that is in short supply,” says Dr. Virginia Moyer, chair of the Preventive Services Task Force, noting how harmful these tests can be. “There’s human suffering involved.”
Adds Clyde Behney, the Institute of Medicine’s deputy executive officer: “It’s a very sad testament to the system’s workings.” The Institute, part of the National Academy of Sciences, advises the government on health issues.
The government is sending mixed signals, medical experts say, with one agency discouraging older patients from getting preventive screening tests and another one paying for them — and implicitly endorsing their use. All the while, the tests get promoted by corporations that have a financial interest in them being administered. Even some diaper companies get involved, experts say, noting that they can financially benefit from men getting medically questionable prostate tests and then winding up incontinent.
The $1.9 billion spent on excessive testing, meanwhile, represents only a fraction of how much these screenings actually cost the health care system, asserts Dr. H. Gilbert Welch, a Dartmouth medical professor, who says the most expensive part of screening involves the extensive battery of follow-up exams and procedures, such as biopsies.
“The test is chump change. It’s all the stuff that happens afterward that costs a lot,” says Welch, author of Overdiagnosed: Making People Sick in Pursuit of Health.
Welch calls overdiagnosis, the process of detecting medical abnormalities that will never harm patients’ health, “the biggest problem posed by modern medicine.”
iWatch News’ findings come in the midst of an intense national debate over the future of Medicare, the financially strapped health care program for seniors and the disabled. Republicans ignited a political firestorm earlier this year, proposing a radical overhaul of the entitlement program that would give seniors vouchers to buy private health insurance. Democrats condemned the plan and insisted that President Obama’s landmark health care reform could control Medicare’s rapidly escalating costs. Medicare costs are now being examined anew by the so-called Super Congress searching for long-term spending cuts.
If unnecessary screenings were cut, health care could actually be improved, says Dr. Mark Stoler, a medical professor at the University of Virginia. “We’re brainwashed in America to think that more is better,” he says.
But the “more is better” mindset is difficult to budge — especially where Medicare is involved.
Every time Medicare tries to rein in spending, “the great R word comes out,” says Gail Wilensky, a former director of the Medicare program, referring to health care rationing.
Any suggestion of an upper age limit on preventive cancer screening would likely be greeted with howls of age discrimination, medical experts say. Congress has often overruled Medicare administrative decisions designed to reduce costs.
“There will always be a political advocate or medical manufacturer who can point to a life being saved by screening, no matter how much it makes no sense from an epidemiologic perspective,” says Dr. Peter Albertsen, a urologist and associate dean at the University of Connecticut Health Center. “This is too politically sensitive. No one wants to see someone develop cancer.”
Despite repeated requests, the Centers for Medicare and Medicaid Services refused to comment on iWatch News’ findings or on the broader question of whether CMS has ever considered curbing preventive screenings for the elderly. A CMS spokesman would say only that “decisions on who gets these screenings and whether to administer them are between patients and their doctors.”
For Medicare administrators, says Wilensky, “there’s real reluctance to interfere with the doctor-patient relationship.
Screening on autopilot
Medicare should at least consider refusing to pay for preventive screenings for the terminally ill, say researchers, who recently discovered that a significant number of patients with advanced cancer were still undergoing preventive tests.. “Even when the benefits have been rendered futile,” 15 percent of terminally ill men received prostate cancer screenings, while 9 percent of terminally ill women got mammograms and 6 percent got Pap smears, according to a study published last year in the Journal of the American Medical Association.
Doctors are often reluctant to tell sickly or elderly patients that they can’t possibly live long enough to benefit from cancer screening tests, says Dr. James Goodwin, a geriatrician at the University of Texas Medical Branch. Sometimes, he says, he’ll order unnecessary tests for insistent patients, thinking it’s most important to maintain people’s trust for future medical treatments. “Medicine is a social interaction,” he says.
At American medical schools, meanwhile, the importance of preventive screening gets drilled into doctors. After learning to make every effort to find potential health problems, it’s difficult for them to follow updated guidelines that say less screening is better.
“It is very hard to get out of these habits,” says Dr. Howard Brody, director of the University of Texas’ Institute for the Medical Humanities. “It feels like going without clothes on.”
Financial considerations, of course, play a huge role, too. Screening can generate enormous profits — especially for physicians who own testing or treatment equipment. Studies show that doctors who own such equipment typically do two to three times more procedures than their counterparts, Dr. Brody says.
Medicare’s fee-for-service structure also fosters more tests, since doctors get paid by the exam. The threat of medical malpractice lawsuits is never far away, either, discouraging doctors from trying too hard from talking patients out of tests. “No one ever gets sued for overscreening,” Goodwin says.
With so many economic and cultural pressures, the latest and most comprehensive medical research can get completely ignored.
“We have guidelines and scientific articles, but they have no teeth,” Dr. Stoler adds. “We have chaos.”
The U.S. Preventive Services Task Force guidelines were never meant to be mandates, and only recently gained a bit of regulatory heft. Under President Obama’s health care plan, its ratings are used to determine whether patients need to make co-pays for preventive screenings. Patients no longer need to pay anything for preventive tests that the task force recommends: those receiving either the task force’s “A” or “strongly recommended” rating or its “B” or “recommended” rating. In addition, beginning in 2009, the Secretary of Health and Human Services received administrative authority to expand Medicare’s preventive services, if a service gets an A or B rating from the task force.
Still, the panel’s upper age limits on screenings are primarily designed to help health care providers weigh the risks and benefits of each test.
“The issue of when you stop screening is an extremely difficult one,” says Moyer, the task force chair. While slow-growing cancers won’t cause serious symptoms for at least a decade, some tests can cause incontinence, bowel perforations, and even death.
There’s no point in screening for slow-growing cancers in people who will likely die in the next decade of something else, she says. “People all think they’re the exception.”
Concerns over prostate tests
Prostate cancer screenings and follow-up exams have so many risks and such dubious benefits that the task force does not recommend anyone take the tests. For men 75 or older, the tests received the panel’s lowest rating: a D, meaning “discourage the use of this service." The preventive services panel is expected next week to propose the same D rating for tests given to younger men, according to CNN. Currently, for men under 75, the tests get an I rating, which means there is insufficient evidence to determine that the test’s benefits outweigh its risks.
Yet Medicare spent more than $149 million on prostate screening tests for these older men between 2003 and 2008, iWatch News found. That’s 36 percent of all Medicare spending for such tests during this period.
More than $4 million of this money was spent on testing men in their 90s — even though prostate cancer usually grows quite slowly.
The decision to have Medicare pay for these controversial tests did not come from Medicare administrators; instead it was mandated in 1997 by Congress, which ignored the advice of its own research experts.
When Congress asked the Office of Technology Assessment, its now-defunct research agency, about whether the government should pay for the prostate tests, the agency cautioned: “An unrestricted, permanent benefit might imply that science actually has established the benefit of early detection.” At that time, the governments of England, Sweden, Australia and the Netherlands opposed routine screening for all ages, as did the U.S. and Canadian preventive services task forces.
Medical societies in the United States, meanwhile, were divided on the tests’ effectiveness, with some touting them as “some sort of screening marvel” and other denouncing them, said Behney, then one of the Office of Technology Assessment’s assistant directors. The problem was that the tests were notoriously inaccurate and could lead to unnecessary treatments with devastating side effects, such as incontinence and impotence.
But the legislation had some powerful backers. Sen. Richard Shelby, R-Ala., had sponsored the 1995 version of the legislation, which was cosponsored by the late Sen. Ted Stevens, an Alaska Republican. Both men were prostate cancer survivors.
After Congress authorized Medicare to pay for the tests, experts continued their warnings. Dr. Harold Sox, then president-elect of the American College of Physicians, testified at a congressional hearing that Medicare’s directors needed to “strongly caution physicians to avoid routine screening.” It was hard to get the message heard, with prominent politicians and athletes testifying that the screening tests had saved their lives.
Now, though, an increasing number of scientists question the usefulness of the PSA test, the common blood test used to detect prostate cancer. Several recent studies have shown that the screenings do not lower the cancer’s death rate.
The test’s accuracy remains an issue. The blood test detects high levels of an enzyme called prostate-specific antigen, but that enzyme can be elevated for lots of reasons — not just because of prostate cancer. Even Dr. Richard Ablin, who discovered the antigen, has called the test “hardly more effective than a coin toss.”
“The manufacturers of the PSA test sold the urological community on a test that cannot detect what it purports to detect,” Dr. Ablin proclaims on his website. The PSA blood test alone may not be harmful, but serious risks — and hefty expenses — occur with what often follows: biopsies, radiation therapy, and possibly surgery.
Making matters even more complex: confusion over which prostate cancers are dangerous. Some cancers grow so slowly that they will never affect a man’s health, yet it’s hard to tell which ones are more aggressive.
So, if someone gets diagnosed with prostate cancer, figuring out whether to treat them is not an easy decision. About 30 to 40 percent of men who undergo prostate cancer treatment become impotent, while 20 to 30 percent become incontinent, experts say.
“Screening is about fifty times more likely to ruin your life than it is to save your life,” says Dr. Otis Brawley, chief medical officer of the American Cancer Society, citing the results of one key study.
Yet prostate cancer screening remains a huge industry in the United States. Hospitals can generate enormous profits from them and sometimes offer free screenings to recruit new patients. By offering free tests to just 1,000 patients, a hospital can bill Medicare and insurance companies $4.9 million in follow-up procedures, Brawley said — a figure calculated by previous administrators at an Atlanta hospital where he once worked.
HealthFair, which takes screening vans to corporations and community events, used to advertise its services to hospitals on the Internet, saying: “With patient revenue being down as much as 30 percent in some specialty physician groups, a partnership ... can bring tremendous value to you.”
Zero, the Project to End Prostate Cancer, meanwhile, now takes its vans to 60 locations around the country each year, offering free PSA tests — a practice that Brawley believes is unethical. Mass screening programs, he says, “actually deceive men into thinking that screening is better than the science tells us.” Jamie Bearse, Zero’s chief operating officer, said every man receives information about early detection, adding “the American Cancer Society condemns some men to death with its stance on PSA testing today.”
Even Kimberly-Clark, the maker of Depends adult diapers, has launched campaigns to end prostate cancer, donating money to Zero.
Says Brawley: “While it is a question as to whether prostate screening saves lives, it definitely sells diapers.” A Kimberly-Clark spokesman said its campaign’s intent was not to sell diapers. The campaign’s goal was “bringing an end to this terrible disease,” according to a company press release.
Medicare reimburses health care providers large sums for some prostate cancer treatments, paying as much as $40,000 a patient for intensity-modulated radiation therapy. The government insurance program spent an estimated $1 billion in 2008 on this therapy, according to an analysis of Medicare records by The Wall Street Journal.
“I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster,” Dr. Ablin wrote in a New York Times op-ed column last year. Eliminating routine PSA screening, he said, “would save billions of dollars and rescue millions of men from unnecessary, debilitating treatments.”
Leading manufacturers of prostate cancer screening tests did not respond to requests for comment.
A glut of colon cancer screenings
Unlike prostate cancer screenings, colon cancer tests are not controversial at all. With colonoscopies, polyps can be detected and removed long before they become cancerous.
But as people age, colonoscopy risks increase and the benefits of the tests decline.
People over 80, for instance, are 75 percent more likely to experience severe side effects from the procedure, such as bowel perforations, compared to people in their late 60s, a recent study showed. Yet they may not get any benefits from the tests for more than a decade, since it can take that long for polyps to become cancerous.
Given the shifts in risks and benefits, the U.S. Preventive Services Task Force does not recommend routine colon cancer screening for people over 75.
The net benefits of screening are small for people between 76 and 85, the panel says. For those over 85, it says, the benefits do not outweigh the harms.
Yet iWatch News found that Medicare spent more than $323 million doing colon cancer screenings for people 75 and older between 2003 and 2008. That’s more than 30 percent of what Medicare spent on these tests during that time period.
More than $34 million of this money was spent screening people 85 and older.
One of nearly every four Medicare recipients, meanwhile, gets expensive colonoscopy tests too frequently, a recent study showed. Instead of getting the routine screenings once a decade, as recommended, these people were taking the tests every seven years, says Dr. Goodwin, who led the research project.
Public health campaigns urging people to get regular screenings are considered a great success, but “the lessons got overlearned,” Goodwin said.
People were more likely to be screened too frequently if they got their tests done in an office or by doctors who did a large number of procedures, Goodwin found. The providers usually billed these extra tests as diagnostic, meaning they claimed the patients showed some sort of cancer symptoms. But when Goodwin investigated the actual claims, he said, “a lot of the indications were real bogus.”
Medicare reimburses hospitals an average of almost $800 per test.
Not all doctors believe testing over the age limits is excessive.
At the Banner Arizona Medical Clinic in Peoria, Ariz., many colon cancer screenings were performed on patients 85 or older, the iWatch News analysis showed. But this clinic serves patients from nearby Sun City, Ariz., the nation’s first planned community for active seniors. Some patients are 85, but “they look like they’re 60,” said Dr. Deepa Shah, one of the clinic’s gastroenterologists.
Dr. Shah said that she did not believe the clinic did any screening colonoscopies on 85-year-olds. But she said there are some patients who want aggressive treatments well into their 90s, recalling a man who recently underwent chemotherapy to treat rectal cancer when he was 92.
Breast cancer politics
Of the four major cancer screenings, mammography is the most expensive — and has generated the most controversy. When a National Institutes of Health panel recommended in 1997 that women in their 40s did not need routine screenings, committee members were accused of condemning American women to death.
Two years ago, when the U.S. Preventive Services Task Force recommended essentially the same thing, the reaction was no less emotional. The suggestion remains the task force’s best known — and most contentious — stance. When some people explain why they disregard task force guidelines, they refer to its breast cancer statement. Many misinterpreted the statement to mean that women in their 40s should not have the test, Moyer said. The actual statement, which came in the middle of the health reform debates, says mammograms should not be routinely recommended to women in their 40s.
Political opposition to the recommendation even led to a little-known provision in the landmark health reform law, which ensures that insurance companies — and Medicare — will completely pay for mammograms for all women — including those in their forties. Lawmakers needed to add the provision because the health reform law eliminates copays only for preventive services tests that receive the task force’s positive “A” and “B” recommendations. Mammography screenings for women under 50 have a “C” rating, which means the task force does not recommend routinely providing the service, but “there may be considerations that support providing the service in an individual patient.”
What the task force said about mammograms for older women is not nearly as well remembered: there is insufficient evidence to recommend screenings for those 75 and over. Many breast cancers grow so slowly that older women would die of other causes before the cancer affected them, the task force said. In addition, women in this age group who do get breast cancer are more likely to get a type which is much more easily treatable, so early detection is not such a key concern.
Still, Medicare spent more than $1 billion screening these older women for breast cancer between 2003 and 2008, iWatch News found. That was 38 percent of what Medicare spent on breast cancer screening during this period.
Medicare spent more than $21 million just to test women in their 90s, the analysis discovered. In 2008, the analysis showed, at least a few dozen women 98 or older were getting mammograms.
Joan Miles, 90, says she still gets annual mammograms because “no one said I should stop.”
Miles, of Fleming Island, Fla., says she seeks out the best medical advice available, reading health newsletters, such as the respected Mayo Clinic Health Letter, and even travels to Mayo Clinic’s hospital in nearby Jacksonville, Fla., when she needs an operation. She follows a healthy regimen: eating a low-fat diet, walking two miles a day, lifting weights every week, and getting an annual physical exam.
“When I have my yearly physical, my primary always makes an appointment for me to have a mammogram, plus a full blood profile and bone scan,” she says. She says she’s never questioned the need for the test.
Some of the inappropriate breast cancer screenings have been fostered by pay-for-performance plans, which grade doctors on their cancer screening rates, experts say.
California regulators mandated cancer screenings in some health plans for a while, creating all kinds of distress among elderly patients, says Dr. Louise Walter, a geriatrics professor at University of California in San Francisco.
When Dr. Walter investigated problems at one health plan, she discovered that half of the women given mammograms had dementia and many became distressed because they did not understand what was happening to them. A 98-year-old woman became so agitated after her mammogram that her daughter refused follow-up tests.
Only two of the 216 women screened benefited from the mammograms, Walter concluded. She questioned the propriety of using cancer screening rates to measure quality of care, saying that screening women with dementia raises ethical issues. Screening such women should be assessed on a case by case basis, she says.
California eventually revised its screening policies.
Pap smear screenings
Cervical cancer screening is considered one of the greatest success stories of preventive medicine. Cervical cancer was one of the leading killers of American women until the 1950s, when women started getting Pap smear exams. Since then, the death rate has plummeted by more than 70 percent, with only about 4,000 women a year now dying from the disease.
But now, most American women get way too many of these screening tests, medical researchers say. “Roughly half of what’s being done is not a benefit to the patient,” says Philip Castle, executive director of the American Society for Clinical Pathology’s health services research institute.
The U.S. Preventive Services Task Force says women over 65 no longer need routine screenings, as long as their several latest Pap tests were normal and they are not at high risk for cervical cancer— that includes about 98
percent of all women in that age group, experts say. Unlike other cancers, cervical cancer does not occur more frequently with age; it plateaus about age 55.
Yet the iWatch News investigation found that Medicare spent about $344 million screening women 65 and older between 2003 and 2008. That’s more than 81 percent of total Medicare spending on these tests.
The task force also says that women don’t need Pap smears if they have had hysterectomies for problems unrelated to cancer.
Yet 10 million women who had their cervixes removed had unnecessary Pap smear screenings in 2002, an article in the Journal of the American Medical Association concluded. These were women with no history of cancer.
The authors conducted the study, in part, to figure out whether task force guidelines had an impact. The answer? Not really. Six years after the task force recommended against screening women with hysterectomies, the proportion of such women being screened did not decline at all, researchers found.
Maria Levada, an obstetrician and gynecologist in Valley Stream, N.Y., has performed many cervical cancer screenings on women 65 and older. She also says she has performed Pap smears on women who have had hysterectomies, despite the guidelines that say they are unnecessary.
“Patients are scared of cancer of any kind,” says Levada, adding that one-fourth of her patients are older than 65. “I have a few patients in their 90s who are sexually active with younger men.” Cervical cancer is linked to a sexually transmitted virus.
Levada says she gives Pap smears to women with hysterectomies every few years to search for cancer of the vaginal wall, she says. While she says these cancers are rare, “they are also more difficult to treat.”
But experts say such tests are unnecessary.
“It’s ridiculous,” Dr. Castle says about the prospect of these vaginal cancer tests. Vaginal cancers affect only about one in every 100,000 women, he says, and even when there’s an abnormal finding on a Pap smear, it’s unclear how to treat it. “There is zero evidence that this benefits the patient.”
As for testing sexually active women in their 90s, Stoler says that is not necessary either. Not only are these sexually-transmitted cancers slow-growing, but hormonal changes in women over 80 make it almost impossible for viruses that cause these cancers to survive.
Levada, 63, practices in Nassau County on Long Island, which she says is one of the most litigious counties in the United States. While she says she doesn’t practice defensive medicine, she adds, “It’s very hard not to order a test here and there just in case there’s a millionth of a chance you’ll miss something.”
Medicare did not begin paying for cervical cancer screening until 1990. It was a major shift for the government program, which until then had reimbursed health care providers only for cancer diagnosis and treatment.
At first, Medicare paid for patients to be screened only once every three years, and it reimbursed pathologists just $7.15 for analyzing each test sample, well under actual costs. Before long, though, pathologists began lobbying the government to double the payments. They argued that reimbursement rates were so low that laboratories would be unable to pay pathologists to analyze the tests.
Dr. James Navin, a Hawaii pathologist, launched the lobbying campaign in 1996, focusing first on trying to get Medicare administrators to raise the reimbursement rate. He worked with other pathologists to gather evidence that the rates were too low and also met with key staff members for former Vice President Al Gore and the Office of Management and Budget, according to news accounts.
When Medicare administrators rejected his request, arguing that there was not enough evidence to justify such a substantial increase, Dr. Navin turned to his congressman for help. Congress rarely passes legislation to change an individual Medicare reimbursement rate, but then-Rep. Neil Abercrombie, D-Hawaii, (now governor) proposed legislation that would do just that in 1998. Abercrombie’s office did not respond to a request for comment.
It took more than a year of lobbying, with pathologists and other physician groups first forming a coalition called People for Annual Pap Smears and later, enlisting the help of women’s groups. They cast the legislation as a women’s issue, calling one version the “Investment in Women’s Health Act.” Eventually, the reimbursement proposal got rolled into a massive budget bill, which passed Congress in November 1999. The doctors not only managed to double their reimbursement rate, they also got Medicare to increase its payment frequency, paying for patient tests every two years.
The American Society of Clinical Pathology spent $140,000 on lobbying in 1999, with some of that money supporting the reimbursement increase, lobbying records show.
Three years later, the Food and Drug Administration approved new tests that could do a better job detecting cervical cancer. Those tests could identify a strain of the sexually-transmitted human papillomavirus (HPV), which researchers had discovered caused virtually all cervical cancer.
The new HPV tests can detect 99
percent of cervical cancers and need to be repeated only every three to five years. By contrast, the Pap test had to be repeated annually because it had such a large error rate, missing as many as 30 percent of cancers.
Even though the HPV tests have been on the market now for eight years, medical practice has barely budged. Only 19 percent of doctors surveyed said they would wait three years to conduct a Pap test, after negative findings on both Pap and HPV tests, a recent study found.
“Sixty million women get Paps every year,” says Dr. Mark Schiffman, a senior investigator at the National Cancer Institute.. “A large percentage do not need to be getting them.”
Gynecologists may say publicly that patients insist on getting annual Pap smears or that they need annual wellness exams. But privately, doctors admit that they could never meet their revenue goals if these annual medical rituals disappeared, said Castle of the American Society for Clinical Pathology. The hunt for cervical cancer generates between $4 billion and $6 billion a year, he says.
The HPV tests, meanwhile, have resulted in a boondoggle of their own. For a while, doctors ordered two types of HPV tests on all patients: tests for low-risk HPVs and tests for high-risk HPVs. But then, researchers discovered that the tests for low-risk HPV did not detect cancer at all.
“Any money that’s spent on this test is wasted,” Dr. Stoler says.
Medical experts have spent years trying to get the government to either take the low-risk test off the market or refuse to pay for it. But Medicare administrators have been too preoccupied with other issues to deal with the reimbursement question, Castle says. The FDA cannot remove the tests from the market unless there is “specific evidence reported to them that the tests are harmful to patients,” a spokeswoman says.
Castle says he is concerned that some cancers are going undiagnosed because people are getting the wrong HPV test, but cannot prove that is happening.
Castle and other experts have also tried to convince Qiagen, the company that makes the test, to withdraw it from the market. But Qiagen refuses, they say, because researchers continue to order the tests.
Some doctors say that Qiagen’s sales representatives tell them that the tests remain valid, says Dr. Ann Moriarty, an Indianapolis pathologist.
Shelley Ducker, a Qiagen spokeswoman, says the company only promotes the test for high-risk HPVs to clinicians. But it keeps the test for low-risk HPVs on the market for scientists and industry researchers, who are studying different HPV strains and their role in various diseases. Some doctors who analyze HPV tests, though, are infuriated. Dr. Dina Mody, medical director of cytology at Methodist Hospital in Houston, says she is so frustrated by the confusion that she calls every doctor who orders the low-risk test to explain there is no clinical indication for it.
She says that she’s heard all kinds of crazy things, like one doctor telling her his patient insisted on the test because she thought results would show whether her boyfriend was cheating on her.
She now refuses to perform the tests, even though she’s lost several doctors’ business.
“I’m not going to do these tests, if there’s no clinical indication,” she says. “Why waste money?”
Data editor David Donald contributed to this story.