Join Thousands Of Canadians In The Second Annual Walk To Fight Arthritis

Main Category: Arthritis / Rheumatology
Article Date: 28 Apr 2011 – 2:00 PDT

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It’s time to get walking! On Sunday, May 15, thousands of people in 24 communities across Canada will come together for The Arthritis Society’s Walk To Fight Arthritis, presented by the makers of TYLENOL®. All proceeds will be invested in vital arthritis research and programs for people living with arthritis.

“Last year’s inaugural walk was an outstanding success — in fact, we had more than 3,000 people raise close to $1 million to fight arthritis,” says Steven McNair, President and CEO, The Arthritis Society. “This year’s Walk promises to be even more successful. Every little piece of support brings us closer to our ultimate goal of finding a cure.”

In addition to walking and raising funds through pledging, Canadians are encouraged to visit www.WalkToFightArthritis.ca to share their personal story of living with arthritis. For the first 2,000 approved stories shared, the makers of TYLENOL® will donate $10 per story, per person, towards helping find a cure.

“Arthritis affects both young and old — in fact, of the four million Canadians who live with arthritis, nearly three in five are under the age of 65,” says Pat Smallcombe, Managing Director, Johnson Johnson Inc. “That’s why we’re so proud to be involved in the cause to raise funds and help those struggling with this disease.”

A Chronic Concern Arthritis is the leading cause of pain and disability in North America1 and consists of more than 100 types.2 Most Canadians have been touched by the disease, whether they’re affected by arthritis themselves or are supporting a friend, family member or co-worker. The good news is that steps can be taken, including regular physical activity, such as walking, to manage and even reduce the pain and discomfort of this disease.3 Over-the-counter medications, like TYLENOL® Arthritis Pain, or prescription medications can also play a role in treatment. Anyone with arthritis should consult a healthcare provider about their treatment options.

Registration Is Now Open There are several events taking place across the country on Sunday, May 15, and all locations will offer both 1km and 5km Walk route options. Participants can choose the distance that’s right for them.

“Regardless of where they live, all Canadians can create their own Virtual Walk if their city or town is not listed,” said McNair. “Just gather a group of family, friends or co-workers, set your own route and register online for the virtual walk. It’s a great way to walk on your own schedule while still being eligible for the great incentive prizes.”

While there is no cost to register, participants are encouraged to raise a minimum of $100 in pledges. All participants who raise $100 or more will receive an official Walk to Fight Arthritis t-shirt on event day.

Source:

The Arthritis Society

McNeil Consumer Healthcare



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Seeking A Chikungunya Vaccine: Project To Develop New Method Of Testing Potential Vaccines

Main Category: Tropical Diseases
Also Included In: Immune System / Vaccines;  Arthritis / Rheumatology;  Bio-terrorism / Terrorism
Article Date: 28 Apr 2011 – 4:00 PDT

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It is spread to humans by mosquito bites, causing arthritic symptoms so severe that some victims can’t even walk. While rarely fatal, the effects of the chikungunya virus can last up to a year.

More than two million people have contracted the chikungunya virus in the past five years. Most of the infections have occurred in Southeast Asia, but infectious disease experts consider its spread to the United States likely because of global travel.

With no vaccine available for this debilitating virus, federal health and security officials have targeted it as a possible bioterrorism agent.

Groups around the world are working to develop a vaccine, including a regional team that involves Navin Varadarajan, a University of Houston engineering professor who is working on developing a new method of testing potential vaccines for the chikungunya virus.

Varadarajan, an assistant professor of chemical and biomolecular engineering at UH, received a two-year, $361,000 grant administered by the Western Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research and funded by the National Institutes of Health. He is partnering with researchers at the University of Texas Medical Branch at Galveston and Tulane University.

“What we are looking to study and characterize is a vaccine-induced immunity,” Varadarajan said. “If I have a tube of blood from a vaccinated subject, how do we determine the effectiveness of the vaccine?” Like many vaccines, the ones being developed by the UTMB-Tulane group attack chikungunya in several ways.

Varadarajan is testing the ability of potential vaccines to spur the immune system to attack human cells that essentially have been taken over by the virus and become reservoirs for it to multiply.

When this occurs, the immune system produces CD8 T-cells that kill the co-opted cells. However, each CD8 T-cell is programmed to fight one particular disease. Ideally, the vaccines being tested will spur the immune system to produce CD8 T-cells that recognize only chikungunya-infected human cells.

But isolating and studying CD8 T-cells can be extremely challenging through standard research techniques. The cells are only 10-20 microns across and less than a quarter the width of a human hair, while the blood samples from subjects injected with the vaccine are placed on much larger plates, which makes it difficult to identify CD8 T-cells that are specific to a certain virus.

Varadarajan is developing a specialized polymer slide called a microwell array. Roughly the size of a standard slide, it consists of about 85,000 individual chambers, each 50 microns by 50 microns, just the right size to isolate and study individual cells.

“If we shrink the container small enough so that its dimensions are similar to those of a single cell, we can achieve almost single-cell resolution. So within the same footprint, we can look at lots of cells,” Varadarajan said.

After a blood sample is placed on the microwell, not all the cells isolated in its chambers will be CD8 T-cells programmed to fight chikungunya. To see which ones do, Varadarajan will then introduce cells that have been covered with pieces of the chikungunya virus, spurring the CD8 T-cells that spark chikungunya into action.

Varadarajan will then use a microscope to take images of each chamber and a computer program will analyze these images and identify the CD8 T-cells that are fighting chikungunya. He will next remove those cells from their chambers and clone them by the million, allowing him to study every aspect of the CD8 T-cells that attack chikungunya.

Varadarajan will use that information to evaluate the effectiveness of potential vaccines for chikungunya and provide guidance on vaccine development to his partners.

“Finding a chikungunya vaccine is a priority given the virus’ potential to spread quickly and its possible use in bioterrorism,” said Varadarajan. “With this research, we can help the vaccine developers identify which potential vaccines are most effective and, hopefully, find a suitable one as quickly as possible.”

Source:
Laura Tolley
University of Houston



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Former Roxbury Pharmacist Pleads Guilty In Connection With Stealing Over $550,000 From Masshealth

Main Category: Litigation / Medical Malpractice
Also Included In: Medicare / Medicaid / SCHIP;  Pharmacy / Pharmacist
Article Date: 27 Apr 2011 – 8:00 PDT

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A former Roxbury pharmacist has pled guilty to defrauding the Massachusetts Medicaid Program (MassHealth) of over $555,000 by fraudulently billing for medications that were never prescribed by a doctor or dispensed from his Egleston Square Pharmacy, Attorney General Martha Coakley’s Office announced today.

Aloysius Chukwukere Nsonwu, age 65, of Roslindale, pled guilty in Suffolk Superior Court to the charges of Medicaid False Claims (25 counts), Larceny by False Pretenses (25 counts), and Conspiracy. On February 16, 2011, Nsonwu pled guilty in Federal Court to similar charges in another case. Nsonwu will be sentenced on his Suffolk Superior case after sentencing in his federal case, which is scheduled for June 17, 2011.

In 2007, the Attorney General’s Office began an investigation after the matter was referred by MassHealth’s Provider Compliance unit. Nsonwu was the owner and sole officer of Egleston Square Pharmacy, Inc., located in Roxbury and is an eligible MassHealth provider. Investigators discovered that from December 2004 through January 2009, Nsonwu submitted claims for dispensing the Human Immunodeficiency Virus (HIV) medications Epivir, Zerit, and Viramune to MassHealth using the identification numbers of 25 different MassHealth patients. Each claim listed a prescribing physician who never treated those patients or prescribed those medications. Based on these false claims, MassHealth reimbursements totaling $555,502.11 were deposited into Nsonwu’s Egleston Square Pharmacy bank account.

As a result of the AG’s investigation, the Massachusetts Board of Pharmacy suspended Nsonwu’s license to practice pharmacy in March.

On May 20, 2010, a Suffolk County Grand Jury returned indictments against Nsonwu. He was arraigned in Suffolk Superior Court on June 1, 2010, and released on $50,000 cash bail. Nsonwu pled guilty to all charges in his Suffolk Superior Court case on April 22, 2011. He is currently being held in Federal custody pending his sentencing on June 17, 2011.

This case was prosecuted by Assistant Attorney General Evelyn Y. Tang and was investigated by Investigator Brian Robinson, both of AG Coakley’s Medicaid Fraud Division, with assistance from Massachusetts State Police assigned to the AG’s Office. Ashley Cinelli was the Victim Witness Advocate. The Boston Office of the United States Department of Health and Human Services Office of Inspector General, the United States Attorney’s Office, the Massachusetts State Police, and the United States Marshals Service all assisted in the investigation.

Source:

Office of Massachusetts Attorney General Martha Coakley



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Blood Gas Analyzers for Medical Laboratories

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Rheumatoid Arthritis Patients Treated With Cimzia(R) (Certolizumab Pegol) report Positive Results

Main Category: Arthritis / Rheumatology
Article Date: 26 Apr 2011 – 9:00 PDT

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UCB today announced data which showed that Cimzia®, the only approved PEGylated anti-TNF for the treatment of moderate-to-severe rheumatoid arthritis (RA), plus methotrexate (MTX), versus placebo plus MTX provided a significant improvement in patient physical function, fatigue and pain. A clear association between clinically meaningful improvements in these outcomes and increased work productivity were observed both within and outside the home1.

The data (taken from two large multinational Phase III, multi-centre, double-blind, placebo-controlled studies [RAPID 1 and 2]) published in Rheumatology, showed that a clinically meaningful reduction in RA symptoms was associated with improved productivity at work outside and within the home, as achieved in patients treated with certolizumab pegol plus MTX. Five times as many patients treated with certolizumab pegol^ plus MTX versus placebo plus MTX reported clinically meaningful improvements in RA-associated pain, and two-to-three times as many patients recorded improvements in physical function and fatigue1.
“The pain, fatigue and functional impairment caused by rheumatoid arthritis significantly impact patients’ lives, it decreases their productivity as well as participation in family, social and leisure activities,” said Dr. Johanna M. Hazes, Erasmus MC, University Medical Center, The Netherlands, and lead author. “Importantly these data showed that reducing pain, fatigue and improving function was strongly associated with increased productivity at work, both within and outside the home.”

Patients treated with certolizumab pegol plus MTX reported a decrease in the number of full household work days missed, versus placebo plus MTX, by Week 12 which was associated with clinically meaningful relief of pain (mean decreases of -5.1 vs -2.1 days in non-responders) and fatigue (mean decreases of -4.9 vs -2.5 days), and clinically meaningful improvement in physical function (mean decreases of -5.1 vs. -2.4 days)1.

Improvements were seen in productivity at paid work, with reductions in presenteeism (days with productivity at paid work reduced by ≥50%) by Week 12 being associated with clinically meaningful relief of pain (mean decreases of -6.0 vs. -2.1 days) and fatigue (mean decreases of -6.0 vs -2.7 days), and clinically meaningful improvement in physical function (mean decreases of -6.4 vs -1.9 days). Similar associations were seen between reduced interference of RA with work within and outside home, household productivity and participation in family, social and leisure activities, and improvements in physical function, pain and fatigue1.

Reported serious adverse reactions included infections (including tuberculosis) and malignancies (including lymphoma). The most common adverse reactions belonged to the system organ classes Infections and Infestations, reported in 15.5% of patients on certolizumab pegol and 7.6% of patients on placebo, and General disorders and administration site conditions, reported in 10.0% of patients on certolizumab pegol and 9.7% of patients on placebo. A pooled analysis of the safety data showed there was a low incidence of injection site pain (1.5%) and a low level of discontinuations due to adverse events (5%). Certolizumab pegol demonstrated a favorable risk-benefit profile in patients with at least up to two years of drug exposure.


It is estimated that, in the seven major markets, 5 million people suffer from rheumatoid arthritis2. Prevalence is not split evenly between genders, since women are three times more likely to be affected than men3. Although RA can affect people of all ages, the onset of the disease usually occurs between 30-60 years of age3. RA symptoms often lead to restricted mobility, and permanently damage and disfigure the joints and bones4. Limitations in physical function, mobility and increased levels of pain and fatigue in patients with RA affect their ability to perform work and household activities, and impair their ability to engage in family, social and leisure activities4.

This analysis evaluated data from two large multinational Phase III, multi-centre, double-blind, placebo-controlled studies (RAPID 1 and 2) comparing the efficacy and safety of certolizumab pegol plus MTX versus placebo plus MTX. These findings demonstrated that RA patients treated with certolizumab pegol^ plus MTX^ who experienced clinically meaningful improvements in physical function, fatigue and pain also reported increased productivity within and outside the home, and less interference of RA with their work, household activities and participation in family, social and leisure activities.

Note
About CIMZIA®

Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia^® for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderately to severely active rheumatoid arthritis. Cimzia^® in combination with MTX, is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying
antirheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia^® is a registered trademark of UCB PHARMA S.A.

About RAPID 1

RAPID 1 is a Phase III double-blind placebo-controlled trial, involving 982 adults, that was designed to establish the efficacy and tolerability of certolizumab pegol together with MTX, in the treatment of active RA in patients who did not adequately respond to conventional treatment. Patients were randomly allocated to receive one of three treatment regimens: 393 patients received certolizumab pegol 400 mg and at Weeks 0, 2 and 4, then 200 mg every two weeks; 390 patients received certolizumab pegol 400 mg every 2 weeks; 199 patients received placebo every 2 weeks. RAPID 1 met co-primary endpoints: ACR20 response rate at Week 24 and change from baseline in modified Total Sharp Score (mTSS) at Week 52. Significantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response versus placebo (p≤ 0.001); rates at Week 24 were 58.8%, 60.8%, and 13.6%, respectively, and remained significant at Week 52 (p≤ 0.001). Certolizumab pegol 200 mg and 400 mg
also significantly inhibited radiographic progression; mean changes from baseline in mTSS at Week 52 were 0.4 and 0.2, respectively, versus 2.8 for placebo (rank analysis p≤ 0.001). Certolizumab pegol treated patients reported rapid, significant and clinically meaningful improvements in physical function versus placebo (p≤ 0.001).

About RAPID 2

This Phase III double-blind placebo-controlled trial, involving 619 patients with active adult-onset RA was designed to evaluate the efficacy and tolerability of subcutaneous (SC) liquid certolizumab pegol (200 and 400 mg) together with MTX every 2 weeks compared to placebo together with MTX in patients with active RA despite ≥ 6 months treatment with MTX. Patients were randomly allocated to receive one of three treatment regimens: 246 patients received certolizumab pegol (liquid formulation) 400 mg and at Weeks 0, 2 and 4, then 200 mg every two weeks; 246 patients received certolizumab pegol (liquid formulation) 400 mg every 2 weeks; 127 patients received placebo every 2 weeks. RAPID 2 met its primary endpoint ACR20 response rate at Week 24, and secondary endpoints: change from baseline in mTSS, ACR 50 and ACR 70 responses at Week 24. Significantly more patients in the certolizumab pegol 200 and 400 mg groups achieved an ACR20 response versus placebo (p≤ 0.001); rates were
57.3%, 57.6%, and 8.7%, respectively. Certolizumab pegol 200 and 400 mg also significantly inhibited radiographic progression; mean changes from baseline in mTSS at Week 24 were 0.2 and -0.4, respectively, versus 1.2 for placebo (rank analysis p≤ 0.01). Certolizumab pegol treated patients reported rapid and significant improvements in physical function versus placebo (p≤ 0.001).

Cimzia® (certolizumab pegol) in European Union/ EEA important safety information
Cimzia® was studied in 2367 patients with RA in controlled and open label trials for up to 57 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia^® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritis (any sites), hepatitis (including hepatic enzyme increase), injection site reactions. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic edema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes
cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 5% of patients discontinued taking Cimzia® due to adverse events vs. 2.5% for placebo.

Cimzia® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections, moderate to severe heart failure.

Before initiation of Cimzia®, evaluate patients for both active or inactive (latent) tuberculosis infection. Monitor patients for the development of signs and symptoms of infection during and after treatment with Cimzia^®. If an infection develops, monitor carefully, and stop Cimzia^® if infection becomes serious.

TNF blockers including Cimzia® may increase the risk: of reactivation of Hepatitis B Virus (HBV) in patients who are chronic carriers of the virus; of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia^® should be discontinued and appropriate therapy instituted.

With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia®.

Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia^®. Consider discontinuation of Cimzia® therapy in patients with confirmed significant haematological abnormalities.

The use of Cimzia® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia® should not be administered concurrently with live vaccines or attenuated vaccines. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia^® should be closely monitored for infections.

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision February 2011.

References

1. Hazes, M. et al. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology 2010;49:1900-1910.

2. Rheumatoid Arthritis, Biologics battle up the treatment algorithm. Data Monitor, 7 September 2006.

3. Arthritis Foundation. Rheumatoid Arthritis: Who Gets RA?

4. NRAS. What Is RA?

Source:

UCB



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Gender Differences In Immune Responses To PTSD

Main Category: Anxiety / Stress
Also Included In: Immune System / Vaccines;  Heart Disease;  Arthritis / Rheumatology
Article Date: 27 Apr 2011 – 1:00 PDT

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Men and women had starkly different immune system responses to chronic post-traumatic stress disorder, with men showing no response and women showing a strong response, in two studies by researchers at the San Francisco VA Medical Center and the University of California, San Francisco.

While a robust immune response protects the body from foreign invaders, such as bacteria and viruses, an over-activated response causes inflammation, which can lead to such conditions as cardiovascular disease and arthritis.

In a study published in the March, 2011 issue of Brain, Behavior, and Immunity, the authors took blood samples from 49 men (24 with PTSD and 25 controls) and 18 women (10 with PTSD and 8 controls). They then used gene microarray technology to determine which genes were activated in the subjects’ monocytes, which are immune cells that regularly cross the barrier between the bloodstream and the brain, and thus give a broad picture of immune reaction in both the body and brain.

“We were looking for evidence of inflammation caused by immune activation,” explained lead author Thomas Neylan, MD, director of the PTSD program at SFVAMC and a professor in residence of psychiatry at UCSF. “We know that people with PTSD have higher rates of cardiovascular disease and arthritis, which are diseases associated chronic inflammation. We also hoped that seeing which genes were expressed in PTSD might show us potential therapeutic approaches that we hadn’t thought of.”

The researchers found no evidence of increased immune activation among the men with PTSD compared to those without PTSD. In contrast, the women with PTSD showed significant evidence of immune activation compared to women without PTSD.

“Previous gene microarray studies on PTSD grouped men and women together, which gave inconclusive results,” said senior investigator Lynn Pulliam, MS, PhD, chief of microbiology at SFVAMC and professor of laboratory medicine and medicine at UCSF. “This is the first time that it’s been shown that men and women respond differently to PTSD on a very basic biological level.”

Neylan characterized the finding as “unexpected.”

The researchers do not know why there seems to be such a marked difference between men and women, said Neylan. However, in a study published in the January, 2011 issue (posted in April, 2011) of the journal Disease Markers, they analyzed data collected from the same subjects to explore one possible explanation: gender differences in cell signaling pathways.

“We know that gene expression patterns are determined by hormones and proteins that are circulating in the body, and we know that some of those hormones and proteins are produced in response to signals from the brain or central nervous system,” explained lead author Aoife O’Donovan, PhD, a researcher in psychiatry at SFVAMC and UCSF. “These signaling pathways are used by the brain and central nervous system to communicate with the immune system and tell immune cells what to do.”

The researchers used sophisticated bioinformatics software to look at three different signaling pathways associated with inflammation: NF-kappa B, glucocorticoid receptor (GR), and CREB/ATF.

In the NF-kappa B and GR pathways in both men and women with PTSD, they found evidence of signaling that could promote inflammation.

In the CREB/ATF pathway, however, they found what O’Donovan called “totally contrasting” effects: men with PTSD had increased signaling, which in turn could possibly lead to less inflammation, while women with PTSD had decreased signaling, which could lead to more inflammation.

“This particular pathway might be a clue to the gender difference in monocyte gene expression in PTSD,” said Pulliam.

“It’s still very early,” cautioned O’Donovan, “but these bioinformatics results are telling us something about how PTSD could increase the risk for autoimmune disorders like arthritis as well as cardiovascular disease, cancer, and other diseases of aging. They also point us in the direction of some potential treatment targets, telling us where future investigative energy might be well spent.”

Neylan emphasized that because of the small sample size, particularly among the women, the results of the two studies are suggestive rather than conclusive. “The next step is to look at larger groups of men and women, and we are working on that,” he said.

Notes:

Co-authors of the Brain, Behavior, and Immunity study are Bing Sun, MD, PhD, and Hans Rempel, PhD, of SFVAMC; Jessica Ross, MD, MS, of SFVAMC and UCSF; and Maryann Lenoci, MA, of SFVAMC.

Co-authors of the Disease Markers study are Bing Sun, MD, PhD; Steve Cole, PhD, of UCLA; Hans Rempel, PhD; and Maryann Lenoci, MA.

Both studies were supported by grants from the Department of Defense and the Department of Veterans Affairs Sierra Pacific Mental Illness Research Education Clinical Center. Some of the funds were administered by the Northern California Institute for Research and Education.

Source:
Steve Tokar

University of California – San Francisco



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Medicaid Block Grants Mean Low-Income Older Adults Could Lose Benefits

Main Category: Medicare / Medicaid / SCHIP
Article Date: 27 Apr 2011 – 4:00 PDT

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Based on of its long experience ensuring that states do not limit eligibility
and benefits, the National Senior Citizens Law Center says that the result of block
granting Medicaid would mean taking health care coverage away from millions of low-income
older adults and people with disabilities.

“Our experience has shown that states, if given free rein, intend to serve fewer
people by restricting access and benefits,” said NSCLC Executive Director Paul
Nathanson. “We have fought for years to ensure that states do not ignore Medicaid
law.”

In a Policy Issue Brief entitled “Medicaid Block Grants: Attacking the Safety Net
for Low-Income Older Adults,”
NSCLC shows that the courts were needed to stop state attempts to cut costs through
changing eligibility or benefits mandated by federal Medicaid law. To prove the
point, NSCLC cites several cases that show how states, even when subject to legal
constraints, have sought to circumvent Medicaid law. In these case examples, the
states have:

– Denied eligibility to grandparents raising grandchildren

– Prevented people from filing applications or pressured them to withdraw their
applications

– Created waiting lists seven years long to access home and community based benefits

– Sought to take away coverage from people residing in nursing homes by changing
the medical need standard

– Set reimbursement rates for prescription drugs below costs so that people could
not get their medications

– Tried to be exempted from implementing the nursing home reform law

– Sought to cut adult day care services for people who are eligible for Medicare
and Medicaid

– Ignored spousal impoverishment rules and denied services to a disabled, low-income
spouse of a nursing home resident

– Offered beneficiaries a wheelchair, but would not pay for the battery needed to
operate it

“Proposals to block grant Medicaid, which is a shared federal/state program in which
the federal government currently sets the rules and shares costs with the states,
should set off alarm bells for low-income, older adults, their families and advocates,”
the report states. “There is clear evidence that, given the opportunity, states
will not provide an adequate safety net.”

Medicaid is not only a program for low-income older adults. It provides coverage
for nearly 9 million people over age 65, including middle class individuals who
have impoverished themselves with long-term care benefits. It also covers 8 million
people with disabilities under age 65 as well as 29.5 million children and 15 million
low-income adults. Close to half of all Medicaid beneficiaries are members of ethnic
or racial minorities.

The National Senior Citizens Law Center is a non-profit organization whose principal
mission is to protect the rights of low-income older adults. Through advocacy, litigation,
and the education and counseling of local advocates, we seek to ensure the health
and economic security of those with limited income and resources, and access to
the courts for all.

Source:

National Senior Citizens Law Center



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AAMC Statement On 2012 Hospital Inpatient PPS Proposed Rule

Main Category: Medicare / Medicaid / SCHIP
Article Date: 26 Apr 2011 – 1:00 PDT

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AAMC (Association of American Medical Colleges) President and CEO Darrell G. Kirch, M.D., issued the following statement on the Centers for Medicare and Medicaid Services (CMS) 2012 Inpatient Prospective Payment System (IPPS) Proposed Rule:

“The AAMC is deeply concerned that the proposed cuts to Medicare hospital payments will threaten vital services that seniors depend on at America’s teaching hospitals. These reductions could potentially destabilize these institutions at a time when they are working hard to reduce costs and improve the quality of patient care through such efforts as the recently launched “Best Practices for Better Care” initiative, the development of Healthcare Innovation Zones, and others.

“The more than 3 percent documentation and coding offset adjustment is especially troubling because it does not account for the growing number of older and more complex patients being treated at teaching, and all, hospitals.

“The recommended Medicare cuts come at a time when teaching hospitals already are facing serious payment reductions from Medicaid and state budgets. We strongly urge CMS to reevaluate the documentation and coding adjustment to ensure that America’s teaching hospitals can continue to provide critical health care services for seniors.”

Source:

Association of American Medical Colleges (AAMC)



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CMS Proposes Payment, Policy Changes For Inpatient Rehabilitation Facilities

Main Category: Medicare / Medicaid / SCHIP
Article Date: 26 Apr 2011 – 3:00 PDT

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The Centers for Medicare Medicaid Services (CMS) today issued a proposed rule that would update Medicare payment policies and rates for inpatient rehabilitation facilities (IRFs) in Fiscal Year (FY) 2012. The rule proposes to increase payment rates under the IRF Prospective Payment System (PPS) by a projected 1.8 percent -an estimated $120 million nationwide. The projected update reflects a rebased and revised market basket specific to IRFs, inpatient psychiatric facilities, and long-term care hospitals (the RPL market basket) – currently estimated at 2.8 percent for FY 2012 – less a 1.3 percentage point reduction mandated by the Affordable Care Act, plus 0.3 percentage points due to a proposed adjustment to the outlier threshold.

The proposed rule, which would apply to more than 1,200 Medicare-participating IRFs, including approximately 200 freestanding IRFs and approximately 1,000 IRF units in acute care hospitals and critical access hospitals, seeks to establish a new quality reporting system authorized by the Affordable Care Act.

“The proposed rule would extend Medicare’s ongoing efforts to use its payments to encourage better care for beneficiaries who are treated in inpatient rehabilitation facilities,” said CMS Administrator Donald Berwick, M.D. “The measures IRFs would report under the proposed rule will pave the way for Medicare to work with IRFs to improve patient safety, prevent patients from picking up new illnesses during a hospitalization, and provide well-coordinated person-and-family-centered care.”

The proposed quality reporting system is aligned with the goals of the Partnership for Patients, a new public-private partnership that will help improve the quality, safety, and affordability of health care for all Americans. Initially, IRFs would submit data on two quality measures, “urinary catheter-associated urinary tract infection” and “pressure ulcers that are new or have worsened.” These proposed measures represent two of the nine conditions the Partnership has identified as important places to begin in efforts to reduce harms to patients. A third measure that is currently under development is also discussed as a potential measure for future rulemaking cycles. It would address readmissions within 30 days to another inpatient stay, whether in an acute care hospital, rehabilitation facility, or other setting.

IRFs that do not submit quality data would see their payments reduced by two percentage points beginning in FY 2014. CMS anticipates adding measures for reporting in the future through rulemaking. CMS also plans to establish a process for making the measures data available to the public. As with other data published on the CMS website, IRFs choosing to report quality data would have an opportunity to review the data for accuracy before it became public.


Other provisions in the proposed rule include proposals to:

– Update the case-mix group (CMG) relative weights using FY 2010 IRF claims and FY 2009 IRF cost report data, and to set the high cost outlier threshold at $11,822 for FY 2012, compared with $11,410 for FY 2011. The proposed threshold is projected to maintain outlier payments at three percent of total payments under the IRF PPS in FY 2012.

– Continue using the pre-reclassified and pre-floor hospital wage data to determine the proposed FY 2012 rates. For this proposed rule, CMS used the final FY 2011 hospital inpatient prospective payment system (IPPS) pre-reclassified and pre-floor wage data. CMS is also proposing to update the rural, low-income patient (LIP), and teaching status adjustment factors using the most recent three years of data (FYs 2008 through 2010).

– Allow IRFs to receive temporary adjustments to their full-time equivalent (FTE) intern and resident caps if they take on interns and residents who are unable to complete their training because the IRF that had been training them either closed or ended its resident training program.

“IRFs need to be at the forefront of the quality movement because they play such a critical role in patient care,” said Dr. Berwick. “They’re called on to meet the needs of some of our most vulnerable patients, and they’re responsible for making sure each one of them meets their rehabilitation goals and makes real progress towards improved functional independence.”

CMS will accept comments on the proposed rule until June 21, 2011, and will address all comments in a final rule to be issued by Aug. 1, 2011.

The proposed rule went on display today at the Federal Register’s Public Inspection Desk and will be available under “Special Filings,” until publication date of April 29, 2011 here.

Source:

Centers for Medicare Medicaid Services



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New Hope For MS Lies In Blocking Key Inflammation Molecule

Featured Article
Academic Journal
Main Category: Multiple Sclerosis
Also Included In: Arthritis / Rheumatology;  Neurology / Neuroscience;  Immune System / Vaccines
Article Date: 25 Apr 2011 – 2:00 PDT

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Blocking a key inflammation molecule in the immune system’s T helper cells could be a first step to developing new
treatments to eradicate multiple sclerosis (MS) and other autoimmune diseases, said researchers who wrote about their discovery
in Nature Immunology this week.

An inflammatory cytokine in T helper cells called granulocyte-macrophage colony-stimulating factor, or GM-CSF for short,
appears to be a driving force behind autoimmune diseases, said study leader Dr Abdolmohamad Rostami, professor and chairman
of the Department of Neurology at Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA,
and colleagues.

The immune system comprises an array of cells, processes and molecules that detect and respond to foreign agents, pathogens
and injury to prevent harm and restore health, but in autoimmune diseases these attack healthy tissue instead.

For their study, Rostami and colleagues focused on a group of immune cells called T helper 17 cells (Th17), which normally
protect cells against invasion by pathogens, but are also known to be involved in autoimmune diseases in humans and animal
models, although the mechanisms involved are somewhat of a mystery.

In their study, the team showed that GM-CSF could be a key culprit in the onset of MS, because without it, Th17
cells did not induce MS-like disease in an experimental animal model.

Rostami told the press that their study is the first to show a link between GM-CSF and Th17 cells:

“What we have shown in this paper is that GM-CSF derived from Th17 cells is important in the cell-signaling process that leads
to inflammation in the central nervous system,” he explained.

Blocking this cell-signaling molecule could be a first step to developing new treatments to eradicate MS and other autoimmune
diseases, said Rostami, who is also the Chair of Neurology at Thomas Jefferson University Hospital.

The team discovered that a pathway described as the Interleukin-23 (IL-23)/ Th17/GM-CSF axis is
the main route to development of inflammation in the central nervous system in autoimmune diseases like MS.

IL-23 is a cytokine, a signalling molecule, that is already known to cause autoimmune inflammation in the brain (it is
encephalitogenic), and the researchers found that when exposed to it, Th17 cells produce more GM-CSF.

They bred mice with autoimmune encephalomyelitis (EAE), a common animal model used in
to study the biology of MS.

They found that mice whose Th17 cells could not produce GM-CSF did not go on to develop neuroinflammation, showing GM-
CSF to be the cause of the disease in the animal model.

They also found a feedback loop whereby secretion of GM-CSF by Th17 “stimulated the production of IL-23 by antigen-presenting cells”.

“Such cross-regulation of IL-23 and GM-CSF explains the similar pattern of resistance to autoimmunity when either of the two
cytokines is absent and identifies TH17 cells as a crucial source of GM-CSF in autoimmune inflammation,” they wrote.

In a paper published in an earlier issue of the journal, Rostami and his team described how they discovered another related
mechanism in MS where another cytokine, Interleukin-27 (IL-27), helped block, but did not induce, the onset of symptoms in
animals with an MS-like disease.

Bringing the results of the two papers together, the researchers suggested that while increasing levels of GM-CSF may cause MS,
increasing IL-27 may help quell an overactive immune system.

Rostami said of the earlier paper:

“That was the first time that we had direct evidence that by actively giving IL-27 like a drug, we can suppress EAE in
mice.”

Rostami said if what their recent paper suggests about GM-CSF’s role can be found in human blood samples, it may be possible to
start looking for a new treatment for MS:

“If we can try to neutralize GM-CSF by different means, for example, by trying to mimic it or trying to block the receptor for
GM-CSF, we can hopefully ameliorate the disease,” said Rostami.

“The encephalitogenicity of TH17 cells is dependent on IL-1- and IL-23-induced production of the cytokine GM-
CSF.”

Mohamed El-Behi, Bogoljub Ciric, Hong Dai, Yaping Yan, Melissa Cullimore, Farinaz Safavi, Guang-Xian Zhang, Bonnie N
Dittel, Abdolmohamad Rostami
Nature
Immunology
Published online 24 April 2011
.
DOI:10.1038/ni.2031

Additional sources: Thomas Jefferson University, eBioscience.

Written by: Catharine Paddock, PhD

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today



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