Category Archives: Lab Tests & Diagnostics

Many women receiving unnecessary Pap tests

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Cytological specimen showing cervical cancer specifically squamous cell carcinoma in the cervix. Tissue is stained with Pap stain and magnified x200. PHOTO courtesy of NCIBy Stephanie Stephens,
Health Behavior News Service

As many as half to two-thirds of women who’ve undergone hysterectomies or are older than 65 years in the United States report receiving  Pap tests for cervical cancer.

This prevalence is surprising in light of the 2003 U.S. Preventive Services Taskforce guidelines recommending that women discontinue Pap testing if they have received a total hysterectomy without a history of cervical cancer and if they are over age 65 years with ongoing and recent normal Pap test results.

Performing these unnecessary tests can result in stress for the patient, increased costs, and inefficient use of both provider and patient time, concludes a new study in the American Journal of Preventive Medicine.

“During this time of health care reform, we could probably use our resources more wisely,” said corresponding author Deanna Kepka, Ph.D., M.P.H., assistant professor at the University of Utah’s College of Nursing and Huntsman Cancer Institute. Continue reading

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Only half of US adults being screened for diabetes

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GlucometerBy Sharyn Alden
Health Behavior News Service

A study in American Journal of Preventive Medicine finds that only half of adults in the U.S. were screened for diabetes within the last three years, less than what is recommended by the American Diabetes Association (ADA).

As the rates of obesity have increased, so does the incidence of type 2 diabetes, which also increases the risk for cardiovascular disease.

Up to one-third of people with diabetes are undiagnosed, note the researchers. Continue reading

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Quantifying the ‘Angelina Jolie effect’

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Actress’ impact on genetic testing for breast, ovarian cancer is ‘global and long lasting’

Angelina Jolie - Photo courtesy of the UK Foreign and Commonwealth Office

Angelina Jolie – Photo courtesy of the UK Foreign and Commonwealth Office

By Mary Engel / Fred Hutch News Service

Sept. 18, 2014

The so-called Angelina Jolie effect not only is real but has been “global and long lasting,” leading to a twofold increase in the number of women getting genetic testing to help determine their risk for hereditary breast cancer, according to new studies from the United Kingdom and Canada.

The number of women found to have a genetic mutation that increased their risk also has doubled.

And contrary to concerns that women at low risk for hereditary breast cancer would flood testing centers, researchers said that those being tested are women like Jolie who have a family history of breast cancer or who have personal risk factors such as ethnicity.

Certain ethnic groups, including Ashkenazi Jews, have a higher prevalence of BCRA mutations, which significantly increase breast cancer risk.

Women got the correct message

“What surprised us was that we didn’t get the worried well,” said Dr. Andrea Eisen, head of preventive oncology for breast cancer care at the Sunnybrook Odette Cancer Centre in Toronto and an author of the Canadian study, in a phone interview.  “We got women who got the correct message. That was gratifying.”

Jolie disclosed in a May 2013 op-ed in The New York Times that she had undergone a preventive double mastectomy after finding that she carries the rare BRCA1 gene mutation, which dramatically raises her risk of breast and ovarian cancers. Continue reading

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How much will your x-ray cost? You can find out in New Hampshire

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This KHN story also ran in the .

When Anthem Blue Cross Blue Shield became embroiled in a contract dispute with Exeter Hospital in N.H. in 2010, its negotiators came to the table armed with a new weapon: public data showing the hospital was one of the most expensive in the state for some services.

Local media covering the dispute also spotlighted the hospital’s higher costs, using public data from a state website.

When the dust settled, the insurer had extracted $10 million in concessions from Exeter. The hospital “had to step back and change their behavior,” said health policy researcher Ha Tu, who studied the state’s efforts to make health care prices transparent.

New Hampshire is among 14 states that require insurers to report the rates they pay different health care providers —and one of just a handful that makes those prices available to consumers.

The theory is that if consumers know what different providers charge for medical services, they will become better shoppers and collectively save billions.

In most places, though, it’s difficult, if not impossible to find out how much you will be charged for medical care. And with more people enrolled in high-deductible insurance plans, there is a growing demand for accurate price information. Continue reading

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How Racism Creeps Into Medicine – The Atlantic

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Illustration of the lungs in blueIn 1864, the year before the Civil War ended, a massive study was launched to quantify the bodies of Union soldiers. One key finding in what would become a 613-page report was that soldiers classified as “White” had a higher lung capacity than those labeled “Full Blacks” or “Mulattoes.” The study relied on the spirometer—a medical instrument that measures lung capacity.

via How Racism Creeps Into Medicine – The Atlantic.

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Variation in hospital charges for blood tests called ‘irrational’

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RedBloodCellsBy Roni Caryn Rabin
KHN

One California hospital charged $10 for a blood cholesterol test, while another hospital that ran the same test charged $10,169 — over 1,000 times more.

For another common blood test called a basic metabolic panel, the average hospital charge was $371, but prices ranged from a low of $35 to a high of $7,303, more than 200 times more.

The wide disparity in hospitals’ listed charges for routine blood tests at California hospitals was revealed in a study published in the August issue of BMJ Open. The study examined the listed charges for routine blood tests performed in 2011. Continue reading

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App lets you determine your neighborhood’s radon risk

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Screen Shot 2014-01-21 at 11.28.29From the Washington State Department of Health

Olympia, January 21, 2014 – Washington residents now have a new online map to check and see if their neighborhood has a geological risk for the cancer-causing gas, radon, using a new state app. The new app is offered by the state Department of Health’s Washington Tracking Network.

Some areas of the state, such as Spokane and Clark counties, are well-known for having higher levels of radon, but the new online map shows that there are some areas around the Puget Sound such as Pierce and King counties that might come as a surprise.  Continue reading

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Patients going for free preventive care surprised by charges

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Exclamation PointBy Michelle Andrews
KHN

The new health-care law encourages people to get the preventive services they need by requiring that most health plans cover cancer screenings, contraceptives and vaccines, among other things, without charging patients anything out of pocket.

Some patients, however, are running up against coverage exceptions and extra costs when they try to get those services.  Continue reading

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Check your blood pressure, give your contact info away

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By April Dembosky, KQED

Health insurance companies are on the prowl for more customers. There are still three months to go for people to enroll in health plans under the Affordable Care Act, but insurers don’t want to rely solely on state or federal websites to find them.

solohealthSome are finding a path to new customers by partnering with companies that operate health-screening kiosks –- those machines in supermarkets and drug stores where people check their blood pressure or weight.

One of these kiosks sits in aisle 10 of a Safeway grocery store in a city near San Francisco. Sitting down at the machine is like slipping into the cockpit of a 1980s arcade game. Continue reading

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Nipple aspirator

Nipple aspirate test is no substitute for mammogram – FDA

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Consumer Update from the US Food and Drug Administration

ucm378297Many women admit that getting a mammogram is no fun, and may wish there was an easier, more comfortable way to screen for breast cancer in its earliest and most treatable stages.

Some companies today are promoting a test in which a breast pump is used to collect fluid from a woman’s nipple to screen for abnormal and potentially cancerous cells. This test—called a nipple aspirate—is being marketed as the latest and greatest tool in early breast cancer screening, one that is easier, more comfortable and less painful than the mammogram.

However, there is no clinical evidence to support these claims, says David L. Lerner, M.D., a medical officer at the Food and Drug Administration (FDA) and a specialist in breast imaging.

“FDA’s concern is that the nipple aspirate test is being touted as a stand-alone tool to screen for and diagnose breast cancer as an alternative to mammography,” Lerner explains. “Our fear is that women will forgo a mammogram and have this test instead.” This could result in serious health consequences if breast cancer goes undetected, he notes.

FDA is unaware of any valid scientific data to show that nipple aspirate tests, when used on their own, are an effective screening tool for any medical condition, including the detection of breast cancer or other breast disease, Lerner says. Researchers are still studying whether these tests may one day be used, in conjunction with other medical devices, to screen for disease.

In February 2013 FDA issued a warning letter to Atossa Genetics, Inc. that, among other things, informed the company that their test was misbranded in that its labeling was false or misleading. The agency asked the firm to take prompt action to correct the violations addressed in the warning letter. In October 2013, Atossa initiated a voluntary recall to remove the ForeCYTE Breast Health Test from the market.

Unsubstantiated Claims

In addition to stating that the test can help women 18 years and older determine their risk level for breast cancer, Atossa claimed that its test was “literally a Pap smear for breast cancer.” According to FDA medical officer Michael Cummings, M.D., who reviews obstetrical and gynecological devices for the agency, this claim is unsubstantiated.

“The cervical Pap smear has a known clinical benefit supported by extensive clinical studies over many years,” Cummings says. “Its scientific ability to screen for cervical cancer is unquestioned.” The nipple aspiration test has no such evidence supporting it, he attests.

In addition, Lerner explains that if a Pap smear shows abnormal cells of the cervix, there are follow-up procedures that can be done to try to identify the location of those cells, after which a biopsy of the area is possible. With a breast nipple aspirate, if there are abnormal cells, the test does not target where those cells are coming from, so a biopsy may not be possible. Moreover, while the risk of abnormal cervical cells progressing to cancer is known, the risk of abnormal breast cells progressing to cancer is not.

Lerner says the test may produce results that are falsely positive or falsely negative. “False positives are possible because cells can be damaged in the aspiration process and look abnormal,” he notes. “We are even more concerned about false negatives,” he adds. Companies acknowledge that over 90% of their fluid samples may contain either very scant cells or no cells at all. Yet the companies call such results “diagnostically useful” and even conclude that a patient is healthy based on a cell-free sample, he says. “The test may be missing cancers and giving women dangerous false assurance,” Lerner says.

Mammography Still the Best

The mammogram can be uncomfortable for the woman being screened because it compresses the breast to flatten out the breast tissue and increase the clarity of the X-ray image. Still, FDA is not alone in believing that mammography is the most effective method for screening for breast cancer. Other organizations agree, including the American Cancer Society, the American College of Radiology (the professional society of physicians who specialize in medical imaging) and the National Cancer Institute, a division of the National Institutes of Health.

The National Cancer Institute states that screening mammography can help reduce the number of deaths from breast cancer among women ages 40 to 70. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and that it should not be used as a breast cancer screening technique.

FDA recommends that women who have received a nipple aspirate test as a form of breast cancer screening should also have a mammogram according to screening guidelines or as recommended by their doctor, and should talk to their health care professional about whether additional tests are needed.

“The bottom line is that women should not rely solely on these nipple aspirate tests for the screening or diagnosis of breast cancer, “Lerner says. “Mammography is still the gold standard.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Dec. 12, 2013

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Insurers question value of some genetic tests

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3d Chromosome with DNA visible insideBy Michelle Andrews

The day when a simple blood test or saliva sample can identify your risk for medical conditions ranging from cancer to Alzheimer’s disease seems tantalizingly close.

But while advances in genetic testing increasingly give people critical information that may help prevent disease, genetics experts say sometimes the hype around these tests has outstripped the science.

Insurers, meanwhile, generally only cover tests if there’s strong scientific evidence that it can provide a health benefit to patients.

“The utility of some tests is not as clear as we’d like to think,” says Sharon Terry, president and CEO of the Genetic Alliance, an advocacy organization aimed at promoting health through genetics. “These technologies are advancing at a really rapid rate, and they’ll make a big impact on health. But the data gathering you need to do to determine clinical utility is difficult.” 

Insurers don’t cover a $99 genetic test sold directly to consumers by 23andMe that provides information about more than 240 genetic health conditions and traits that the company says can help people understand their health risks and carrier status for inherited disease, among other things.

In November, the Food and Drug Administration ordered the company to stop marketing the test because the agency concluded it was a medical device and subject to FDA review and approval, which it hadn’t received. In early December, the company announced it would stop selling its health-related genetic reports while it undergoes federal review.

Insurers commonly cover many diagnostic genetic tests that are ordered by doctors, for example, tests to look for rare diseases like cystic fibrosis in infants or children.

Insurers will typically also cover preventive genetic tests if the patient meets criteria based on family history or other risk factors, and if there’s an effective test with proven clinical benefit that’s recommended by a standard-setting organization like the U.S. Preventive Services Task Force.

In such cases, insurers also typically cover genetic counseling to first collect someone’s family and personal history to determine whether that patient is a candidate for a particular genetic test, and then help patients understand their results, says Rebecca Nagy, president of the National Society of Genetic Counselors.

Coverage is generally routine, but in recent years some health plans have begun paying a declining percentage of the cost of testing, says Nagy. “Companies that were covering a test at 90 percent are now covering it at 80 percent,” she says. Testing can be pricey. A genetic test for the BRCA mutations, for example, may cost $3,000 or more.

Under the Affordable Care Act, most health plans must make genetic counseling and testing available without any out-of-pocket cost to women whose family history indicates they have a higher than average risk of having mutations in the BRCA1 or BRCA2 genes that predispose women to breast and ovarian cancers. The ACA prevention coverage requirements are based on recommendations by the U.S. Preventive Services Task Force, which doesn’t recommend other preventive genetic tests.

Women frequently request genetic testing for breast cancer mutations because they believe their risk is higher than it is, say experts.

This is particularly true since the actress Angelina Jolie disclosed that she had a double prophylactic mastectomy to guard against breast cancer after learning she has a mutation in the BRCA1 gene.

But if a woman’s only family history of the illness is one relative who developed breast cancer at age 65, for example, that, by itself, doesn’t mean she’s at higher risk, says Nagy. With counseling, “many times we can give them reassuring numbers.”

In September, health insurer Cigna began requiring genetic counseling for members who were interested in three “commonly ordered and commonly misunderstood” genetic tests, says David Finley, the company’s national medical officer.

The tests covered by the new requirement are those for the BRCA mutations for breast and ovarian cancers, colorectal cancer and Long QT syndrome, an inherited heart condition that can cause sudden, potentially fatal heart arrhythmias.

Doctors who order these tests don’t necessarily suggest patients receive genetic counseling, even though national organizations recommend it, says Finley.

“From our perspective, the only way to make sure that patients are getting the information and taking the time that they need about these tests is to require that they see a genetic counselor,” he says.

Like other insurers, Cigna typically doesn’t cover genetic tests that don’t provide clinical benefit to the patient. “You don’t test for testing’s sake,” says Susan Pisano, a spokesperson for America’s Health Insurance Plans, a trade group.

One of the tests insurers generally don’t cover identifies which of three versions of the APOE gene someone carries. The APOE gene is associated with late-onset Alzheimer’s disease, and someone with two so-called “e4” versions of the gene is at higher risk of developing the disease.

“[The APOE test] is ordered fairly frequently, but we don’t pay for it,” says Cigna’s Finley. “It’s not enough for a test to be accurate and scientifically reliable, it has to benefit the patient. And with the APOE test I don’t think they’ve met those standards.”

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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