Category Archives: Columns

Can I get my insurance to pay for an IUD removal?


Question marksBy Michelle Andrews

Q. I have health insurance through my husband’s union. I need to have my IUD removed and replaced and it is not covered by insurance. The self-pay price is over $1,000. Is there anything I can do about this?

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Treating head lice — every parent’s nightmare

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


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


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


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


Question Q&ABy Michelle Andrews

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


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


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


Use certain laxatives with caution, FDA warns


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

Nipple aspirator

Nipple aspirate test is no substitute for mammogram – FDA


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

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, 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 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.


5 things to remember when shopping on the health insurance marketplaces


The number five 5By Michelle Andrews

They’re here. The state health insurance marketplaces, a signature feature of the Affordable Care Act, open for business today. More than three years in the making, the marketplaces, or exchanges, allow consumers to compare a range of health plans online that meet the standards of the law, apply for subsidies and pick the best policy for their needs.

Here are a few things to keep in mind.

1. Don’t wait until the last minute to look for a plan.

Open enrollment lasts through March. If you’re uninsured and want coverage to start on Jan. 1, you must sign up by Dec. 15. But don’t wait until the day before to shop, say experts.

“Start early,” says Cheryl Fish-Parcham, deputy director of health policy at Families USA, a consumer advocacy organization. “If you have questions, that’ll give you time to ask them.”

With an estimated 7 million people expected to buy coverage through the exchanges, building in extra time into the enrollment process will also give you breathing room if, as expected, the marketplace experiences some glitches in processing your application, determining your eligibility for subsidies, and the like.

2. Look beyond the premium when figuring potential costs.

When you evaluate marketplace plans, consider your total potential financial exposure, including the plan’s deductible, copayments or coinsurance, and the maximum out-of-pocket amount you could be responsible for every year.

Exchange plans in every state will cover a similar package of 10 “essential health benefits,” but consumers’ proportion of the costs will vary: they’ll pay 40 percent of costs if they enroll in a bronze plan, 30 percent of costs in a silver plan, 20 percent in gold and 10 percent in platinum.

This year only, some plans may have separate deductibles for medical services and prescription drugs. And a recent analysis by Avalere Health of exchange plans in six states found significant variations in prescription drug cost sharing. Ninety percent of bronze-level plans it examined charged 40 percent coinsurance for drugs in tiers 3 and 4, which typically include pricey specialty drugs. Many silver level plans, in contrast, charged flat copayments averaging $70 for drugs in those tiers.

“Make sure the benefits are covered the way you want them to be … and look for limits on services,” says Kevin Lucia, a senior research fellow at Georgetown University’sCenter on Health Insurance Reforms.

3. Check provider networks.

It’s been widely reported that one of the ways that insurers have been able to keep premiums more affordable on the exchanges is by limiting provider networks. If it’s important to you that certain doctors or hospitals be in your network, check those details before signing up.

Smaller isn’t necessarily less desirable, say experts. “If all your providers participate in a narrow network, it’s not a problem,” says Jennifer Tolbert, director of state health reform at the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)

4. Estimate your income carefully.

Roughly 80 percent of people who buy exchange plans will qualify for premium tax credits, according to Avalere Health. The credits, available to people with incomes up to 400 percent of the federal poverty level ($45,960 for an individual or $94,200 for a family of four in 2013) will be based on your projected income for next year. They can be sent directly to the insurer, reducing your monthly premium. If your income estimate is too low, however, you could have to repay at tax time any excess amounts you received.

It will be important to monitor your income during the year. Inform the exchange promptly if it changes and you realize your estimate was too high or too low so your tax credit can be adjusted.

5. Don’t be fooled by lookalike websites.

In a handful of states, experts have already encountered websites that look like official state marketplace sites but aren’t. Now that the marketplaces are open, they expect more of these sites to crop up.

“Some could be deceptive but fairly benign [sites] designed to sell legitimate insurance products,” says James Quiggle, a spokesperson at the Coalition Against Insurance Fraud. “Other sites could be malicious and intended to steal your identity.”

One surefire way to ensure that you’re visiting the official health insurance marketplace for your state is through  If you live in one of the 34 states in which the federal government is operating the state exchange, you’ll be directed to information about how to get started picking a plan. If you live in one of the 16 states and the District of Columbia that operate their own state exchange, you can link to your state exchange through the federal website.

Please send comments or ideas for future topics for the Insuring Your Health column to

This article was reprinted from 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.


What options do parents have to get coverage for their kids?


An umbrella sheltering medicines - credit MicrosoftBy Michelle Andrews

As the October launch of the state health insurance marketplaces approaches, parents have many questions about covering their children.

Q. Why is it that the adult children of retired members of the military cannot stay on their parents’ insurance? My husband served for 22 years in the Marine Corps. My adult children are still in college, but they have been dropped from our insurance, Tricare Prime.

A. The Affordable Care Act allows adult children to stay on their parents’ health plan until they reach age 26 in most cases.

But Tricare, the health plan for military service members, is governed by a different set of statutes, and the ACA’s provisions that expand young adult coverage don’t apply to it.

Tricare allows dependent children to remain on their parents’ plan until they turn 21, or until they turn 23 if they’re full-time students who are supported financially by their parents, according to Austin Camacho, chief of the benefit information and outreach branch of Tricare Management Activity.

Once adult children are no longer eligible for regular Tricare, they can enroll in the Tricare Young Adult program, which provides coverage for children up to age 26 who are unmarried and don’t have employer coverage available to them, says Camacho.

Unlike regular Tricare, however, the young adult program is a premium-based plan that costs up to $180 per month.

Q. I am a divorced dad who has responsibility for maintaining my 15-year-old daughter’s health insurance. It was easy when I was working and had a corporate health plan. Now that I am retired and in the Medicare program, I am looking for alternatives when the new exchanges open in October. Can I buy health insurance for just my underage daughter on these new exchanges?

A. Yes, you can. The new health insurance marketplaces, also called exchanges, are required to sell child-only policies for children up to age 21.

If you claim your daughter as a dependent on your tax return and your income is less than 400 percent of the federal poverty level ($62,040 for a family of two in 2013), you may qualify for a premium tax credit to reduce the cost of coverage.

If your ex-wife claims your daughter as a dependent, however, in order to receive the tax credit she would have to apply for it based on her household income, says Brian Haile, a senior vice president for health policy at Jackson Hewitt Tax Service in Nashville.

Depending on your income, your daughter might qualify for health insurance through your state’s Medicaid or CHIP programs for lower income people.

As of January 2013, all but four states covered children in families with incomes up to at least 200 percent of the federal poverty level ($31,020 for a family of two in 2013) through one of those programs, according to the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)

Q. My 21-year-old son is a college student, and I know the Affordable Care Act has made him eligible to remain on my employer-based insurance plan until age 26. However, if it’s cheaper for him to get subsidized coverage through the health insurance marketplace, can he do so?

A. It depends. Almost anyone can shop for coverage on the health insurance marketplace. But your son will only be eligible for subsidies to reduce the cost of coverage under certain circumstances.

If you don’t claim him as a dependent on your tax return and his own income is between 100 and 400 percent of the federal poverty level ($11,490 and $45,960 in 2013), he could be eligible for premium tax credits on the exchange.

But if you do claim him as a dependent, his eligibility for subsidies will be based on your family’s income, not just his own.

It’s also worth looking into Medicaid eligibility for your son. Roughly half of states have decided to expand Medicaid coverage to adults with incomes up to 138 percent of the federal poverty level ($15,856 for an individual in 2013) as provided for under the Affordable Care Act. Medicaid would be even less expensive than a private plan on an exchange.

But if you claim your son as a dependent on your tax return, your family’s income would have to be no more than 138 percent of poverty in order for him to qualify, says Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities.

Please send comments or ideas for future topics for the Insuring Your Health column to

This article was reprinted from 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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FDA moves to reduce use of long-acting opioid pain drugs


The US Food and Drug Administration has changed the labeling on long-acting opioids, such as OxyContin, in an effort to limit the use of these drugs to patients with severe refractory pain. Here’s is the Consumer Update from the FDA released today.

FDA Consumer Update

FDA logojpgConsumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.

In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.

“The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use,” says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA’s Center for Drug Evaluation and Research.

“Altogether, the actions we’re now announcing are part of FDA’s efforts to make opioids as safe as possible for those who need them,” Throckmorton adds.

He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.

How Labeling Will Change

Opioids work by changing the way the brain perceives pain. They are available by prescription as pills, liquids, and skin patches.

Extended-release and long-acting (ER/LA) forms pose a greater safety concern because—as their names suggest—they produce their effects for a longer period, and many contain higher doses compared with immediate release or opioid/non-opioid combination products.

They include, to name a few, long acting versions of opioids such as morphine, oxycodone, and fentanyl.

Currently, labeling on these ER/LA opioids indicate they are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

However, the updated indication for when to prescribe and take these medicines will, when finalized, emphasize that other, less potentially addictive, treatment options should be considered first.

FDA is requiring labeling that says the drugs are “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

The “limitations of use” portion of the new labeling retains language indicating that the drugs are not intended for use as an “as-needed” pain reliever.

Furthermore, the new labeling adds: “Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

This new labeling language emphasizes that patients in pain should be assessed not only by their rating on a pain intensity scale, but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

This framework better enables prescribers to make decisions based on a patient’s individual needs, given the serious risks associated with ER/LA opioids, against a backdrop of alternatives such as immediate release (IR) opioids and non-opioid pain relievers.

It allows prescribers to make an assessment of pain relative to a patient’s ability to perform daily activities or enjoy a reasonable quality of life.

FDA-approved labeling of these pain relievers already describes the effects on newborns of exposure to these drugs while in the mother’s womb and warns against use by women during pregnancy and labor and while nursing.

The new labeling, however, will provide more detail and will elevate the risk of neonatal opioid withdrawal syndrome (NOWS) to the most prominent position in labeling—a boxed warning. Symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

Postmarket Studies

Recognizing the need for more scientific data about the benefits and risks of ER/LA opioids when used over long periods, FDA also decided to require drug companies to conduct longer term studies and trials of ER/LA opioid pain relievers on the market.

The companies must evaluate long-term use, with the goal of assessing a variety of known serious risks, including misuse, abuse, addiction, overdose, and death, as well as the risks of developing increasing sensitivity to pain.

Education to Reduce Risk

Following implementation of the safety labeling changes, certain educational materials for patients and health care professionals will be modified to reflect the new labeling for the ER/LA opioid pain relievers.

As part of the new labeling changes, opioid manufacturers also must revise a paper handout patients receive with their prescription.

The ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) will also be updated after the labeling changes are finalized.

The ER/LA Opioid Analgesics REMS requires manufacturers to make available continuing education courses for health care professionals who prescribe these drugs.

The courses, from accredited sources, teach about risks and safe prescribing and safe use practices of these medications.

“By improving information about the risks of ER/LA opioid pain relievers and by clarifying the populations for whom the benefits outweigh the risks, we aim to improve the safe and appropriate use of these products,” says Throckmorton.

He adds: “This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids.”

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

Sept 10, 2013


What is gluten-free?


An FDA Consumer Update

White Bread by Ricardo PerinaPeople with celiac disease can now have confidence in the meaning of a “gluten-free” label on foods.

The Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it “gluten- free.” The rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard.

This rule has been eagerly awaited by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.

As one of the criteria for using the claim “gluten-free,” FDA is setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label.

This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten.

This level is consistent with those set by other countries and international bodies that set food safety standards.

“This standard ‘gluten-free’ definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled ‘gluten-free’ meet a clear standard established and enforced by FDA,” says Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine.

Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary—not eating gluten. Without a legal definition of “gluten-free,” these consumers could never really be sure if their body would tolerate a food with that label, she adds.

“This is a tool that has been desperately needed,” Levario says. “It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them.”

“Without proper food labeling regulation, celiac patients cannot know what the words ‘gluten free’ mean when they see them on a food label,” says Allessio Fasano, M.D., director of the Center for Celiac Research at MassGeneral Hospital for Children, visiting professor of pediatrics at Harvard Medical School and member of the American Celiac Disease Alliance.

What Is Gluten?

Gluten means the proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains.

As many as 3 million people in the United States have celiac disease. It occurs when the body’s natural defense system reacts to gluten by attacking the lining of the small intestine.

Without a healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious health problems may include diabetes, autoimmune thyroid disease and intestinal cancers.

Before the rule there were no federal standards or definitions for the food industry to use in labeling products “gluten-free.” An estimated 5 percent of foods currently labeled “gluten-free” contain 20 ppm or more of gluten.

How Does FDA Define ‘Gluten-Free’?

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:

  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
  2. an ingredient derived from these grains and that has not been processed to remove gluten
  3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.

The regulation will be published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance.

Taylor says he believes many foods labeled “gluten free” may be able to meet the new federal definition already. However, he adds, “We encourage the food industry to come into compliance with the rule as soon as possible.”

Under the new rule, a food label that bears the claim “gluten-free,” as well as the claims “free of gluten,” “without gluten,” and “no gluten,” but fails to meet the requirements of the rule would be considered misbranded and subject to regulatory action by FDA.

Those who need to know with certainty that a food is gluten-free are heralding the arrival of this definition. “This is a huge victory for people with celiac disease,” says Levario. “In fact, that’s the understatement of the year.”

Says Taylor, “FDA’s ‘gluten-free’ definition will help people make food choices with confidence.”

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

August 2, 2013


Benefits on health marketplace will be similar but costs will vary


By Michelle Andrews

Shopping CartAs the state health insurance marketplaces, also called exchanges, get set to launch in October, many people have questions about the coverage that will be offered there. Here are a few that were posed to me recently.

Q. Are there unintended consequences of shopping through an exchange? For example, are the benefits of a plan with a lower monthly premium less comprehensive than the benefits of an expensive plan? And are there plans available only to people who qualify for subsidies, so that once income increases, the consumer must switch to a different plan?

A. All plans sold on the exchanges must cover 10 so-called essential health benefits, including prescription drugs, emergency and hospital care, and maternity and newborn care.

For the most part, the plans will differ not in which benefits they cover but in the proportion of costs that consumers will be responsible for paying.

There will be four basic types of plans: Platinum plans will pay 90 percent of the cost of covered medical services, on average, while consumers will be responsible for 10 percent; gold plans will pay 80 percent; silver plans will pay 70 percent; and bronze plans, 60 percent. Premiums will vary based on those percentages, so platinum plans generally will be pricier than bronze ones.

Individuals and families 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) may be eligible for federal tax credits to help pay premiums.

Consumers “can use the premium subsidy to purchase any plan,” says Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities.

If your income increases during the year, you may no longer qualify for the same level of assistance, but you won’t have to switch plans.

However, you may have to repay any overpayments that were made to insurers if your projected income turns out to be higher than your actual income.

On the other hand, if your income falls, you may be eligible for a larger tax credit. That’s why it’s important to report any income changes to the exchange promptly.

second type of subsidy available on the exchanges will reduce the amount that people owe in co-payments, deductibles and other out-of-pocket costs. The cost-sharing subsidy is available to individuals and families with incomes up to 250 percent of the poverty level ($28,725 for an individual and $58,875 for a family of four in 2013).

To qualify for this subsidy, you must buy a silver plan, Park says. If your income changes, however, you won’t be responsible for any overpayments.

Q. Once the exchanges open, how much will an insurer be allowed to increase premiums annually? And are those increases based on claims?

A. Premium increases are driven by many factors, including medical costs and the health of the people covered by a particular plan.

The Affordable Care Act discourages insurers from imposing unreasonable premium increases in a couple of ways. Insurers in the small-group and individual markets that want to raise premiums by 10 percent or more must submit data, projections and other information to justify the increase to state or federal regulators, who review the requests and make the information available to the public.

Asking insurers to justify why they want to increase rates should act as a deterrent to unreasonable increases, experts say.

But the law doesn’t give regulators new authority to refuse rate increases, says Timothy Jost, a law professor at Washington and Lee University in Lexington, Va. It does, however, provide funding for states to beef up their rate-review processes.

The Department of Health and Human Services says that increased scrutiny of insurance rates has led to a decrease in rate increases, says Jost, “and that’s probably true.”

In addition, the law requires insurers to spend at least 80 percent of the money they collect in premiums on medical claims and quality improvements rather than on administrative activities such as marketing. If they exceed that limit, they must rebate the excess to consumers.

Insurers will return $500 million to 8.5 million consumers — about $100 per eligible family — by mid-August of this year for overcharges in 2012, according to the Obama administration. Rebates may come in various ways, including a check or a reduction in the following year’s premium.

Q. My parents are legal immigrants over 65 but not yet eligible to buy into Medicare because they haven’t lived in the United States for five years. Will they be able to buy health insurance on the federal exchange?

A. Yes, legal immigrants will be able to shop for coverage on the exchanges, where they may be eligible for premium tax credits if their income is no more than 400 percent of the federal poverty level ($62,040 for a couple in 2013).

Immigrants living in the United States without legal permission, on the other hand, are not permitted to buy coverage on the exchanges even if they wish to pay the entire premium out of pocket.

Please send comments or ideas for future topics for the Insuring Your Health column to

This article was reprinted from 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.


‘Will my family be eligible for subsidized coverage?’


Question marksBy Michelle Andrews

This week, I respond to reader questions about coverage subsidies for families under the Affordable Care Act, filling the gaps in Medicare coverage and laws governing health plans in companies that conduct business in more than one state.

Q. I expect the annual premium for my company’s group plan to be about $24,000, or 50 percent of my family’s income. Will my family be eligible for subsidized coverage on the state insurance exchanges in 2014, provided we meet the poverty-level requirements?

A. It depends. Under the Affordable Care Act, companies with 50 or more workers must offer health insurance coverage that is both affordable and adequate; otherwise, their workers may be eligible for subsidized coverage on the online health insurance exchanges if their income is less than 400 percent of the federal poverty level ($94,200 for a family of four in 2013).

A plan is considered adequate if it covers at least 60 percent of an employee’s covered medical expenses and affordable if the cost for employee-only coverage doesn’t exceed 9.5 percent of a worker’s income.

Some consumer advocates argued that the 9.5 percent test should also apply to the cost of family coverage, which is generally much more expensive than employee-only coverage.

But in a final rule issued in February, the Internal Revenue Service said that it would not consider the premium for family coverage in determining affordability.

If the premium for employee-only coverage at your company is less than 9.5 percent of your income, your family may be out of luck.

“The whole family could be barred from premium tax credits on the exchange,” says Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities.

Depending on family income and size, however, the kids could be eligible for coverage under their state’s Medicaid or CHIP program, Park says.

Q. I am turning 65 in October. I will be selecting a Medigap policy to cover the cost of the coinsurance for charges not covered by Medicare. Are there changes planned in 2014 to govern Medigap costs? And what happens if I choose to change my Medigap policy after one year? Will insurers examine my medical history to determine whether to cover me?

A. Approximately one in four Medicare beneficiaries has a Medigap supplemental policy to cover the gaps in Medicare coverage, including deductibles and 20 percent coinsurance for many charges. Several of the most popular policies cover all of beneficiaries’ deductibles.

In recent years, as part of the effort to bring down the federal deficit, federal officials and policy experts have made several proposals to increase cost-sharing on supplemental policies.

The thinking is that if seniors had to pay for some of the costs of care, they would be more careful in their medical decisions, thus saving Medicare money.

To date, none of those plans has been adopted, and experts say they don’t anticipate major changes anytime soon.

“We do not see any significant changes…in 2014,” says Dan Mendelson, CEO of Avalere Health, a research and consulting firm with experience in Medicare.

After you turn 65 and enroll in Medicare Part B, there’s a six-month open enrollment period during which beneficiaries can sign up for a Medigap policy without having medical conditions taken into account. If you decide to switch plans later on, however, insurers don’t necessarily have to issue you a policy.

Q. I work for a company that is based in one state but has stores in several states. I belong to the company’s group health plan. Which state laws govern my policy — that of the home office or that of the state where I work?

A. Chances are good that your company plan is self-funded, meaning your employer pays for workers’ health-care claims directly rather than contracting with an insurer.

The bigger the company, the more likely it is to be self-funded. Eighty-one percent of workers at companies with 200 or more employees are in a self-funded plan, compared with 15 percent of workers at smaller firms, according to the Kaiser Family Foundation’s 2012 survey of employer-sponsored health benefits. (Kaiser Health News is an editorially independent project of the Kaiser Family Foundation.)

If your company is self-funded, it doesn’t matter where it’s based because self-funded health plans are not subject to state insurance laws.

So, for example, it wouldn’t have to comply with state coverage mandates that require health plans to provide certain benefits, such as treatment for autism or infertility.

Because large companies often provide relatively generous benefit packages anyway, the impact of those exceptions on workers may be small, say experts.

Please send comments or ideas for future topics for the Insuring Your Health column to

This article was reprinted from 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.