COMPANY TO PAY $18 MILLION FOR ALLEGED IMPROPER SETTINGS OF TEMP MONITORS FOR VACCINE SHIPMENTS

FROM:  U.S. JUSTICE DEPARTMENT 

Friday, August 8, 2014

McKesson Corp. to Pay $18 Million to Resolve False Claims Allegations Related to Shipping Services Provided Under Centers for Disease Control Vaccine Distribution Contract

McKesson Corporation has agreed to pay $18 million to resolve allegations that it improperly set temperature monitors used in shipping vaccines under its contract with the Centers for Disease Control and Prevention (CDC), the Justice Department announced today.  McKesson is a pharmaceutical distributor with corporate headquarters in San Francisco.

“Companies must comply with the requirements they agree to when they contract with the government to provide products that protect the public,” said Assistant Attorney General Stuart F. Delery for the Justice Department’s Civil Division.  “If a contractor does not adhere to the terms it negotiated, its conduct not only hurts taxpayers but also could jeopardize the integrity of products, like vaccines, that Americans count on to be safe.”

The government alleged that McKesson failed to comply with the shipping and handling requirements of its vaccine distribution contract with the CDC.  Under the contract, McKesson provided distribution services, receiving vaccines purchased by the government from manufacturers and then distributing the vaccines to health care providers.  The government alleged that the contract required McKesson to ensure that during shipping, the vaccines were maintained at proper temperatures by, among other things, including electronic temperature monitors set to detect when the air temperature in the box reached two degrees Celsius and below or eight degrees Celsius and above.  The government alleged that, from approximately April 2007 to November 2007, McKesson failed to set the monitors to the appropriate range, and as a result, knowingly submitted false claims to the CDC for shipping and handling services that did not satisfy its contractual obligations.

According to the CDC, redundant measures were and are used to ensure vaccines are kept at appropriate temperatures during shipping.  The most important of these were validated packing procedures used to maintain proper vaccine temperatures.  Temperature monitors provided a secondary safeguard. For more information about vaccine storage and handling, please visit the CDC website or contact the CDCs press office at 404-639-3286 and media@cdc.gov .

“Ensuring the integrity and performance of government contracts is paramount, especially when they impact programs intended to protect young children” said Derrick L. Jackson, special agent in charge of the U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG) in Atlanta.  “Holding accountable those who fail to meet their obligations – thereby violating the trust of the American taxpayer -- continues to be a top OIG priority.”

The allegations resolved by today’s settlement were originally raised in a lawsuit filed against McKesson by Terrell Fox, a former finance director at McKesson Specialty Distribution LLC, under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery.  Fox’s share of the settlement has not been determined.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $20.2 billion through False Claims Act cases, with more than $14 billion of that amount recovered in cases involving fraud against federal health care programs.

The case was handled by the Civil Division’s Commercial Litigation Branch and the U.S. Attorney’s Office for the Middle District of Tennessee, with assistance from HHS-OIG and Office of General Counsel.

The claims settled by this agreement are allegations only, and there has been no determination of liability.  The lawsuit is captioned United States ex rel. Fox v. McKesson Corp., No. 3:12-cv-00766 (M.D. Tenn.).

CDC SAYS 1 IN 6 BETWEEN THE AGES OF 2 AND 19 ARE OBESE

FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

One in 6 obese

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

A study by the Centers for Disease Control and Prevention finds some signs that the weight gains of America’s young people are tapering off. The researchers saw this in data from 2008 to 2011 on almost 12 million low-income youngsters in 40 states.

But it doesn’t mean the weights are all healthy. The CDC says 1 in 6 people between the ages of 2 and 19 is obese. And researcher Ashleigh May says the excess weight produces a health burden:

“During childhood, things like high cholesterol, high blood sugar, asthma, and even mental health problems can occur. And children who are overweight or obese are more likely to become overweight or obese adults.’’

The study is in CDC’s Morbidity and Mortality Weekly Report.

Learn more at healthfinder.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

Last revised: October 24, 2013

CDC SAYS 100,000 AMERICANS QUIT SMOKING BECAUSE OF MEDIA CAMPAIGN

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC Press Release: More than 100,000 Americans quit smoking due to national media campaign
Centers for Disease Control and Prevention (CDC) sent this bulletin at 09/09/2013 10:20 AM EDT
Press Release

More than 100,000 Americans quit smoking due to national media campaign
Landmark tobacco education ad campaign more than doubled goals
An estimated 1.6 million smokers attempted to quit smoking because of the Centers for Disease Control and Prevention’s “Tips From Former Smokers” national ad campaign, according to a study released by the CDC. As a result of the 2012 campaign, more than 200,000 Americans had quit smoking immediately following the three-month campaign, of which researchers estimated that more than 100,000 will likely quit smoking permanently. These results exceed the campaign’s original goals of 500,000 quit attempts and 50,000 successful quits.
The study surveyed thousands of adult smokers and nonsmokers before and after the campaign. Findings showed that, by quitting, former smokers added more than a third of a million years of life to the U.S. population. The Tips campaign, which aired from March 19 to June 10, 2012, was the first time a federal agency had developed and placed paid advertisements for a national tobacco education campaign. Ads featured emotionally powerful stories of former smokers living with smoking-related diseases and disabilities. The campaign encouraged people to call 1-800-QUIT-NOWCall: 1-800-QUIT-NOW, a toll-free number to access quit support across the country, or visit a quit-assistance website. The study on the campaign’s impact is published today by a medical journal, The Lancet.

“This is exciting news. Quitting can be hard and I congratulate and celebrate with former smokers - this is the most important step you can take to a longer, healthier life,” said CDC Director Tom Frieden, M.D., M.P.H. “I encourage anyone who tried to quit to keep trying – it may take several attempts to succeed.’’
The study found that millions of nonsmokers reported talking to friends and family about the dangers of smoking and referring smokers to quit services. Almost 80 percent of smokers and almost 75 percent of non-smokers recalled seeing at least one of the ads during the three-month campaign.

CDC REPORTS OBESITY DECLINES AMONG LOW-INCOME PRESCHOOLERS IN SEVERAL STATES

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION

Obesity among low-income preschoolers declines in many states
Nineteen states and territories report decreases in obesity among this group

After decades of rising rates, obesity among low-income preschoolers declined slightly in 19 states and U.S. territories from 2008 through 2011, according to the latest Vital Signs report from the Centers for Disease Control and Prevention.

The report found that Florida, Georgia, Missouri, New Jersey, South Dakota, and the U.S. Virgin Islands saw at least a one percentage point decrease in their rate of obesity. Twenty states and Puerto Rico held steady at their current rate. Obesity rates increased slightly in three states.

Previous research shows that about one in eight preschoolers is obese in the United States. Children are five times more likely to be overweight or obese as an adult if they are overweight or obese between the ages of three and five years.

“Although obesity remains epidemic, the tide has begun to turn for some kids in some states,” said CDC Director, Tom Frieden, M.D., M.P.H. “While the changes are small, for the first time in a generation they are going in the right direction. Obesity in early childhood increases the risk of serious health problems for life.”

“Today’s announcement reaffirms my belief that together, we are making a real difference in helping kids across the country get a healthier start to life,” said First Lady Michelle Obama. “We know how essential it is to set our youngest children on a path towards a lifetime of healthy eating and physical activity, and more than 10,000 childcare programs participating in the Let’s Move! Child Care initiative are doing vitally important work on this front. Yet, while this announcement reflects important progress, we also know that there is tremendous work still to be done to support healthy futures for all our children.”

CDC SAYS 20% OF TEEN BIRTHS ARE REPEAT BIRTHS

FROM: CENTERS FOR DISEASE CONTROL AND PREVENTION
New CDC Vital Signs: Nearly 20 percent of teen births are repeat births
Repeat births can be prevented

Nearly one in five teen births is a repeat birth, according to a Vital Signs report from the Centers for Disease Control and Prevention. Although teen births have fallen over the past 20 years, the number of repeat births remains high and there are substantial racial/ethnic and geographic differences.
Repeat births: A repeat birth is a second (or more) pregnancy resulting in a live birth before the age of 20. More than 365,000 teens, ages 15-19 years, gave birth in 2010, and almost 67,000 (18.3 percent) of those were repeat births.
Racial disparities: Repeat teen births were highest among American Indian/Alaska Natives (21.6 percent), Hispanics (20.9 percent), and non-Hispanic blacks (20.4 percent), and lowest among non-Hispanic whites (14.8 percent).
Geographic disparities: Repeat teen births ranged from 22 percent in Texas to 10 percent in New Hampshire. Data show that although nearly 91 percent of teen mothers who were sexually active used some form of contraception in the postpartum period, only 22 percent used contraceptives considered to be "most effective" (that is, where the risk is less than one pregnancy per 100 users in a year.)
There are things that can be done to prevent repeat teen births. Health care providers, parents, guardians, and caregivers can talk to both male and female teens about avoiding pregnancy by not having sex and can discuss with sexually active teens the most effective types of birth control to prevent repeat teen pregnancy.

HHS SAYS 1 IN 6 PEOPLE WILL GET SICK FROM A FOODBORNE ILLNESS THIS YEAR

FROM: U.S DEPARTMENT OF HEALTH AND HUMAN RESOURCES
From the U.S. Department of Health and Human Services, I’m Nicholas Garlow with HHS HealthBeat.

One in 6 people will get a foodborne illness this year. A new study at the Centers for Disease Control and Prevention looked at which foods are more likely to make us sick. Produce accounted for nearly half of all illnesses. Poultry and meat accounted for the most deaths.

Dr. John Painter is an epidemiologist at the CDC.

"Keep eating your vegetables. As it turns out, many foodborne illnesses are attributed to vegetables, but one reason for that is we eat so many of them."

Contamination of food can occur anywhere from the farm to the table. But you can protect yourself by taking these steps: Wash your hands and food prep surfaces. Separate raw meat, poultry, seafood, and eggs from foods that will not be cooked. Cook and chill foods to proper temperatures.

CDC SAYS NOROVIRUS LEADING CAUSE OF GASTROENTERITIS IN CHILDREN



Credit:  CDC

FROM: CENTERS FOR DISEASE CONTROL AND PREVENTION
Norovirus is now the leading cause of severe gastroenteritis in US children

Norovirus is now the leading cause of acute gastroenteritis among children less than 5 years of age who seek medical care, according to a new study published in the New England Journal of Medicine. Norovirus was responsible for nearly 1 million pediatric medical care visits for 2009 and 2010 in the United States, amounting to hundreds of millions of dollars in treatment costs each year.

"Infants and young children are very susceptible to norovirus infections, which often result in a high risk of getting dehydrated from the sudden onset of intense vomiting and severe diarrhea," said Dr. Daniel Payne, an epidemiologist in the Division of Viral Diseases at the Centers for Disease Control and Prevention. "Our study estimates that 1 in 278 U.S. children will be hospitalized for norovirus illness by the time they turn 5 years of age. It is also estimated that about 1 in 14 children will visit an emergency room and 1 in 6 will receive outpatient care for norovirus infections."

The researchers tracked infants and young children requiring medical care for acute gastroenteritis, which causes inflammation of the stomach and intestines, from October 2008 through September 2010. The study looked at more than 141,000 children less than 5 years of age living in three U.S. counties. Lab testing was done to confirm specimens for norovirus.

Norovirus was detected in 21 percent (278) of the 1,295 cases of acute gastroenteritis, while rotavirus was identified in only 12 percent (152) of the cases. About 50 percent of the medical care visits due to norovirus infections were among children aged 6 to 18 months. Infants and 1-year-old children were more likely to be hospitalized than older children. However, overall rates of norovirus in emergency rooms and outpatient offices were 20 to 40 times higher than hospitalization rates. Nationally, the researchers estimated that in 2009 and 2010, there were 14,000 hospitalizations, 281,000 emergency room visits, and 627,000 outpatient visits due to norovirus illness in children less than 5 years of age. This amounted to an estimated $273 million in treatment costs each year.

"Our study confirmed that medical visits for rotavirus illness have decreased," said Dr. Payne. "Also, our study reinforces the success of the U.S. rotavirus vaccination program and also emphasize the value of specific interventions to protect against norovirus illness." Norovirus vaccines are currently being developed, which may be especially important for young children and elderly people who are high risk.

Norovirus is highly contagious. Each year, more than 21 million people in the United States get infected with norovirus and develop acute gastroenteritis, and approximately 800 people die. Young children and elderly people are more likely to suffer from severe norovirus infections. The virus spreads primarily through close contact with infected people, such as caring for someone who is ill. It also spreads through contaminated food, water and hard surfaces. The best ways to reduce the risk of norovirus infection are through proper hand washing, safe food handling, and good hygiene.

HHS SAYS STUDY FINDS LOWER SALT CONSUMPTION WOULD SAVE LIVES

Photo Credit:   Wikimedia Commons.

FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
I’m Ira Dreyfuss with HHS HealthBeat.

Researchers looking at three computer models have figured out what would happen if we all started to use a little less sodium – commonly, salt – in our food. At the University of California, San Francisco, Pamela Coxson had the computer models assume we could work our way, a bit at a time, to the dietary equivalent of a half teaspoon less salt a day over 10 years:

"All three models predicted mortality reductions on the order of hundreds of thousands of avoided deaths over the 10 years."

That’s up to a half million lives.

Most of the sodium we get is in prepared foods and meals out, so it pays to look hard at the nutrition labeling.

The study in the journal Hypertension was supported by the Centers for Disease Control and Prevention.

HHS CLAIMS MANY GET SICK DUE TO IMPROPER FOOD HANDLING

Photo Credit:  FDA

FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
From the U.S. Department of Health and Human Services, I’m Nicholas Garlow with HHS HealthBeat.

Eat and be well? The Centers for Disease Control and Prevention says that, each year, 1 in 6 of us gets sick from food, largely due to improper handling and cooking of ingredients.

At the CDC, researcher Hannah Gould:

"Four foods have been linked to many outbreaks in the last two years. Beef, poultry, such as chicken and turkey, milk, particularly milk th at hasn’t been pasteurized, and fish."

Gould says you can’t tell when something has gone bad just by looking and smelling. So she says the best treatment is prevention in preparation. Clean by washing your hands and food prep surfaces. Separate so meat doesn’t touch vegetables. And cook and chill to correct temperatures.

An article on food handling is in CDC’s Morbidity and Mortality Weekly Report.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Nicholas Garlow.

Last revised: March 12, 2013

JUSTICE SETTLES LAWSUIT WITH DENTAL SCHOOL OVER EXCLUSION OF HEPATITIS B INFECTED APPLICANTS

FROM: U.S. JUSTICE DEPARTMENT

Tuesday, March 5, 2013
Justice Department Settles with the University of Medicine and Dentistry of New Jersey Over Discrimination Against People with Hepatitis B

The Justice Department announced today that it has reached a settlement with the University of Medicine and Dentistry of New Jersey School (UMDNJ) under the Americans with Disabilities Act (ADA). The settlement resolves complaints that the UMDNJ School of Medicine and the UMDNJ School of Osteopathic Medicine unlawfully excluded applicants because they have hepatitis B. This is the first ADA settlement ever reached by the Justice Department on behalf of people with hepatitis B.

In 2011, the two applicants in this matter applied and were accepted to the UMDNJ School of Osteopathic Medicine, and one of them was also accepted to the UMDNJ School of Medicine. The schools later revoked the acceptances when the schools learned that the applicants have hepatitis B. The Justice Department determined that the schools had no lawful basis for excluding the applicants, especially because students at the schools are not even required to perform invasive surgical procedures, and that the exclusion of the applicants contradicts the Centers for Disease Control and Prevention’s (CDC) updated guidance on this issue.

According to the CDC’s July 2012 "Updated Recommendations for Preventing Transmission and Medical Management of Hepatitis B Virus (HBV) – Infected Health Care Workers and Students," no transmission of Hepatitis B has been reported in the United States from primary care providers, clinicians, medical or dental students, residents, nurses, or other health care providers to patients since 1991.

"Excluding people with disabilities from higher education based on unfounded fears or incorrect scientific information is unacceptable," said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division. "We applaud the UMDNJ for working cooperatively with the Justice Department to resolve these matters in a fair manner."

"It is especially important that a public institution of higher learning – especially one with a mission to prepare future generations of medical professionals – strictly follow the laws Congress has enacted to protect from discrimination those people who have health issues," said U.S. Attorney for the District of New Jersey Paul Fishman. "The remedies to which the school has agreed should ensure this does not happen again."

Under the settlement agreement, the UMDNJ must adopt a disability rights policy that is based on the CDC’s Hepatitis B recommendations, permit the applicants to enroll in the schools, provide ADA training to their employees and provide the applicants a total of $75,000 in compensation and tuition credits.

Both of the applicants in this matter come from the Asian American Pacific Islander community. The CDC reports that Asian American Pacific Islanders (AAPIs) make up less than 5 percent of the total population in the United States, but account for more than 50 percent of Americans living with chronic Hepatitis B. Nearly 70 percent of AAPIs living in the United States were born, or have parents who were born, in countries where hepatitis B is common. Most AAPIs with Hepatitis B contracted Hepatitis B during childbirth . The Civil Rights Division is committed to ensuring that this community is not subjected to discrimination because of disability.

Title II of the ADA prohibits state and local government entities, like the UMDNJ, from discriminating against individuals with disabilities in programs, services, and activities. State and local governments must also make reasonable modifications in policies, practices, and procedures when the modifications are necessary to avoid discrimination on the basis of disability, unless those modifications would result in a fundamental alteration.

CHILDREN WITH HIGH RISK OF DEATH FROM FLU

FROM: CENTERS FOR DISEASE CONTROL AND PREVENTION

Children with neurologic disorders at high risk of death from flu

Health care and advocacy groups join to protect children most vulnerable to influenza

A disproportionately high number of children with neurologic disorders died from influenza-related complications during the 2009 H1N1 pandemic, according to a study by scientists with the Centers for Disease Control and Prevention. The report in the journal Pediatricsunderscores the importance of influenza vaccination to protect children with neurologic disorders. CDC is joining with the American Academy of Pediatrics, Families Fighting Flu and Family Voices to spread the message about the importance of influenza vaccination and treatment in these children.


The Pediatrics study looked at influenza-related deaths in children during the 2009 H1N1 pandemic based on data submitted to CDC from state and local health departments. The number of pediatric deaths associated with 2009 H1N1 virus infection reported to CDC during the pandemic was more than five times the median number of pediatric deaths that were reported in the five flu seasons prior to the pandemic. Sixty-eight percent of those deaths occurred in children with underlying medical conditions that increase the risk of serious flu complications.

Of the 336 children (defined as people younger than 18 years) with information available on underlying medical conditions who were reported to have died from 2009 H1N1 flu-associated causes, 227 had one or more underlying health conditions. One hundred forty-six children (64 percent) had a neurologic disorder such as cerebral palsy, intellectual disability, or epilepsy. Of the children with neurologic disorders for whom information on vaccination status was available, only 21 (23 percent) had received the seasonal influenza vaccine and 2 (3 percent) were fully vaccinated for 2009 H1N1.

"We’ve known for some time that certain neurologic conditions can put children at high risk for serious complications from influenza," said Dr. Lyn Finelli, chief of the surveillance and outbreak response team in CDC’s Influenza Division. "However, the high percentage of pediatric deaths associated with neurologic disorders that occurred during the 2009 H1N1 pandemic was a somber reminder of the harm that flu can cause to children with neurologic and neurodevelopmental disorders."

"Flu is particularly dangerous for people who may have trouble with muscle function, lung function or difficulty coughing, swallowing or clearing fluids from their airways," said study coauthor and pediatrician Dr. Georgina Peacock. "These problems are sometimes experienced by children with neurologic disorders," said Peacock, of CDC’s National Center on Birth Defects and Developmental Disabilities

The most commonly reported complications for children with neurologic disorders in this study were influenza-associated pneumonia and acute respiratory distress syndrome (ARDS). Seventy-five percent of children with a neurologic condition who died from 2009 H1N1 influenza-related infection also had an additional high risk condition that increased their risk for influenza complications, such as a pulmonary disorder, metabolic disorder, heart disease or a chromosomal abnormality.

CDC is partnering with the American Academy of Pediatrics and influenza advocacy groups to help promote awareness about the importance of influenza prevention and treatment in these high risk children. Since the H1N1 pandemic, children with neurologic conditions continue to represent a disproportionate number of influenza-associated pediatric deaths. CDC, the American Academy of Pediatrics (AAP), Family Voices, and Families Fighting Flu recognize the need to communicate with care takers about the potential for severe outcomes in these children if they are infected with flu.

"Partnering with the American Academy of Pediatrics, influenza advocacy groups and family led-organizations CAN help prevent influenza in children at highest risk," said CDC Director Dr. Thomas R. Frieden.

The partnering organizations are working to coordinate communication activities with their constituents, which include parents and caregivers, primary care clinicians, developmental pediatricians and neurologists in hopes to increase awareness about flu prevention and treatment in children with neurologic disorders.

"The American Academy of Pediatrics, Families Fighting Flu and Family Voices were all natural partners when we thought about how to reach as many key people as possible with this message," Dr. Peacock adds. "The collaboration and energy around this effort has been fabulous."

"Our network of physicians is committed to influenza prevention in all children, and especially in reducing complications in those children at higher risk for experiencing severe outcomes as a result of influenza-like illness," says Robert W. Block, M.D., president of the AAP. "This coalition can more broadly engage the entire community of child caregivers to express how serious flu can be for these children. These efforts emphasize why the medical home is so important for children and youth with special health care needs."

Family Voices is a national family-led organization supporting families and their children with special health care needs. Ruth Walden, a parent of a child with special needs and president of the Family Voices Board of Directors, says, "It’s frightening to think that flu can potentially lead to so many complications or even death. We’re pleased to see organizations working together to educate families and providers about the importance of prevention."

Families Fighting Flu, an advocacy group dedicated to preventing influenza, has a long history of reaching out to families who’ve lost loved ones to flu. "Throughout the years we’ve seen firsthand how flu can affect these kids and their families’ lives. We understand that prevention is absolutely critical," explains Laura Scott, executive director of Families Fighting Flu. "Working with other groups only expands our mission of keeping kids safe throughout the flu season."

CDC recommends that everyone aged 6 months and older get an annual influenza vaccination, including people who are at high risk of developing serious complications. Flu vaccine is the best prevention method available. Antiviral drugs, which can treat flu illness, are a second line of defense against flu.

                                                     

 Photo: Flu Virus. Credit: CDC