Archive for the ‘Medicine Information’ Category.

Health and Human Services Announce New Program

News Release

FOR IMMEDIATE RELEASE
Thursday, September 2, 2010
Contact: HHS Press Office
(202) 690-6343

Cincinnati, Detroit selected as final health IT pilot communities under innovative HHS Recovery Act Beacon Program

HHS Secretary Kathleen Sebelius today announced that Cincinnati and Detroit are the two final pilot communities selected under the new Beacon Community Program that is using health information technology to help tackle leading health problems in communities across the country.  At the same time, the program will also allow HHS to look for new ways to share the lessons learned by funded communities and, working with local and national health care foundations, develop support networks for other communities that want to employ similar innovative approaches.

The two awardees announced today, Greater Cincinnati HealthBridge, Inc. in Cincinnati and Southeastern Michigan Health Association in Detroit, join 15 other projects selected in May for the Beacon Community Cooperative Agreement Program.  The other communities that previously received Beacon program funding include Tulsa, Okla.; Stoneville, Miss.; Brewer, Maine; Danville, Pa.; Salt Lake City, Utah; Indianapolis, Ind.; Spokane, Wash. New Orleans, La.; Rochester, Minn.; Providence, R.I.; Grand Junction, Colo.; Concord, N.C.; San Diego, Calif.; Hilo, Hawaii, and Buffalo, N.Y.  Beacon projects are expected to initially create dozens of new jobs in each of the communities paying an average of $70,000 per year for a total of over 1,100 jobs up-front, while accelerating development of a nationwide health IT infrastructure that will eventually employ tens of thousands of Americans. 

“The Beacon program uses health information technology tools to link health providers and other community-wide resources in new and innovative ways,” Secretary Sebelius said.  “Under the Beacon program, communities first identify leading health problems that are unique to their community, develop innovative, health IT-related strategies, and work together through community collaborations to implement their strategies and track their performance.”

The Beacon Community awards are part of an overall $100 billion federal government investment in science, innovation and technology the Administration is making through the Recovery Act to spur domestic job creation in emerging industries and create a long-term foundation for economic growth.  There has been significant interest in the program, with over 100 applications for the final two Beacon program slots.  David Blumenthal, M.D., national coordinator for Health Information Technology, said the applications demonstrated widespread readiness in communities across America to use health IT to address specific challenges in health and health care.

“Beacon communities are designed to point the way toward maximizing community resources to address specific health goals at the local level, including quality of care, the cost of care, and the health of the whole population,” Dr. Blumenthal said.  “We have seen first-hand through the Beacon application process that a great many communities have promising ideas and are starting to use health IT in innovative ways.  We look forward to engaging and helping these communities through a broader nationwide effort.”

In the near term, HHS’ Office of the National Coordinator for Health IT will work closely with other federal partners and the private sector to identify and share promising health IT health care solutions among communities across America.

“Although we could only select two additional Beacon communities, we are incredibly impressed by the creativity and focus exhibited by communities over the course of this competition,” said Blumenthal. “Local leadership is an essential ingredient to improving health care. The Beacon Community application process provides strong evidence that communities throughout the country are mobilizing for positive change, using health IT as a critical foundation for improving health care.”

Like other Beacon communities, today’s awardees will coordinate community efforts toward specific goals:

The Greater Cincinnati HealthBridge, Inc. – $13.8 million over three years – HealthBridge will serve a 16-county area spanning three states surrounding greater Cincinnati. Under the Beacon program, HealthBridge and its partners will use its advanced health information exchange program to develop new quality improvement and care coordination initiatives focusing on patients with pediatric asthma, adult diabetes, and encouraging smoking cessation. For example, not only will physicians and other providers receive more timely and accurate information about when their patients experience a medical complication or are hospitalized, they will have new support from care managers to use this information effectively to intervene early and assist patients in managing their health and avoiding further complications. This program will provide better clinical information and IT “decision support” tools to physicians, health systems, federally qualified health centers, and critical access hospitals. As part of the Beacon program, this health IT community collaboration will also provide patients and their families with timely access to data, knowledge, and tools to make informed decisions and manage their own health and health care.

The Southeastern Michigan Health Association (SEMHA) – $16.2 million over three years – The SEMHA and its partners in the greater Detroit area will use health IT tools and strategies to prevent and better manage diabetes, which today affects a large percentage of residents of the city of Detroit. This community collaboration will leverage existing and new technologies across health care settings to improve the availability of patient information at the point of care, regardless of where the patient is in the health system. Furthermore, the community will provide practical support to physician practices to help clinicians, nurses, and others make the best use of electronic health data to catch potential health complications before they arise.  The city’s clinical community will have the capacity to track clinical outcomes with the overarching goal of making long-term, sustainable improvements in the quality and efficiency of diabetes care in Detroit, Hamtramck, Highland Park, Dearborn and Dearborn Heights.

The Beacon program is one of several new programs created by the Health Information Technology Economic and Clinical Health (HITECH) Act as part of the Recovery Act last year.  HITECH included $2 billion for technical assistance, training and demonstration programs supporting the adoption of heath information technology, including electronic health records (EHRs).  Total funding for the Beacon program initiatives is $250 million plus an additional $15 million for technical assistance and evaluation.  In addition, HITECH authorized incentive payments to health care professionals and hospitals to reward adoption and meaningful use of EHRs.  The incentive payments, provided through Medicare and Medicaid, could total as much as $27 billion over 10 years.  These Recovery Act incentive payments, along with the Affordable Care Act, are part of broader efforts in Medicare and Medicaid to transform payments to reward better quality care.

More information about Beacon Communities can be found at:  http://Healthit.hhs.gov/Programs/Beacon

For information about the Affordable Care Act and other efforts to promote improved care delivery, see: http://www.healthcare.gov

For information about other HHS Recovery Act programs, see: http://www.hhs.gov/recovery

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President signs Medicare Declaration

THE WHITE HOUSE

 Office of the Press Secretary

For Immediate Release July 30, 2010

45TH ANNIVERSARY OF MEDICARE AND MEDICAID

- – - – - – -

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

 When President Lyndon B. Johnson signed Medicare and

Medicaid into law on July 30, 1965, millions of Americans and

about half our Nation’s seniors lacked health care coverage,

unable to afford basic health care services or weather a medical

emergency. The signing of Medicare forged a promise with older

Americans — that those who have contributed a lifetime to our

national life and economy can enjoy their golden years with

peace of mind and the security of reliable medical insurance.

Medicaid created an essential partnership between the Federal

Government and the States to provide a basic health care safety

net for some of the most vulnerable Americans: low-income

children, parents, seniors, and people with disabilities.

Forty-five years later, we must ensure this inviolable trust

between America and its citizens remains stronger than ever.

Medicare and Medicaid support longer, healthier lives and

economic security for some of the neediest among us. Since

their expansion in 1972, Medicare and Medicaid have covered

millions of people with disabilities, protecting individuals

who otherwise might not have access to affordable health

coverage. Today, Medicare provides over 47 million Americans

with dependable medical insurance, and is the largest health

care provider in our Nation. State Medicaid programs provide

health and long-term care coverage to more than 56 million

low-income Americans. With too many communities stricken by the

economic crisis, Medicaid provides a critical support for those

struggling to raise healthy families or cope with illness or

injury. No American should be one illness away from financial

ruin, and we must continue to keep Medicare and Medicaid strong

for the millions of beneficiaries who rely on these vital safety

nets.

 Medicare is not simply an entitlement program that starts at age 65 — it is earned over a lifetime. The health care reforms in the landmark Affordable Care Act (ACA) renew and strengthen our pledge to America’s seniors and families, ensuring Medicare and Medicaid will be there when they need it.

Guaranteed Medicare benefits will not change, and participants will see greater savings, improved quality, and increased accountability in their health care coverage.

My Administration is taking steps to extend the life of the Medicare trust fund and to slow the growth of Medicare costs. The ACA helps accomplish this by addressing overpayments more to insurance companies that operate Medicare Advantage plans; aggressively fighting waste, fraud, and abuse; and better coordinating the care of individuals with chronic conditions.

The ACA also helps seniors and people with disabilities in Medicare who fall in the Part D coverage gap for prescription  drug costs, or the “donut hole,” and Medicare beneficiaries who reach the donut hole this year are receiving a $250 rebate.

Additionally, beneficiaries will see 50 percent discounts on brand name drugs in the coverage gap starting next year, and an end of the coverage gap altogether by 2020. To encourage health maintenance, the ACA enables Medicare to provide a free annual physical examination and other effective preventative care services, like certain colorectal cancer screenings and

mammograms, with no co-pays or deductibles. Through focus on preventative care, increased efficiencies, and better management, the ACA is modernizing the health care system to make it work better for older Americans.

 As President, I will protect the promise of Medicare and Medicaid, and make sure they continue to be strong and solvent for our children and grandchildren. As we celebrate the 45th anniversary of these critical programs, we reflect on a moment when our Nation made an enduring commitment to care for those who have given the most to our society, and those living in poverty. Let us continue protecting Medicare and Medicaid so older Americans can age with dignity, and so all Americans can live longer, healthier, and happier lives.

NOW, THEREFORE, I, BARACK OBAMA, President of the

United States of America, by virtue of the authority vested in

me by the Constitution and the laws of the United States, do

hereby proclaim July 30, 2010, as the 45th Anniversary of

Medicare and Medicaid. I call upon all Americans to observe

this day with appropriate ceremonies and activities that

recognize the vital safety net that Medicare and Medicaid

provide for millions of Americans.

IN WITNESS WHEREOF, I have hereunto set my hand this

thirtieth day of July, in the year of our Lord two thousand ten,

and of the Independence of the United States of America the

two hundred and thirty-fifth.

 BARACK OBAMA

 # # #

New Health Care Access Guidance Promotes Preventive Medical Care Services for People with Mobility Disabilities

News Release

FOR IMMEDIATE RELEASE
Thursday, July 22, 2010
Contact: CRT (202)514-2007 TDD (202)514-1888
HHS (202) 690-6343

New Health Care Access Guidance Promotes Preventive Medical Care Services for People with Mobility Disabilities

WASHINGTON –The Department of Justice’s Civil Rights Division and the Department of Health and Human Services’ (HHS) Office for Civil Rights today issued new technical assistance guidance for medical providers which will help people with mobility disabilities obtain accessible medical care.  Access to Medical Care for Persons with Mobility Disabilities will assist medical care providers in understanding how the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act of 1973 apply to them.  This 19-page document includes an overview of general ADA requirements, commonly asked questions, and illustrated examples of accessible facilities, examination rooms, and medical equipment.

“It is critical that all individuals, including those with disabilities, have access to health care.  But far too often, barriers prevent people with disabilities from visiting a doctor’s office or a clinic,” said Assistant Attorney General for the Civil Rights Division Thomas E. Perez. 

“Due to barriers, people with disabilities are less likely to receive even basic medical treatment that will prevent routine small problems from turning into major and possibly life threatening ones.  This guidance promotes the core values of the health care reform legislation championed by this Administration,” said Georgina C. Verdugo, director of HHS’ Office for Civil Rights.

Title III of the ADA prohibits discrimination on the basis of disability by private hospitals, doctors’ offices, clinics and other health care providers. Section 504 of the Rehabilitation Act of 1973, as amended prohibits disability based discrimination by all health care providers that receive federal financial assistance. 

For more information about the ADA or to obtain copies of Access to Medical Care for Individuals with Mobility Disabilities visit www.ada.gov or call the ADA Information Line at 1-800-514-0301 (V) or 1-800-514-0383 (TTY).  For more information about Section 504, see www.hhs.gov/ocr/.

Disability Pride Parade

The Disability Pride Parade will take place in 2010 on July 24th.
Not only will there be the parade but there will also be exhibits in Daley Center of organizations which serve individuals with disabilities.

The overall mission of the Disability Pride Parade is:

    To change the way people think about and define “disability”;
    To break down and end the internalized shame among people with Disabilities; and
    To promote the belief in society that Disability is a natural and beautiful part of human diversity in which people living with Disabilities can take pride.

The specific objectives for the parade are:

    To organize a fully inclusive, annual event that will celebrate and strengthen the pride, power, and unity of people with disabilities, our families, and allies;
    To generate national visibility of the Disability community

At the request of Sage Publications, Sarah Triano wrote the following definition of “Disability Pride” for the Encyclopedia of Disability:

” ‘Disability Pride represents a rejection of the notion that our physical, sensory, mental, and cognitive differences from the non-disabled standard are wrong or bad in any way, and is a statement of our self-acceptance, dignity and pride. It is a public expression of our belief that our disabilities are a natural part of human diversity, a celebration of our heritage and culture, and a validation of our experience. Disability Pride is an integral part of movement building, and a direct challenge to systemic ableism and stigmatizing definitions of disability. It is a militant act of self-definition, a purposive valuing of that which is socially devalued, and an attempt to untangle ourselves from the complex matrix of negative beliefs, attitudes, and feelings that grow from the dominant group’s assumption that there is something inherently wrong with our disabilities and identity.’

Hospital Rights Problems

Have you had the following type problems in Chicago hospitals? 

  • Exam rooms too small to move around in

  • Exam tables are too high and can’t be lowered, or you are told to bring someoneto lift you to access medical equipment

  • Long waits or refusal of service because of your disability

  • Important information not given to you in accessible format

  • No qualified sign language interperter at appointments

  • No service animals allowed

If you have had these type of problems please contact the following persons:

            Judy Panko Reis, M.A., M.S.
           Access Living
          1-800-613-8549 (Voice)
          1-888-253-7003 (TTY)
         Email: jreis@accessliving.org

       Sarah Price
      Equip for Equality
     1-800-537-2632  Ext 7339 (V)
    1-800-610-2779 (TTY)
   Email:sarah@equipforequality.org

   Andres Gallegos
  Robbins, Saloman and Pat Ltd (law firm)
  1-312-456-0381 (Voice)
 Email:agallegos@rsplaw.com
    

Drug Information

News Release

FOR IMMEDIATE RELEASE
Tuesday, April 27, 2010
Contact: Department of Justice
(202) 514-1888

Pharmaceutical Giant Astrazeneca To Pay $520 Million

WASHINGTON – AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT) announced today.  Such unapproved uses are also known as “off-label” uses because they are not included in the drug’s FDA approved product label.

The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.

Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA.  Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company.  Once approved, the drug may not be marketed or promoted for off-label uses. 

The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders.  In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only.  In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania).  In October 2006, the FDA approved Seroquel for bipolar depression.

The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA.  Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness).  These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.

In March 2006, AstraZeneca brought certain conduct to the attention of the government and then cooperated in the investigation of the allegations being settled today.

The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel.  In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct.  AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.

“Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General Eric Holder.  “This Administration is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies.”

The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel.   AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel.  The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute.

“Rooting out health care fraud is a top priority for the Obama Administration, said Kathleen Sebelius, Secretary of the Department of Health and Human Services. “Today’s settlement sends a clear warning to any individual or company seeking to defraud our health care system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong. It reflects the unprecedented energy, resources, and new ideas that this administration has devoted to identifying, prosecuting, and ultimately preventing health care fraud. With the new anti-healthcare fraud resources in the Affordable Care Act, there has never been a worse time to try to steal from our health care system.”

“Consumers are entitled to rely on the claims pharmaceutical companies make about the drugs they sell,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “Working with our federal and state partners, we will protect the integrity of our public health programs by ensuring that kickbacks from drug companies do not taint the medical decisions of health care professionals.”

“When pharmaceutical companies interfere with the FDA’s mission to insure that drugs are safe and effective, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania.  “People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors’ judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues.”

In addition to the civil settlement agreement, resolution of the matter includes a  Corporate Integrity Agreement (CIA) between AstraZeneca and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a board of directors committee annually review the company’s compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that AstraZeneca send doctors a letter notifying them about the settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging.  AstraZeneca is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

“As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed — all leading to better protection for patients,” said Department of Health and Human Services Inspector General Daniel R. Levinson.

The government’s investigation was triggered by a whistleblower lawsuit filed under the FCA’s qui tam provisions in the Eastern District of Pennsylvania.  As part of today’s resolution, James Wetta, the whistleblower in that action, will receive more than $45 million from the federal share of the civil recovery.

This settlement is part of the government’s emphasis on combating health care fraud and another step for the HEAT initiative, which was announced by Attorney General Holder and Secretary Sebelius in May 2009.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid fraud through enhanced cooperation. One of the most powerful tools in that effort is the FCA, which the Justice Department has used to recover almost $2.8 billion since January 2009 in cases involving fraud against federal health care programs.  The Justice Department’s total recoveries in FCA cases since January 2009 are over $3.75 billion.

The civil settlement was reached by the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Commercial Litigation Branch of the Justice Department’s Civil Division.  This investigation was conducted by the Department of Health and Human Services Office of Inspector General, U.S. Postal Service’s Office of Inspector General and the FDA’s Office of Criminal Investigations.  Assistance was provided by representatives of FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.