WASHINGTON — The official in charge of Medicare and Medicaid for the last 17 months says 20 to 30 percent of health spending is “waste” that yields no benefit to patients, and that some of the needless spending is a result of onerous, archaic regulations enforced by his agency.
The official, Dr. Donald Berwick, listed five reasons for what he called the “extremely high level of waste”: overtreatment of patients, the failure to coordinate care, the administrative complexity of the health care system, burdensome rules and fraud.
In an interview Thursday, his last day on the job, Berwick reflected on his successes, failures and frustrations in trying to engineer a rapid transformation of the health care.
President Barack Obama nominated Berwick to be the administrator of the Centers for Medicare and Medicaid Services in April 2010. While the Senate was investigating Berwick's qualifications, Obama circumvented Congress by giving him a temporary recess appointment, a shortcut that infuriated Republicans and irked some Democrats. The appointment was due to expire at the end of this year.
“I came with an agenda,” Berwick said. “I wanted to try to change the agency to be a force for improvement, covering one out of three Americans.”
Asked why Americans were still deeply divided over the new health care law, signed 20 months ago, Berwick said: “It's a complex, complicated law. To explain it takes a while. To understand it takes an investment that I'm not sure the man or woman in the street wants to make or ought to make.”
After last year's health care reform law gave prosecutors expanded enforcement tools, President Barack Obama pledged that auditors would cut deeply into fraud he estimated at tens of billions of dollars each year. Efforts in Tennessee alone have netted court orders and settlements recouping more than $100 million this year, up from $3 million the year before, authorities said.
"It used to be that if you were a U.S. attorney, the fraud cases didn't seem like the sexiest thing in the world," said Patrick Burns of the Washington, D.C.-based nonprofit Taxpayers Against Fraud. "Suddenly, fraud fighting, instead of having been a career liability, is in fact a career-maker."
U.S. Attorney Jerry Martin, in interviews and speeches, has vowed to prosecute fraud cases of all sizes in Middle Tennessee, from individuals running sham storefronts to elaborate false-billing schemes. Prosecutors here have closed several cases in recent years, ranging from an $82.6 million judgment against a company charged with overbilling for equipment to a probation sentence for a Nashville-area psychiatrist and minister who billed Medicare for prayer sessions described as psychotherapy.
Martin believes a lack of oversight in prior years led to widespread abuse throughout the system, with millions more to be saved in the federal safety-net programs in Tennessee. The National Health Care Anti-Fraud Association estimates that 3 to 10 percent of all health care spending is fraudulent.
The Murfreesboro Ambulance Service investigation actually began before the effort to root out Medicare and Medicaid fraud ramped up. It started with a 2006 audit by AdvanceMed, a Nashville firm hired by the Centers for Medicare and Medicaid Services.
The case came to the attention of auditors when the company surged to the top of transport service providers in the state, according to court records. In 2005, it became the fifth-highest paid provider of transport services among 82 companies that drove patients to dialysis appointments.
Auditors saw patients riding in the front seat of the ambulance, as well as trips carrying more than one patient at a time. Both circumstances should have disqualified them from Medicare and Medicaid reimbursement.
Company medics changed their habits briefly during the two-week audit in December 2006, records show. After being told to do so by supervisors, they put patients — previously allowed to walk — onto stretchers.
Days later, the records show, they went back to more casual rides, allowing patients to sit in the cab.
After interviews with five medics, Covington described a top-down scheme in which supervisors told medics to change descriptions in their driving logs to ensure reimbursement. Writing that patients "walked," for example, was barred, he said, although the rule was never put in writing.
All told, authorities charge, the ambulance company filed improper claims from 1998 to 2006 and collected more than $587,000 in reimbursements from Medicare and Medicaid.
Some of the money, prosecutors say, went to a Corvette and a Harley-Davidson motorcycle they seized.
The company employed about 30 employees and ran eight ambulances as of September 2008, according to court records. After authorities searched the Medlock home that year, Kathy Medlock told The Daily News Journal that her company had "nothing to hide," and blamed an unnamed "disgruntled employee" for triggering the probe.
"We are squeaky clean and will remain squeaky clean," she said.
The Medlocks each face maximum 20-year sentences and $250,000 fines.
Now that they're looking more closely at fraud, local authorities are still striving to get a handle on how widespread it is.
Martin, who spoke at the Taxpayers Against Fraud annual convention earlier this year, made it clear he "absolutely was looking for business," Burns said.
Anna Grizzle, a lawyer who helps health care companies develop regulatory compliance programs, said health care firms and their lawyers have gotten the message Martin and other prosecutors are sending. She said many are paying much closer attention to the complex rules of Medicare and Medicaid than they once were.
"Now more than ever, you need an active and robust compliance program to help the provider identify any potential problems or mistakes and correct those mistakes," she said. "The fear is, with the increased enforcement, with the changes to the laws ... a provider could be caught up in a situation where it's an innocent billing mistake."
Burns' group encourages use of the False Claims Act, which allows whistleblowers to file sealed lawsuits and invite federal prosecutors to take up cases. First passed by Congress during the Civil War, the act was updated in 2009 and strengthened as part of the 2010 health care reform law.
Martin has doubled the number of local prosecutors handling such cases, which are becoming more commonplace nationwide. It's just one more tool the government is using to go after fraud.
NEW YORK — As scientists struggle to find a vaccine to prevent infection with the AIDS virus, a study in mice suggests hope for a new approach — one that doctors now want to test in people.
The treated mice in the study appeared to have 100 percent protection against HIV. That doesn't mean the strategy will work in people. But several experts were impressed.
"This is a very important paper (about) a very creative idea," says the government's AIDS chief, Dr. Anthony Fauci. He didn't take part in the research.
The new study involved injecting mice with a protective gene, an idea that's been tested against HIV infection in animals for a decade.
In the nearly 30 years since HIV was identified, scientists haven't been able to find a vaccine that is broadly effective. One boost came in 2009, when a large study in Thailand showed that an experimental vaccine protected about a third of recipients against infection. That's not good enough for general use, but researchers are now trying to improve it.
Researchers reported the new results in mice online Wednesday in the journal Nature. They hope to test the approach in people in a couple of years. Another research team reported similar success in monkeys in 2009 and hopes to start human tests even sooner.
A traditional vaccine works by masquerading as a germ, training the body's immune system to build specific defenses in case the real germ shows up. Those defenses are generally antibodies, which are proteins in the blood that have just the right shape to grab onto parts of an invading virus. Once that happens, the virus can't establish a lasting infection and is cleared from the body.
Scientists have identified antibodies that neutralize a wide range of HIV strains, but they've had trouble getting people's immune systems to create those antibodies with a vaccine.
The gene-injection goal is straightforward. Rather than trying to train a person's immune system to devise effective antibodies, why not just give a person genes for those proteins? The genes can slip into cells in muscle or some other tissue and make them pump out lots of the antibodies.
The mouse work is reported by David Baltimore and colleagues at the California Institute of Technology.
Ordinary mice don't get infected with HIV, which attacks the immune system. So the research used mice that carried human immune system cells.
Baltimore's team used a harmless virus to carry an antibody gene and injected it once into a leg muscle. The researchers found that the mice made high levels of the antibody for more than a year. The results suggest lifetime protection for a mouse, Baltimore said, although "we simply don't know what will happen in people."
Even when the mice were injected with very high doses of HIV, they didn't show the loss of certain blood cells that results from HIV infection. Baltimore said researchers couldn't completely rule out the possibility of infection, but that their tests found no evidence of it. He said a few hundred mice appeared to be protected.
The work was funded by the federal government and the Bill and Melinda Gates Foundation. Baltimore said his lab has filed for patents.
"I think it's great," said Dr. Philip R. Johnson of the Children's Hospital of Philadelphia, who reported similar results in monkeys in 2009. "It provides additional evidence this is a concept that's worth moving forward."
Johnson said he has discussed doing a human trial with federal regulators and is preparing an application for permission to go ahead. If all goes well, a preliminary experiment to test the safety of the approach might begin in about a year, he said. Baltimore said his group is also planning human experiments that he hopes will start in the next couple years.
Fauci, who is director of the National Institute of Allergy and Infectious Diseases, cautioned that mouse results don't always pan out in human studies. He also said both the gene approach and standard vaccines should be pursued because it's not clear which will work better.
The biggest headache for Jimu Zishi is the rainy or snowy weather, as it would make the rugged mountain paths a tougher challenge and her shoes would always become worn-out after such a trip, says the 34-year-old woman.
Her mother hopes that she quit the job, but Jimu Zishi has persisted.
"The pains are worthwhile as I feel I have to play my role when HIV is taking its toll on my locals," she says.
Locked in deep mountains, China's largest Yi community in Liangshan, a prefecture which administers Zhaojue, can not yet escape the ravage from the demon of AIDS.
A juncture of Sichuan and Yunnan, a province adjacent to the drug source of the Golden Triangle in Southeast Asia, ethnic Yi people in Liangshan unfortunately falls into a victim of heroin, and the Yi communities have to face greater risks of HIV infections because of popular needle sharing among drug users.
A total of 24,768 HIV carriers have been reported in the prefecture as of September, 2011 while the number was 21,565 last year. It is recorded that there are currently 11,549 drug addicts across the prefecture.
Jimu Zishi is only one of the Yi people who have been awakened to the cruel truth -- the Yi ethnic group, one of the oldest minorities in China with a history of more than 2,000 years, will have to face a survival crisis if drugs and the virus of AIDS are not stemmed in their mountains.
HIGH PREVALENCE
Yi is not the unique case. In other major ethnic minority communities, AIDS has been spreading in a notable way.
In Xinjiang Uygur Autonomous region, the disease has been seen as a taboo for the majority of Muslim. People considered HIV carriers dirty.
So far more than 30,000 HIV carriers and AIDS patients have been reported in this region, ranking fifth in the country.
In Yunnan province and Guangxi Zhuang Autonomous Region, homes to dozens of ethnic minorities, AIDS is regarded among the high risk diseases, as these regions have witnessed rampant drug abuse and frequent cross-border marriages.
Huang, a Guangxi resident, married Nguyen, a former Vietnamese sex worker in 2004. Two years later, she suffered recurring herpes outbreaks on her face. The couple spent a lot of money but the outbreaks didn't stop. Finally a doctor suggested they take a HIV test. Both of them showed positive results.
"In Xinjiang's Yili Kazakhstan Prefecture and Yunnan's Ruili City and Longchuan County, AIDS infection rates are over one percent, which is higher than the country's average and can be categorized into high prevalence areas," said Chen Zhu, minister of health.
There are 780,000 HIV carriers and AIDS patients in China, according to Chen.
Officials and experts worry that AIDS spread in ethnic minority regions, which are economically lagging behind and poorer than most parts of China, will slow down their development and cause social instability.
Healthy pregnant women should be able to choose where to give birth, say British researchers who compared the safety of home births with deliveries at clinics and hospitals.
The risks were higher for first-time mothers who gave birth at home, but the overall risk was low regardless of where the delivery happened, investigators said in this week’s issue of the British Medical Journal.
For the study, researchers reviewed data for nearly 65,000 mothers and babies between 2008 and 2010 in England. Of those, the births included:
19,706 in hospital obstetric wards.
16,840 at home.
11,282 in "freestanding" midwifery units — independent facilities where there are no doctors or access to anesthetics.
16,710 in "alongside" midwifery units, often housed within hospitals.
All of the pregnancies were low risk in terms of the health of the women whose babies were carried to full term.
Among the first-time moms with planned home births, there were 9.3 adverse events per 1,000 births, such as babies born with encephalopathy, a type of brain injury, due to labour problems and stillbirth. In comparison, there were 5.3 adverse events per 1,000 births for those planning a hospital birth.
For women who had given birth before, there were no major differences.
"These results will enable women and their partners to have informed discussions with health professionals in relation to clinical outcomes and planned place of birth," Prof. Peter Brocklehurst from the University of Oxford for the Birthplace in England and his co-authors said.
If the pregnancy and labour are not complicated, a high level of specific expertise isn't needed, Brocklehurst said.
More than 90 per cent of pregnant women in England give birth in a hospital, with midwives delivering more than 60 per cent of babies.
Birth isn't an abnormal process, it's a physiological process," he said. "And if your pregnancy and labor is not complicated, then you don't need a high level of specific expertise."
Brocklehurst added that about 50 percent of pregnant women in England — those who are low-risk — should be able to choose where to have their baby.
More than 90 percent of pregnant women in England now give birth in a hospital. Some officials say the new study should prompt women to consider alternatives.
"This is about giving women a choice," said Mary Newburn of NCT, a U.K. charity for parents, one of the study's authors. She said midwife-run birth centers in England have a more homelike environment, with privacy, sofas and birthing pools.
In Britain, midwives deliver more than 60 percent of babies already. Similar care is provided in the Netherlands, where about a quarter of all births happen at home. Elsewhere in Europe, most births are led by doctors, although midwives may also be involved.
In the United States, however, less than one percent of births happen at home. The American College of Obstetricians and Gynecologists does not support planned home births and warns evidence shows they have a higher risk of newborn death compared to planned hospital births.
The training of midwives in the U.S. varies by state — and some have no regulations.
Brocklehurst and colleagues collected data for nearly 65,000 mothers and babies between 2008 and 2010 in England. Of those, there were 19,706 births in hospital obstetric wards, 16,840 births at home, 11,282 births in "freestanding" midwifery units — independent clinics where there are no doctors or access to anesthetics — and 16,710 births in "alongside" midwifery units, often housed within hospitals.
All the pregnancies were low-risk, meaning the mothers were healthy and carried their baby to term. Women planning C-sections or expecting twins or multiple births were excluded from the study.
In the U.K.'s hospital obstetric wards, most low-risk women don't see a doctor during labor and are only treated by midwives.
There didn't appear to be a difference for the infants' health based on where the mothers planned to give birth.
But researchers found a higher risk for first-time mothers planning a home birth. Among those women, there were 9.3 adverse events per 1,000 births, including babies with brain damage due to labor problems and stillbirth. That compared to 5.3 adverse events per 1,000 births for those planning a hospital birth.
The study was published Friday in the medical journal, BMJ. It was paid for by Britain's department of health and another government health research body.
Dr. Tony Falconer, president of the Royal College of Obstetricians & Gynecologists, said his group supports "appropriately selected home birth." He noted the higher risk of problems among first-time mothers choosing a home birth and said that raised questions about where they should deliver.
For Emily Shaw of London, giving birth in a hospital wasn't appealing. She wanted home births for both her sons but because her first baby was induced into labor, she had to deliver him in a hospital in October 2008.
Shaw delivered her second son at home in April. "I felt much more comfortable there," she said. "Instead of getting into a car to go to the hospital, the midwives came to me."
"It was nice to have the home comforts during labor," she added, saying she could eat in her own kitchen and use her own bathroom. "And unlike the hospital, they didn't kick out my partner in the middle of the night.
Perhaps no one is more worried than a parent with a sick child in the hospital.
But families are doing more than just venting their fears and frustrations when they complain about the care their child is receiving, a new Canadian study suggests.
It found relatives were much more likely to officially report problems than hospital staff, and that their com-plaints often had merit. Almost half of parents' complaints were legitimate patient-safety concerns, "not merely reports of dissatisfaction," the study found.
The study was published Monday in the Canadian Medical Association Journal.
British Columbia researchers tested whether having a system for family members to report "adverse events" - incidents that negatively affected the recovery or health of their child - while in hospital would affect the rate at which health care providers reported the incidents.
The findings revealed just 2.5 per cent of the adverse events reported by families were also reported by health care providers.
"Parents are often much more aware of things that go wrong because they're there at the bedside with one patient all the time," said Dr. Mark Anser-mino, senior author of the study.
"Whereas the health care provider has multiple patients to look after and may not have the same vested interested in looking after that patient. Parents are much better observers of that individual subject than multiple health care providers will be."
Many hospitals in Canada have established systems for health care providers to report errors in a patient's care to help prevent similar mistakes from happening again.
Researchers from British Columbia conducted a study to determine whether an adverse event system involving families would result in a change in events reporting by health care providers. The researchers expected that reporting rates would increase and that families would provide useful information on patient safety.
The study included 544 families whose children were on an inpatient ward that provided general medical, general surgical, neurologic or neurosurgical care in British Columbia's Children's Hospital to babies, children and adolescents. Each family submitted a report and of these 544 participants, 201 (37%) noted at least one adverse event or near miss during hospitalization, for a total of 321 adverse events. Adverse events included medication problems such as a reaction or incorrect dosage, treatment complications, equipment problems and miscommunication. Most of these events — 313 out of 321 — were not reported by the hospital.
However, "the results of this study showed that the introduction of a family-initiated adverse event reporting system administered at the time of discharge from a pediatric inpatient surgical ward was not associated with a change in the rate of reporting of adverse events by health care providers," writes Dr. Jeremy Daniels, University of British Columbia, with coauthors.
Only 2.5% of the events noted by families were documented by health care providers, although "almost half of the adverse events reported by families represented valid safety concerns, not merely reports of dissatisfaction," states the authors. In 139 cases, families received apologies for these incidents.
"The initiation of [the] family-based patient safety reporting system provided new opportunities to learn and improve the safety of health care provision without an additional reporting burden for health care providers," write the authors. "Giving families the opportunity to report patient safety events did not remove the barriers to reporting by providers (time pressure, culture of blame, fear of reprisal and lack of belief in the value of reporting) but served to complement such reporting."
The authors conclude that "further research is needed to delineate how best to harness the potential of families to improve the safety of the health care system."
