Category Archives: Advice and Tips

New hepatitis C treatments – FDA Consumer Update

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fda-logo-thumbnailFrom the US Food and Drug Administration

At the approval of several new drugs for hepatitis C is  welcome news for baby boomers—who make up three of four adults with the hepatitis C virus—and millions of other Americans, many of whom don’t yet know they are infected and carriers, says the US Food and Drug Administration in this Consumer Update.

Hepatitis C can be cured, and today’s drug therapies are very effective and easier for patients to take, says Jeffrey S. Murray, M.D., the deputy director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research. Murray is an internist who specializes in infectious diseases.

A Preventable and Curable Disease

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Can I cancel my exchange plan if my boss decides to offer coverage?

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Question Q&ABy Michelle Andrews
KHN

Q. My husband and I recently bought an HMO plan from Blue Cross Blue Shield on our state exchange.

Now my employer tells us he’s going to begin offering health insurance this month.

What if that’s a better plan and/or a better price?

Can I cancel the one I just purchased and sign up for my employer’s plan? Continue reading

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Medications for allergies – an FDA Consumer Update

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bee on flowerConsumer Update from the FDA

You’re sneezing, your eyes are itchy and you feel miserable. Seasonal allergies aren’t just a nuisance, they are real diseases that can interfere with work, school or recreation, and can range from mild to severe.

May is National Asthma and Allergy Awareness Month, and many allergy treatment options are approved by the Food and Drug Administration (FDA). For the first time, these include three sublingual (under the tongue) prescription products to treat hay fever (also called “allergic rhinitis”)—with or without eye inflammation (called “conjunctivitis”)—caused by certain grass pollens and short ragweed pollen.

The new products—GrastekOralair and Ragwitek—can be taken at home, but the first dose must be taken in a health care provider’s office.

About Allergies

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FDA warns consumers to stop using GenStrip Blood Glucose Test Strips.

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GenStrips

From the FDA

The US Food and Drug Administration is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels.

GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are “third-party” blood glucose monitoring test strips. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini). Continue reading

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Treating head lice — every parent’s nightmare

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Two lice viewed under an electron microscope. Note the claws used to grasp onto individual hairs. Credit: CDC

Lice viewed under an electron microscope, their claws grasping onto individual hairs. – CDC

Consumer Update from the FDA

Head lice. Every parent’s nightmare.

A year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA).

An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention.

Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.

Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans. Continue reading

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Watch out for websites claiming to be Canadian pharmacies, FDA warns

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Consumer Update from the US Food and Drug Administration

pills capsules in orbit FDADon’t order medicines from web sites that claim to be Canadian pharmacies.

Most are not legitimate pharmacies, and the drugs they supply are illegal and potentially dangerous.

Claiming to be a Canadian pharmacy is one of the hallmarks of Internet sites that sell illegal prescription drugs which, in many cases, are not made in Canada at all, but in a number of other countries. Continue reading

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A reader asks: Will a tax lien affect my premium tax credit?

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Question Q&ABy Michelle Andrews
KHN

Q. If I owe state and/or federal taxes and have a lien against me, and I apply for and receive a premium tax credit for health insurance on a state marketplace, will this have to be paid back at some future point?

A. There’s no clear guidance on this issue in the regulations, say tax experts. Continue reading

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Readers Ask: Are premium subsidies permanent; Do I have to meet an asset test tor Medicaid?

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Question Q&ABy Michelle Andrews, KH
January 10, 2014

Q. Are the subsidies under the health law a permanent fixture, or are they only required for the first two or three years, and then we’ll be expected to pay the full premium?

A. Unless Congress and the president enact a law repealing them, the subsidies are here to stay. The premium tax credits and cost-sharing subsidies that can make marketplace plans more affordable are written into the law as mandatory spending, says Jennifer Tolbert, director of state health reform at the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.) Continue reading

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Use certain laxatives with caution, FDA warns

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Alert IconThe US Food and Drug Administration warns that laxatives containing sodium phosphate are potentially hazardous if not taken as directed. People with certain health conditions or taking certain medications are at particularly high risk. The FDA has issued the warning after there have been dozens of reports of serious side effects, including 13 deaths, associated with the use of sodium phosphate laxatives. 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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Consumers shopping for coverage outside the marketplaces may be confused by mix of plans offered

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Illustration: Steve Goodwin/7rains

Illustration: Steve Goodwin/7rains

By Michelle Andrews

The state health insurance marketplaces that opened Oct. 1 give consumers who are looking for coverage on the individual market a whole new way to shop for health plans.

At the same time, health insurance brokers and insurers will also continue to sell plans directly to customers. Sorting out who’s selling what can be confusing.

What’s more, some brokers and insurers will not just sell policies that are outside the marketplaces. They may also offer marketplace plans and their customers may be eligible for subsidies for those marketplace plans. While shoppers can find good coverage going any of these routes, the plans and services offered may differ in important ways.

The Affordable Care Act has fundamentally changed the market for individual health insurance. In the past, insurers held nearly all the cards. In most states, they could turn applicants for coverage down if they had even minor pre-existing medical conditions.

The plans that were offered typically failed to cover common conditions such as pregnancy, and insurers generally faced few restrictions on the premiums they charged.

Starting in January, the individual market – including policies sold on the marketplaces and outside them — will become much more consumer-friendly and consistent. Insurers will no longer be allowed to deny coverage to people who are sick, and premiums will only be permitted to vary based on a few factors, including age, tobacco use, family size and where someone lives.

Every individual plan will have to cover a set of 10 comprehensive “essential health benefits,” including maternity and newborn care, hospitalization and prescription drugs, among other things.

Instead of myriad cost-sharing options, consumers will pick from four plan types: bronze plans will pay for 60 percent of medical expenses, silver plans will pay for 70 percent, gold plans 80 percent and platinum plans 90 percent. The maximum amount people will be on the hook for out-of-pocket will be capped at $6,350 for individuals and $12,700 for families.

Whether someone shops on the state marketplaces, also called exchanges, or outside them, these elements will be consistent among all plans starting in January.

The major difference between plans sold only outside the marketplaces by brokers and insurers and those that have been vetted and approved by a state exchange is that only exchange plans will make health law subsidies available to people with incomes up to 400 percent of the federal poverty level ($45,960 for an individual and $94,200 for a family of four in 2013).

But while marketplaces will sell only exchange plans, some brokers and insurers will sell both subsidized exchange plans and standard, non-subsidized individual market plans.

Brokers help consumers drill down for detailed plan information about participating providers and covered benefits, among other things, says Susan Rider, an independent insurance broker with Gregory & Appel Insurance in Indianapolis.

“Just because a plan covers autism benefits, it might not cover the specific benefits I need,” she says. “A consumer may not know to ask, but that’s where brokers come in.”

Still, consumer advocates say they’re concerned that brokers or insurers may not direct consumers first to all the exchange plans for which they could receive a subsidy to reduce their costs.

“I’d encourage anybody looking for a plan to go first to the exchange website and get a full sense of the range of options that are there,” says Sabrina Corlette, project director at Georgetown University’s Center on Health Insurance Reforms.

Insurance brokers and insurers who want to sell exchange plans must undergo training in order to do so. They typically receive a commission on plans that they sell for which they have an agreement with the insurer.

That happens for both plans sold on and off the exchange. Brokers that sell marketplace plans on the Internet must at a minimum provide consumers with the names of every available exchange plan. Other brokers don’t have to present all exchange plan options to consumers.

“They can steer people to the plans that they’re affiliated with and presumably know more about,” says Jennifer Tolbert, director of state health reform at the Kaiser Family Foundation (KHN is an editorially independent program of the foundation.) “It’s not a reason for people not to use a broker, but it’s important for people to understand.”

Likewise, consumers who go directly to an insurer’s website will see all the exchange plans it offers, as well as a link to the marketplace, where they can see all exchange plans available from other insurers.

However, consumers might fail to consider all their options because they’d see just a single insurer’s plans first, says Cheryl Fish-Parcham, deputy director of health policy at Families USA, an advocacy group.

In addition to their expertise, there may be other reasons to consider shopping with a broker or insurer. For one thing, not all insurers are represented on the exchanges; in some cases the number may be very limited. Consumers who want to buy a policy from a particular insurer may need to shop outside the marketplace.

And for people whose income is close to or exceeds 400 percent of the federal poverty level, “it may not be worth the hassle of filling out the subsidy application and maybe changing your carrier and your provider,” says Carrie McLean, director of customer care for ehealthinsurance.com, an online web broker that has been authorized to sell exchange plans in the 34 states in which the federal government is running the exchanges or partnering with the states. “That’s going to be important for consumer choice.”

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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