by Lena Groeger

The fine is just the latest of more than a dozen the Red Cross has racked up in the last decade.

In 2003, a federal court, frustrated by repeated blood safety violations by the Red Cross, gave the FDA the power to fine the organization.

Forty-six million dollars in penalties later, many of the same violations — understaffing, ineffective screening of donors, failure to recall infected blood — are outlined in the recent letter the FDA sent to the executive vice president of Biomedical Services for the Red Cross.

The 32-page letter describes hundreds of violations over several months in 2010 at 16 Red Cross facilities across the country, and details how the Red Cross repeatedly failed to properly track and record information about donors and blood units.

(To see a history of Red Cross fines and many of the documents cited in this article go to ProPublica’s timeline of Red Cross fines.)

For example, the agency failed to notify health departments when donors had infectious diseases such as HIV and syphilis, failed to add new donors with infected blood to a national list of people who aren’t allowed to donate, and failed to review records of donors who had bad reactions, such as a 16-year-old who lost consciousness and fell to the floor after giving a unit of blood.

It also failed to follow written procedures, such as the case of a phlebotomist in Arizona who stuck herself with a needle before sticking a donor with the same needle to draw blood. The case went unreported for a month, because a staff member “was not aware of the need to immediately notify a Medical Director,” according to the inspection letter.

In a recent statement, the Red Cross said it was disappointed that the FDA issued the fine for “an inspection conducted so long ago” and noted that it has “already taken corrective steps to address those matters and that improvements in operations have been made.”

In an email to ProPublica, a Red Cross spokeswoman also said there is no evidence that these violations endangered any patients, adding that the blood supply is safer than it has ever been.

The spokeswoman said the agency has made significant improvements, including reducing the number of problems system-wide by at least 65 percent, and is investing in technology upgrades.

For example, the agency recently upgraded software and computer equipment at blood drives to better collect and track donor information.

The FDA’s letter laying out the fines says the Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.”

The FDA also noted that “many of the violations recounted in this letter are virtually identical to violations charged in previous [letters].” In June 2010 the FDA imposed a $16 million penalty on the Red Cross for the same type of violations.

The chronic problems raise the question of whether penalties are working at all.

The Red Cross has been making promises and failing to keep them for over a decade, according to Sidney Wolfe, who heads the health research group at the consumer watchdog organization Public Citizen.

Wolfe said he wrote to head of the FDA in 2000, urging it to hold the Red Cross in contempt of court. A federal court first put the Red Cross under government supervision in 1993 after finding blood safety lapses. A decade later, in 2003, the court empowered the FDA to impose fines.

“But fast-forward nine years ahead, and we have the same violations,” Wolfe said.

If the Red Cross disagrees with an assessment, it can ask the FDA to reevaluate the penalty, but in most cases the fine only changes by a few thousand dollars.

Most of the recent problems inspectors cited have to do with managing records and tracking blood donors. The Red Cross says it is unaware of any infections or deaths that stemmed from problems noted in the report, and that “serious problems” account for only three percent of the total problems found.

The FDA doesn’t think that’s good enough.

“FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences,” said FDA spokeswoman Patricia El-Hinnawy.

The government requires that the Red Cross (like any blood services operation) have multiple safeguards for its blood services.

That includes asking a donor questions to identify any risks, checking his or her name against a national list of people who aren’t allowed to give blood, testing for infectious diseases, keeping track of blood units so infected blood isn’t released, and investigating any deviations from standards.

Because blood transfusions always carry a degree of risk, the FDA considers every step in that process critical to minimizing problems.

“Failure of an individual safeguard does not automatically translate into the release of unsafe products,” an FDA spokeswoman told ProPublica in an email, “however, it may increase the potential for risk.”

In 2008, the Red Cross consolidated its blood work to two facilities: one in Charlotte, N.C., and the other in Philadelphia. The offices are in charge of managing, tracking and, if need be, recalling blood.

But according to the inspection letter, both offices have been chronically understaffed, and simply haven’t been able to carry out their required functions in a timely or effective manner. As of 2010, the offices had a backlog of about 18,000 donor management cases.

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By Michelle Andrews

The 2010 health-care overhaul creates state-based health plans for those who have medical conditions that make them uninsurable in the private market.

These “preexisting-condition insurance plans” (PCIPs) are intended to act as a bridge until 2014, when insurers will no longer be able to refuse to cover people with medical problems or charge them more than other consumers.

As of November, about 45,000 people had signed up for those plans, far fewer than the up to 400,000 that was originally projected.

However, there is a much larger group, more than 220,000 people, who have coverage through 35 state high-risk pools that were in existence before the overhaul was passed.

Because of restrictions in the new law, they can’t sign up for the PCIP plans, even though the coverage is often cheaper (thanks in part to federal funding) and more comprehensive. For these people, 2014 can’t come soon enough..

Together they pay $1,304 a month for coverage. Chris’s plan has a $2,500 deductible while Kristi’s is $1,000. The plans generally cover 80 percent of their medical bills.

Chris Petersen, who supported the health-care overhaul, nevertheless thinks the law failed him and his wife. “This is the biggest check I write out every month,” he says. “The new federal plan would have been a lot cheaper.”

If the Petersens had been allowed to sign up with the PCIP in Iowa, their combined premium would have been $958 for policies with $1,000 deductibles.

More From This Series: Insuring Your Health

People such as the Petersens, however, are stuck between a rock and a hard place: To qualify for a PCIP, they must first be uninsured for six months.

Experts say this requirement was included in the law to discourage people in the existing state high-risk pools and other private insurance plans from doing exactly what they would do if better, cheaper coverage became available: switch plans.

It’s clear why they might be tempted. Premiums in the new pools can’t exceed rates for standard individual coverage in the state, while the high-risk pools in some states charge twice that. The new plans must also cover preexisting conditions immediately, in contrast to the older state pools, some of which exclude such coverage for up to a year.

“Much as everybody would like to drop [the six-month requirement], if you did you’d have to increase expenditures,” says Sandy Praeger, the Kansas insurance commissioner, who chairs the health insurance and managed-care committee of the National Association of Insurance Commissioners. Federal funding for the program through 2013 is $5 billion.

Learn about Washington State’s Pre-existing Condition Insurance here.

Although enrollment in the PCIPs has been far lower than originally projected, health-care spending by the individuals who have signed up for coverage has been much higher than anticipated, say experts.

“The people coming into the PCIPs act more like the long-term uninsured,” says Jean Hall, an associate research professor at the University of Kansas who co-authored a report about the PCIPs for the Commonwealth Fund. “They’re not accustomed to managing on a day-to-day basis; they’re accustomed to going to the emergency department when things get bad.”

Nine states have asked the Department of Health and Human Services for more money to fund their PCIPs in 2012. However, it appears the program won’t run out of money soon. Through the end of September 2011, just $386 million of the $5 billion allocated had been spent, according to HHS figures.

(Some experts caution against relying too much on September spending figures, since enrollment has increased since then and claims may take months to clear.)

“As you would expect, some states have exceeded projections and others have not,” says an HHS spokesman. “We have the capacity to accommodate the needs of the program.”

For people who can’t get into the new plans, however, that’s small comfort.

Jill Judy and Mark Brown signed up for the Arkansas high-risk pool a few years ago when Mark’s benefits ran out after his retirement from a management job at a company that repossesses boats. Judy, 49, has mild cerebral palsy, which she hasn’t been treated for since she was a child, and Brown, 62, had an angioplasty 15 years ago and still sees a cardiologist.

Individual insurers wouldn’t cover them, so they ended up in the state’s high-risk pool. Although Judy says she’s grateful that she has coverage, it’s hardly ideal.

The premiums for the two of them come to just under $1,000 a month. But the plan has a $10,000 deductible and a $1 million cap on lifetime benefits. “People like my husband and myself are paying $12,000 a year for nothing,” she says.

She estimates they could get better coverage and save 30 percent in the Arkansas PCIP. “But we don’t qualify because we’re not willing to be uninsured for six months,” she says. “It’s screwy.”

Please send comments or ideas for future topics for the Insuring Your Health column to questions@kaiserhealthnews.org.

Local Resources:

• Statewide Health Insurance Benifits Advisors (SHIBA) provides free, unbiased advice from volunteers: www.oic.wa.gov/shiba/
• Benefits.gov: www.benefits.gov
• King County Project Access: www.kcprojectaccess.org
• Washington Basic Health (insurance assistance): www.basichealth.hca.wa.gov/understanding.shtml
• Washington Health Plan: www.washingtonhealth.hca.wa.gov
• Washington State Office of the Insurance Commissioner: www.insurance.wa.gov
• To search for a community clinic near you go to: http://findahealthcenter.hrsa.gov

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.

Photo by Sanja Gjenero

Imagine if finding out the cost of a particular treatment or procedure at a doctors’ office was as easy as locating the prices of entrees at a restaurant. The menu might read: school physicals – $40; office visit for a cold – $80; diabetes screening – $200.

But to the dismay of some consumer advocates, this push for health care pricing transparency never made it out of the kitchen.

While a Florida state House committee approved legislation that would expand the state’s requirement that certain providers post the out-of-pocket prices of common health care services, a state Senate committee shot down a similar measure after an aggressive lobbying push by health care provider groups.

Organizations representing the state’s doctors weren’t wild about the idea that certain facilities would have to display bulletin-board sized postings of their prices.

Jeff Scott, general counsel for the Florida Medical Association, said that providers are all for transparency, but they don’t need the government telling them exactly how they should do it.

“Next thing you know they’re going to say it has to be neon or include pictures,” he said.

But providers’ most strenuous objections were to provisions in the legislation that would require providers to disclose prices to out-of-network patients and limit so-called balance billing, which happens in health care settings when providers bill patients the difference between what they charge for a service and what insurers pay it.

Meanwhile, the state already requires urgent care centers to post in their reception area the prices of their 50 most frequently used services, and the posting must be at least 15 square feet.  Physicians are not required to do so, but they must follow the same rules if they post prices voluntarily.

Under the proposed legislation, ambulatory care centers and diagnostic-imaging centers would have had to follow the same rules as urgent care centers, and the original bills also would have expanded the requirement to physicians.

The House committee-approved bill softened this language to maintain the voluntary status quo for doctors. Both bills would have required physicians to provide patients with a written statement of prices at each visit.

Richard Polangin, health care policy coordinator for the Florida Public Interest Research Group, said the legislation would have been a boon for consumers, many of whom are unaware that prices can vary among doctors and facilities.

The bills would “enable persons who must pay for doctor visits, diagnostic images such as CT scans and MRIs, and for care at ambulatory surgery centers, to know the cost in advance,” he said. “The uninsured and persons with insurance deductibles would be able to make more informed health care decisions.”

Insurers and business groups also supported the legislation. And, though the measure’s future is uncertain, at least one person involved in the lobbying effort said work would continue.

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.

The latest casualty of the Great Recession may soon be the nation’s elderly. Cuts in government payments for patient care and less construction of new nursing homes are already taking a toll.

Add to this the aging baby boom generation and you have a worst-case scenario in which older people who need full-time care won’t be able to get it.

“We believe we’re at a tipping point,” says Mark Parkinson, head of the American Health Care Association (AHCA), which represents nursing homes.

If so, the timing couldn’t be worse. The first baby boomers hit age 65 last year. By 2030, 20 percent of the U.S. population will be at least 65, up from 13 percent today.

Number of Persons 65+ in the U.S. 1900 - 2030 (numbers in millions) - U.S. Administration on Aging

In that same period, the number of 85-year-olds will increase more than 50 percent and the number of 100-year-olds nearly triple. But the number of nursing homes dropped almost 9 percent from 2000 to 2009.

Nursing homes and hospitals are places that everyone wants to avoid … until they can’t. Most people say they want to age at home, but as retiring boomers get older, more will need the type of 24-hour care that only a nursing home or hospital can offer.

That’s because the prevalence of chronic illnesses like Alzheimer’s disease, cancer and diabetes increases with age. Fifty-five percent of all cancers are diagnosed in individuals 65 and older, and by 2030, 7.7 million of those 65 and older will suffer from Alzheimer’s, 50 percent more than today according to the Alzheimer’s Association.

Several trends are cutting into the number of nursing homes. Many homes were constructed during the 1960s under Lyndon Johnson’s Great Society programs. Often those homes are closed because they are old or, with their long hallways and large, multi-resident rooms, don’t fit what current residents want, says Robert Kramer of the National Investment Center for the Seniors Housing and Care Industry.

But the recession has made getting private financing for new nursing home construction tougher. From 2007 to 2011, the number of under-construction nursing home units (the sections of a facility that provide only nursing care) declined by a third.

“I cannot tell you of anyone who has actually developed a new skilled nursing facility in at least the last five years in California,” says Edward Steinfeldt, a consultant to developers of retirement housing and health care.

And existing nursing homes are struggling. They long have lost money on patients whose stays are covered by state-run Medicaid programs, which pay for long-term care for chronically or terminally ill patients who have run out of money.

According to a report this month by the AHCA, in 2011 nursing homes lost at least $20 per Medicaid resident per day nationwide. Total losses came to $6.3 billion nationally, the highest yearly total ever, with higher deficits to come next year, according to the report.

That’s a huge hit since Medicare payments are responsible for more than 20 percent of nursing home revenues. (Medicaid provides about 50 percent of revenues, and most of the rest comes from private long-term care insurance and people who pay out of pocket.)

For the 187-bed nonprofit Lutheran Home in Milwaukee, which has gross receipts of about $20 million, the Medicare slash will take $700,000 to $750,000 straight off the organization’s bottom line this year says CEO Scott McFadden.

The real estate crash has added to nursing homes’ budget crunch. Many clients sell their homes and use the money to pay out of pocket for long-term care services from a nursing home.

Related Article: Tools to help you choose a good nursing home.

By obliterating more than $8 trillion in home equity, the collapse cut the number of patients who can pay their own way. McFadden says that the private-paying clients his home serves used to run out of money in two or three years. Now they’re broke much more quickly.

Once they can’t pay, Medicaid picks up only some of the tab, and the Lutheran Home then starts losing money on them. It’s illegal for a Medicaid-certified nursing home to ask a patient to leave just because they run out of money.

Residing at a nursing home is not cheap. The median annual cost of a private U.S. nursing home room rose to $77,745 in 2011—up almost 30 percent from 2005.

People without chronic conditions have less costly options—it takes about $43,500 yearly to pay for a home health care aide who doesn’t have specialized medical skills, and $39,000 to live in an assisted living facility that provides help with activities of daily life like cooking, but doesn’t necessarily offer health care services.

If nursing homes continue to be squeezed, they may need to cut more staff. A November 2011 report by the University of California-San Francisco concluded that poor quality of care is already endemic in many nursing homes, especially the largest for-profit chains where staffing levels have been cut the deepest to save money.

Local Resources for nursing homes and senior care

• Aging & Disability Services – Seattle/King County: www.agingkingcounty.org
• Aging & Disability Services Administration – Washington State: www.aasa.dshs.wa.gov
• Commission on Accreditation of Nursing Home Facilities: www.carf.org
• Eldercare Locator: www.eldercare.gov/Eldercare.NET/Public/Home.aspx
• Long-term Care Information: www.longtermcare.gov
• Medicare’s Nursing Home Compare service.
• Medicare: Alternatives to Nursing Home Care

Parkinson maintains that so far, homes in his association are keeping up their level of service with less money by eliminating managers, freezing wages, and cutting capital improvements like painting walls and replacing carpets—anything to avoid laying off caregiver staff.

Bill Mulligan, a managing director at Ziegler Capital Management, which provides low-cost financing for nursing home developments, argues that given the decreasing supply and rising demand, nursing homes are still a good investment.

“The demographics are going to level off the number [of homes], maybe even increase it at some point,” he says. But Steinfeldt, who also works with developers, has little confidence in their profitability: “Why would you go into a business that can’t cover its costs?”

If major shortages of nursing home space do surface, they’ll likely show up in urban and high-poverty areas first. Widespread waiting lists have already been reported in Tallahassee in Florida, Rapid City in South Dakota, and San Francisco. Homes also have been closing in poor neighborhoods—a study published last year in the Archives of Internal Medicine showed that nursing homes shut down there more often than elsewhere (the hardest hit cities were New Orleans, Oklahoma City, San Francisco, and Dallas).

And Medicaid patients may have an increasingly hard time finding nursing homes that will take them–Kramer says when homes replace their old buildings, they often cut the number of beds to make space for more private rooms and sophisticated medical facilities that can attract the higher paying Medicare and private-pay clients.

“Every adult is going to face this nursing home crisis in some way, whether it’s through their own care or the care of loved ones,” says McFadden. “Ignoring it is not going to make it better.”

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.

(Kaiser Health News in an editorially-independent program of the foundation.)

Majority Of Americans Think Ideology Will Affect High Court’s Ruling On Health Law 

By Mary Agnes Carey
KHN Staff Writer

With the Supreme Court just two months away from hearing a historic legal challenge to the 2010 health law, nearly 60 percent of the public expects the justices to depend more on personal ideology than a legal analysis of the individual mandate, according to the Kaiser Family Foundation’s January health tracking poll.

Just 28 percent of those surveyed believe the justices will base their decision on the mandate without regard to politics and ideology, according to the survey.

The poll also asked about general views of the Supreme Court and found three quarters of the public believe that justices sometimes let their ideological views influence their decisions.

Seventeen percent of those surveyed say justices usually decide cases based on legal analysis.

The court will hear oral arguments in March in a case brought by 26 states and others.

As the Republican presidential nomination fight continues, the poll also found that most Republicans are not swayed by charges from GOP contenders that former Massachusetts Gov. Mitt Romney holds health policy views similar to those of President Barack Obama.

Romney’s opponents have repeatedly criticized him for signing a 2006 Massachusetts law that is similar in some aspects to the federal health law.

But the poll found that 49 percent of Republicans say the two men’s views are different, while three in 10 say they are similar. Twenty-two percent had no opinion.

However, when asked specifically for their opinions about the 2006 Massachusetts health law, 69 percent of likely GOP primary voters responded that they didn’t know enough to say whether they viewed the law favorably or unfavorably.

Furthermore, 64 percent of these voters said they don’t know enough to judge whether the Massachusetts law is similar to or different from the 2010 federal health law.

The poll also found that the individual mandate, a requirement that most Americans purchase health insurance by 2014 or pay a fine, remains unpopular, with 67 percent of Americans having an unfavorable view of the provision and 30 percent supporting it.

The January poll found that 37 percent of Americans have a favorable view of the health law while 44 percent have an unfavorable view.

In the foundation’s December tracking poll, 41 percent of Americans had a favorable view of the law while 43 percent had an unfavorable view.

The Kaiser poll surveyed 1,206 adults from Jan. 12 to 17. It has a margin of error of +/- 3 percentage points.

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.