CDC SAYS EARLY TREATMENT OF ROCKY MOUNTAIN SPOTTED FEVER MAY SAVE MILLIONS, PREVENT PREMATURE DEATH AND DISABILITY

FROM:  U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
Prevention and early treatment of RMSF in Arizona may save millions by preventing premature death and disability

Several Arizona American Indian communities severely impacted by outbreak, CDC/IHS study finds

The mounting costs of an epidemic of Rocky Mountain spotted fever (RMSF) among several American Indian tribes in Arizona suggests that prevention and control efforts would be cost effective.  A recent study released by experts at the Centers for Disease Control and Prevention (CDC) and the Indian Health Service (IHS), in partnership with Arizona tribes, describes an estimated $13.2 million in losses linked to the epidemic of RMSF between 2002 and 2011, on two Indian reservations. Cost estimates include medical costs, time off work, and loss of lifetime productivity due to early death. These values underestimate the actual cost of the epidemic because long-term losses from disability and expensive medical procedures are not included. Preventing tick bites is the most important step in preventing severe illness and death from RMSF. CDC, IHS, state, and tribal governments are working together to develop effective prevention programs to gain control of this devastating epidemic.

“Rocky Mountain Spotted Fever is completely preventable,” said Naomi Drexler, CDC epidemiologist and one of the study’s authors. “State, federal and tribal health authorities have been working together since the start of the epidemic to build effective community-based tick control programs, and these efforts have produced remarkable reductions in human cases. These programs are costly, but medical expenses and lives lost cost four times more than RMSF prevention efforts. Increasing access to these prevention efforts is critical to save lives and protect communities.”

Published in The American Journal of Tropical Medicine and Hygiene, the study reviewed 205 medical records from two American Indian communities at the center of the epidemic. Over 80 percent of RMSF cases required emergency room visits, 14 percent were admitted to the intensive care unit for severe illness, and 7 percent were fatal. The average cost per death from RMSF ($775,467) is more than five times that of pneumococcal disease ($140,862) in the United States. More than half of RMSF deaths were among children, raising the long-term social costs of the epidemic.

RMSF is a severe disease caused by the bacterium Rickettsia rickettsii and spread through the bite of an infected tick. RMSF begins with non-specific symptoms such as fever and headache, vomiting, diarrhea, and sometimes rash. Severely ill patients may require amputation of fingers, toes or limbs due to blood loss; heart and lung specialty care; and management in intensive care units. More than 20 percent of untreated cases are fatal; the average time from the beginning of symptoms to death is only eight days.

CHILDREN'S HOSPITAL SETTLES FALSE CLAIMS ACT ALLEGATIONS; WILL PAY $12.9 MILLION

FROM:  U.S. JUSTICE DEPARTMENT
Monday, June 15, 2015

Children's Hospital to Pay $12.9 Million to Settle False Claims Act Allegations
Children’s Hospital, Children’s National Medical Center Inc. and its affiliated entities (collectively CNMC) have agreed to pay $12.9 million to resolve allegations that they violated the False Claims Act by submitting false cost reports and other applications to the components and contractors of the Department of Health and Human Services (HHS), as well as to Virginia and District of Columbia Medicaid programs, the Department of Justice announced today.  CNMC is based in Washington, D.C., and provides pediatric care throughout the metropolitan region.

“The false reporting alleged in today’s settlement deprived the Medicare Trust Fund of millions of taxpayers’ dollars,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.  “Such conduct wastes critical federal health care program funds and drives up the costs of health care for all of us.”

“The integrity of federal health care programs depends on honest and accurate reporting from the hospitals and other health care providers that receive hundreds of billions of tax dollars every year,” said Acting U.S. Attorney Vincent H. Cohen Jr. of the District of Columbia.  “This settlement demonstrates our commitment to defending the integrity of the system and ensuring that taxpayer money goes to meet the most critical health care needs.  We will continue to work with whistleblowers like the former employee who came forward in this case to battle waste, fraud and abuse that fuel the skyrocketing cost of health care.”

According to the settlement agreement, CNMC misstated information on cost reports and applications in two distinct manners to HHS.  This false information was used by HHS and Medicaid programs to calculate reimbursement rates to CNMC.  The United States contended that CNMC misreported its available bed count on its application to HHS’ Health Resources and Services Administration under the Children’s Hospitals Graduate Medical Education (CHGME) Payment Program.  The CHGME Payment Program provides federal funds to freestanding children’s hospitals to help them maintain their graduate medical education programs that train pediatric and other residents.  The United States further contended that CNMC filed cost reports misstating their overhead costs, resulting in overpayment from Medicare and the Virginia and District of Columbia Medicaid programs.

The settlement resolves allegations brought in a lawsuit filed under the qui tam or whistleblower provisions of the False Claims Act by James A. Roark Sr., a former employee of CNMC.  Under the act, a private citizen can sue on behalf of the United States and share in any recovery.  The United States is entitled to intervene in the lawsuit, as it did here.  As part of the resolution, Mr. Roark will receive $1,890,649.98.

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 $24.3 billion through False Claims Act cases, with more than $15.3 billion of that amount recovered in cases involving fraud against federal health care programs.

This matter was handled by the U.S. Attorney’s Office of the District of Columbia with assistance from the Civil Division’s Commercial Litigation Branch and the HHS’ Office of Inspector General.

HHS SAYS PREVENTION PROGRAM REDUCES FALL AMONG ELDERLY

FROM:  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
June 8, 2015
Comprehensive prevention program effectively reduces falls among older people
HHS-supported study tests falls intervention program

Families and physicians have a new tool in the fight against falls- a comprehensive prevention program developed by the U.S. Department of Health and Human Services that reduces both falls and resulting use of long-term care such as nursing homes.

The prevention program, which includes clinical in-home assessments of health, physical functioning, falls history, home environment, and medications to create customized recommendations, was developed by HHS based on the research evidence on risk factors and interventions. Using a randomized control trial, the program was tested among long-term care insurance policy holders age 75 and older to determine whether the intervention was effective and, if so, the impact on long-term care utilization.

The study found that the program led to significantly lower rates of falls over a one-year study period. Those who received the intervention had a 13 percent lower rate of falls, and an 11 percent reduction in risk of falling compared to the control group. Participants also had a significantly lower rate of injurious falls. Long-term care insurance claims were 33 percent lower over a three-year period. The intervention, which cost $500 per person to administer, saved $838 per person.

Falls- which happen to 1 in 3 people age 65 and over every year-- can cause pain, suffering, and death, and cost an estimated $35 billion in health care spending in 2014. They are a leading risk factor for needing long-term care at home or in a nursing facility. Given the impact of falls, findings from the HHS-funded study give hope for reducing the rate of falls among the growing population of older adults.

“While falls are preventable, we need to intervene at the right time in a way that is comprehensive and yet individually tailored,” said Richard Frank, Ph.D., the assistant secretary for planning and evaluation at HHS, whose office funded the study. “Preventing falls helps everyone: the older person, their family, and the health and long-term care systems. And this study shows that by investing in falls prevention, we can reduce long-term care use and spending.”

The risk factors for a fall include fear of falling, gait and balance problems, certain medications, clutter in the home, and some health conditions. Few interventions have taken a comprehensive approach to address all of the risk factors through one program.

Although this study focused on the rate of falls and long-term care utilization and costs, future research will examine the impact of the intervention on health care utilization and costs.

“We expect to see a similar or greater return on investment in terms of health care costs,” added Richard Frank.

PRESIDENT OBAMA'S SPEECH ON HEALTH CARE IN AMERICA

FROM:  THE WHITE HOUSE
June 09, 2015
The President's Speech to the Catholic Health Association on Health Care in America

Today, at the invitation of the Catholic Health Association, President Obama will address their annual conference and thank them for their dedication to helping ensure all Americans have access to health care. The President will discuss how the passage of the Affordable Care Act reflects our values and the kind of country we strive to be.  He will also describe how the Affordable Care Act has become part of the fabric of an improved American health care system, one where we and our children can rely on health security throughout our lives, and make the most of our opportunities as a result.

Additionally, the White House released updated data on how the Affordable Care Act is working in every state in the country. Five years after healthcare reform became a reality, more than 16 million Americans have gained coverage, and the Affordable Care Act has improved coverage for virtually everyone who already had insurance.  Americans can no longer be discriminated against for having pre-existing conditions, women can't be charged more just for being women, and there are no longer lifetime limits on the care Americans receive.  And hospitals, doctors and other providers are changing the way they operate to deliver better care at lower cost.

The White House also launched a new interactive long form webpage -- "Health Care in America" -- which includes an embedded letter to the President written by the late Senator Ted Kennedy as he endured brain cancer, having instructed his wife to send the letter to the President after he passed away. A lifelong champion for health reform, Senator Kennedy encouraged the President to endure the fight for health care reform and thanked him "one last time" for carrying it forward. The page also includes an interactive timeline that contextualizes a century-long fight for real health reform in America, dozens of stories of Americans whose lives have benefited from reform, and a live player that will stream the President's remarks tomorrow.

President Obama’s remarks will be livestreamed HERE, and excerpts of his prepared remarks are included below:

“The rugged individualism that defines America has always been bound by a set of shared values; an enduring sense that we are in this together. That America is not a place where we simply ignore the poor or turn away from the sick. It’s a place sustained by the idea that I am my brother’s keeper and I am my sister’s keeper. That we have an obligation to put ourselves in our neighbor’s shoes, and to see the common humanity in each other.

So after nearly a century of talk, after decades of trying, after a year of sustained debate, we finally made health care reform a reality for America.”

…

“Five years in, what we’re talking about is no longer just a law. This isn’t about the Affordable Care Act. This isn’t about Obamacare. This isn’t about myths or rumors that won’t go away.

This is reality. This is health care in America.”

DOJ FILES BRIEF REGARDING HEALTH CARE FOR PRISONERS WITH GENDER DYSPHORIA

FROM:  U.S. JUSTICE DEPARTMENT
Friday, April 3, 2015
Justice Department Files Brief to Address Health Care for Prisoners Suffering from Gender Dysphoria

The Department of Justice filed a statement of interest today in the Middle District of Georgia in Diamond v. Owens, et al.  The plaintiff in that case, a transgender prisoner, alleges that the Georgia Department of Corrections failed to provide adequate care for her gender dysphoria.  The statement of interest discusses the unconstitutionality of “freeze-frame” policies, such as the policy allegedly used in the Georgia Department of Corrections.  These policies unconstitutionally prohibit treatment beyond the type of care the prisoner received in the community prior to incarceration.  Through this filing, without taking a position on the merits of the allegations, the United States stated that the Eighth Amendment mandates individualized assessment and care for gender dysphoria.

“By taking action in this case, the Justice Department is reminding departments of corrections that prison officials have the obligation to assess and treat gender dysphoria just as they would any other medical or mental health condition,” said Acting Assistant Attorney General Vanita Gupta of the Civil Rights Division.  “Prisoners with gender dysphoria should not be forced to suffer needlessly during their incarceration simply because they were not receiving care, or could not prove they were receiving care, in the community.  Freeze-frame policies can have serious consequences to the health and well-being of transgender prisoners, who are among the most vulnerable populations incarcerated in our nation’s prisons and jails.”

Based on the facts as alleged, Ashley Diamond was first diagnosed with gender dysphoria as a teenager, nearly twenty years ago.  She began taking feminizing hormones, which helped her develop secondary sex characteristics and helped ease the significant physical and emotional discomfort she felt with her biological sex.  Yet, when she entered the Georgia Department of Corrections, she was not identified or referred for continuation of this treatment.  Instead, her hormone therapy was terminated and she was placed in a secure prison for men.

When Ms. Diamond requested treatment during her incarceration, she was evaluated by Department medical personnel who confirmed Diamond’s gender dysphoria and recommended reinstatement of hormone therapy and other clinically-indicated treatments.  However, department officials continued to deny this treatment, telling Diamond that she was ineligible for treatment pursuant to the department’s policy.  Because the department did not properly identify Diamond’s gender dysphoria at intake and refer her for treatment at that time, she was, and continues to be, denied necessary medical care.

The facts alleged in this case indicate that the Department of Corrections relied on its freeze-frame policy to deny Diamond the care recommended by the department’s own physicians, in violation of the Eighth Amendment.  As stated by the Justice Department in its filing, “[t]wo things are clear from the record in this case: one, the generally accepted standards for treatment of gender dysphoria require treatment decisions be individualized; and two, Ms. Diamond did not receive individualized care.”

VA HAS NEW GRANTS TO HELP HOMELESS VETS

FROM:  U.S. VETERANS ADMINISTRATION
VA Announces New Grants to Help End Veteran Homelessness
March 31, 2015, 02:04:00 PM

VA Announces New Grants to Help End Veteran Homelessness
Initiative Targets 45,000 Homeless and At-Risk Vets and Families in High Need Communities

WASHINGTON – Secretary of Veterans Affairs Robert A. McDonald today announced the award of nearly $93 million in Supportive Services for Veteran Families (SSVF) 3-year grants that will help approximately 45,000 homeless and at-risk Veterans and their families. The grants will be distributed to 24 non-profit agencies in 15 communities, with $30 million in awards being distributed to the Los Angeles area.

“The Department of Veterans Affairs is committed to using evidence-based approaches such as SSVF to prevent homelessness and produce successful outcomes for Veterans and their families,” said Secretary McDonald. “This is a program that works, because it allows VA staff and local homeless service providers to work together to effectively address the unique challenges that make it difficult for some Veterans and their families to remain stably housed.”

 Under the SSVF program, VA is awarding grants to private, non-profit organizations and consumer cooperatives that provide services to very low-income Veteran families living in – or transitioning to – permanent housing.  The grants announced today will provide additional resources to the fourth year operations of the SSVF program.

 “With the addition of these crucial resources, communities across the country continue an historic drive to prevent and end homelessness among Veterans,” said Matthew Doherty, Acting Executive Director of the U.S. Interagency Council on Homelessness.  “The SSVF program gives Veterans and their families the rapid assistance they need to remain in permanent housing or get back into permanent housing as quickly as possible.”

Through the homeless Veterans initiative, VA committed more than $1 billion in FY 2014 to strengthen programs that prevent and end homelessness among Veterans. VA provides a range of services to homeless Veterans, including health care, housing, job training and education.

MOST WHO SELECTED 2015 HEALTH PLANS THROUGH HEALTHCARE.GOV ARE GETTING ASSISTANCE TO LOWER PREMIUMS

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

December 30, 2014

87 percent of people who selected 2015 plans through HealthCare.gov in first month of open enrollment are getting financial assistance to lower monthly premiums

A report released by the Department of Health and Human Services today provides the first detailed analysis of enrollment in the Marketplaces for the first month of the 2015 open enrollment period.   About 87 percent of people who selected health insurance plans through HealthCare.gov for coverage beginning Jan. 1, 2015 were determined eligible for financial assistance to lower their monthly premiums, compared to 80 percent of enrollees who selected plans over a similar period last year. In addition, more than 4 million people in both the state and federal Marketplaces signed up for the first time or reenrolled in coverage for 2015 during the first month of open enrollment. That includes more than 3.4 million people who selected a plan in the 37 states that are using the HealthCare.gov platform for 2015, and more than 600,000 consumers who selected plans in the 14 states that are operating their own Marketplace platform for 2015.

Today’s report includes data through December 15 for the 37 states using the HealthCare.gov platform, and through December 13 for 12 states and the District of Columbia that are using their own Marketplace platforms. Data for California are through December 14.  Data for automatic reenrollments are not yet available in the vast majority of states, so today’s report does not fully capture the number of people who selected plans leading up to the deadline for Jan. 1, 2015 coverage. In particular, the automatic reenrollment process for the 37 states using the HealthCare.gov platform began on December 16 and was completed for the vast majority of consumers on December 18.

HHS also released a Weekly Enrollment Snapshot that captures more recent enrollment activity in the 37 states using the HealthCare.gov platform. The Weekly Snapshot shows that from November 15 to December 26, nearly 6.5 million consumers selected a plan or were automatically reenrolled.

“We’re pleased that nationwide, millions of people signed up for Marketplace coverage starting January 1. The vast majority were able to lower their costs even further by getting tax credits, making a difference in the bottom lines of so many families,” HHS Secretary Sylvia M. Burwell said. “Interest in the Marketplace has been strong during the first month of open enrollment. We still have a ways to go and a lot of work to do before February 15, but this is an encouraging start.”

Detailed findings for HealthCare.gov states through December 15:
More than 3.4 million people selected a plan through December 15 in the 37 states that are using the HealthCare.gov platform for 2015, including Oregon and Nevada.  Of those:
87 percent selected a plan with financial assistance compared to 80 percent in the early months of the first open enrollment period.

33 percent were under 35 years of age compared to 29 percent in the early months of the first open enrollment period.

Nearly 1 million consumers selected a plan in the three days leading up to December 15. That is almost one third (28 percent) of total plan selections from November 15 through December 15.

Of the 3.4 million plan selections, 48 percent (1.6 million) reenrolled in a Marketplace plan and 52 percent (1.8 million) signed up for the first time.
The most recent Weekly Enrollment Snapshot with data available through December 26 can be found here.

Detailed findings for the 14 states using state based Marketplace enrollment platforms:
More than 600,000 consumers selected plans in the 14 states that are operating their own Marketplace platform for 2015.  That includes:
161,752 Marketplace plan selections in two states reporting only data for new consumers (California and New York);
153,011 Marketplace plan selections in seven states reporting data on new consumers and consumers actively reenrolling in Marketplace coverage (Colorado, District of Columbia, Hawaii, Maryland, Massachusetts, Minnesota, and Rhode Island); and
318,075 Marketplace plan selections in five states reporting data on new enrollees, consumers actively reenrolling in Marketplace coverage, and automatic reenrollees (Connecticut, Idaho, Kentucky, Vermont, and Washington).

The information contained in this report provides the most systematic summary of enrollment-related activity in the Marketplaces to date. Data for the various metrics are counted using comparable definitions for data elements across states and Marketplace types. But because many states extended their plan selection deadlines for January 1 coverage, the report does not include the full count of consumers who will have selected coverage that begins Jan. 1, 2015.

Open Enrollment in the Marketplace runs from Nov. 15, 2014, through Feb. 15, 2015.  Consumers should visit HealthCare.gov to review and compare health plan options. Consumers shopping for health insurance coverage should sign up by Jan. 15, 2015, in order to have coverage effective on Feb. 1, 2015.  If consumers who were automatically reenrolled decide in the coming weeks that a better plan exists for their families, they can make that change at any time before the end of open enrollment on February 15.

SECRETARY KERRY'S OP-ED ON AFGHAN ELECTIONS

FROM:  U.S. STATE DEPARTMENT 

Op-Ed

John Kerry

Secretary of State

TOLOnews

Washington, DC

July 30, 2014

---

Again and again, through all my visits to your country, I've been struck by one profound fact: Afghans want and deserve a better future. You want to live without fear, to have the best possible education for your children, health care systems that provide dignity and the jobs and other opportunities that come with a stable economy.

Something else has been clear to me: Democracy is the path Afghans have chosen to achieve that better life.

For more than a decade, President Hamid Karzai has led Afghanistan through triumph and tragedy. I've worked closely with him, and I know that one of his lasting legacies will be how Afghanistan makes its first democratic, peaceful transfer of power.

Afghans took an enormous step on the road toward a stronger democracy in April and June when millions of people went to the polls to choose the country's next president. Every vote was a courageous endorsement of democracy, and an expression of hope for the future.

The United States knows from our own history the road to democracy is bumpy and the journey is not completed overnight. Democracy requires building credible institutions, overcoming divisions, building trust and working together for a brighter future.

Today, Afghanistan and its two presidential candidates face one of those bumps in the road -- a moment of decision. Their ability to overcome the obstacles and work together to honor the votes of millions of their citizens will determine the future of Afghanistan and its relationship with the international community.

The United States, the United Nations and the international community are engaged in the post-election process solely to help the Afghan election institutions restore credibility to the voting. Experts tell me that the audit under way in Kabul is the largest and most complicated election audit ever undertaken anywhere.

Few countries could meet this challenge alone.

Specialists from the UN are working side by side with their Afghan colleagues to ensure that the audit meets the laws of Afghanistan, the highest international standards and, most importantly, the expectations of Afghans. The process, which has been painstaking and slow, will accelerate with the end of Eid al-Fitr. But democracy can't be rushed and every legitimate vote deserves to be counted and respected. The Afghan Independent Election Commission, the UN and dozens of international observers are working night and day to conclude the audit.

The audit is only one part of the challenge confronting democracy in Afghanistan today. Equally important are the actions of the two candidates, Dr. Ashraf Ghani and Dr. Abdullah Abdullah, and their political teams.

On July 12, the two candidates shook hands and agreed to respect the results of the audit. They also agreed to build a unity government that will lead Afghanistan to a better future. The political agreement responds to a challenging situation that requires cooperation between the two leaders and their broad range of supporters.

In reaching the agreement, Dr. Abdullah and Dr. Ghani showed incredible statesmanship. In any democracy, it's very hard after an intense campaign as a presidential candidate to come to that moment where you must put your own aspirations and those of your supporters second to the greater long-term interests of your country. Both candidates managed to overcome their reservations and those of their backers. They set aside political interests in favor of the national interest. They exhibited the statesmanship we expect from great leaders.

Their challenge now is to translate that agreement into a strong working relationship in the new government, whoever wins. The time for politics is over. The time for cooperation is at hand. There is no time to waste, and I encourage both teams to work cooperatively on the critical issues facing their country even as the audit continues.

It's not for outsiders to describe the contents of the political framework both candidates accepted a few days ago. But I was there in the room, and I can tell you what is not in that one-page document.

It does not violate the Afghan constitution – it respects Afghan institutions and the role of the president as the head of government. It does not establish a parliamentary system – it creates a new position of chief executive who will report to the president until the president convenes a loya jirga to determine whether a permanent change is in the best interests of the country.

What the agreement does provide is a critical opportunity for both candidates to move beyond political competition to real statesmanship. It is a chance for them to work together to build an inclusive government that represents all sectors of Afghan society – Pashtuns, Tajiks, Uzbeks and Hazaras, men and women.

Yes, democracy is an evolutionary process. It isn't easy. But every democracy reaches a decisive moment where the interests of the country must outweigh the interests of politicians. Afghanistan is at that critical point today. Its leaders cannot afford to miss the chance to help bring their people the better lives they deserve and demand. And that is a challenge for two statesmen who both love Afghanistan.

NSF REPORTS ON TELE-ROBOTICS

FROM:  NATIONAL SCIENCE FOUNDATION 

Tele-robotics puts robot power at your fingertips

University of Washington research enables robot-assisted surgery and underwater spill prevention

At the Smart America Expo in Washington, D.C., in June, scientists showed off cyber-dogs and disaster drones, smart grids and smart healthcare systems, all intended to address some of the most pressing challenges of our time.

The event brought together leaders from academia, industry and government and demonstrated the ways that smarter cyber-physical systems (CPS)--sometimes called the Internet of Things--can lead to improvements in health care, transportation, energy and emergency response, and other critical areas.

This week and next, we'll feature examples of Nationals Science Foundation (NSF)-supported research from the Smart America Expo. Today: tele-robotics technology that puts robot power at your fingertips. (See Part 1 of the series.)

In the aftermath of an earthquake, every second counts. The teams behind the Smart Emergency Response System (SERS) are developing technology to locate people quickly and help first responders save more lives. The SERS demonstrations at the Smart America Expo incorporated several NSF-supported research projects.

Howard Chizeck, a professor of electrical engineering at the University of Washington, showed a system he's helped develop where one can log in to a Wi-Fi network in order to tele-operate a robot working in a dangerous environment.

"We're looking to give a sense of touch to tele-robotic operators, so you can actually feel what the robot end-effector is doing," Chizeck said. "Maybe you're in an environment that's too dangerous for people. It's too hot, too radioactive, too toxic, too far away, too small, too big, then a robot can let you extend the reach of a human."

The device is being used to allow surgeons to perform remote surgeries from thousands of miles away. And through a start-up called BluHaptics--started by Chizeck and Fredrik Ryden and supported by a Small Business Investment Research grant from NSF--researchers are adapting the technology to allow a robot to work underwater and turn off a valve at the base of an off-shore oil rig to prevent a major spill.

"We're trying to develop tele-robotics for a wide range of opportunities," Chizeck said. "This is potentially a new industry, people operating in dangerous environments from a long distance."

-- Aaron Dubrow, NSF
Investigators
Fredrik Ryden
Howard Chizeck
Blake Hannaford
Tadayoshi Kohno
Related Institutions/Organizations
BluHaptics Inc
University of Washington

REMARKS BY SECRETARY OF STATE KERRY AT GANDHI MEMORIAL HOSPITAL ADDIS ABABA, ETHIOPIA

FROM:  U.S. STATE DEPARTMENT 

Remarks During Visit to Gandhi Memorial Hospital

Remarks

John Kerry

Secretary of State

Gandhi Memorial Hospital

Addis Ababa, Ethiopia

May 1, 2014

---

SECRETARY KERRY: Thank you. Thank you very much. Thank you. Good morning,
everybody. How are you?

AUDIENCE: Good morning.

SECRETARY KERRY: What an incredible, incredible energy I can feel here. You all are amazing in the work that you are doing. And in the small little spaces that I just walked through, I saw how much is going on every single day. So you are maximizing each moment and you’re maximizing every bit of space, and I congratulate you on that.

As I was walking in here, I asked about some of the other activities, and I learned that 25 babies are born here every day – 7,000 or so babies a year, right? And 30 – about 35 percent of those babies are born by cesarean section, so you can imagine how much work is going on here every single day. It’s really quite extraordinary.

And this part of the hospital, the Gandhi Memorial Hospital, is really special. The sign that is back here – you’re just sort of hiding it – but it talks about Ethiopia and the United States of America investing in a healthy future together. And there’s a lot of power in those words, “investing in a healthy future together.” We are doing it together. You’re doing the day-to-day hard work every single day. We’re trying to provide as much medical expertise and as much insight, knowledge as we can to help. But this is your – this is really your program and it’s about your future.

And I am so impressed by the way in which people in Ethiopia have grabbed onto this, and you are making a difference everywhere. Back in 2004, there were about 2.7 million Ethiopians who were HIV-positive, living with the disease. That has been cut by at least a third, but most importantly, for young children, for the children coming into the world, because of the progress that we’ve been able to make, those children now have the chance of being able to live HIV-free. And we are learning how to prevent the transmission of HIV/AIDS from mother to child, from generation to generation, or from wife to unaffected husband or vice versa. This is a huge advance.

There were about, I think, 15,000 children being able to receive antiretroviral drugs back in 2004. Today, it’s about 335,000 who are receiving antiretroviral drugs, and today, there’s an incredible new program in place, the sort of – I guess it’s Plan B+. And through Plan B+, we are now able to guarantee that a mother or a pregnant girl, woman, will be able to receive lifetime antiretroviral drugs if they take part in the program and we are able to be able to make sure that child is born, as a result, HIV-free. That program is taking hold and that’s the promise that is coming through because of PEPFAR, so that we can actually defeat this disease. It’s a huge impact.

Now, I know a story about this hospital. I know that there was a young woman named Ababa who was diagnosed HIV-positive. And she was, after her diagnosis, trying to get to a health center, and she was out in the rain and she was exhausted and tired and she didn’t know – she didn’t have the strength to be able to get where she was going. But some health workers saw her. They didn’t just drive past her. They didn’t ignore her. They helped her. They brought her to the health center. And they were able to find housing for her, they were able to give her treatment, and today, she is one of the people who’s out on the cutting edge of helping other people to know that there is a better alternative, there’s help, there are people there who are ready to be able to make a difference.

So on behalf of every American, I can tell you that Americans are very, very proud to be able to help in this. We’re really – this is the best of countries working together and the best of people working across big oceans and big continents, but coming together because we believe in something for each other. And I think all of you are really amazing leaders in your own right because you’re doing the hardest work every single day. You are working here to make a difference in the lives of other people. And the example of what you’re achieving here in Ethiopia is an example that we can take all over the world.

So I hope you feel very proud of it. I want you to know how pleased I am to be able to come here today and learn something about the Gandhi Memorial Hospital and to meet all of you who are working so hard. So thank you very, very much for everything you are doing, and congratulations to all of you. Thank you. (Applause.)

PRESIDENT'S WEEKLY ADDRESS FOR APRIL 5, 2014

FROM:  THE WHITE HOUSE

Weekly Address: The President’s Budget Ensures Opportunity for All Hard-Working Americans

WASHINGTON, DC — In this week’s address, the President highlighted the important differences between the budget he’s put forward – built on opportunity for all – and the budget House Republicans are advocating for, which stacks the deck against the middle class. While the President is focused on building lasting economic security and ensuring that hard-working Americans have the opportunity to get ahead, Republicans are advancing the same old top-down approach of cutting taxes for the wealthiest Americans and slashing important investments in education, infrastructure, and research and development.

The audio of the address and video of the address will be available online atwww.whitehouse.gov at 6:00 a.m. ET, Saturday, April 5, 2014.

Remarks of President Barack Obama
Weekly Address
The White House
April 5, 2014

Hi, everybody. 

Today, our economy is growing and our businesses are consistently generating new jobs.  But decades-long trends still threaten the middle class.  While those at the top are doing better than ever, too many Americans are working harder than ever, but feel like they can’t get ahead.

That’s why the budget I sent Congress earlier this year is built on the idea of opportunity for all.  It will grow the middle class and shrink the deficits we’ve already cut in half since I took office.

It’s an opportunity agenda with four goals. Number one is creating more good jobs that pay good wages. Number two is training more Americans with the skills to fill those jobs. Number three is guaranteeing every child access to a great education.  And number four is making work pay – with wages you can live on, savings you can retire on, and health care that’s there for you when you need it. 

This week, the Republicans in Congress put forward a very different budget.  And it does just the opposite: it shrinks opportunity and makes it harder for Americans who work hard to get ahead. 

The Republican budget begins by handing out massive tax cuts to households making more than $1 million a year.  Then, to keep from blowing a hole in the deficit, they’d have to raise taxes on middle-class families with kids.  Next, their budget forces deep cuts to investments that help our economy create jobs, like education and scientific research. 

Now, they won’t tell you where these cuts will fall.  But compared to my budget, if they cut everything evenly, then within a few years, about 170,000 kids will be cut from early education programs.  About 200,000 new mothers and kids will be cut off from programs to help them get healthy food.  Schools across the country will lose funding that supports 21,000 special education teachers.  And if they want to make smaller cuts to one of these areas, that means larger cuts in others. 

Unsurprisingly, the Republican budget also tries to repeal the Affordable Care Act – even though that would take away health coverage from the more than seven million Americans who’ve done the responsible thing and signed up to buy health insurance.  And for good measure, their budget guts the rules we put in place to protect the middle class from another financial crisis like the one we’ve had to fight so hard to recover from.

Policies that benefit a fortunate few while making it harder for working Americans to succeed are not what we need right now.  Our economy doesn’t grow best from the top-down; it grows best from the middle-out.  That’s what my opportunity agenda does – and it’s what I’ll keep fighting for.  Thanks.  And have a great weekend.

FTC CHAIR RELEASES HIGHLIGHTS FROM 2013

FROM:  FEDERAL TRADE COMMISSION 
FTC Chairwoman Releases 2013 Annual Highlights

Federal Trade Commission Chairwoman Edith Ramirez released the agency’s 2013 Annual Highlights today at the Spring Meeting of the American Bar Association’s Section of Antirust Law in Washington emphasizing the agency’s work to protect consumers and promote competition during the past calendar year.

“The hallmark of our work has been, and will continue to be, our ability to adapt established tools – law enforcement, policy initiatives and education – to address economic challenges and technological advances that Congress could never have imagined when it created the FTC,” said Ramirez in her Highlights message.
The agency’s Enforcement Highlights address a range of law enforcement actions in industries including health care, technology, and energy and the environment. Promoting competition in the health care and pharmaceutical industries that reduces costs to consumers remains a top priority for the Commission and among the most notable accomplishments last year in this area, the FTC obtained two Supreme Court victories (FTC v. Actavis Inc., and FTC v. Phoebe Putney).

Focusing on the technology sector, the agency took its first actions involving mobile cramming and the Internet of Things. Law enforcement to stop consumer fraud continued to be a high priority for the agency along with its complementary order enforcement program. The FTC’s actions resulted in redress orders of more than $297 million and civil penalty orders of $20 million.

As noted in Policy Highlights, the Commission filed 18 advocacy and amicus briefs on topics such as non-physician health care professionals, dental therapy education programs, and local taxicab regulations. Staff conducted 11 workshops on a range of topics including biologic medicines, native advertising, and the Internet of Things, to name a few. The Commission and staff also published 16 reports on topics including mobile payments and mobile privacy disclosures, among others. The FTC also continued to lead efforts to develop strong mutual enforcement cooperation and sound policy with its international partners.

Finally, the FTC’s Education and Outreach Highlights recognizes the agency’s work to alert businesses to compliance standards, and to alert consumers to the tell-tale signs of fraud and deceptive business practices. Among the agency’s many educational products produced in 2013, the FTC released new guidance for media to spot false weight-loss claims; developed information for mobile app developers; hosted the first Military Consumer Protection Day; and launched its Competition Matters blog.

VA, KAISER PERMANENTE PARTNER TO SOLVE VETERANS HEALTH CARE PROBLEMS

FROM:  VETERANS AFFAIRS

FOR IMMEDIATE RELEASE February 19, 2014 VA Partners with Kaiser Permanente Better Care and Innovative Research behind Collaboration
WASHINGTON – The Department of Veterans Affairs (VA) is collaborating with Kaiser Permanente, a leading member of the health care industry, to pool resources and ideas to solve some of the largest and most complex challenges in VA health care. "VA is always on the lookout for opportunities for partnerships with the private sector and other federal agencies to enhance care for Veterans,"said Secretary of Veterans Affairs Eric K. Shinseki. "We are proud to partner with Kaiser Permanente for the health and wellbeing of our Nation's Veterans." The partnership will enable more effective research and sharing of "best practices," focusing initially on four areas: Telehealth and virtual care; Genomics; Care of Veterans who are members of Kaiser Permanente; and Advanced analytics to use large data sets and population management with appropriate patient privacy protections. Together VA and Kaiser Permanente will develop recommendations for how to design care using advanced analytics and technologies as well as research. This is not the first major collaboration between the two organizations.

 In 2010, Kaiser Permanente and VA launched a pilot program to exchange medical data using the Nationwide Health Information Network. The innovative pilot, launched in 2009, allows clinicians from both organizations to obtain a more comprehensive view of a patient's health record using electronic health record information, including information about health issues, medications and allergies while ensuring that patient privacy and confidentiality are protected. "We are eager to continue to redesign the experience of our Veterans seeking health care to increase ease of access and quality of services,"said Patrick Littlefield, Acting Director of VA Center for Innovation, "We're excited about this partnership to make way for useful and tangible outputs." With over 8 million enrollees, VA operates the largest integrated health care delivery system in the United States, with a mission to honor America's Veterans by providing exceptional health care that improves their health and well-being. VA provides a broad range of primary care, specialized care, and related medical and social support services. More information is available at http://www.va.gov/health/. VA is also the Nation's largest provider of health care education and training for physician residents and other health care trainees. VA advances medical research and development in areas that most directly address the diseases and conditions that affect Veterans and eligible beneficiaries. # # #

JOHNSON & JOHNSON TO PAY OVER $2.2 BILLION TO RESOLVE ALLEGATIONS RELATED TO DOCTOR KICKBACK SCHEME

FROM:  U.S. JUSTICE DEPARTMENT 
Monday, November 4, 2013
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists

WASHINGTON - Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.


“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder.  “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”


The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.


“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West.  “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”


In addition to imposing substantial monetary sanctions, the resolution will subject J&J to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).  This agreement is designed to increase accountability and transparency and prevent future fraud and abuse.


“As patients and consumers, we have a right to rely upon the claims drug companies make about their products,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery.  “And, as taxpayers, we have a right to ensure that federal health care dollars are spent appropriately.  That is why this Administration has continued to pursue aggressively – with all of our available law enforcement tools -- those companies that corrupt our health care system.”


J&J Subsidiary Janssen Pleads Guilty to Misbranding Antipsychotic Drug


In a criminal information filed today in the Eastern District of Pennsylvania, the government charged that, from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded.  For most of this time period, Risperdal was approved only to treat schizophrenia.  The information alleges that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion.  The information alleges that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia.  The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.


In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients.  Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million.  Janssen’s guilty plea will not be final until accepted by the U.S. District Court.

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information.  Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA.  Before approval, the FDA must determine that the drug is safe and effective for those specified uses.  Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded.  The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth.  “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health.  The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

J&J and Janssen Settle Civil Allegations of Targeting Vulnerable Patients  with the Drugs Risperdal and Invega for Off-Label Uses

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities.  The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger.  “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.”  The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”

The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks.  For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events.  A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).”  When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly.  In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.”  The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities.  The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production.  Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.  Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.  Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal.  Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen.  Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.

As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega.  This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal.  Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments.  The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million.  The federal government and Texas each received $59 million from the Texas settlement.

Kickbacks to Nursing Home Pharmacies

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients.  In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.”  These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes.  Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients.  Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs.  The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million.  In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz.  “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”

Off-Label Promotion of the Heart Failure Drug Natrecor

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor.  In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity.  This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs.  These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug.  Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor.  Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor.  In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.

“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch.  “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”

Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement

In addition to the criminal and civil resolutions, J&J has executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).  The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business.  Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct.  J&J may recoup monies from executives who are current employees and from those who have left the company.  The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians.  On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA.  J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.

“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson.  "Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management.  The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing."

Coordinated Investigative Effort Spans Federal and State Law Enforcement

This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud.  Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.

The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch.  The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch.  Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.

One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act.  Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.

The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery.  From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million.  Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability.

CHANGES LOOKED AT FOR GROWTH OF MILITARY PAY AND BENEFITS

FROM:  U.S. DEFENSE DEPARTMENT 
Military Must Slow Growth for Military Pay, Health Care
By Jim Garamone
American Forces Press Service

SEOUL, South Korea, Oct. 1, 2013 - The military has to look at the entire package of compensation, health care and retirement, Army Gen. Martin E. Dempsey told a U.S. Forces Korea Town Hall meeting here today.

 The chairman of the Joint Chiefs of Staff and his wife, Deanie, spent an hour answering question from the joint service audience. Budget issues were a main concern for the service members.

Personnel costs have to be brought under control, the chairman said. He assured the service members that any changes to military retirement would be grandfathered. "So the question is what do we do with retirement for the next generation of soldiers, sailors, airmen and Marines," he said. "But compensation ... and health care costs are growing at rates that are unsustainable to the all-volunteer force."

This does not mean cuts, the chairman said, "we may not actually have to reduce pay and benefits, but we have to slow the growth."

Last year, for example, DOD recommended a 1 percent pay raise for military personnel. Congress upped the total to 1.8 percent. Slowing the rate by just that much would have saved DOD $13 billion. Instead, the money to pay for the raise came out of readiness accounts, the chairman said.

In an interview with reporters traveling with him, Dempsey expanded on this. He noted he has been through three drawdowns in his career that began in 1974 – the post-Vietnam drawdown, the post-Cold War drawdown and the current one. This one is alarming to him because it is the steepest drawdown he has seen.

"The steepness of it puts us in a position to not exert enough control on balancing our requirements across all the accounts, whether they are manpower accounts, modernization, maintenance, training, family care," he said. "It's extraordinarily challenging to try to balance the budget because of the steepness of this drawdown."

He is worried about the long-term effects of the drawdown. Under sequester, DOD must cut an additional $52 billion from the budget in fiscal 2014. "If I were able to shrink the force, close some unnecessary infrastructure, potentially cancel some weapons systems that we don't think are as important as others, I think I can probably balance it and not affect readiness to the extent we are," he said.

But Congress will not allow another base realignment and closure process, and Congress has continued some weapons systems the department has specifically said it does not need. "Because there are parts of the budget that are untouchable to me at this point," he said. "Unless I can touch some of those things, it all comes out of readiness, which means the next group to deploy will be less ready than they should be.

"That's not a position that our armed forces should be in as the greatest military on the planet serving the greatest nation on the planet."

And sequestration could continue to be a year-by-year process, and that is dangerous "because we are asking the force to live with uncertainty and do it a year at a time," he said. "Eventually I think they are going to lose faith if we do it a year at a time."