“These documents are intended to offer a vision for the future and potential options for CMS to pursue to improve the quality and value of health care delivered in the United States and to shift the Medicare FFS program away from paying providers based solely on the volume of services and instead paying them for quality and value of care,” said Kerry Weems, CMS acting Administrator.

Health care today represents one-seventh of the economy with spending totaling more than $2 trillion annually. By 2017, the nation is expected to spend roughly $4 trillion on health care: 21 percent of gross domestic product.

Medicare costs are continuing to skyrocket as well. Last spring, the Medicare Part A Hospital Insurance Trust Fund had been projected to go bankrupt in 2019, 11 years from now. The Medicare chief actuary recently observed that because of the current economic crisis, this date could be moved three years earlier – 2016.

“It is incumbent on us to use the lessons we’ve learned with many of the tools we have implemented to help the nation’s health care leaders as they look to improve the health care system in a time that’s even more critical because the projected rate of growth in health care costs is climbing at an unsustainable rate,” said Weems.

The papers linked to www.cms.hhs.gov/QualityInitiativesGenInfo/ outline the activities that CMS has undertaken to implement value driven health care, including summaries of the various projects to test the policy and concepts designed to provide high quality, affordable health care. The papers provide steps to implement quality and resource use measurement to improve the delivery of care and offer a roadmap to assist in implementing value-based purchasing for Medicare’s FFS payment systems.

These papers are also intended to provide information to policy makers about the demonstrations and pilot programs that are already underway and to articulate the overarching principles guiding further efforts.

The concept behind value-based purchasing is to encourage care delivery patterns that are not only high quality, but also cost-efficient and to move away from the traditional FFS payment systems that pay health care providers to perform services without regard to their quality. In order for a value-based purchasing payment to function, it must be based on standardized quality measures provide information about care that is accurate, reliable, and relevant in a patient-centered way and also based on resource-use measures that can evaluate health care performance in a way that enables comparisons of how efficiently health care is delivered.

By: CMS HHS – Sat, 01/17/2009 – 05:33

FDA accepted most of the recommendations but “complained” that reviewing financial information prior to the start of trials “would increase its workload for no clear gain, especially since many drugs or devices that enter clinical trials never reach the market,” the editorial states. According to the Times, “Such bureaucratic excuses seem lame,” adding, “Surely it would be better for [FDA] to eliminate potential conflicts before they can bias a trial than try to mitigate them after the results are in.”

The editorial concludes that FDA’s “lax performance underscores the need for Congress to pass legislation requiring all drug and device makers to report their financial arrangements with doctors in a public databank,” adding, “That would make it harder for clinical investigators or sponsoring companies to hide potential conflicts, including those that might bias clinical trials for the FDA” (New York Times, 1/13).

Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

By: kaisernetwork.org – Wed, 01/14/2009 – 15:40

Hospital demand for blood (needed for emergency care and surgery) has increased beyond seasonal expectations while levels of blood donation have been below forecast. Blood supplies have dropped below the five-day safety level, and for some types of blood are at a less than two-day level. Some rationing of supply has been imposed upon the 200 hospitals served by NYBC and its regional operations.

“Blood is traditionally in short supply during the winter months due to the holidays, travel schedules, inclement weather and illness,” said Dr. Robert L. Jones, New York Blood Center President & CEO. January, in particular, is a difficult month for blood centers, especially following the holidays when donation levels plummet.

The current severe economic downturn has also impacted donation levels with many traditional donor groups canceling, downsizing, or postponing their blood drives to another time of year. Additionally, with 15% of regional blood collection coming from high schools and colleges, winter recess contributes substantially to the current shortfall.

“The health of our community depends on people scheduling a few minutes for blood donation, to prevent additional rationing and possible cancellation of surgery,” Dr. Jones said.

Facts About Our Blood Supply

* Ordinarily, a 5-7 day supply is required to ensure that blood is available for scheduled surgical procedures, medical treatments for cancer patients and to meet emergency or unexpected disaster needs.

* To meet local needs, New York Blood Center and its regional operations in Manhattan, Brooklyn / Staten Island, Long Island, Hudson Valley and New Jersey require 2,000 blood donations each day to supply the needs of 200 hospitals.

* Approximately every two seconds, someone needs blood, and one out of three people will need a life-saving blood transfusion in their lifetime. If all eligible blood donors gave at least twice a year, it would greatly help in maintaining an adequate blood supply.

* Fewer than five percent of healthy Americans eligible to donate blood actually donate each year. In New York, only two percent actually donate.

* People can donate blood every 56 days. Red blood cells must be used within 42 days, platelets within five days, and plasma can be frozen and used for up to one year.

* A single blood donation can help save the lives of up to three people. Car accident and trauma victims need as many as 50 or more red cell transfusions, and burn victims can use up to 50 platelet transfusions

* Any company, community organization, place of worship, or individual may host a blood drive.

* Blood donors receive free mini-medical exams on site including information about their temperature, pulse rate, blood pressure and hemoglobin level.

* Eligible donors include those people at least age 16 with parental consent (in NY) or 17 (in NJ), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People over 75 may donate with a doctor’s note.

We Need You

* We’re making an emergency appeal for donors:

o High demand from hospitals (surgery, emergencies, care of cancer patients).

o Winter weather means cancellation of many blood drives.

o Recession-related layoffs and business closings mean additional cancelled blood drives.

o January is always one of our toughest months, since it takes awhile for people to get back into regular work routines, get back to school from holiday breaks, and begin participating in blood drives.

* Patient care is at risk

o Blood supply is below the 5-day safety level (and for some types, less than a 2-day supply), and falling.

o Our projections are also way down, and that’s why we’re asking the public for help.

o We especially need Type o and Rh negative blood, but encourage all donors to contact us

* Some blood types are being rationed to hospitals with possibility of more drastic measures should the shortage worsen

o Severe rationing is possible.

o Nightmare scenario is ERs shutting down because they don’t have enough blood to handle emergencies

* Four million Americans would die each year without donated blood, and the only place to get this precious resource is from volunteer blood donors

* New York Blood Center requires 2,000 each and every day.

* One out of three people will need a life-saving blood transfusion in their lifetime

* Each donation can save up to three lives

* Medical advances have increased the need for blood

* One patient can use large amounts of blood

o Car accident, burn and other and trauma victims need 50 or more transfusions

Who can help

* Donors must be 17- to 75-years-old (16 in New York with parent consent, and over 75 with doctor’s note)

* Donors must weigh at least 110 pounds and be in good health

* 60% of the population is eligible, and on average 5% give nationwide

* In New York, 2% actually donate

* Approximately 70% of donors give only once per year

* If 5% of the people eligible gave, or everyone who gave once gave twice, there would be no blood shortage

* People can donate red blood cells every 8 weeks (56 days) and platelets every 3 days

All donors receive free mini-medical exams on site and information about their temperature, pulse rate, blood pressure and hemoglobin level. Eligible donors include those people at least age 16 with parental consent (in NY) or 17 (in NJ), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. Inquiries are also welcomed from organizations who would like to schedule an emergency blood drive.

By: New York Blood Center – Wed, 01/14/2009 – 16:46

The researchers wanted to better understand how the membrane protein, CD30, contributes to lymphoma. CD30 is a cell surface receptor that communicates signals from the extracellular environment into the cell resulting in a cellular response. It has been recognized since the early 1980s that CD30 is present in very high amounts in certain lymphomas and leukemias — much more than in normal cells. CD30 protein is also known to stimulate mast cells to release proteins that regulate the recruitment of inflammatory cells.

“This makes CD30 an attractive therapeutic target,” says study author Casey Wright, Ph.D., who conducted the research while at U-M. Wright is now an assistant professor of pharmacy at the University of Texas at Austin.

In the study, the researchers uncovered an unexpected partner protein that interacts with CD30. This protein, known as ARNT, is best characterized for its role in mediating the metabolism of environmental toxins and also for mounting the hypoxic response in cells exposed to low oxygen levels.

“Our research describes a novel role for ARNT, which had never been implicated in the signaling pathway of a membrane protein like CD30,” says Wright, who conducted the study as a research fellow at the University of Michigan Medical School. His co-author is Colin Duckett, Ph.D., associate professor of molecular medicine and genetics and of pathology at the U-M Medical School.

In some lymphomas, like Hodgkin’s lymphoma, the increased presence of CD30 results in a continual activation of five cellular proteins that are collectively referred to as nuclear factor-kappaB (NF-kB). “NF-kB turns on genes whose products are involved in cellular proliferation and, thus, sustained NF-kB activity is thought to lead to cancer,” Wright says.

The researchers also found that ARNT is a negative regulator of CD30 signaling in that it shuts down NF-kB at the DNA level. “This is an important finding because how NF-kB is regulated at the level of DNA is less clear,” says Wright.

“The regulation of NF-kB by ARNT provides a link between human exposures to environmental toxins and the subsequent cancers of the immune system, like lymphoma, that often arise,” he says. “While these findings are significant, this is only the beginning, and there is much more work to be done before we realize the full impact of our results.”

By: University Of Michigan – Wed, 01/14/2009 – 17:10

A group of proteins called ankyrins, or anchor proteins, were first discovered in human red blood cells by Vann Bennett, MD, a Howard Hughes Medical Institute investigator and James B. Duke Professor of Cell Biology, Biochemistry, and Neurobiology. Ankyrins are a family of proteins that assist in attaching other proteins to the fragile cell membrane, and in the case of red blood cells, this helps cells resist shearing forces when blood is pumped vigorously throughout the body.

Bennett’s team was exploring the function of anchor protein ankyrin-B (ankB) by knocking out gene expression of the gene that makes the protein. They found newborn mice missing ankB had splayed shoulder bones, which stuck out of the animals’ backs like wings, rather than lying flat, a symptom of a muscular problem.

“I went back to my pediatric textbook and saw images of people with a form of muscular dystrophy who had splayed shoulder bones,” said Bennett, “This opened our eyes to the possibility that, in addition to defects in controlling heart rhythm that we have studied before, the mice might also suffer from muscular dystrophy.”

The team turned its attention to ankB with regard to muscle cell organization. They knew that people with Duchenne muscular dystrophy were missing the protein dystrophin, and that dystrophin is needed for a protein complex to form and protect the cells’ thin plasma-membrane layer from forces exerted by muscle cells contracting.

“Without dystrophin, you lose the entire protective complex, but nobody knew why,” Bennett said. “We have found the outlines of a pathway through which dystrophin assembled this complex. The missing piece of the puzzle was the ankyrin proteins.” The work appears in Cell journal.

The protective layer is located at a very particular place on the muscle cell membrane, where costameres, riblike structures, hold the bundled muscle cells together. This is similar to a steel cables attaching to a specific point along a suspension bridge to distribute the forces and keep the flexible bridge intact, Bennett said.

When the protective protein layer isn’t present, muscle contraction forces may break the cell membrane, toxins pour in and vital enzymes stream out. The muscle cells die.

The first experiment for the new study asked if the protein dystrophin was found on the cell plasma membrane in the study animals which lacked ankB. It was not.

Beta-dystroglycan, the core component of the dystrophin-glycoprotein complex that is responsible for attaching dystrophin to the muscle membrane, also was missing, which suggested that a loss of ankyrin-B is linked to a loss of at least two key proteins in the cell membrane, Bennett said.

The researchers needed to continue their studies in adult mice with fully formed muscle cells to observe them in action, because muscle cells in culture don’t have properly functioning costameres. They knew, however, that knocking out ankyrin-B causes the mice to die soon after birth.

Fortunately, Gai Ayalon, PhD, a postdoctoral fellow in the Bennett laboratory, devised a method that let researchers manipulate gene expression in a specific section of adult muscle, rather than in the whole animal. “This development let us look right away at what happened in adult mice when we produced ankyrin loss only in leg muscle,” Ayalon said.

Next, they studied what happened when they turned off ankyrin-G (ankG), a different anchor protein, in muscle cells. They found that the cells needed ankG to help dystrophin and beta-dystroglycan stay in place at the costameres.

Ayalon exercised the mice to learn how the muscle cells fared without ankG. The cells tore apart.

The researchers also discovered that ankB stabilized a set of structures found in all cells, called microtubules. These structures are like tracks for the molecular motors that carry the dystrophin molecules from the site where they are made to their specific destination. Ankyrin B helps microtubules align so dystrophin molecules can travel to the membrane and then ankyrin G holds them in place, Bennett explained.

“I’m excited because ankyrin-B’s ability to anchor microtubules could have broad implications in many cell types,” Bennett said.

By: Duke University Health System – Wed, 01/14/2009 – 17:16

These actions result from an investigation commenced upon the arrest of five employees of Pinecrest for alleged abuse of residents. The five employees, including two shift supervisors and one home supervisor, were arrested after an internal investigation conducted in partnership with the District Attorney.

After the arrest, there were claims by employees of fear of retaliation for reporting abuse. Upon learning of these comments, Levine asked the State Inspector General to conduct an independent review of the policies, procedures and environment of care of the facility in October 2008.

“Louisiana’s most precious and vulnerable people rely upon the services of Pinecrest and other state facilities to maintain their dignity and their rights. In fact, because of past allegations by the Attorney General of the United States of violations of the rights of the residents of Pinecrest, Louisiana had, in the past, been subject to scrutiny. We now find ourselves in a situation where employees of Pinecrest have been accused of abuse, and other employees expressed concern about speaking out about such abuse,” Levine said.

“When the employees were recently arrested, I was disturbed to have read that other employees had been afraid to speak out about the abuse. At that time, I asked the Inspector General to conduct an independent review of Pinecrest—including assessing the environment, culture and policies—and to provide me with recommendations.

“There is no excuse for an employee of the state who witnesses potential abuse to withhold that information, and there is certainly no excuse for any employee to feel threatened when they do report potential abuse or violations of policies designed to protect residents or ensure the integrity of the facility. Anything less than an open environment is unacceptable, and I will hold management accountable for ensuring all steps are taken to ensure a safe and dignified environment for these precious and vulnerable citizens of our state.”

Immediate actions ordered by the Secretary include:

1. All existing and new staff at the Pinecrest facility will receive new training provided by the Louisiana Attorney General on Jan. 14 and 22, 2009, on reporting suspected abuse or unexplained patient injuries.

2. All existing and new staff will receive training annually.

3. DHH will appoint an ethics and compliance officer to establish a statewide compliance program for DHH facilities – to include the ability to provide employees a confidential avenue for reporting of alleged violations of policies or procedures that may impact the operating integrity of a facility.

4. DHH is implementing more frequent monitoring and reporting, including routine visits and observations by administrative and executive-level staff after hours and on weekends to provide additional oversight.

5. DHH will strictly enforce mandatory reporting when suspected abuse or neglect takes place. The policy will be amended to reflect that employees may be terminated immediately for failure to report suspected abuse. Any applicable state laws related to reporting of abuse will continue to be enforced.

In addition to these steps, DHH continues to aggressively investigate all allegations of abuse reported through the DHH abuse hotline. All allegations are taken seriously, and are investigated immediately upon receipt.

DHH maintains a zero-tolerance policy toward abuse and has a standing policy of suspending any employee suspected of abuse while an investigation is pending. All investigations are reported to local law enforcement and the Attorney General’s office immediately upon receipt of an allegation by the Department.

By: Louisiana Department Of Health – Thu, 01/15/2009 – 05:21

Approximately 170 patients of the Upper Manhattan Dialysis Center of Beth Israel Medical Center at 2465-67 Broadway in Manhattan are being notified in person or by mail that they may have been exposed to hepatitis C and possibly other bloodborne viruses while being treated at the facility.

“This situation is an example of infection prevention guidelines in action: frequent testing can quickly identify a problem. Steps can be taken right away to correct possible problems, and patients can be notified and tested,” said Health Commissioner Richard F. Daines, M.D. He commended the facility on the completeness of testing and response. Patients who receive care at Upper Manhattan Dialysis Center are routinely screened for hepatitis B and C, both bloodborne viruses.

The transmission was identified after routine testing conducted by the facility identified a patient who became infected with hepatitis C while receiving treatment at the facility. DOH’s investigation concluded that transmission had occurred at the dialysis center. The facility and DOH each conducted a thorough investigation that included an assessment of infection control procedures by a panel of independent experts. Neither assessment found major deficiencies, and the facility incorporated all of the experts’ recommendations immediately.

DOH is recommending that only patients who were dialyzed at the Upper Manhattan Dialysis Center since February 2007 be tested promptly. Information packets are in the process of being delivered to all at-risk patients. Letters advise patients to get tested for the hepatitis C virus, hepatitis B virus, and human immunodeficiency virus (HIV). Testing can be done through the facility. There is no evidence at this time that any patient has contracted hepatitis B or HIV at the facility.

Hepatitis C is a liver disease caused by the hepatitis C virus and is spread by contact with the blood of an infected person. It is estimated that 1.6 percent of the population of New York State has been infected with hepatitis C.

By: New York Department Of Health – Thu, 01/15/2009 – 14:29

“With the election of the first African-American president of the United States, our society has taken a landmark step towards deracializing human conduct,” says Stephen C. Ekker, PhD, Rochester, MN, Editor-in-Chief of Zebrafish. “As scientists, we contribute to this work by sharing genetic insights to demystify skin color and race.”

Guest Editors Keith C. Cheng, MD, PhD, Department of Pathology, Penn State College of Medicine, and David M. Parichy, PhD, Department of Biology, University of Washington, have compiled an intriguing collection of original scientific papers and historical perspectives on the study of pigmentation in zebrafish, a vertebrate that shares genetic mechanisms of skin color with humans. The Special Focus on Pigmentation Biology includes a Roundtable Discussion entitled, “Research Implications of Pigment Biology in Zebrafish,” by Cheng, Parichy, and Ekker.

Keith Cheng explains that zebrafish “have outstanding potential as an educational tool–to ‘demystify’ race, to increase public understanding of the role of model systems and evolution in science, and to enhance appreciation of both genetic and environmental factors that impact human health and society.” Fish research has already played an important part in the discovery of genetic changes that make the largest known contribution to the lighter skin color of Europeans. Variation–or genetic polymorphisms–in these DNA sequences are key determinants of pigmentation among different human populations.

The special issue of Zebrafish also includes an essay by Steven A. Farber that provides historical perspective on the first application of genetics to manage human society–a scientific area that lead to the eugenics movement. A series of papers on pigmentation biology features a report on the study of skin cancer in fish by Leonard Zon and colleagues, and a paper by Keith Hultzman, Alexander Scott, and Stephen Johnson that explores the science behind regeneration and stem cell biology using pigment patterning as a major readout of organogenesis. Additional papers focus on natural variation of male ornamental traits of the guppy, the link between pigment and fish behavior, and pigment dilution mutants in fish models connected to lysosome-related organelles and vesicular traffic genes.

By: Mary Ann Liebert, Inc. – Thu, 01/15/2009 – 14:51

The studies were undertaken in hospitals in each of the six WHO regions. Analysis shows that the rate of major complications following surgery fell from 11% in the baseline period to 7% after introduction of the checklist, a reduction of one third. Inpatient deaths following major operations fell by more than 40% (from 1.5% to 0.8%).

“The concept of using a brief but comprehensive checklist is surprisingly new to us in surgery. Not everyone on the operating teams were happy to try it. But the results were unprecedented. And the teams became strong supporters,” said Dr Atul Gawande, main author of the study and team leader for the development of the WHO surgical safety checklist.

Data was collected from 7688 patients – 3733 before and 3955 after the checklist was introduced.

The study was carried out in hospitals in both high and lower income settings—in Ifakara (Tanzania), Manila (Philippines), New Delhi (India), Amman (Jordan), Seattle (United States of America), Toronto (Canada), London (United Kingdom) and Auckland (New Zealand). The reductions in complications proved to be of equal magnitude in high and lower income sites in the study.

Implications for other medical fields

“These findings have implications beyond surgery, suggesting that checklists could increase the safety and reliability of care in numerous medical fields,” Dr Gawande said. “The checklists must be short, extremely simple, and carefully tested in the real world. But in specialties ranging from cardiac care to paediatric care, they could become as essential in daily medicine as the stethoscope.”

The safe surgery checklist, which was launched by WHO as a recommended guideline for safe practice last year, has since gained global recognition by operating theatre staff, including surgeons and anaesthetists.

It requires only a few minutes to complete at three critical points during operative care – before anaesthesia is administered, before skin incision and before the patient leaves the operating room. It is intended to ensure the safe delivery of anaesthesia, appropriate prophylaxis against infection, effective teamwork by the operating room staff and other essential practices in perioperative care.

“The immediate response to the checklist has been remarkable, and the studies undertaken in the pilot hospitals are significant. They will make a major contribution towards our goal of having 2500 hospitals around the world using the safe surgery checklist by the end of this year,” said Sir Liam Donaldson, Chair of the WHO World Alliance for Patient Safety and Chief Medical Officer for England.

By: World Health Organization – Thu, 01/15/2009 – 16:02

The $9 starter pack of bupropion ER 150mg, the generic equivalent of Zyban, is now available at Walmart, Neighborhood Market and Sam’s Club pharmacies in a 17-tablet, 10-day supply. This announcement is part of the retailer’s January Healthy Living initiative, which aims to help Americans maintain their better eating, smoking cessation and exercise pledges in 2009.

“Times are tight right now, and Walmart is committed to helping our customers maintain their healthy lifestyles in both good economic times and bad,” said Dr. John Agwunobi, Walmart senior vice president and president, health and wellness. “With our affordable smoking cessation offerings, we’re hopeful that smokers who are committed to quitting will be able to get the tools they need to stop smoking and still be able to afford everyday household items so they can live better.”

According to the Centers for Disease Control and Prevention (CDC), nearly 43 million Americans currently smoke, with 70 percent of them saying they want to stop. However – given today’s current economic landscape – money previously set aside for smoking cessation products may now be re-allocated toward items American families need most. Smoking cessation medication for $9 at Walmart may help reverse this trend as the bupropion ER starter pack – initiated at the request of both health care professionals and customers – is low-priced and affordable for consumers who want to quit.

“The public health community has long recognized that the cost of either cigarettes or smoking cessation medications has served as a determining factor for smokers to continue smoking or finally to decide to quit,” said Cheryl G. Healton, Dr. P.H., President and CEO of the American Legacy Foundation. “This move by Walmart to provide science-based smoking cessation therapies that smokers can more easily afford is a huge step forward in helping millions of smokers finally quit for good. We applaud Walmart and hope other retailers will follow their example. It can only result in longer, healthier lives.”

According to the CDC, smoking cessation treatments, including counseling and medications, can double quitting success rates. In addition to the bupropion ER starter pack, Walmart also currently offers the following over-the-counter and prescription products for consumers and physicians to consider for continued success toward a smoke-free lifestyle:

* Nicorette Coated Gum 120-count bonus pack, assorted flavors ($39.84)

* NicoDerm Step 1 21-count bonus pack patches or Step 2 14-count patches ($39.84)

* Commit Lozenges 96-count bonus pack, assorted flavors ($34.84)

* Equate-Brand Nicotine Gum, Patches, and Lozenges

* 60-tablet, 30-day supply of bupropion ER 150mg ($27)

“Quitting smoking is tough, but we know that when smokers have the resources available to help, their rates of success are higher,” said Terry Music, chief mission officer, American Cancer Society. “In addition to accessing smoking cessation medications, smokers wanting to quit should make a quit plan to further increase their chance of success. By calling the American Cancer Society Quitline at 1-800-227-2345, smokers can talk with a trained counselor who can explain how best to use the cessation treatments and provide other tips and tools to help in a successful quit attempt.”

By: Wal-Mart Stores, Inc. – Thu, 01/15/2009 – 16:09