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Health & Fitness (233)

WASHINGTON (AP) -- Huge list prices charged by hospitals are drawing increased attention, but a federal law meant to limit what the most financially vulnerable patients can be billed doesn't seem to be making much difference.

A provision in President Barack Obama's health care overhaul says most hospitals must charge uninsured patients no more than what people with health insurance are billed.

The goal is to protect patients from medical bankruptcy, a problem that will not go away next year when Obama's law expands coverage for millions.

Because the Affordable Care Act doesn't cover everyone, many people will remain uninsured. Also, some who could sign up are expected to procrastinate even though the law requires virtually everyone to have health insurance.

Consumer groups that lobbied for a "fair pricing" provision are disappointed. A university researcher who's studied the issue says the government doesn't seem to be doing much enforcement, and at least one state, Colorado, enacted a stricter rule since the federal statute passed.

Critics say the law has several problems:

-It applies only to nonprofit institutions, which means about 40 percent of all community hospitals are exempted. By comparison, the Colorado law also covers for-profit hospitals.

-It lacks a clear formula for hospitals to determine which uninsured patients qualify for financial aid, and how deep a discount is reasonable. A California law spells out such a formula for that state's hospitals.

-More than three years after Obama signed his law, the Internal Revenue Service has not issued final rules explaining how hospitals should comply with the federal billing limits. Delay doesn't signal a high priority.

"We still hear the same stories about patients who are being sent to (debt) collection," said Jessica Curtis, director of the hospital accountability project at Community Catalyst, a Boston-based advocacy group that led the push for billing limitations. "It's the same behavior that we were seeing before the passage of the Affordable Care Act."

The Obama administration responds that fair pricing is the law of the land, and that hospitals are expected to comply even if the IRS has not finalized the rules. The agency has begun compliance reviews, a spokeswoman said.

The health law "helps to protect patients from hidden and high prices and unreasonable collection actions," said Treasury Department spokeswoman Sabrina Siddiqui.

The American Hospital Association says it urges members to limit charges to the uninsured in line with the federal law. But neither the administration nor the industry has statistics on how many hospitals are doing so.

Health and Human Services Secretary Kathleen Sebelius recently took on hospital pricing policies when she released federal data that document wide disparities in what different hospitals charge for the same procedures.

Most patients never face those list prices because private insurers negotiate lower rates and government programs such as Medicare get to set what they will pay. The burden of paying list price falls on the uninsured and people with skimpy policies. It's unclear that the federal requirements are helping at all.

Justin Farman, a nursing student from Watertown, in upstate New York, was diagnosed with a blood cancer last fall, when he was uninsured.

Going without health insurance is a calculated risk taken by many young people starting out their careers. Farman, 26, said the $120 his employer charged monthly for premiums was too much for his budget. Besides, he was in good shape and an avid weightlifter. But months of deep tiredness and unexplained weight loss led him to consult doctors, and he was eventually diagnosed with lymphoma.

Treatment at Upstate University Hospital in Syracuse was successful, but Farman faced more than $54,000 in medical bills, between the hospital and doctors.

"After I went into remission, the bills started to roll in," said Farman. The hospital did not tell him that financial assistance might be available, Farman said.

He had to fend off collection agencies. "That's not too fun," he added.

A spokesman for Upstate said the federal fair pricing law does not appear to apply to the hospital because it is publicly owned and not incorporated as a nonprofit under federal law. Spokesman Darryl Geddes said he could not discuss individual cases, but the hospital does not decline care to anyone based on the individual's ability to pay. Upstate maintains a financial assistance program that complies with state law, he added.

Part way through his treatment, Farman was able to get on Medicaid. With the help of a community agency, he also applied for assistance under New York law to help pay for his medical care during the period he was uninsured. On Friday, he received a letter saying his application had been approved and his debts would be greatly reduced.

Such discounts should be taken up front, advocates say.

Congress needs to take a second look at the federal law, says University of Southern California health policy professor Glenn Melnick.

As written, the law leaves it up to hospitals to determine which uninsured people qualify for discounted bills, and that could create a whole new set of disparities.

"One hospital could say it applies to people at 100 percent of the poverty line, and another could say 200 percent," Melnick explained. He called the enforcement provisions were "very weak."

A California law could serve as a model, he said. It defines the patients who qualify for assistance as those who are uninsured or making at or below 350 percent of the federal poverty line - $40,215 for an individual and $82,425 for a family of four. Those patients cannot be charged more than the hospital would receive from Medicare.

"This issue will not go away," said Melnick. "Even when the (Affordable Care Act) is fully implemented, there will be millions and millions of people without insurance."

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Wednesday, 26 June 2013 09:41
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PHOENIX (AP) -- President Barack Obama has championed two sweeping policy changes that could transform how people live in the United States: affordable health care for all and a path to citizenship for the 11 million immigrants illegally in the country.

But many immigrants will have to wait more than a decade to qualify for health care benefits under the proposed immigration overhaul being debated by Congress, ensuring a huge swath of people will remain uninsured as the centerpiece of Obama's health care law launches next year.

Lawmakers pushing the immigration bill said adding more recipients to an already costly benefit would make it unaffordable.

Health care analysts and immigration proponents argue that denying coverage will saddle local governments with the burden of uninsured immigrants. They also fear a crisis down the road as immigrants become eligible for coverage, but are older, sicker and require more expensive care. Those placed on provisional status would become the nation's second-largest population of uninsured, or about 25 percent, according to a 2012 study by the Urban Institute.

"All health research shows that the older you get, the sicker you become, so these people will be sicker and will be more expensive on the system," said Matthew O'Brien, who runs a health clinic for immigrants in Philadelphia and researches health trends at Temple University.

The Affordable Care Act will make health insurance accessible for millions of uninsured people starting in January through taxpayer-subsidized private policies for middle-class families and expanded access to Medicaid, the program for low-income people funded by federal and state dollars. The proposed immigration overhaul explicitly states immigrants cannot receive Medicaid or buy coverage in new health care exchanges for more than a decade after they qualify for legal status, and only after certain financial and security requirements have been met.

Immigrants with provisional status may obtain insurance through employers once they have legal status to work, but many are unskilled and undereducated, and tend to work low-wage jobs at small businesses that don't have to provide the benefit under the health care law. Immigrants illegally in the country also can access community health centers, but the officials who run those clinics said they are overwhelmed by the demand.

"We can't help everybody," said Bethy Mathis, executive director of Wesley Community Center in Phoenix. The clinic serves 7,000 patients a year who seek everything from vaccinations and relief from minor medical problems to care for long-term health conditions such as diabetes.

Debate over whether immigrants illegally in the country should be eligible for federal benefits nearly sank Obama's health care reform before it was passed by Congress in 2010. For lawmakers pushing immigration reform, there was no question that immigrants would continue to be excluded.

"That's one of the privileges of citizenship," said Republican Sen. John McCain, one of the so-called Gang of Eight pushing the immigration bill, during a conference call with reporters. "That's just what it is. I don't know why we would want to provide Obamacare to someone who is not a citizen of this country."

The issue has received more attention in recent weeks. Some House Republicans have threatened to kill the immigration bill unless immigrants are required to pay for all their health care costs even after they receive green cards or become citizens. Democratic Sen. Barbara Boxer, meanwhile, said she wants the government to distribute at least $250 million to state and local governments because they are the ones who will feel the financial pain of immigrants being left out of the health care law.

Pregnant women, children, seniors and the disabled are eligible for emergency Medicaid services regardless of their immigration status.

The politics behind the bill offer little solace to immigrant families struggling with growing medical bills.

Isabel Castillo came to the U.S. illegally with her parents when she was a child. She's now 28 and has not gone for an annual physical exam since 2007. Every pain triggers debate over whether it's worth a medical visit or not.

"You are like, `God, should I go, should I wait? The bill is going to be so high,'" Castillo said. "You just wait until you can't tolerate the pain anymore and then you go to the emergency room."

Immigrants who are U.S. citizens are also affected by the limits on health care access if they provide for family members here illegally.

High school student Jacqueline Garcia of Phoenix works two jobs to support her 13-year-old brother and 52-year-old grandmother, who has severe diabetes. The woman's mobility is limited, her vision and memory are fading and she sometimes suffers from seizures. The children were born in the United States and are being raised by the grandmother, who does not have lawful status and as a result does not qualify for Medicaid.

"Every time she gets sick, I have to take her to the doctor. It's really expensive," Garcia said. "What if my grandmother doesn't make it for the 10 years? I mean, I am always going to be struggling. That's too long."

Opponents said they understand the concerns of immigrants not getting health care, but it becomes an issue of the added expense.

"We aren't saying people shouldn't get health care. The question is who is going to pay for it?" said Ira Mehlman, spokesman for the Federation for American Immigration Reform, a national group that opposes the immigration overhaul. "They would all be on Medicaid or heavily subsidized in some other way."

Critics of the decision said immigrants are eager to pay for affordable health care insurance and already support federal benefits by paying sales and income taxes. They note that adults unable to overcome health emergencies are less likely to contribute to the workforce and society.

"The risk of them being uninsured if they are in the country illegally is the same risk of anyone else in the country not being insured," said Stephen Zuckerman, a health economist for the Urban Institute. "It's always more expensive to treat people at a more advanced stage of disease."

In North Carolina, Jessica Sanchez-Rodriguez said she has undergone a series of surgeries and medicines to treat her spina bifida, a developmental congenital disorder, and an ailment that leads to brain swelling. Her parents brought her illegally from Mexico when she was 11 months old. As a minor, she received subsidized medical care, but she was cut off when she turned 18 in February.

Her family is trying to raise money for a $55,000 surgery to connect a catheter to her bladder.

"It's terrible," Sanchez-Rodriguez said. "I have to go to school with these pains."

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Friday, 21 June 2013 10:51
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LONDON (AP) -- About a third of women worldwide have been physically or sexually assaulted by a former or current partner, according to the first major review of violence against women.

In a series of papers released on Thursday by the World Health Organization and others, experts estimated nearly 40 percent of women killed worldwide were slain by an intimate partner and that being assaulted by a partner was the most common kind of violence experienced by women.

"Violence against women is a global health problem of epidemic proportions," WHO Director-General Dr. Margaret Chan said in a statement.

WHO defined physical violence as being slapped, pushed, punched, choked or being attacked with a weapon. Sexual violence was defined as being physically forced to have sex, having sex because you were afraid of what your partner might do and being compelled to do something sexual that was humiliating or degrading.

The report also examined rates of sexual violence against women by someone other than a partner and found about 7 percent of women worldwide had previously been a victim.

In conjunction with the report, WHO issued guidelines for authorities to spot problems earlier and said all health workers should be trained to recognize when women may be at risk and how to respond appropriately.

Globally, the WHO review found 30 percent of women are affected by domestic or sexual violence by a partner. The report was based largely on studies from 1983 to 2010. According to the United Nations, more than 600 million women live in countries where domestic violence is not considered a crime.

The rate of domestic violence against women was highest in Africa, the Middle East and Southeast Asia, where 37 percent of women experienced physical or sexual violence from a partner at some point in their lifetime. The rate was 30 percent in Latin and South America and 23 percent in North America. In Europe and Asia, it was 25 percent.

Some experts said screening for domestic violence should be added to all levels of health care, such as obstetric clinics.

"It's unlikely that someone would walk into an ER and disclose they've been assaulted," said Sheila Sprague of McMaster University in Canada, who has researched domestic violence in women at orthopedic clinics. She was not connected to the WHO report.

"Over time, if women are coming into a fracture clinic or a pre-natal clinic, they may tell you they are suffering abuse if you ask," she said.

For domestic violence figures, scientists analyzed information from 86 countries focusing on women over the age of 15. They also assessed studies from 56 countries on sexual violence by someone other than a partner, though they had no data from the Middle East. WHO experts then used modeling techniques to fill in the gaps and to come up with global estimates for the percentage of women who are victims of violence.

In a related paper published online in the journal Lancet, researchers found more than 38 percent of slain women are killed by a former or current partner, six times higher than the rate of men killed by their partners. Heidi Stoeckl, one of the authors at the London School of Hygiene and Tropical Medicine, said the figures were likely to be an underestimate. She and colleagues found that globally, a woman's highest risk of murder was from a current or ex-partner.

Stoeckl said criminal justice authorities should intervene at an earlier stage.

"When a woman is killed by a partner, she has often already had contact with the police," she said.

Stoeckl said more protective measures should be in place for women from their partners, particularly when he or she has a history of violence and owns a gun.

"There are enough signs that we should be watching out for that," she said. "We certainly should know if someone is potentially lethal and be able to do something about it."

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Thursday, 20 June 2013 10:22
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ATLANTA (AP) -- A vaccine against a cervical cancer virus cut infections in teen girls by half in the first study to measure the shot's impact since it came on the market. The results impressed health experts and a top government top health official called them striking.

The research released Wednesday echoes studies done before the HPV vaccine became available in 2006. But the new study is the first evidence of just how well it works now that it is in general use.

Only about half of teen girls in the U.S. have gotten at least one dose of the expensive vaccine, and just a third of teen girls have had all three shots, according to the latest government figures.

"These are striking results and I think they should be a wake-up call that we need to increase vaccination rates," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention.

Cervical cancer is caused by certain types of the common sexually transmitted virus called HPV, for human papillomavirus. The vaccine, which costs about $130 per dose, protects against a few of those strains, including two blamed for 70 percent of cervical cancers. The shots work best if given before someone is sexually active so the emphasis has been on giving the shots to 11- and 12-year olds.

The CDC study compared infection rates in girls ages 14 to 19 before and after the vaccine became available. The proportion infected with the targeted HPV strains dropped 56 percent, from about 12 percent before the vaccine was sold to 5 percent. That result was for all teens after it was on the market, whether or not they were vaccinated.

Among girls who had gotten the vaccine, the drop in HPV infections was higher - 88 percent.

There are two vaccines against HPV, but the study mainly reflects the impact of Gardasil, the Merck & Co. vaccine that came on the market in 2006. A second vaccine approved in 2009 - GlaxoSmithKline's Cervarix - probably had relatively little bearing on the results, said the CDC's Dr. Lauri Markowitz, the study's lead author.

Both vaccines are approved for use in males and females - in ages 9 to 26 for females, and 9 to 21 in males. The vaccine was only recommended for boys in late 2011, and the CDC has not yet reported data on how many boys have gotten the shot since then. HPV vaccination requires three shots over 6 months.

An estimated 75 to 80 percent of men and women are infected with HPV during their lifetime. Most don't develop symptoms and clear it on their own. But some infections lead to genital warts, cervical cancer and other cancers. The study didn't look at cervical cancer rates. It can take many years for such cancers to develop, and not enough time has passed to know the vaccine's impact on cancer rates, CDC officials said.

The study involved interviews and physical examinations of nearly 1,400 teen girls in 2003 through 2006 and of 740 girls in 2007 through 2010.

The vaccine's impact was seen even though only 34 percent of the teens in the second group had received any vaccine. That could be due to "herd immunity" - when a population is protected from an infection because a large or important smaller group is immune.

Only about 20 percent of those vaccinated got all three doses. That result will likely feed an ongoing discussion about whether all three doses are necessary, Markowitz said.

Overall, the study found no significant change over time in the proportion of teens who'd ever had sex and in those who had multiple sex partners. However, it did find that a higher percentage of vaccinated teens said they'd had three or more sex partners.

That could have driven down infection rates, Markowitz noted, if the teens who got vaccinated were the ones at highest risk of getting an infection and spreading it.

The research was released online by the Journal of Infectious Diseases.

--- Online: HPV info: HTTP://WWW.CDC.GOV/HPV/ © 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Thursday, 20 June 2013 10:20
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WASHINGTON (AP) -- Medicare begins a major change next month that could save older diabetics money and time when they buy crucial supplies to test their blood sugar - but it also may cause some confusion as patients figure out the new system.

On July 1, Medicare opens a national mail-order program that will dramatically drop the prices the government pays for those products but patients will have to use designated suppliers. The goal is to save taxpayers money but seniors should see their copays drop, too.

Don't care about the convenience of mail delivery? Just over half of the 4.2 million diabetics with traditional Medicare coverage used mail-order last year, but starting July 1 beneficiaries also can get the new lower price at drugstores enrolled in the Medicare program.

"Those who like the face-to-face interaction with the pharmacist have that choice," stressed Jonathan Blum, Medicare deputy administrator. "We want to preserve both options."

It's the biggest expansion yet of a larger, and somewhat controversial, initiative that's predicted to save taxpayers nearly $26 billion over the next decade by cracking down on waste and fraud in the medical equipment industry. Diabetics aren't the only Medicare patients affected. Depending on where they live, patients who rent home oxygen gear and hospital beds, or who need power wheelchairs, walkers and certain other equipment also could see changes in their suppliers and lower prices as a pilot test of this so-called competitive bidding program expands from nine metro areas to a total of 100 on July 1. Medicare is supposed to apply the lower pricing nationally by 2016.

The diabetes initiative is the first to go nationwide - and Blum said it should put an end to unscrupulous practices such as shipping cartons of supplies to diabetics who haven't run out yet and billing Medicare for the cost.

The concern: Potentially hundreds of thousands of older patients may have to switch mail-order suppliers. The American Diabetes Association worries they won't get the word before their supplies run short - or might be pressured to switch to a cheaper brand of blood-sugar monitor and the matching supplies even though that's against the rules.

"We're sort of torn, truthfully," said Krista Maier, the association's associate director of public policy. "It will save the Medicare program money, which is good for its sustainability. The challenge is ensuring that beneficiaries' testing of their blood glucose isn't disrupted."

Here are some questions and answers about the program:

Q: What's the big change?

A: Until now, hundreds of mail-order companies could bill Medicare for the test strips, lancets and other supplies that diabetics use to measure and track their blood sugar. Under the new national program, Medicare patients can order from only 18 mail-order companies that won government contracts and will be subject to more oversight. (The change doesn't apply to Medicare Advantage patients.)

Check the list at HTTP://WWW.MEDICARE.GOV/SUPPLIER or by calling 1-800-MEDICARE. Some companies operate under multiple names.

Q: What if the new companies don't sell my brand?

A: Medicare's list shows different suppliers sell a mix of top-selling brands as well as generics - and you're not required to change your existing monitor. But you may need to shop around or get a doctor's note that specifies you need a specific type, so plan ahead.

Q: What's the price difference?

A: Medicare has paid about $78 for 100 test strips and lancets, just over a month's supply for someone who tests his or her blood sugar three times a day. Remarkably, that rate was higher than other insurers typically pay. Starting July 1, that reimbursement will drop to about $22. The patient copay is 20 percent, so it will drop from about $15 to less than $5.

Q: What if I want to buy at my local drugstore instead?

A: Ask if it accepts "Medicare assignment," meaning it has to honor the July 1 prices. Some large chains are reassuring customers that they're participating. But pharmacies that aren't enrolled in Medicare are allowed to charge patients more.

Q: How did the program work in the nine test cities?

A: Medicare says patients had plenty of supplies. But surprisingly, mail-order claims dropped the first year. The Department of Health and Human Services' inspector general discovered that some suppliers were billing Medicare for drugstore-sold supplies - which at the time were reimbursed at a higher rate - even though they actually shipped cheaper mail-order supplies. Congress later closed that loophole, mandating the same reimbursement for drugstores and mail-order starting July 1.

Q: What's happening with other medical equipment?

A: That part of the initiative has hit some bumps. Medicare had awarded contracts to nearly 800 suppliers of those items but it turned out that some didn't have certain licenses required by state authorities. Medicare says it has voided 30 of 96 supplier contracts in Tennessee, but that enough remain to do the job. It is investigating the situation in Maryland.

The home supply industry's American Association for Homecare, which opposes Medicare's competitive bidding program, says the licensing issue is a symptom of broader problems. Members of Congress last week asked Medicare to delay the program's expansion, but that's not expected to happen.

© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
Wednesday, 19 June 2013 11:32
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CHICAGO (AP) -- A nonprofit group helping to spread the word about President Barack Obama's health care overhaul launched a campaign Tuesday that will target states with high numbers of uninsured Americans and tackle their skepticism with straightforward messages.

The "Get Covered America" campaign will include door-to-door visits by volunteers, brochures handed out at farmers markets and churches and, possibly, partnerships with sports leagues and celebrities, said Anne Filipic, a former White House official who recently became president of Enroll America, the group sponsoring the campaign.

The group's research shows 78 percent of uninsured adults don't know about opportunities that will be available to them in 2014 under the Affordable Care Act, Filipic said Tuesday during a phone call with reporters. The campaign is expected to cost tens of millions of dollars, including a seven-figure media ad buy.

"If they don't know about it, then they won't enroll," Filipic said. "We've done our research. We know people want to know what the law means for them in a `just the facts' sort of way."

Health and Human Services Secretary Kathleen Sebelius has drawn criticism from Republicans for making fundraising calls for Enroll America. Earlier this month, Sebelius told members of Congress she made five phone calls for Enroll America, two of which involved actual fundraising solicitations, to Robert Wood Johnson Foundation and H&R Block, entities not regulated by HHS.

She also called three health care companies to "suggest that the entities take a look at the organization (Enroll America)" but did not make a fundraising solicitation to those three. They were Johnson & Johnson, Ascension Health and Kaiser Permanente.

Sebelius said the HHS secretary has the legal authority to raise money for initiatives that support government health programs.

The federal government itself will spend millions on marketing and advertising about the health law, but the spending will vary greatly across the nation because some Republican-led states haven't sought federal dollars for ad campaigns.

Enroll America's campaign will start with 50 events in 18 states, Filipic said. The group has staff on the ground in eight states, including Texas and Florida and others where government officials have resisted key parts of Obama's health law such as the expansion of Medicaid.

"We know that most of the uninsured don't know about the new coverage options coming this fall, let alone whether or not their state is expanding Medicaid," Filipic said. "Many of the uninsured are eligible for Medicaid today but have not enrolled, and those who are not eligible for Medicaid may qualify for coverage through the marketplace."

Obama's national health law requires that nearly all Americans have health insurance beginning in 2014 or pay a penalty. New insurance marketplaces are scheduled to be operating in every state by Oct. 1. People who are uninsured will be able to comparison-shop for affordable health plans on these websites and many will qualify for tax credits to help them pay for coverage.

The organization is building a predictive model to determine where to target the uninsured and will track which of its tactics are most effective, Filipic said.

"We're going to be doing a lot of testing to see what works," she said. "What moves someone to attend an event or call a phone number? We'll be doing a lot of work to test and analyze that."

In a parallel effort, a group called Doctors for America plans to host training sessions for doctors and print posters and brochures for medical waiting rooms.

Skepticism about the law's benefits is widespread. Enroll America's January survey of 1,814 adults found that most people are skeptical they'll be able to find affordable health insurance that covers their needs. When presented with a specific premium amount they might pay, less than a third of respondents felt that the premium was in the affordable range.

"Survey results suggest using a specific premium amount may actually turn away just as many people as it might motivate," according to the survey report on Enroll America's website.

Broader statements - such as "You might be able to get financial help to pay for a health insurance plan" and "If you have a pre-existing condition, insurance plans cannot deny you coverage" - tested better with the survey group.

Enroll America has staff on ground in Texas, Florida, Ohio, Arizona, Michigan, New Jersey, North Carolina and Pennsylvania. It soon will add staff in Illinois and Georgia.

Kicking off the campaign this week, the Get Covered America team and its community partners plan to host more than 50 events in Arizona, Arkansas, California, Delaware, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Texas.
Wednesday, 19 June 2013 11:29
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NEW YORK (AP) -- By the time 10-year-old Sarah Murnaghan finally got a lung transplant last week, she'd been waiting for months, and her parents had sued to give her a better shot at surgery.

Her cystic fibrosis was threatening her life, and her case spurred a debate on how to allocate donor organs. Lungs and other organs for transplant are scarce.

But what if there were another way? What if you could grow a custom-made organ in a lab?

It sounds incredible. But just a three-hour drive from the Philadelphia hospital where Sarah got her transplant, another little girl is benefiting from just that sort of technology. Two years ago, Angela Irizarry of Lewisburg, Pa., needed a crucial blood vessel. Researchers built her one in a laboratory, using cells from her own bone marrow. Today the 5-year-old sings, dances and dreams of becoming a firefighter - and a doctor.

Growing lungs and other organs for transplant is still in the future, but scientists are working toward that goal. In North Carolina, a 3-D printer builds prototype kidneys. In several labs, scientists study how to build on the internal scaffolding of hearts, lungs, livers and kidneys of people and pigs to make custom-made implants.

Here's the dream scenario: A patient donates cells, either from a biopsy or maybe just a blood draw. A lab uses them, or cells made from them, to seed onto a scaffold that's shaped like the organ he needs. Then, says Dr. Harald Ott of Massachusetts General Hospital, "we can regenerate an organ that will not be rejected (and can be) grown on demand and transplanted surgically, similar to a donor organ."

That won't happen anytime soon for solid organs like lungs or livers. But as Angela Irizarry's case shows, simpler body parts are already being put into patients as researchers explore the possibilities of the field.

Just a few weeks ago, a girl in Peoria, Ill., got an experimental windpipe that used a synthetic scaffold covered in stem cells from her own bone marrow. More than a dozen patients have had similar operations.

Dozens of people are thriving with experimental bladders made from their own cells, as are more than a dozen who have urethras made from their own bladder tissue. A Swedish girl who got a vein made with her marrow cells to bypass a liver vein blockage in 2011 is still doing well, her surgeon says.

In some cases the idea has even become standard practice. Surgeons can use a patient's own cells, processed in a lab, to repair cartilage in the knee. Burn victims are treated with lab-grown skin.

In 2011, it was Angela Irizarry's turn to wade into the field of tissue engineering.

Angela was born in 2007 with a heart that had only one functional pumping chamber, a potentially lethal condition that leaves the body short of oxygen. Standard treatment involves a series of operations, the last of which implants a blood vessel near the heart to connect a vein to an artery, which effectively rearranges the organ's plumbing.

Yale University surgeons told Angela's parents they could try to create that conduit with bone marrow cells. It had already worked for a series of patients in Japan, but Angela would be the first participant in an American study.

"There was a risk," recalled Angela's mother, Claudia Irizarry. But she and her husband liked the idea that the implant would grow along with Angela, so that it wouldn't have to be replaced later.

So, over 12 hours one day, doctors took bone marrow from Angela and extracted certain cells, seeded them onto a 5-inch-long biodegradable tube, incubated them for two hours, and then implanted the graft into Angela to grow into a blood vessel.

It's been almost two years and Angela is doing well, her mother says. Before the surgery she couldn't run or play without getting tired and turning blue from lack of oxygen, she said. Now, "she is able to have a normal play day."

This seed-and-scaffold approach to creating a body part is not as simple as seeding a lawn. In fact, the researchers in charge of Angela's study had been putting the lab-made blood vessels into people for nearly a decade in Japan before they realized that they were completely wrong in their understanding of what was happening inside the body.

"We'd always assumed we were making blood vessels from the cells we were seeding onto the graft," said Dr. Christopher Breuer, now at Nationwide Children's Hospital in Columbus, Ohio. But then studies in mice showed that in fact, the building blocks were cells that migrated in from other blood vessels. The seeded cells actually died off quickly. "We in essence found out we had done the right thing for the wrong reasons," Breuer said.

Other kinds of implants have also shown that the seeded cells can act as beacons that summon cells from the recipient's body, said William Wagner, director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. Sometimes that works out fine, but other times it can lead to scarring or inflammation instead, he said. Controlling what happens when an engineered implant interacts with the body is a key challenge, he said.

So far, the lab-grown parts implanted in people have involved fairly simple structures - basically sheets, tubes and hollow containers, notes Anthony Atala of Wake Forest University whose lab also has made scaffolds for noses and ears. Solid internal organs like livers, hearts and kidneys are far more complex to make.

His pioneering lab at Wake Forest is using a 3-D printer to make miniature prototype kidneys, some as small as a half dollar, and other structures for research. Instead of depositing ink, the printer puts down a gel-like biodegradable scaffold plus a mixture of cells to build a kidney layer by layer. Atala expects it will take many years before printed organs find their way into patients.

Another organ-building strategy used by Atala and maybe half a dozen other labs starts with an organ, washes its cells off the inert scaffolding that holds cells together, and then plants that scaffolding with new cells.

"It's almost like taking an apartment building, moving everybody out ... and then really trying to repopulate that apartment building with different cells," says Dr. John LaMattina of the University of Maryland School of Medicine. He's using the approach to build livers. It's the repopulating part that's the most challenging, he adds.

One goal of that process is humanizing pig organs for transplant, by replacing their cells with human ones.

"I believe the future is ... a pig matrix covered with your own cells," says Doris Taylor of the Texas Heart Institute in Houston. She reported creating a rudimentary beating rat heart in 2008 with the cell-replacement technique and is now applying it to a variety of organs.

Ott's lab and the Yale lab of Laura Niklason have used the cell-replacement process to make rat lungs that worked temporarily in those rodents. Now they're thinking bigger, working with pig and human lung scaffolds in the lab. A human lung scaffold, Niklason notes, feels like a handful of Jell-O.

Cell replacement has also worked for kidneys. Ott recently reported that lab-made kidneys in rats didn't perform as well as regular kidneys. But, he said, just a "good enough organ" could get somebody off dialysis. He has just started testing the approach with transplants in pigs.

Ott is also working to grow human cells on human and pig heart scaffolds for study in the laboratory.

There are plenty of challenges with this organ-building approach. One is getting the right cells to build the organ. Cells from the patient's own organ might not be available or usable. So Niklason and others are exploring genetic reprogramming so that, say, blood or skin cells could be turned into appropriate cells for organ-growing.

Others look to stem cells from bone marrow or body fat that could be nudged into becoming the right kinds of cells for particular organs. In the near term, organs might instead be built with donor cells stored in a lab, and the organ recipient would still need anti-rejection drugs.

How long until doctors start testing solid organs in people? Ott hopes to see human studies on some lab-grown organ in five to 10 years. Wagner calls that very optimistic and thinks 15 to 20 years is more realistic. Niklason also forecasts two decades for the first human study of a lung that will work long-term.

But LaMattina figures five to 10 years might be about right for human studies of his specialty, the liver.

"I'm an optimist," he adds. "You have to be an optimist in this job."

--- Michael Rubinkam in Lewisburg, Pa., and Allen Breed in Winston-Salem, N.C., contributed to this story.
Monday, 17 June 2013 11:28
Published in Health & Fitness
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