30 December 2013


Story first appeared on NYTimes.com.

A popular surgical procedure worked no better than fake operations in helping people with one type of common knee problem, suggesting that thousands of people may be undergoing unnecessary surgery, a new study in The New England Journal of Medicine reports.

The unusual study involved people with a torn meniscus, crescent-shaped cartilage that helps cushion and stabilize knees. Arthroscopic surgery on the meniscus is the most common orthopedic procedure in the United States, performed, the study said, about 700,000 times a year at an estimated cost of $4 billion.

The study, conducted in Finland, involved a small subset of meniscal tears. But experts, including some orthopedic surgeons, said the study added to other recent research suggesting that meniscal surgery should be aimed at a narrower group of patients; that for many, options like physical therapy may be as good.

The surgery, arthroscopic partial meniscectomy, involves small incisions. They are to accommodate the arthroscope, which allows doctors to see inside, and for tools to trim torn meniscus and to smooth ragged edges of what remains.

The Finnish study does not indicate that surgery never helps; there is consensus that it should be performed in some circumstances, especially for younger patients and for tears from acute sports injuries. But about 80 percent of tears develop from wear and aging, and some researchers believe surgery in those cases should be significantly limited.

“Those who do research have been gradually showing that this popular operation is not of very much value,” said Dr. David Felson, a professor of medicine and epidemiology at Boston University. This study “provides information beautifully about whether the surgery that the orthopedist thinks he or she is doing is accomplishing anything. I think often the answer is no.”

The volunteer patients in the Finnish study all received anesthesia and incisions. But some received actual surgery, others simulated procedures. They did not know which.

A year later, most patients in both groups said their knees felt better, and the vast majority said they would choose the same method again, even if it was fake.

“It’s a well-done study,” said Dr. David Jevsevar, chairman of the committee on evidence-based quality and value of the American Academy of Orthopaedic Surgeons. “It gives further credence or support to a number of studies that have shown that giving arthroscopy to patients is not always going to make a difference.”

Dr. Jevsevar, an orthopedic surgeon in St. George, Utah, said he hoped the study would spur research to better identify patients who should have surgery.

“Are there operations that are done that do not need to be done? I’m sure that’s the case, but we don’t know the magnitude,” he said. “We still think there’s benefit in arthroscopic meniscectomy in appropriate patients. What we need to define in the future is what’s the definition of appropriate patient.”

One factor is whether pain is caused by the torn meniscus or something else, especially osteoarthritis, which often accompanies tears. Another possible consideration is whether mechanical knee function is affected.

“Take 100 people with knee pain; a very high percentage have a meniscal tear,” said Dr. Kenneth Fine, an orthopedic surgeon who also teaches at George Washington University. “People love concreteness: ‘There’s a tear, you know. You have to take care of the tear.’ I tell them, ‘No. 1, I’m not so sure the meniscal tear is causing your pain, and No. 2, even if it is, I’m not sure the surgery’s going to take care of it.”

Dr. Fine added: “Yours truly has a meniscal tear. It just causes pain. I’m not having any mechanical symptoms; my knees are not locking. So I’m not going to let anybody operate.”

He likened the recent studies to attempts to educate people that “it’s not really good to take antibiotics for the common cold. There’s a lot of pressure to operate. Financial, obviously. But also, if a primary care doctor keeps sending me patients who are complaining of knee pain and I keep not operating on them, then the primary care doctor is going to stop sending me patients.”

The new research builds on a groundbreaking 2002 Texas study, showing that patients receiving arthroscopy for knee osteoarthritis fared no better than those receiving sham surgery. A 2008 Canadian study found that patients undergoing surgery for knee arthritis did no better than those having physical therapy and taking medication. Now many surgeons have stopped operating on patients with only knee arthritis.

Earlier this year, a study at seven American hospitals found that patients with meniscal tears and osteoarthritis did not experience greater improvement with surgery than those receiving physical therapy, although after six months, one-third of the physical therapy group sought surgery. (Their surgical results were not reported.)

An author of that study, Dr. Robert Marx of the Hospital for Special Surgery, said his conclusion was that often physical therapy should be tried before surgery. Still, “properly selected patients do benefit from knee arthroscopy,” he said. “When you have someone who doesn’t have arthritis and they have a painful meniscal tear, you’re going to make that person very happy.”

Dr. Marx expressed some skepticism about the Finnish study, which involved patients with only meniscal tears, not perceptible arthritis. He wondered if the tears were small or if the pain was caused by the kneecap, adding, “I cannot believe that this would be the same population of patients I would operate on.”

Dr. Teppo Jarvinen, an author of the Finnish study, said whether meniscal tears caused the participants’ pain was unknown, but arthritis was an unlikely cause, since they seemingly had none. About 10 percent of meniscal tear patients have no arthritis, he said.

The study involved five hospitals and 146 patients, ages 35 to 65, with wear-induced tears and knee pain. About half had mechanical problems like locking or clicking knees.

Most patients received spinal anesthesia, remaining awake (one hospital used general anesthesia). Surgeons used arthroscopes to assess the knee. If it matched study criteria, nurses opened envelopes containing random assignments to actual or sham surgery. In real surgery, shaver tools trimmed torn meniscus; for fake surgery, bladeless shavers were rubbed against the outside of the kneecap to simulate that sensation. Nobody evaluating the patients later knew which procedure had been received.

After a year, each group reported similar improvement, even those with clicking or locking knees. Two in the surgery group needed further surgery; five in the sham group requested surgery. Dr. Jarvinen acknowledged the possibility that fake surgery had some placebo effect but said results were too strong for that to explain everything.

Dr. Frederick Azar, first vice president of the orthopedic surgeons academy, said the study focused on a minority of patients, those he already did not operate on; he operates mostly on patients with mild to moderate arthritis whose meniscal tears appear to be causing pain.

“Arthroscopy is a very useful tool,” he said. Still, he said, “I’m sure there are some physicians who may look at this and say it may change the way they approach their patients, in terms of surgery or not surgery.”

18 December 2013


Story first appeared on Catholic.org.

LOS ANGELES, CA (Catholic Online) - "We believe that the case is closed -- supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful." Such were the findings in an editorial published this week in the Annals of Internal Medicine. "These vitamins should not be used for chronic disease prevention. Enough is enough."

Consumers are being told not to waste their money on these supplements. "The 'stop wasting your money' means that perhaps you're spending money on things that won't protect you long term," editorial co-author Dr. Edgar Miller, a professor of medicine and epidemiology at Johns Hopkins Bloomberg School of Public Health in Baltimore says.

"What will protect you is if you spend the money on fruits, vegetables, nuts, beans, low fat dairy, things like that . exercising would probably be a better use of the money."

The results were from three studies that tracked multivitamins link to cancer protection, heart health and brain and cognitive measures.

It's a pervasive practice here in the United States. It's estimated that vitamin and mineral supplements are taken by half of all Americans.
He first such review looked at vitamin supplementation's role in preventing chronic disease. That review found no evidence that vitamin and mineral supplementation would reduce heart disease in pill takers. The panel at that time concluded there was no solid evidence for or against taking vitamins and minerals alone, or that a multivitamin to prevent heart disease or cancer.

Even more sobering was the finding that taking beta-carotene or vitamin E may raise the risk for lung cancer for already at-risk individuals.

The second study looked at cognitive health and whether long-term use of multivitamins would have any effect. Based on the results of memory tests, the researchers found the multivitamin did nothing to slow cognitive decline among elderly men as compared to placebo takers.

"These data do not provide support for use of multivitamin supplements in the prevention of cognitive decline," wrote the authors.

The third study looked at multivitamins and minerals role in preventing another heart attack. The researchers found no difference in rates of another heart attack, chest pain, the need for hospitalization, cardiac catheterization, or rates of stroke and early death between vitamin-takers and placebo-takers.

In short: researchers say that the American public should not forsake eating well and exercise with store-bought multi-vitamins.

17 December 2013


Story first appeared in the Detroit Free Press.

An estimated 75% of the anti-bacterial liquid soaps and body washes sold in the United States contain triclosan, a germ-killing ingredient. The only problem is, the Food and Drug Administration has no idea whether it actually works -- and there's some evidence it may pose health risks.

To find out, the FDA today issued a proposed rule requiring manufacturers to prove that their antibacterial cleaners are safe and more effective than plain soap and water. If companies can't show that their products are safe and effective, the soaps would have to be reformulated or relabeled to remain on the market.

"We want companies to actually test these products so that consumers that purchase them have a sense whether there really is any benefit at all over plain soap and water," said Sandra Kweder, deputy director of the office of new drugs at FDA's Center for Drug Evaluation and Research.

"Consumers assume that by using antibacterial soap products they're protecting themselves and their families from illness -- but we don't have any evidence that they're better than simple soap and water," Kweder said.

The advertising used for these products makes consumers think if they wash with them they won't get sick, said Kweder. "You'll see pictures of people sneezing and coughing and looking pretty ill."

But many of those images "look like people who have viral illnesses" such as the common cold, she said. Viruses are the most common cause of infections in the United States and antibacterial agents have no effect on them.

Currently the only use for which triclosan has been shown to be effective is as an anti-gingivitis ingredient in toothpaste, said Kweder.

These products often sell for slightly more than regular soaps, so consumers are paying a premium for something which may be no better, or even worse, than plain soap and water.

"Simple hand washing with soap and water still remains one of the most effective ways to decrease the risk of spreading infections after preparing food, using the toilet, or after coughing or blowing your nose," said Frank Netter, director of global public health at Quinnipiac University's medical school in Hamden, Conn.

The federal ruling on triclosan and other antibacterial ingredients lends new support to longstanding warnings from scientists who say the chemicals can interfere with hormone levels.

"Given our emerging understanding of chemicals as hormone disruptors, this is a remarkable and positive step towards protecting children," said Leonardo Trasande, a professor of environmental medicine at New York University's Langone Medical Center.

Some evidence suggests that there may be an association between triclosan exposure and allergies. Because of that "there is little justification for widespread use of triclosan when soap and water or alcohol based hand sanitizers are available, said Trasande.

There are also concerns that the widespread use of antibacterial soaps may contribute to antibiotic resistance. "There are laboratory data showing that bacteria exposed to these products do change their resistance patterns," said Kweder. FDA wants to know more.

The agency's proposal comes more than 40 years after the agency was first tasked with evaluating triclosan and similar ingredients. Ultimately, the government agreed to publish its findings only after a legal battle with an environmental group, which accused the FDA of delaying action.

What the FDA decides to do and whether triclosan continues to be allowed in household cleaners could have broader implications for a $1 billion industry that includes hundreds of anti-bacterial products from toothpaste to toys.

The FDA has been working on this question since 2005, said Colleen Rogers, one of the agency's lead microbiologists.

The rules would not affect hand sanitizers, said Kweder. While soap and water work better than alcohol-based sanitizers "they're effective for use when water's not available."

The proposed rule gives companies until December 2014 to submit data and studies. The agency's goal is to finalize the rule "one way or the other" around September 2016, Kweder said.


Story first appeared in the Detroit Free Press.

Eric Allen went to bed March 1, thinking he had a light flu. By the time he staggered into the hospital in London, Ky., the next day, he was coughing up bits of lung tissue. Within hours, organs failing, he was in a coma.

Tests showed that Allen, 39, had a ravaging pneumonia caused by Methicillin-resistant Staphylococcus aureus, or MRSA, an antibiotic-resistant bacteria once confined to hospitals and other health care facilities. Allen hadn't been near a doctor or a hospital.

Same with the next victim, a 54-year-old man, who came in days later and died within hours. And the victim after that, a 28-year-old woman, dead on arrival.

The doctors were alarmed.

"What really bothered me was the rapidity of their deterioration, a matter of hours," says Muhammad Iqbal, a pulmonologist who chairs the infection control committee at Saint Joseph-London hospital. "We were worried that something was spreading across the community."

Indeed, a deadly form of MRSA had sprung from nowhere, picking off otherwise healthy people. The cases thrust Iqbal and his colleagues to the front lines of modern medicine's struggle against antibiotic resistant bacteria -- perhaps the nation's most daunting public health threat.

No drug-defying bug has proved more persistent than MRSA, none has caused more frustration and none has spread more widely. In recent years, new MRSA strains have emerged to strike in community settings, reaching far beyond hospitals to infect schoolchildren, soldiers, prison inmates, even NFL players.

In metro Detroit, MRSA infections have broken out in recent months in schools from Northville to Belleville to St. Clair Shores.

The first of a handful of MRSA cases at Northville High School was reported in August. Since then, the district has added two additional custodians to the day shift to clean the building while classes are in session, according to information on the district's website. Additional hand sanitation stations were set up, and the school undergoes a deep cleaning every weekend. Custodians also switched to a more aggressive disinfectant.

In May, all buildings within the Mt. Clemens Community School District were closed for cleaning after a teacher and para-professional at the high school were diagnosed with MRSA infections.

A USA TODAY examination finds that MRSA infections, particularly outside of health care facilities, are much more common than government statistics suggest. They sicken hundreds of thousands of Americans each year in various ways, from minor skin boils to deadly pneumonia, claiming upward of 20,000 lives. The inability to detect or track cases is confounding efforts by public health officials to develop prevention strategies and keep the bacteria from threatening vast new swaths of the population.

"It's not about winning or losing the battle (against MRSA), it's that the battle is shifting," says Ramanan Laxminarayan, a Princeton University scholar who heads the Center for Disease Dynamics, Economics & Policy. "You're seeing people who are young and healthy getting this (in the community), and it's very serious. ... And it's not picked up in the statistics."

To assess the evolving threat, USA TODAY reviewed federal data on hospitalizations and infection rates, academic studies and an array of government reports. Key findings:

  • Most cases go uncounted: Hundreds of thousands of MRSA cases a year are not included in government incidence estimates because the Centers for Disease Control and Prevention can track only the sliver of cases that escalate to life-threatening infections. In 2011, the CDC reported 80,500 such cases, but that figure represents less than 20% of the hospitalizations that year in which billing data show a MRSA diagnosis. Countless more cases, typically less-serious skin infections, were treated outside hospitals.
  • Successes are masking new threats: The medical establishment has made substantial headway reducing MRSA linked to health care facilities, cutting the worst of those infections 30% or more since 2005. That widely touted progress obscures the fact that there's been little or no decline in cases from community-based strains.
  • Infections in kids are climbing: MRSA cases in children continue to rise, jumping 10% a year among youths ages 3 months to 17 years. A much larger share of the infections hitting children have been linked to community strains that can pass from kid to kid by, say, brushing against a victim at school or handling a contaminated object, such as a locker room towel.
  • Officials have a patchwork control plan: Health officials have made little progress developing strategies to reduce severe infections from the community strains that have grown increasingly prevalent. That's partly because most states, like the federal government, collect virtually no data on where and when most community-based cases occur.

"The challenge now is in the community," says Robert Daum, an infectious disease physician and founder of the University of Chicago's MRSA Research Center. "With all due respect to our public health authorities, they made the transition in their minds very slowly that the epidemiology of MRSA had shifted. ... So we are left with a community problem that has been largely unaddressed."

Old bug, new threats

Staphylococcus aureus bacteria have been around for ages, but today's staph infections aren't what they used to be.

Staph occurs naturally and often exists without consequence on people's skin. It most often creates problems when it gets into cuts, causing skin infections -- from small pimples to painful boils -- that usually can be treated easily by doctors. In some cases, the infections advance, destroying tissue and causing large abscesses that can require hospitalization. When staph enters the bloodstream or attacks the lungs as bacterial pneumonia, it becomes especially dangerous -- often fatal.

In the 1940s, penicillin proved effective in treating staph infections, but the bacteria quickly grew resistant, so doctors switched to methicillin. By the 1960s, staph had beaten that, too.

Methicillin-resistant Staphylococcus aureus -- MRSA -- had arrived.

For the next 30 years, MRSA struck mainly in hospitals, creeping into patients via surgical sites, catheters and other paths. Then, in the '90s, new "community-associated" strains began showing up in people who'd had no contact with the medical system -- and the MRSA problem got far more complicated.

Community MRSA strains cause more than half of all the skin and soft tissue infections that send people to the hospital, various studies show. The good news is that there still are antibiotics that work against them -- most of the time. The bad news is that there are other, more dangerous strains that pose especially grave threats.

Perhaps most worrisome, some community strains carry a toxin linked to a lung-ravaging "necrotizing" pneumonia that tends to strike people with the flu or other underlying illnesses. When that pneumonia takes hold, victims often die in as little as 72 hours.

In a CDC-led report out this year, researchers found that MRSA is making its biggest gains among children. Not only did the study document a 10%-a-year rise in MRSA in kids from 2005-2010, it also found that the proportion of those cases involving community-associated MRSA jumped 55%.

Though upward of 30% of the public have garden-variety staph on their bodies, the CDC estimates that just 2% or so carry MRSA.

The CDC has issued guidelines encouraging better hygiene -- bathing and hand washing -- and warning people not to share personal items, such as sports equipment, towels or razors.

Many MRSA researchers say the best way to tackle community MRSA is to develop a vaccine for staph.

MRSA: What it is

  • MRSA is a contagious bacterium that in its different strains can cause medical issues ranging from easily treatable skin infections to painful, flesh-eating abscesses to even death.
  • MRSA is resistant to many antibiotics in the penicillin family.
  • MRSA infections cause nearly 19,000 deaths each year in the United States, far surpassing AIDS/HIV-related deaths of about 12,500 in 2005.

Where it comes from

Staph is commonly found in the nose and on the skin, mainly armpit, groin and genital areas, and normally does not cause illness. However, when the bacteria enter the body they can cause small infections such as pimples and boils.

Staph generally spreads through direct contact with the hands of someone who is infected or carrying the organism.

MRSA wounds look similar to spider bites.

Those at greatest risk

Anyone can get a staph infection. However, it is most commonly found among hospital patients, and there is an increase in staph cases among athletes, prison inmates and children. Risk is highest if you:

  • Are around an infected person.
  • Live in crowded conditions.
  • Play in close-contact sports.
  • Have poor personal hygiene.
  • Have recently used antibiotics.
  • Are an injection-drug user.
  • Have a weakened immune system.
  • Are a man who has sex with men.

What you can do

Although MRSA can't be effectively treated with common antibiotics, Vancomycin has some success. Newer antibiotics are being developed. Here are some preventive measures:

  • Wash hands carefully. This is the most effective measure.
  • Clean shared athletic equipment.
  • Don't share personal hygiene items like razors or towels.
  • Avoid contact with surfaces contaminated with wound drainage.
  • Keep infected areas covered with clean dry bandages.

10 December 2013


Story first appeared on CrainsDetroit.com.

Detroit Medical Center has filed a lawsuit to effectively block the planned acquisition of Barbara Ann Karmanos Cancer Institute by Flint-based McLaren Health Care Corp.

In a filing late Friday in Oakland County Circuit Court, the DMC asked Judge Wendy Potts to grant the eight-hospital for-profit system a permanent injunction to prevent McLaren and Karmanos from completing “any clinical or other affiliation” that would interfere “with the DMC’s agreements (that converts) to its own benefit the DMC’s exclusive affiliate and brand – Karmanos.”

The DMC also is asking Potts to consider triple the amount of unspecified damages awarded to it, plus attorney fees.

DMC’s lawsuit was prompted by an Oct. 30 announcement in which officials from Karmanos said they would sell the downtown Detroit cancer hospital’s assets for an unspecified amount to McLaren.

DMC officials, including CEO Joe Mullany, immediately criticized the deal and hinted it violated a 2005 sale agreement in which DMC sold its cancer business to Karmanos for the low price of $9.9 million. Karmanos initially had offered $45 million.

Three Wayne State University representatives on the Karmanos board voted against the McLaren acquisition. Wayne State officials have turned down numerous requests by Crain’s for an interview, although the university issued a statement last month saying they would continue to work with Karmanos.

Last week, McLaren and Karmanos filed a lawsuit against DMC seeking to have Potts determine whether Karmanos can advertise and market its services with McLaren in Oakland County.

The 2005 sale agreement prohibited Karmanos, with few exceptions, from marketing or advertising its services in the tri-county area of Oakland, Wayne or Macomb counties with anyone other than DMC, DMC alleges.

The DMC filed a motion on Nov. 27 to have the circuit court dismiss McLaren’s complaint for declaratory judgment. Like its counter-suit filed Dec. 6, DMC said Karmanos is liable for breach of contract and McLaren for tortuous interference with its prior agreement with Karmanos.

McLaren and Karmanos officials were unavailable for comment at deadline.

However, Conrad Mallett Jr., DMC’s chief administrative officer, said DMC still hopes to resolve its disagreement with Karmanos outside of court.

“If Karmanos affiliated with McLaren to get our attention, they have gotten it,” said Mallett, adding that lawyers for DMC, Karmanos and McLaren are talking about resolving the dispute.

“If they want the judge to rule, I expect McLaren will lose because it is clear our affiliation agreement with Karmanos was breached,” Mallett said.

One of the main points of disagreement between Karmanos and DMC has to do with whether the 2005 agreement between the two health care organizations provided for an exclusive affiliation.

“The contractual centerpiece that is repeated throughout the DMC/Karmanos agreements is the agreement of long-term exclusive affiliation between Karmanos and the DMC and that the Karmanos name would be publicly-affiliated exclusively with the DMC,” said the DMC counter-suit.

For example, the agreement specifies that Karmanos advertise and market itself to the public as “affiliated with the Detroit Medical Center.”

The agreement also requires Karmanos at the Detroit Medical Center to be on the Karmanos name, logo, website, all signage, all stationary and all materials sent to the public.

“Since signing the McLaren/Karmanos 2013 agreement, Karmanos does not use the phrase ‘affiliated with the Detroit Medical Center’ in its website,” the DMC counter-suit said.

Karmanos also does not use “affiliated with DMC” on its letterhead and other materials distributed to the public, the DMC said.

DMC also alleges that Karmanos concealed for more than a year from DMC and Wayne State that it was negotiating an affiliation with McLaren. The DMC said its agreement with Karmanos requires notification and approval of any affiliation with other organizations.

McLaren officials have told Crain’s they are comfortable their purchase agreement with Karmanos is legal. They are less sure about whether they can use the Karmanos name on cancer centers at McLaren Oakland, a hospital in Pontiac, McLaren Cancer Clarkston and other McLaren health care facilities in Oakland County.

Greg Lane, McLaren’s chief administrative officer, told Crain’s last week that McLaren believes it has the right to jointly market services with Karmanos in Oakland County. He said the DMC-Karmanos agreement allows for a co-branding exception at McLaren Macomb in Mount Clemens and an outpatient cancer center also located in Mount Clemens.

“What is not clear is the impact any agreement between McLaren and Karmanos will have on Detroit,” Mallett said.

“We are very concerned that the Detroit community, which suffers from some of the highest rates of cancer in the country, will be negatively affected by this affiliation. We can’t stand by and say ‘good luck and God speed.’”


Story first appeared on USATODAY.com.

The federal health care exchange is incorrectly determining that some people are eligible for Medicaid when they clearly are not, leaving them with little chance to get the subsidized insurance they are entitled to as the Dec. 23 deadline for enrollment approaches.

State and industry officials haven't quantified the problem yet, but the National Association of State Medicaid Directors may release information next week after following up on reports from around the country, says Executive Director Matt Salo.

Here's what happens: When consumers applying for insurance put their income information into subsidy calculators on HealthCare.gov — the exchange handling insurance sales for 36 states — it tells them how much financial assistance they qualify for or that they are eligible for Medicaid. If it's the latter, consumers aren't able to obtain subsidies toward the insurance, although they could buy full-priced plans.

If the Medicaid determination is wrong, consumers should file an appeal with the federal marketplace, says Department of Health and Human Services spokeswoman Joanne Peters, but she says she does not have an estimate on how long that would take.

Brokers are reporting that some of their clients are in insurance limbo as they wait for the error to be corrected by HHS or their states so they can reapply.

Jessica Waltman, top lobbyist for the National Association of Health Underwriters, says she's heard a number of reports from around the country of people making as much as $80,000 a year being told they qualify for Medicaid on HealthCare.gov.

"I have heard on multiple occasions from brokers in various states over the past eight weeks that they have had wacky Medicaid determinations with people who clearly make way too much money for Medicaid," she says.

HealthCare.gov is "working smoothly for the vast majority of users," says Peters, but she noted some people may have technical difficulties or complicated family or tax situations that require extra assistance.

HHS has added more call center employees and in-person assistants for people who need extra help, she says.

But insurance brokers say that when people call the HealthCare.gov "800" number to explain that they can't possibly be eligible for Medicaid, they are told they are eligible if the site says so.

"It's a very, very unfortunate state of affairs," says Waltman.

HHS said it will begin sending Medicaid application files to states this week given that HealthCare.gov's mechanism to transfer accounts to state Medicaid offices still isn't working. The data received up until now haven't given states enough information to determine Medicaid eligibility, says Salo, but he hopes that, as promised, the new files will.

"Claims from some states about our process for testing the Medicaid eligibility and enrollment systems are inaccurate," says Peters. "We are eager to work with states to ensure their systems are functioning properly and to extend Medicaid coverage to those who are eligible through the generous Medicaid funding made possible by the Affordable Care Act."

HHS is working "extremely hard" to make sure people will have coverage no matter what on Jan. 1, says Salo. While states support that goal, "some want more assurances that people enrolled in Medicaid are actually eligible," he says.

HHS has told states they won't be penalized if they enroll people in Medicaid who HHS erroneously said were eligible, says Salo.

That's little consolation for consumers who can't buy subsidized insurance on the exchange because of apparent mistakes.

Jacob Hawkins of Plano, Texas, makes about $50,000 a year as a self-employed pool builder, yet his family of three was deemed eligible for Medicaid. His wife, Holly, is due to have their second child in February and is worried she won't have insurance in time. She filed an appeal of the Medicaid determination, but doubts it will be approved before the Dec. 23 deadline.

"I'm frustrated, mad and there's no one to help," says Hawkins.

Being married with a $50,000 income will get you a decline from Medicaid, even with a pregnant wife, says Hawkins' broker, Connie Louanne Trebing. " I know, because I just had a couple declined in a similar situation," she says.

Some of the files of those supposedly eligible for Medicaid in Texas include people who don't live in Texas and who are already signed up for Medicaid, says Stephanie Goodman, spokeswoman for the Texas Health and Human Services Commission.

Illinois expects about 19,000 files shortly from HHS. Illinois state spokesman Mike Claffey says he doesn't know how many may have problems, but Chicago broker Jordan Wishner says seven of them will be from his office and definitely will be wrong.

He has three clients of his own and an agent in his office has another four who are clearly above 138% of the federal poverty limit ($32,499 for a family of four), yet are being told they are eligible for Medicaid, which blocks their efforts to buy subsidized insurance.

"What am I supposed to do with the clients that are being told they qualify for Medicaid when they actually do not?" asks Wishner, who owns The Health Insurance Shoppe, a retail insurance store. "Send in an appeal with 16 days left? Seriously?"

With this much uncertainty, "it's frustrating that there is no place for a broker to get help with errant cases and try to avert problems," says Waltman.

State exchanges and insurance companies have dedicated customer service support for insurance agents and brokers who try to correct problems "before they escalate," says Waltman. On the federal exchange, brokers call the same help line as consumers.

"We do not want this woman giving birth and not having coverage," says Waltman, referring to Hawkins. "This is absolutely what the law was trying to prevent from ever happening again."

05 December 2013

'You deserve better': Obama offers fix for canceled health insurance plans

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Saying "we fumbled the rollout," President Barack Obama announced a fix to the vexing problem of canceled health insurance policies Thursday. He told insurers they don’t have to cancel plans next year just because of the Affordable Care Act.

Insurers can continue the plans for 2014 on two conditions — they have to tell people what their plans don’t cover, and they have to let people know they do have the option of going onto the health insurance exchanges to buy new plans with federal government subsidies and perhaps go onto Medicaid.

"Insurers can extend current plans that otherwise would have been canceled in 2014," Obama said.

He also apologized for the messy rollout of the health insurance exchanges. "We should have done a better job of getting this right on Day One," Obama told an hour-long White House news conference. "We did fumble the ball on it and one of the things I am going to do is make sure we get it fixed."

Critics of the health reform law, known widely as Obamacare, have made hay with reports that tens of thousands of people have been getting cancellation notices from their insurance companies, despite Obama’s repeated promises that people who like their insurance plans can keep them. NBC News first reported that the White House knew the cancellations were coming.

"This is something I deeply regret because it's scary getting a cancellation notice," Obama said at the news conference. "It’s on me. Those who got cancellation notices do deserve better and they received an apology from me. But they deserve more than words."

One main goal of Obamacare was to get rid of what the White House says are the worst abuses of the insurance industry -- caps on coverage, policies that charged women three to five times what a similar man was charged, policies that didn’t pay for cancer screening.

Some of the policies that have been canceled were very inexpensive, part of the reason for the outrage. But insurance and health industry experts say it’s because they were so bare-bones, they wouldn’t have paid for much if they were ever needed. The White House keeps stressing that the new rules level the playing field a little bit, and offer most people much more in terms of coverage.

"A lot of people think, 'I've got pretty good health insurance', until they get sick," Obama said. "If you received one of those letters, I encourage you to look at the marketplace."

Health and Human Services Secretary Kathleen Sebelius has also pointed out that the policies being canceled are mostly individual policies, not the big group policies offered by employers that cover most Americans. Those policies often change every year anyway, HHS says.

According to America’s Health Insurance Plans, the industry’s group, 19 million Americans have individual plans.

Democrats who support the law have been pushing the White House to come up with some way to fix the problem. Health officials point out it’s a very small percentage of people who are actually affected by the cancellations, but the political and public relations damage has been extensive.

Obama eventually apologized in an exclusive NBC news interview last week. He apologized again Thursday for the disastrous debut of the HealthCare.gov website.

"I was not informed directly that the website would not be working the way it was supposed to,” he said. "I get accused of a lot of things but I don't think I am stupid enough to go around saying this is going to be like shopping on Amazon or Travelocity a week before the website opens if I thought that it wasn't going to work."

"Clearly we and I did not have enough awareness about the problems on the website, even a week into it," he added.

The Health and Human Services Department released figures that show only 26,000 people got on the federally run website in October, the first month the exchanges were open. But more than 75,000 more got on using state-run websites, and more than 26 million have at least gone online to have a look.

Tech officials blamed poor management and analysts said the site's failure was a new political low for the administration.

The new plan announced by Obama gets out in front of a Republican-crafted plan that was due to come up in Congress Friday. House minority leader Nancy Pelosi called that GOP proposal “a very dangerous bill” that is “completely disruptive” to the insurance pools, characterizing it as simply another Republican attempt to gut – not repair – the underlying health care law.

House Speaker John Boehner rejected Obama's plan. "True to form, it appears this is little more than a political response designed to shift blame rather than solve the problem," Boehner, an Ohio Republican, said. "This problem cannot be papered over by another ream of Washington regulations. Americans losing their coverage because of the president's health care law need clear, unambiguous legislation that guarantees the plan they have and like will still be allowed. That's why the House will be voting on the Keep Your Health Plan Act tomorrow, and the president should support it."

Pelosi said Democrats will try to present their own idea for a vote on Friday to complement Obama’s “administrative” approach. “We are in agreement. We must have a fix, and we will,” she said.

Health insurance companies expressed concern about Obama's proposal. "Changing the rules after health plans have already met the requirements of the law could destabilize the market and result in higher premiums for consumers," Karen Ignagni, CEO of America's Health Insurance Plans, said in a statement.

"Premiums have already been set for next year based on an assumption of when consumers will be transitioning to the new marketplace. If now fewer younger and healthier people choose to purchase coverage in the exchange, premiums will increase and there will be fewer choices for consumers. Additional steps must be taken to stabilize the marketplace and mitigate the adverse impact on consumers."

One fear is that if too many people are allowed to keep their older, cheap policies, they won’t join the pool of people buying on the exchanges – and that’ll drive up prices next year for everyone else. The more healthy people are in the pool buying policies, the more they offset the sicker people, and the less insurance companies can charge everyone. White House officials said they’ll watch and see what happens in the next year, and tweak as necessary.

Price is the main concern of most Americans when it comes to buying insurance, and the administration is keen to be able to say Obamacare is keeping prices low.

04 December 2013


This story first appeared in The Washington Post

Over the past few weeks, if you've been paying attention at all to the unfolding disaster of people trying and failing to sign up for Obamacare online, one name keeps coming up: CGI Federal, the IT contractor that has orchestrated most of the Healthcare.gov Web site. By most accounts, it's been a complete train wreck, for reasons both technical and bureaucratic. Here's what you need to know about the company at the center of it all.

What is CGI Federal?

CGI Federal is a wholly owned subsidiary of the Canadian firm CGI Group, which was founded in Quebec City in 1976 by a pair or 26-year-olds named Serge Godin and Andre Imbeau. (CGI stands for "Conseillers en Gestion et Informatique" in French, which roughly translates to "Information Systems and Management Consultants"). Growing through scores of acquisitions, and providing outsourced IT services to massive companies such as Bell Canada and Quebec's provincial pension plan, CGI's business model depends on embedding itself deeply within an institution.

"The ultimate aim is to establish relations so intimate with the client that decoupling becomes almost impossible," read one profile of the company.

It's now based in Montreal and has a market capitalization of $8.9 billion on annual revenues of about $4.8 billion. Godin, who stepped aside as CEO in 2006, is now a billionaire and makes upwards of $4 million a year. After buying British rival Logica in July, CGI doubled its employee base, and became Canada's biggest tech firm. CGI Group has 72,000 employees in 400 offices worldwide — many of them in India — and 11,000 in the United States, with D.C.-area locations in Fairfax, Manassas, Washington, and Baltimore.

Wait, why haven't I heard of this giant company?

CGI Federal is a relative newbie on the U.S. government IT contracting scene. It bought the U.S. contractor American Management Systems in 2004, but only started ramping up business after 2008, and accelerated in 2010 with the $1.1 billion acquisition of U.S.-based military IT contractor Stanley Inc. That sent its contracting work through the roof:

Still, CGI is only the 29th largest federal IT contractor, with about $950 million in contracts in 2012, compared to number one Lockheed Martin's $14.9 billion. They also don't make high-profile weapons systems, but rather the guts of government Web sites that rarely bear their names.

That said, they've learned quickly, and see the U.S. federal government as their area of biggest growth. CGI Federal's health-care practice has grown 90 percent year over year, largely due to the Healthcare.gov project. And for a contractor, ballooning projects are a good thing. "In the Federal Government business, we continue to see more extensions and ceiling increases on our existing work, while we further leverage our position on contract vehicles," said CEO Michael Roach on their latest earnings call. Those "contract vehicles" now amount to $200 billion, which Roach later referred to as a "hunting license."

"Accordingly, we continue to view U.S. Federal Government as a significant growth opportunity," Roach continued. CGI Federal now has an $8 billion pipeline of future task orders — doubling its federal business over the period of a year — including big-ticket items such as $871 million for the Defense Information Services Agency,  a $143 million contract to do visa processing in China, and a five-year, "indefinite quantity" contract for the Department of Homeland Security and Coast Guard. (It's also working with state governments too — California, for example, handed it a $399 million contract to revamp its tax processing system).

What was their track record before getting the Healthcare.gov gig?

Experience in similar types of projects is very important in getting federal contracts. CGI had done work in the healthcare arena, and not all of it good: Its performance on Ontario, Canada's health-care medical registry for diabetes sufferers was so poor that officials ditched the $46.2 million contract after three years of missed deadlines, the Washington Examiner reported. A spokeswoman for CGI says that both parties are bound by confidentiality agreements, but they're working on resolving the situation.

It has, however, helped deliver complex projects on time and on budget. Back in 2009, the White House's Recovery Board retained CGI Federal to adapt a well-functioning system it had built for the U.S. Environmental Protection Agency into FederalReporting.gov, another very complex, public-facing and high-volume site that would handle all contracts granted under federal stimulus legislation. This one got built in six weeks, for much less money, and won accolades for its flexibility and reliability.

How did CGI land the Healthcare.gov contract?

CGI Federal's winning bid stretches back to 2007, when it was one of 16 companies to get certified on a $4 billion "indefinite delivery, indefinite quantity" contract for upgrading Medicare and Medicaid's systems. Government-Wide Acquisition Contracts — GWACs, as they're affectionately known — allow agencies to issue task orders to pre-vetted companies without going through the full procurement process, but also tend to lock out companies that didn't get on the bandwagon originally. According to USASpending.gov, CGI Federal got a total of $678 million for various services under the contract — including the $93.7 million Healthcare.gov job, which CGI Federal won over three other companies in late 2011.

It's also true that CGI Federal began lobbying as it started winning government work. According to OpenSecrets.org, it has spent $800,000 since 2006 lobbying on several different tax and appropriations bills. That's nothing, though, compared to the many millions of dollars deployed by heavy hitters like Lockheed Martin and Raytheon.*

What exactly were they responsible for?

According to a June report from the Government Accountability Office, a total of 55 contractors were retained to work on the rollout of the federal health-care marketplace. CGI Federal was the primary one, and had received $88 million out of the $394 million that had been spent at that point (the next biggest recipient got $55 million). Along with building sites for the states that elected to participate in the federal marketplace, it's in charge of knitting all the pieces together, making Quality Software Services' data hub work seamlessly with Development Seed's sleek user interface and Oracle's identity management software — or "designing an IT solution that is adaptable and modular to accommodate the implementation of additional functional requirements and services," as CGI Senior Vice President Cheryl Campbell put it in a September hearing on the progress of the site.

What exactly went wrong?

That is a matter of some disagreement. And the answer isn't necessarily that CGI is wholly responsible.

Some people think that the system was underfunded: Donald Berwick, who administered the federal Centers for Medicare and Medicaid Services in 2010 and 2011, says the site failed because they didn't have enough money to build it from the start. Others point fingers at the Department of Health and Human Services, which took years to issue final specifications, preventing CGI from really getting started until this spring.

Either way, it's clear that the site itself isn't well constructed: IT professionals told the Wall Street Journal that in addition to specific pieces not working, the whole thing was "built on a sloppy software foundation," potentially due to the haste with which code was written. Slate described just how difficult it is to coordinate multiple contractors creating different components of a complex Web portal.

Evan Burfield, who founded the relatively small company that worked with CGI to build Recovery.gov, says the problem lies more in a federal procurement apparatus that makes it nearly impossible for an agile newcomer to bid on projects that in the private sector would take much less time and money. Plus, with so many contractors, everyone could technically fulfill the requirements in their statement of work, and the thing can still not work in the end.

"If it had been a $4 million Web site, it would've had higher likelihood of being a success," Burfield says. "It's not just CGI. It's any collection of government contractors, if you put them together, will find a way to put together something complex enough to justify $400 million."

Even though White House technology officials like Todd Park understand the value of lean development and have taken steps to open the procurement system to smaller companies, the overall structure of contracting rules would require an act of Congress to change.

What's it like inside the company these days?

The healthcare.gov debacle has taken its toll on the working environment at CGI Federal's 10-story complex in Fairfax, Va., according to a staffer working on a related project who asked not to be named. "There's been a lot of agitation and anger, because CGI really prides itself on having family flexibility," he said, noting the firm's liberal telework policy. Instead, the Obamacare contract has sucked more and more staff off other projects, and people have been working around the clock to first get the site ready for Oct. 1, and then fix it when things started to go wrong. "There's a lot of frustration," the staffer said. "People are getting sick, fainting in conference calls."

That's only an escalation in an already unstable work environment. The firm has grown very quickly and turnover is high, as people get poached by larger contractors that can pay higher salaries, the staffer said. Offices sometimes have more contractors than full-fledged staff — which makes things difficult when you're putting together a project that requires as much specialized knowledge as a health-care exchange.

One thing is clear, though: CGI's leadership is really excited about the health-care work, and wants everyone to think it's going okay. Last week, they held an annual meeting with a dinner reception at a nearby Marriott. "They addressed some of the health-care exchange things that people have been hearing on the news," the staffer recalled. "Vague things about how health care is changing in the U.S. and how CGI is going to be at the forefront of that. 'You guys have probably heard some stuff, but this is indicative of any huge rollout of any project.' "

A CGI spokeswoman declined to comment on the staffer's observations.

How's the market reacting to it?

Pretty well actually! Here's the one-month chart from the New York Stock Exchange:

CGI Group's stock has been on the upswing since its huge acquisition of Logica, which added $3 billion in market cap. And it hasn't been punished much by the negative press in recent weeks, either. TD Bank Securities research sent the following note to clients:

"Our concern was that CGI (as a main contractor on the federal health exchange) would be linked in a negative way to exchange difficulties. This by and large has not happened – there is no indication that CGI failed to deliver on its commitments — and the stock is up 4% since Oct. 1 (when enrollment in exchanges began)."

Because of how federal contracting works, it's also unlikely that CGI will be less competitive on bids in the future.

* Corrected to reflect the fact that Booz Allen Hamilton does not lobby, period.


This story first appeared in Reuters.

WASHINGTON (Reuters) - U.S. insurers fear that a surge in enrollments on the revamped government-run healthcare website could create more problems for insurance companies already struggling with error-filled applications for coverage three weeks before a sign-up deadline.

In what could become the next major headache for President Barack Obama's signature domestic policy, a group representing leading U.S. insurers said on Tuesday that technology fixes that will enable millions of people to sign on to HealthCare.gov have not fully addressed faulty data that the site has been sending these companies about their new enrollees.

The problems include enrollment forms with erroneous personal information and duplicate or missing applications. In some cases, consumers who believe they have signed up may not have a file with the insurer.

The warning coincided with an effort by Obama to win back support for the healthcare overhaul after the website's disastrous October 1 debut sent his job approval ratings plummeting and threatened to damage fellow Democrats in next year's congressional elections.

The website, which allows consumers to shop for insurance policies, is a main component of the 2010 Affordable Care Act aimed at providing health benefits to millions of uninsured Americans.

Daniel Durham, a vice president for policy and regulatory affairs at America's Health Insurance Plans, a lobby group for health insurers, said companies were regularly receiving faulty enrollment forms. He did not give details on how frequently the errors were appearing.

"So far we've been able to deal with these issues because there's been relatively low volume," Durham said. "But now that the floodgates are open at the front end... we're going to see a lot more volume. And health plans just don't have the personnel to do all this manually."

Durham said insurers need "clean" enrollment files so they can be processed by the December 23 deadline for coverage to start on January 1.


The White House said that more than a million people had visited HealthCare.gov on Monday, the first day after major technical repairs to the website. It did not say how many people had completed applications and enrolled in new plans.

The botched rollout of Obamacare has hurt the popularity of the initiative. Opposition to the healthcare law stood at 59 percent in a Reuters/Ipsos poll conducted in mid-November.

Obama on Tuesday encouraged Americans to look beyond the website and recognize the benefits of the law known as Obamacare. "The bottom line is this law is working and will work into the future. People want the financial stability of health insurance," Obama said in a speech.

While Obama and his aides have been focusing on fixing the most visible problems with the website, insurers say that serious technical issues are still plaguing the so-called "back end" of the portal that transmits important user information to insurance companies.

"It's a real problem for plans when the enrollment file never comes over, and then you get the consumer calling, and the plan has no record of that individual," Durham said at a forum organized by Georgetown University and law firm Arent Fox. "Time is short. January 1 is coming around fairly quickly here."

Cynthia Michener, spokeswoman for Aetna Inc, the third-largest U.S. insurer, said the company is continuing to receive flawed enrollment files, including duplicate records.

She also said that while there have been improvements with the website's performance, Aetna is helping "identify, prioritize and test additional issues."

White House spokesman Jay Carney, meanwhile, said the government was working with experts to make sure every enrollment form on the site is accurate.

"We believe that and are confident that they will be able to ensure that accuracy in time for the January 1st beginning of coverage for those who have signed up for it," he said.


Republicans in Congress and conservative groups have attacked the law relentlessly as an example of government overreach, criticism that has snowballed since the problems with HealthCare.gov.

Obama's job approval rating is at historic lows. A Reuters-Ipsos poll released on Tuesday showed his overall job approval rating at 38 percent, with 63 percent of respondents saying the country is on the wrong track. The November 29-December 3 poll of 1,494 Americans is accurate to plus or minus 2.6 percentage points for all adults.

The administration is trying to win back disgruntled Democrats facing a backlash from the healthcare debacle when they run for re-election next year in Congress.

Democrats in the House of Representatives who met with White House officials on Tuesday said they plan to counter Republican attacks on the law with stories about people it has helped.

Some Democrats, however, remain frustrated by the botched rollout. "I'm glad they're working on it but I'm still very disappointed. I'm still absolutely bewildered as to why they weren't ready," said Representative Carol Shea-Porter, Democrat from New Hampshire.

The federal website was supposed to make it easy to buy health insurance in 36 states. Other states run their own online marketplaces.