Kashi Company Voluntarily Recalls One Variety of Kashi® Granola Bars and One Variety of Bear Naked® Granola Due to Potential Health Risk Related to Sunflower Seeds - FDA Safety Alerts & Drug Recalls

Kashi Company today announced a voluntary recall of Kashi® Trail Mix Chewy Granola Bars and Bear Naked® Soft Baked Granola, Cinnamon + Sunflower Butter in the continental United States because they contain ingredients made from sunflower seeds distributed by our supplier, SunOpta, that have the potential to be contaminated with Listeria monocytogenes.

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Expanded Voluntary Recall on Certain Backroad Country Brand Sunflower Kernel Products - FDA Safety Alerts & Drug Recalls

Troyer® Cheese Inc, under advice from its packaging facility concerning, CRANBERRY NUT DELIGHT MIX PREPACK, HONEY ISLAND CRUNCH MIX PREPACKAGED, PRETZELS PEANUT BUTTER PREPACKAGED, WALNUT HALVES/PIECES PREPACKAGED, SUNFLOWER SEEDS R&S PREPACKAGED AND SUNFLOWER SEEDS R&S BULK is recalling a limited number of products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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Gold Medal, Gold Medal Wondra, and Signature Kitchens Flour Recalled Due to Possible E. coli O121 Contamination - FDA Safety Alerts & Drug Recalls

General Mills is collaborating with health officials to investigate an ongoing, multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour (sold in Safeway, Albertsons, Jewel, Shaws, Vons, United, Randalls, and Acme). Out of an abundance of caution, a voluntary recall is being made.

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Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome in Older Adults - Geriatrics

Improved survival with combination antiretroviral therapy has led to a dramatic increase in the number of human immunodeficiency virus (HIV)–infected individuals 50 years of age or older such that by 2020 more than 50% of HIV-infected persons in the United States will be above this age. Recent studies confirm that antiretroviral therapy should be offered to all HIV-infected patients regardless of age, symptoms, CD4+ cell count, or HIV viral load. However, when compared with HIV-uninfected populations, even with suppression of measurable HIV replication, older individuals are at greater risk for cardiovascular disease, malignancies, liver disease, and other comorbidities.

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FDA approves Ocaliva for rare, chronic liver disease - FDA Press Releases

Today the U.S. Food and Drug Administration granted accelerated approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.

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Projected Savings and Workforce Transformation from Converting Independence at Home to a Medicare Benefit - American Geriatric Society

The Independence at Home (IAH) Demonstration Year 1 results have confirmed earlier studies that showed the ability of home-based primary care (HBPC) to improve care and lower costs for Medicare's frailest beneficiaries. The first-year report showed IAH savings of 7.7% for all programs and 17% for the nine of 17 programs that surpassed the 5% mandatory savings threshold. Using these results as applied to the Medicare 5% claims file, the effect of expanding HBPC to the 2.2 million Medicare beneficiaries who are similar to IAH demonstration participants was projected. Total savings ranged from $12 billion to $53 billion depending on the speed and extent of dissemination of HBPC among this IAH-like population. Using a fixed growth rate, as hospitalists experienced in their first decade, 35% coverage would be achieved at the end of 10 years, with total 10-year savings through IAH reaching $37.5 billion and $17.3 billion accruing to the Centers for Medicare and Medicaid Services as a net reduction in overall expenditures, with $12.6 billion from Medicare Parts A and B savings.

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A Bipartisan Approach to Better Care and Smarter Spending for Elderly Adults with Advanced Chronic Illness - American Geriatric Society

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Whole Foods Market store in California issues consumer advisory on kimchi products due to undeclared food allergens - FDA Safety Alerts & Drug Recalls

Whole Foods Market is issuing an advisory to customers who purchased Spicy Kimchi, White Kimchi, Kimchi Fried Rice and Kimchi Guacamole from one of its Los Angeles-area stores because the items contained fish, shellfish or tree nuts (pine nuts) that were not listed on product labels. All potentially affected products have been removed from store shelves, and the company is recalling the items out of an abundance of caution. People who have an allergy or severe sensitivity to tree nuts, fish or shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.

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Sweet Earth Natural Foods Issues Voluntary Recall of Mispackaged Big Sur Burritos That Contain the Santa Cruz Burrito: Potential Allergy Concern for Those with Milk Allergy - FDA Safety Alerts & Drug Recalls

Sweet Earth Natural Foods is voluntarily recalling its Big Sur Burrito, 7 oz, due to a packaging error. As a result, a small number of these products contain an undeclared milk allergen.

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Sid Wainer and Son Recalls Domaine de Provence La Cucina Tart Shells and Domaine de Provence Neutral 3" Cone Tart Shells Due to Undeclared Allergens - FDA Safety Alerts & Drug Recalls

Sid Wainer & Son of New Bedford, MA is voluntarily recalling Domaine de Provence La Cucina Tart Shells and Domaine de Provence Neutral 3� Cone Tart Shells due to undeclared allergens. People who have an allergy or severe sensitivity to Tree Nuts, specifically Coconut and Eggs run the risk of a serious or life-threatening allergic reaction if they consume these products.

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FDA approves Zinbryta to treat multiple sclerosis - FDA Press Releases

The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.

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Medicare’s “Big Data” Tools Fight & Prevent Fraud to Yield Over $1.5 Billion in Savings - CMS Blog

By Dr. Shantanu Agrawal, Raymond Wedgeworth and Kelly D. Bowman

A version of this commentary was published in May 24 editions of Modern Healthcare. New anecdotal content has been added. Please see the following link to view the original content – http://ift.tt/1sCrdv6

Over the past five years, the CMS has successfully implemented a Fraud Prevention System using “big data” and predictive analytics approaches to fight fraud, waste and abuse in the Medicare fee-for-service program. Taking “big data” mainstream has given the CMS the ability to better connect with public and private predictive analytics experts and data scientists, as well as collaborate more closely with law enforcement. The Fraud Prevention System’s “big data” effort has had a profound impact on fraudulent providers and illegitimate payments by allowing us to quickly identify issues and take action. For example, the FPS identified a home health agency in Florida that billed for services that were never rendered. Due to the FPS, CMS placed the home health agency on prepayment review and payment suspension, referred the agency to law enforcement, and ultimately revoked the agency’s Medicare enrollment. In Texas, FPS identified an ambulance company submitting claims for non-covered services and services that were not rendered. Medicare revoked the ambulance company’s enrollment. Likewise, FPS identified that an Arizona, medical clinic had questionable billing practices, such as billing excessive units of services per beneficiary per visit. Upon review of medical records, it was discovered that physicians had been delivering repeated and unnecessary neuropathy treatments to beneficiaries. The medical clinic was revoked in 2015 from Medicare enrollment.

Through cases like these, the CMS is seeing impressive results nationwide. This predictive analytics technology contributed to more than $1 billion in savings in 2014 and 2015. The Fraud Prevention System, or FPS, is innovative in that we have moved beyond the reactive “pay and chase” approach toward a more effective, proactive strategy that aims to prevent these illegitimate payments in the first place. Since its June 2011 inception, the FPS has identified significant savings by running sophisticated analytics on 4.5 million Medicare claims on a daily basis, prior to payment. Year after year, the FPS has continued to improve its ability to identify or prevent fraud. Since the beginning of the program, over $1.5 billion in inappropriate payments has been identified by the system through new leads or contributions to existing investigations. Also, in 2015, the CMS marked its first-ever national return-on-investment of $11.60 for every dollar the federal government spends on this program integrity system. As we moved toward preventing inappropriate payments, we also successfully developed ways to measure costs avoided due to removing certain providers from the Medicare program and tracking return on investment. These methodologies to calculate cost avoidance have achieved certification by HHS’ Office of Inspector General, the first such certification in the history of federal healthcare programs. The CMS is now working to develop next-generation predictive analytics with a new system design that even further improves the usability and efficiency of the FPS. Using it and other advanced tools, we are committed to addressing fraud, waste and abuse in the Medicare program to better protect beneficiaries and taxpayers.

Filed under: Uncategorized

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FDA approves new diagnostic imaging agent to detect recurrent prostate cancer - FDA Press Releases

The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.

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Application of bacterial cytological profiling to crude natural product extracts reveals the antibacterial arsenal of Bacillus subtilis - Journal of Antibiotics

Application of bacterial cytological profiling to crude natural product extracts reveals the antibacterial arsenal of Bacillus subtilis

The Journal of Antibiotics 69, 353 (May 2016). doi:10.1038/ja.2015.116

Authors: Poochit Nonejuie, Rachelle M Trial, Gerald L Newton, Anne Lamsa, Varahenage Ranmali Perera, Julieta Aguilar, Wei-Ting Liu, Pieter C Dorrestein, Joe Pogliano & Kit Pogliano

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Improvement of the productivity of ecumicin, a novel anti-tuberculosis agent, from new Nonomuraea sp. MJM5123 - Journal of Antibiotics

Improvement of the productivity of ecumicin, a novel anti-tuberculosis agent, from new Nonomuraea sp. MJM5123

The Journal of Antibiotics 69, 362 (May 2016). doi:10.1038/ja.2015.122

Authors: Ying-Yu Jin, Jin-Yong Kim, Seung Hwan Yang, Hanki Lee & Joo-Won Suh

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Synthesis and structure–activity relationships of novel lincomycin derivatives. Part 1. Newly generated antibacterial activities against Gram-positive bacteria with erm gene by C-7 modification - Journal of Antibiotics

Synthesis and structure–activity relationships of novel lincomycin derivatives. Part 1. Newly generated antibacterial activities against Gram-positive bacteria with erm gene by C-7 modification

The Journal of Antibiotics 69, 368 (May 2016). doi:10.1038/ja.2015.119

Authors: Yoshinari Wakiyama, Ko Kumura, Eijiro Umemura, Kazutaka Ueda, Satomi Masaki, Megumi Kumura, Hideki Fushimi & Keiichi Ajito

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In vitro activity of dalbavancin and five comparator agents against common and uncommon Gram-positive organisms isolated from cancer patients - Journal of Antibiotics

In vitro activity of dalbavancin and five comparator agents against common and uncommon Gram-positive organisms isolated from cancer patients

The Journal of Antibiotics 69, 381 (May 2016). doi:10.1038/ja.2015.120

Authors: Kenneth V I Rolston, Weiqun Wang, Lior Nesher, Samuel A Shelburne & Randall A Prince

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PM100117 and PM100118, new antitumor macrolides produced by a marine Streptomyces caniferus GUA-06-05-006A - Journal of Antibiotics

PM100117 and PM100118, new antitumor macrolides produced by a marine Streptomyces caniferus GUA-06-05-006A

The Journal of Antibiotics 69, 388 (May 2016). doi:10.1038/ja.2015.121

Authors: Marta Pérez, Carmen Schleissner, Rogelio Fernández, Pilar Rodríguez, Fernando Reyes, Paz Zuñiga, Fernando de la Calle & Carmen Cuevas

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Maniwamycins: new quorum-sensing inhibitors against Chromobacterium violaceum CV026 were isolated from Streptomyces sp. TOHO-M025 - Journal of Antibiotics

Maniwamycins: new quorum-sensing inhibitors against Chromobacterium violaceum CV026 were isolated from Streptomyces sp. TOHO-M025

The Journal of Antibiotics 69, 395 (May 2016). doi:10.1038/ja.2015.126

Authors: Atsushi Fukumoto, Chikana Murakami, Yojiro Anzai & Fumio Kato

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New p-terphenyls from the fruiting bodies of Pseudomerulius curtisii and their antioxidant activity - Journal of Antibiotics

New p-terphenyls from the fruiting bodies of Pseudomerulius curtisii and their antioxidant activity

The Journal of Antibiotics 69, 400 (May 2016). doi:10.1038/ja.2015.117

Authors: Byung Soon Hwang, In-Kyoung Lee & Bong-Sik Yun

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Biosynthetic origin of anthracimycin: a tricyclic macrolide from Streptomyces sp. - Journal of Antibiotics

Biosynthetic origin of anthracimycin: a tricyclic macrolide from Streptomyces sp.

The Journal of Antibiotics 69, 403 (May 2016). doi:10.1038/ja.2015.118

Authors: Enjuro Harunari, Hisayuki Komaki & Yasuhiro Igarashi

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Improved antibiotic production and silent gene activation in Streptomyces diastatochromogenes by ribosome engineering - Journal of Antibiotics

Improved antibiotic production and silent gene activation in Streptomyces diastatochromogenes by ribosome engineering

The Journal of Antibiotics 69, 406 (May 2016). doi:10.1038/ja.2015.123

Authors: Xuping Shentu, Nannan Liu, Gu Tang, Yukinori Tanaka, Kozo Ochi, Jianfeng Xu & Xiaoping Yu

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FDA approves first buprenorphine implant for treatment of opioid dependence - FDA Press Releases

The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

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Voluntary Recall On Certain Backroad Country Brand Sunflower Kernel Products - FDA Safety Alerts & Drug Recalls

Millersburg, OH - Troyer Cheese Inc, under advice from its packaging facility concerning, CRANBERRY NUT DELIGHT MIX PREPACK, HONEY ISLAND CRUNCH MIX PREPACKAGED, PRETZELS PEANUT BUTTER PREPACKAGED, and WALNUT HALVES/PIECES PREPACKAGED, is recalling a limited number of products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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FDA issues final food defense regulation - FDA Press Releases

The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

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Cover - American Geriatric Society

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Issue Information-About the AGS - American Geriatric Society

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Issue Information-Masthead - American Geriatric Society

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Issue Information-Officers of the AGS - American Geriatric Society

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Issue Information-TOC - American Geriatric Society

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Hospitalizations During a Physical Activity Intervention in Older Adults at Risk of Mobility Disability: Analyses from the Lifestyle Interventions and Independence for Elders Randomized Clinical Trial - American Geriatric Society

Objectives

To determine whether moderate-intensity physical activity (PA) and health education (HE) are differentially associated with categories of hospitalizations or subgroups of participants.

Design

Multicenter randomized controlled trial in which participants were randomized to a PA or HE program for an average of 2.6 years.

Setting

Eight field centers.

Participants

Sedentary men and women aged 70–89 with lower extremity physical limitations but able to walk 400-m in 15 minutes or less (N = 1,635).

Interventions

Structured, moderate-intensity PA (n =  818) at a center (2×/wk) and at home (3–4×/wk) that included aerobic, strength, balance, and flexibility training or HE (n =  817) of educational workshops and upper extremity stretching exercises.

Measurements

All-cause inpatient hospitalizations ascertained at 6-month intervals.

Results

There were 1,458 hospitalizations (49.1% of PA, 44.4% of HE; risk difference = 4.68%, 95% confidence interval (CI) = −0.18–9.54; hazard ratio (HR) = 1.16, 95% CI = 1.00–1.34). The intervention effect on incident hospitalization did not differ according to race, sex, Short Physical Performance Battery score, age, or history of cardiovascular disease or diabetes mellitus. PA was associated with higher rates of hospitalization in the middle baseline gait speed category, than HE (<0.8 m/s: HR = 0.93, 95% CI = 0.76–1.14; 0.8–1.0 m/s: HR = 1.54, 95% CI = 1.23–1.94; >1.0 m/s: HR = 1.05, 95% CI = 0.67–1.65; interaction P = .005).

Conclusion

A PA program in older adults at risk for mobility disability did not lead to a different risk of specific types of hospitalizations than a HE program overall. Baseline gait speed may be a marker for risk of hospitalization during a PA intervention, because individuals with moderate baseline gait speed in the PA group had slightly higher rates of hospitalization than those in the HE group.

Trial Registration: ClinicalTrials.gov identifier: NCT01072500.

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Racial Disparities in Cognitive Performance in Mid- and Late Adulthood: Analyses of Two Cohort Studies - American Geriatric Society

Objectives

To examine whether the attenuation of racial disparities observed in physical health outcomes at older ages can be extended to cognitive outcomes in mid- and late-life samples.

Design

Cross-sectional associations between race and cognitive functioning were examined as a function of age.

Setting

The National Survey of Midlife Development in the United States (MIDUS) and the Washington Heights-Inwood Columbia Aging Project (WHICAP).

Participants

Non-Hispanic African American or white individuals aged 40 and older (MIDUS; n = 3875, 10.5% African American) and non-Hispanic African American or white individuals aged 65 and older without a diagnosis of dementia (WHICAP; n = 2,729, 53.8% African American).

Measurements

Composite scores of executive functioning and episodic memory.

Results

Independent of main effects of age, birth cohort, sex, education, and chronic health conditions, significant interactions between age and race indicated that racial disparities in episodic memory and executive functioning were larger at younger than older age in both samples.

Conclusion

Attenuation of racial inequalities in older age can be extended to cognitive outcomes, which probably reflects selective survival. Research on cognitive disparities or on race-specific causes of cognitive outcomes in old age must incorporate corrections for selective survival if the goal is to identify causal predictors of cognitive outcomes rather than merely statistical predictors.

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Association Between Hypovitaminosis D in Elderly Women and Long- and Short-Term Mortality—Results from the Osteoporotic Prospective Risk Assessment Cohort - American Geriatric Society

Objectives

To investigate the association between low vitamin D levels (<50 nmol/L) and 10-year mortality in women aged 75 and older.

Design

Prospective with 15 years of follow-up.

Setting

Malmö, Sweden.

Participants

Population-based cohort of 75-year-old women (N = 1,044).

Measurements

Serum 25-hydroxyvitamin D (25(OH)D) levels at age 75 (n = 1,011), 80 (n = 642), and 85 (n = 348) were categorized as low (<50 nmol/L), intermediate (50–75 nmol/L) and high (>75 nmol/L) at all ages. Hazard ratios (HRs) for all-cause mortality between ages 75 and 90 were calculated according to 25(OH)D category.

Results

Between ages 80 and 90, all-cause mortality (HR = 1.8, 95% confidence interval (CI) = 1.3–2.4, P < .001; adjusted for comorbidities (aHR) = 1.9, 95% CI = 1.4–2.6, P < .001) was significantly higher in women with low 25(OH)D levels than in those with high levels. Osteoporosis had the greatest effect on mortality, but even after excluding women with osteoporotic fracture during the risk of dying associated with low 25(OH)D remained greater (HR = 1.8, 95% CI = 1.2–2.7, P = .002; aHR = 1.7, 95% CI = 1.2–2.5, P = .006).

Conclusion

In this observational study of women aged 75 and older, 25(OH)D levels of less than 50 nmol/L were associated with greater all-cause mortality for up to 10 years. This difference was at least partially independent of comorbidities and fracture, indicating that low 25(OH)D not only is an indicator of impaired health, but also plays a role in disease outcome.

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Systematic Review of Prevalence and Predictors of Frailty in Individuals with Human Immunodeficiency Virus - American Geriatric Society

Objectives

To describe the prevalence and predictors of frailty in individuals with the human immunodeficiency virus (HIV) using systematic review methodology.

Design

Review.

Setting

Community.

Participants

Older adults with HIV.

Measurements

Medline, CINAHL, EMBASE, PsychInfo, and PubMed were searched for original observational studies with populations including individuals with HIV in which frailty was assessed using the frailty phenotype or a variant thereof. Studies were examined for frailty prevalence and predictors of the syndrome in those with HIV.

Results

Thirteen of 322 citations were included for full review. All demonstrated the presence of frailty in individuals with HIV, with prevalence ranging from 5% to 28.6% depending on population studied. HIV was a risk factor for frailty. Predictors of frailty included older age, comorbidities, diagnosis of acquired immunodeficiency syndrome, and low current CD4⁺ cell count.

Conclusion

HIV appears to be an independent risk factor for frailty, with frailty occurring in individuals with HIV at rates comparable with older individuals without HIV. Heterogeneity in study populations and frailty assessment measures hamper accurate description of the problem. Future longitudinal work with standardized methodology is needed to describe prevalence accurately and confirm predictors.

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Gait Speed as a Guide for Blood Pressure Targets in Older Adults: A Modeling Study - American Geriatric Society

Objectives

To evaluate the potential for gait speed to inform decisions regarding optimal systolic blood pressure targets in older adults.

Design

Forecasting study from 2014 to 2023 using the Cardiovascular Disease Policy Model, a Markov model.

Setting

National Health and Nutrition Examination Survey.

Participants

U.S. adults aged 60–94 stratified into fast walking, slow walking, and poor functioning (noncompleters) based on measured gait speed.

Measurements

Lowering SBP to a target of 140 or 150 mmHg was modeled in persons with (secondary prevention) and without (primary prevention) a history of coronary heart disease or stroke. Based on clinical trials and observational studies, it was projected that slow-walking and poor-functioning participants would have greater noncardiovascular mortality. Myocardial infarctions (MIs), strokes, deaths, cost, and disability-adjusted life years (DALYs) were measured.

Results

Regardless of gait speed, it was projected that secondary prevention to a systolic blood pressure (SBP) of 140 mmHg would prevent more events and save more money than secondary prevention to 150 mmHg. Similarly, primary prevention to 140 mmHg in fast-walking adults was projected to prevent events and save money. In slow-walking adults, primary prevention to 150 mmHg was projected to prevent MIs and strokes and save DALYs but was cost saving only in men; intensification to 140 mmHg is of uncertain benefit in slow-walking individuals. Primary prevention in poor-functioning adults to a target of 140 or 150 mmHg SBP is projected to decrease DALYs.

Conclusion

The most cost-effective SBP target varies according to history of cardiovascular disease and gait speed in persons aged 60–94. These projections highlight the need for better estimates of the benefits and harms of antihypertensive medications in a diverse group of older adults, because the net benefit is sensitive to the characteristics of the population treated.

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Using an Atrial Fibrillation Decision Support Tool for Thromboprophylaxis in Atrial Fibrillation: Effect of Sex and Age - American Geriatric Society

Objectives

To assess the appropriateness of oral anticoagulant therapy (OAT) in women and elderly adults, looking for patterns of undertreatment or unnecessary treatment.

Design

Retrospective cohort study.

Setting

Primary care practices of an academic healthcare system.

Participants

Adults (aged 28–93) with nonvalvular atrial fibrillation (AF) seen between March 2013 and February 2014 (N = 1,585).

Measurements

Treatment recommendations were made using an AF decision support tool (AFDST) based on projections of quality-adjusted life expectancy calculated using a decision analytical model that integrates individual-specific risk factors for stroke and hemorrhage.

Results

Treatment was discordant from AFDST-recommended treatment in 45% (326/725) of women and 39% (338/860) of men (P = .02). Although current treatment was discordant from recommended in 35% (89/258) of participants aged 85 and older and in 43% (575/1,328) of those younger than 85 (P = .01), many undertreated elderly adults were receiving aspirin as the sole antithrombotic agent.

Conclusion

Physicians should understand that female sex is a significant risk factor for AF-related stroke and incorporate this into decision-making about thromboprophylaxis. Treating older adults with aspirin instead of OAT exposes them to significant risk of bleeding with little to no reduction in AF-related stroke risk.

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Depressive Symptoms and Orthostatic Hypotension Are Risk Factors for Unexplained Falls in Community-Living Older People - American Geriatric Society

Objectives

To investigate risk factors for unexplained falls in older community-dwelling individuals.

Design

Prospective cohort study.

Setting

Community population, Sydney, Australia.

Participants

Older adults (N = 529; mean age 79.8 ± 4.4, 52.2% female).

Measurements

Participants provided information demographic, medical, and medication characteristics and completed cardiovascular (tilt table test, pulse wave velocity), cognitive, and sensorimotor assessments at baseline. Falls were then recorded in monthly fall diaries for 12 months. Unexplained fallers (UFs) were those who reported falls due to a blackout, dizziness, feeling faint, or “found themselves suddenly on the ground.”

Results

Of the 523 participants available at follow-up, 238 (45.5%) reported one or more falls; 35 participants fulfilled the definition of UFs. UFs were more likely than balance-related fallers (BFs) (n = 203) and nonfallers (n = 291) to have orthostatic hypotension (39.4%, 20.5% and 22.4%, respectively) and depressive symptoms (24.2%, 10.1%, and 7.9% respectively). More UFs (88.6%) than BFs (70.9%) had injurious falls. A multivariate logistic regression model revealed that depressive symptoms and orthostatic hypotension were significant and independent determinants of UF status.

Conclusion

Approximately 15% of fallers had unexplained falls, which were more likely to result in injuries. Depressive symptoms and orthostatic hypotension increased the risk of unexplained falls, whereas cognitive deficits and sensorimotor and balance impairments did not. Future research should investigate whether psychotherapy and physical exercise to improve mood and medication reviews and nonpharmacological therapies for the treatment of orthostatic hypotension and depression are effective at reducing the risk of unexplained falls in older people.

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Are Obese Residents More Likely to Be Admitted to Nursing Homes That Have More Deficiencies in Care? - American Geriatric Society

Objectives

To determine whether obese older adults who qualify for nursing home (NH) placement are as likely as nonobese adults to be admitted to NHs that provide adequate quality of care.

Design

Retrospective study.

Setting

NHs in New York State.

Participants

Individuals aged 65 and older newly admitted to a NH in New York State in 2006–07.

Measurements

Total and healthcare-related deficiency citations for each facility were obtained from the Online Survey, Certification, and Reporting file. Bivariate and multivariate regression analyses were used to assess the association between obesity (body mass index (BMI) 30.0–39.9 kg/m²) and morbid obesity (BMI ≥ 40.0 kg/m²) separately and admission to facilities with more deficiencies.

Results

NHs that admitted a higher proportion of morbidly obese residents were more likely to have more deficiencies, whether total or healthcare related. These NHs also had greater odds of having severe deficiencies, or falling in the top quartile ranking of total deficiencies. After sequentially controlling for the choice of facilities within the inspection region, resident characteristics, and facility covariates, the association between morbid obesity and admission to higher-deficiency NHs persisted.

Conclusion

Residents with morbid obesity were more likely to be admitted to NHs of poorer quality based on deficiency citations. The factors driving these disparities and their impact on the care of obese NH residents require further elucidation.

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Host Resistance and Immune Aging - Geriatrics

Human immune system aging results in impaired responses to pathogens or vaccines. In the innate immune system, which mediates the earliest pro-inflammatory responses to immunologic challenge, processes ranging from Toll-like Receptor function to Neutrophil Extracellular Trap formation are generally diminished in older adults. Dysregulated, enhanced basal inflammation with age reflecting activation by endogenous damage-associated ligands contributes to impaired innate immune responses. In the adaptive immune system, T and B cell subsets and function alter with age. The control of cytomegalovirus infection, particularly in the T lineage, plays a dominant role in the differentiation and diversity of the T cell compartment.

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Pitching Medicaid IT in Silicon Valley - CMS Blog

By Andy Slavitt, CMS Acting Administrator @aslavitt 

Earlier this year, I announced a new effort to connect new, innovative companies and their investors to the state Medicaid program IT space. Since this announcement, I have been encouraged by the initial interest from companies that may not have otherwise ever thought about participating in this important health insurance program that covers more than 72 million Americans.  

That’s why I’m in Silicon Valley today to participate in a forum on bringing technological advances to Medicaid. The forum is convening states, innovative tech companies, and federal Medicaid officials on how to collaborate to improve the delivery of Medicaid health coverage in states.  

These meetings will help in getting two very different cultures – state government and tech companies – speaking the same language and exploring opportunities to work together to continue to improve care delivery within Medicaid.  

While there are 56 different state, district, and territorial Medicaid programs, there is a lot of commonality in their IT needs. There is always new IT procurement and opportunities for new, innovative vendors in this space. This industry is primed for a new era — Software as a Service software– that has real time capabilities and requirements and Federal sponsorship for a 90 percent match on qualifying IT investments. 

Investment gravitates to needs and problems it can solve. There is no greater opportunity than bringing technical know-how, innovation and creativity to improve the health of Americans with health, social and economic challenges.  

CMS is fully committed financially and operationally to partner with states and the private sector to improve state programs. The federal government alone invests more than $5 billion per year in Medicaid IT and matches up to 90 percent on new projects. Still, there may be some apprehension by IT companies – large or small, new or established – to engage in bidding for state government contracts.  

But, we’re working to tear down these barriers and taking it past the opportunity to make a new market.  

We’ve already created a one-stop-shop for the tech community to connect with states looking for innovative solutions. On this site, vendors can easily find links to states’ Medicaid procurement websites and to any open state Medicaid IT Requests for Proposals. 

We are also doing more to bring these two groups together. CMS is developing a “playbook” to help companies translate states’ requests for proposals into work they believe can move the needle. We are also inviting vendors to seek pre-certification from CMS for their Medicaid IT solutions and put their names and products on a “Pre-Certified Medicaid Modules” list on our Medicaid.gov website.  

Finally, to help be a bridge between states and the tech sector, we are actively recruiting a full time entrepreneur-in-residence fully committed to the Medicaid space.  

It is an exciting time to be in the Medicaid space. With Medicaid expansion, Medicaid has become America’s health plan. Medicaid has always served some of our most vulnerable citizens: the elderly, disabled, low-income, pregnant women, and children. New policies strengthen consumer access and driving improved quality and additional care options for people at home and in their communities. Stronger approaches to IT underpin these promising new directions.

This work has the potential to leave a legacy in the lives it touches for many years to come. Engaging the tech community and federal and state policy makers in this substantial modernization effort is just the beginning. 

Filed under: Uncategorized

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CMS Continues Progress toward a Safer Health Care System through Integrated Efforts to Improve Patient Safety and Reduce Hospital Readmissions - CMS Blog

By: Patrick Conway, MD, MSc, CMS Acting Principal Deputy Administrator and Chief Medical Officer

We know that it is possible to improve national patient safety performance resulting in millions of people avoiding infections and adverse health events. A report released by the Agency for Healthcare Research and Quality back in December showed an unprecedented 39 percent reduction in preventable patient harm in U.S. hospitals compared to the 2010 baseline. This has resulted in 2.1 million fewer patients harmed, 87,000 lives saved, and nearly $20 billion in cost-savings from 2010 to 2014. The nation has also made substantial progress in reducing 30-day hospital readmissions.

I have been working in the field of quality improvement for 20 years, and I have never before seen results such as these. This work, though, is far from done, and it is imperative that we sustain and strengthen efforts to address patient safety problems, such as central line infections and hospital readmissions. Today, we at CMS are excited to continue progress toward a safer health care system by releasing a Request for Proposal (RFP) for Hospital Improvement and Innovation Networks (HIINs).

The HIINs, which will be part of the Quality Improvement Organization (QIO) initiative, will continue the good work started by the Hospital Engagement Networks (HENs) under the Partnership for Patients initiative. These organizations will tap into the deep experience, capabilities and impact of QIOs, hospital associations, hospital systems, and national hospital affinity organizations with extensive experience in hospital quality improvement. The HIINs will engage and support the nation’s hospitals, patients, and their caregivers in work to implement and spread well-tested, evidence-based best practices.

QIOs that have developed strong relationship with HENs under the Partnership for Patients initiative have decades of experience with quality improvement and are currently supporting more than 250 communities nationally in work to improve care transitions and reduce adverse drug events across a wide variety of health care and community-based organizations.  HENs involved in supporting the Partnership for Patients initiative have established relationships and trusted partnerships with over 3,700 acute care hospitals. These efforts involve approximately 80 percent of all people discharged from hospitals across the nation.

The further integration of work across these influential networks will permit the continued and increased systematic use of proven practices to improve patient safety and reduce readmissions, at a national scale in all U.S. hospitals. Through 2019, the new HIINs will commit to and pursue bold new national aims to achieve a 20 percent decrease in overall patient harm and a 12 percent reduction in 30-day hospital readmissions as a population-based measure (readmissions per 1,000 people) from the 2014 baseline, thereby bolstering the impact of both the QIO program and the Partnership for Patients.

The procurement for the HIINs will be a full and open competition, and CMS encourages all interested parties to submit a proposal that will continue to build on the successes achieved so far. Organizations who were a HEN in the first and second rounds of the Partnership for Patients or QIOs and other organizations that meet the RFP criteria are welcome to submit a proposal for the HIIN opportunity, but will compete for selection against all other organizations submitting proposals.

More information about today’s RFP may be found at FedBizOpps.gov.

Filed under: Uncategorized

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Evaluation of the immunogenicity and protective effects of a trivalent chimeric norovirus P particle immunogen displaying influenza HA2 from subtypes H1, H3 and B

Evaluation of the immunogenicity and protective effects of a trivalent chimeric norovirus P particle immunogen displaying influenza HA2 from subtypes H1, H3 and B

Emerging Microbes & Infections 5, e51 (May 2016). doi:10.1038/emi.2016.51

Authors: Xin Gong, He Yin, Yuhua Shi, Xiaoqiu He, Yongjiao Yu, Shanshan Guan, Ziyu Kuai, Nasteha M Haji, Nafisa M Haji, Wei Kong & Yaming Shan

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Outbreaks of serotype 4 fowl adenovirus with novel genotype, China

Outbreaks of serotype 4 fowl adenovirus with novel genotype, China

Emerging Microbes & Infections 5, e50 (May 2016). doi:10.1038/emi.2016.50

Authors: Jianqiang Ye, Guangchen Liang, Jianjun Zhang, Weikang Wang, Na Song, Ping Wang, Wenlv Zheng, Quan Xie, Hongxia Shao, Zhimin Wan, Chengming Wang, Hongjun Chen, Wei Gao & Aijian Qin

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Candida haemulonii species complex: an emerging species in India and its genetic diversity assessed with multilocus sequence and amplified fragment-length polymorphism analyses

Candida haemulonii species complex: an emerging species in India and its genetic diversity assessed with multilocus sequence and amplified fragment-length polymorphism analyses

Emerging Microbes & Infections 5, e49 (May 2016). doi:10.1038/emi.2016.49

Authors: Anil Kumar, Anupam Prakash, Ashutosh Singh, Harish Kumar, Ferry Hagen, Jacques F Meis & Anuradha Chowdhary

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Detection of Borrelia burgdorferi sensu stricto in Amblyomma americanum ticks in the southeastern United States: the case of selective compatibility

Detection of Borrelia burgdorferi sensu stricto in Amblyomma americanum ticks in the southeastern United States: the case of selective compatibility

Emerging Microbes & Infections 5, e48 (May 2016). doi:10.1038/emi.2016.45

Authors: Nataliia Rudenko, Maryna Golovchenko, Kerry Clark, James H Oliver & Libor Grubhoffer

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C. J. Dannemiller Co. Annouces Recall of "Sunflower Kernels, Roasted and Salted" and "Sunflower Kernels, Roasted No Salt" Because of Possible Listeria monocytogenes - FDA Safety Alerts & Drug Recalls

C. J. Dannemiller Co. is recalling SunOpta 50# bags and 30# cases of roasted sunflower kernels roasted and salted, and sunflower kernels roasted no salt because they have the potential to be contaminated with Listeria.

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E S Foods Recalls Meal Breaks Containing Sunflower Seeds Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

E S Foods of Woodbury, NY is recalling 3700 cases of Meal Breaks items containing individually packed Sunrich Natural Sunflower Kernels (Roasted & Salted), Net Wt 1 oz., because the sunflower seeds have the potential to be contaminated with Listeria monocytogenes.

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Hickory Harvest Expands Recall of Certain Sunflower Kernel Products Because of Possible Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Hickory Harvest Foods, under advice from its sunflower kernel supplier, SunOpta, is expanding their recall of a limited number of products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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First Source Recalls "Various Products Containing Sunflower Kernels Received From Our Supplier Sunopta" Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

FIRST SOURCE of Tonawanda, NY, is recalling the following items because they have the potential to be contaminated with Listeria monocytogenes:

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Food Gusto, Inc. Issues Allergy Alert on Undeclared Milk in Birdy 3 in 1 Coffee Mix (Robusta) - FDA Safety Alerts & Drug Recalls

Food Gusto, Inc. of Paterson, NJ, is recalling its Birdy 3 in 1 coffee mix (Robusta) because product contains undeclared milk. People who have an allergy or serve sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Ultimate Nutrition Issues Allergy Alert on Possible Undeclared Milk Allergen in Amino Gold Products - FDA Safety Alerts & Drug Recalls

Ultimate Nutrition Inc. of Farmington, CT, is recalling its dietary supplement, Amino Gold because they may contain undeclared milk in the form of hydrolyzed whey protein. People who have allergies to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.

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Updated: The Pictsweet Company Notifies Consumers That Select Kroger Brand Frozen Vegetables Shipped into the Western US are Included in Previously Announced Recall - FDA Safety Alerts & Drug Recalls

As part of the on-going CRF Frozen Foods recall, The Pictsweet Company is notifying consumers that certain Kroger brand frozen vegetable sold in Fry's, King Soopers, City Market, Ralphs, Food 4 Less, Smith's, QFC, and Fred Meyer are included in the recall announced Friday, May 6. These products were packaged by The Pictsweet Company and contain Green Beans or Green Peas recently recalled by CRF Frozen Foods due to a health risk.

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Hy-Vee Voluntarily Recalls Six Trail Mix Products Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six trail mix products across its eight-state region due to possible contamination with Listeria monocytogenes. The products include Hy-Vee Caramel Cashew Honey Crunch Trail Mix, Hy-Vee Dark Chocolate Cranberry Trail Mix, Hy-Vee Mountain Trail Mix, Hy-Vee Mountain Trail Mix To Go, Hy-Vee Berry Trail Mix and Hy-Vee Santa Fe Trail Mix.

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Papa John's Salad and Produce Recalls Oriental Salad with Sesame Ginger Dressing Due to Possible Listeria monocytogenes Contamination - FDA Safety Alerts & Drug Recalls

Phoenix Arizona, Papa John's Salad and Produce, Inc. is voluntarily recalling Oriental Salad with Sesame Ginger Dressing due to possible Listeria monocytogenes contamination. This voluntary action is being undertaken in cooperation with the US Food and Drug Administration because the recalled products contain sunflower kernels that are part of the recent SunOpta sunflower kernel recall expansion.

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Dakota Style Foods, Inc. Recalls Product Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Dakota Style Foods, Inc. of Clark, South Dakota is recalling 6,930 cases of sunflower kernels because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Dakota Style Foods, Inc. Recalls Product Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Dakota Style Foods, Inc. of Clark, South Dakota is recalling 6,930 cases of sunflower kernels because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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TreeHouse Foods Expands Voluntary Product Recall Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

TreeHouse Foods, Inc. (NYSE: THS) today expanded its voluntary recall of products containing sunflower kernels which may be contaminated with Listeria monocytogenes (L.mono).

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The Caramel Factory, LLC Issues An Allergy Alert - FDA Safety Alerts & Drug Recalls

The Caramel Factory, LLC of Batesville, MS, is recalling a number of candies, chocolates and baked goods for undeclared allergens. People who have allergies to peanuts, tree nuts, milk, eggs, soy, and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA modernizes Nutrition Facts label for packaged foods - FDA Press Releases

FDA modernizes Nutrition Facts label for packaged foods

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Expanded Recall Period of Certain Sunflower Kernel Products Due to Possible Contamination By Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

TORONTO - As a precaution, SunOpta expanded its voluntary recall of a limited number of sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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FDA approves new, targeted treatment for bladder cancer - FDA Press Releases

The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer.

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Well Care Compounding Pharmacy Issues Voluntary Statewide Recall of All Sterile Compounded Products Due to Lack Of Assurance if Sterility Concerns - FDA Safety Alerts & Drug Recalls

Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration's (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.

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Providing Quality, Affordable Durable Medical Equipment for Beneficiaries - CMS Blog

By Sean Cavanaugh, CMS Deputy Administrator and Director, Center for Medicare

Traditionally, Medicare pays for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) using a fee schedule that is based on historic supplier charges from the 1980s.  Numerous studies from the Department of Health and Human Services Office of Inspector General and the Government Accountability Office have shown these fee schedule prices to be excessive and that taxpayers and Medicare beneficiaries bear the burden of these high payments. CMS has worked for many years to improve how Medicare pays for DMEPOS items with the goal of ensuring that people with Medicare get the equipment they need while reducing costs for beneficiaries and taxpayers.

Since 2011, we have operated the DMEPOS competitive bidding program to set payment amounts for covered DMEPOS items in certain areas in the country. The Program has saved more than $580 million in nine markets at the end of the Round 1 Rebid’s three-year contract period (January 1, 2011 through December 31, 2013). And, after the first two years of Round 2 and the national mail-order programs (July 1, 2013 – June 30, 2015), Medicare has saved approximately $3.6 billion. Health monitoring data indicate that its implementation is going smoothly with few inquiries or complaints and no negative impact on beneficiary health outcomes.   By all measures, the DMEPOS competitive bidding program has been a great success for beneficiaries and taxpayers.

At the beginning of this year, in compliance with statute, we phased in new rates in non-competitive bidding areas based on information from the DMEPOS competitive bidding program. We phased in these new rates with a blend of 50 percent of the unadjusted payment rates and 50 percent of the adjusted payment rates on January 1, 2016.  We are also using the same real-time monitoring system we use in competitive bidding areas to ensure beneficiaries are receiving the equipment they need.  This data monitoring tracks access to items and services and a number of clinical outcome measures such as mortality, hospitalizations, and emergency room visits.

Today, we posted monitoring data that shows our efforts succeeded in saving the Medicare program money while continuing to provide equipment to those who need it. The data reveals that suppliers in these non-competitive bidding areas have continued to accept the new, adjusted DMEPOS payment rates as payment in full. If the new, lower fee schedule amounts do not cover the suppliers’ costs, these suppliers could require beneficiaries to pay the difference between the new and old rates. But according to the data, barely any of them did so. This suggests that the adjusted fee schedule rates continue to be more than adequate to cover the costs of furnishing the DMEPOS items in all areas.

Overall, there has been no change in the percentage of claims for which suppliers are accepting the new payment rates as payment in full.  For the first four months in 2016, suppliers accepted the new rates as payment in full for 99.88 percent of the claims submitted, compared to 99.87 percent for the first four months in 2015. The rate of acceptance remained at 99.90 percent for items furnished in rural areas in 2016, while the rate of acceptance in non-contiguous areas changed only slightly in 2016 (99.81 percent) compared to 2015 (99.90 percent).

The data are broken out for eight geographic regions of the contiguous United States, as well as non-contiguous areas (i.e., Alaska, Hawaii, Puerto Rico, Virgin Islands, etc., combined). It also compares the rate of assignment of claims for DMEPOS items furnished in rural areas versus non-rural areas. The rate of assignment of claims in 2016 continues to be very high overall in both rural and non-rural areas. Finally, the data is broken out for several different categories of DMEPOS items. The monitoring data are available at: http://ift.tt/1svWErl.

We expect to post additional data on assignment rates, access to items and services, and health outcomes in the near future.

Based on our monitoring efforts, and the continued high voluntary acceptance of assignment across all non-competitive bidding areas, including rural areas and non-contiguous areas, we believe that the partially adjusted fees implemented in January have had no negative impact on beneficiary access to quality items and services. We will continue to monitor all data very closely leading up to and following implementation of the phase in of the fully adjusted DMEPOS fee schedule adjustments on July 1, 2016.

Filed under: Uncategorized

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The Quaker Oats Company Issues Voluntary Recall of Quaker Quinoa Granola Bars Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Quaker Quinoa Granola Bars after an ingredient supplier was found to have distributed sunflower kernels that may be contaminated with Listeria monocytogenes (L.mono). There have been no reported illnesses to date. However, Quaker is initiating the voluntary recall in an abundance of caution to protect public health.

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Dr. Praeger's Sensible Foods, Inc. Announces Voluntary Recall of Various Dr. Praeger's and Ungar's Products Related to CRF Frozen Vegetable Recall for Possible Health Risk - FDA Safety Alerts & Drug Recalls

Dr. Praeger's Sensible Foods, Inc. is voluntarily recalling various not-ready-to-eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. This voluntary action is being undertaken in cooperation with the US Food and Drug Administration because the recalled products contain vegetables that are part of the recent CRF Frozen Foods recall.

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A Precautionary Recall of Three Cases of The Farmers Market Chopped Asian Salad Kit is Announced Due to Possible Exposure to Allergens - FDA Safety Alerts & Drug Recalls

A precautionary recall of three cases (containing 6 salads each) of 6.25 ounce The Farmers Market Chopped Asian Salad Kit with Product Code G126B22 and Use-by Date of May 20, 2016 has been issued due to possible exposure to undeclared allergens (soy, almonds, wheat). The product, manufactured by Fresh Express, was marketed and distributed by Giant Eagle Inc.

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How U.S. Doctors Die: A Cohort Study of Healthcare Use at the End of Life - American Geriatric Society

Objectives

To compare healthcare use in the last months of life between physicians and nonphysicians in the United States.

Design

A retrospective observational cohort study.

Setting

United States.

Participants

Fee-for-service Medicare beneficiaries: decedent physicians (n = 9,947) and a random sample of Medicare decedents (n = 192,006).

Measurements

Medicare Part A claims data from 2008 to 2010 were used to measure days in the hospital and proportion using hospice in the last 6 months of life as primary outcome measures adjusted for sociodemographic characteristics and regional variations in health care.

Results

Inpatient hospital use in the last 6 months of life was no different between physicians and nonphysicians, although more physicians used hospice and for longer (using the hospital: odds ratio (OR) = 0.98, 95% confidence interval (CI) = 0.93–1.04; hospital days: mean difference 0.26, P = .14); dying in the hospital: OR = 0.99, 95% CI = 0.95–1.04; intensive care unit (ICU) or critical care unit (CCU) days: mean difference 0.35 more days for physicians, P < .001); using hospice: OR = 1.23, 95% CI = 1.18–1.29; number of days in hospice: mean difference 2.06, P < .001).

Conclusion

This retrospective, observational study is subject to unmeasured confounders and variation in coding practices, but it provides preliminary evidence of actual use. U.S. physicians were more likely to use hospice and ICU- or CCU-level care. Hospitalization rates were similar.

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Montero Farms Recalls Orange Habanero Peppers Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Montero Farms of McAllen, Texas is recalling Orange Habanero Peppers, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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HMSHost Recalls Multiple Brands of Cape Cod Cranberry Trail Mix Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

HMSHost of Bethesda, Maryland is recalling multiple brands of trail mix, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Hy-Vee Voluntarily Recalls Frozen Hy-Vee Vegetable Fried Rice and Frozen Hy-Vee Chicken Fried Rice Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its frozen Hy-Vee Vegetable Fried Rice and frozen Hy-Vee Chicken Fried Rice products across its eight-state region due to possible contamination with Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Voluntary Recall on Piggly Wiggly Brand Yellow Cut Corn - FDA Safety Alerts & Drug Recalls

As part of the CRF Frozen Foods recall, McCall Farms Incorporated is notifying consumers that it is recalling Piggly Wiggly brand frozen Yellow Cut Corn due to the potential risk that it may contain Listeria monocytogenes. McCall Farms was notified by its supplier, CRF Frozen Foods, of this potential contamination.

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SOS Telecom, Inc. Recalls New Unapproved Drugs Marked as Dietary Supplements - FDA Safety Alerts & Drug Recalls

SOS Telecom, Inc. of Bayside, NY is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making this tainted dietary supplement and unapproved drug.

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Round One Health Care Innovation Awards Show Some Promising Results - CMS Blog

By: Dr. Patrick Conway, CMS Principal Deputy Administrator and Chief Medical Officer

The Health Care Innovation Awards is a Centers for Medicare & Medicaid Services (CMS) Innovation Center initiative that tests new payment and service delivery models and aims to find better ways to deliver care and bring down costs for Medicare, Medicaid, and/or Children’s Health Insurance Program (CHIP) enrollees. Today we are sharing the second annual independent evaluation reports of round one of the Health Care Innovation Awards. Overall, these evaluation reports show a wide range of experiences that have resulted in tangible benefits for patients and helped inform CMS in the development of new payment and service delivery models.

Where data are available, these reports describe preliminary impact estimates on key outcome measures such as hospitalizations and readmissions. A number of awardees showed favorable results on one or more measures of cost, hospitalizations, readmissions, and emergency room visits. Here are some early highlights of a few of the awards:

• Innovative Oncology Business Solutions, Inc. – through its Community Oncology Medical Home – reached more than 2,100 cancer patients through seven community oncology practices across the United States. Through comprehensive and coordinated oncology care, the model established pathways that:
  • allowed providers to identify and manage symptoms in real time;
  • improved patient access to providers through same-day appointments and extended night and weekend office hours; and
  • provided disease management guidance for providers to improve treatment decision-making, symptom recognition, and assistance with patients’ self care, pain management, and caregiver support.

The evaluation report shows that this award demonstrated a significant reduction in hospital readmissions and emergency room visits. In addition, qualitative findings suggest that staff highly value the triage pathways for making their workflow more efficient, and patients greatly appreciate weekend hours and increased capacity for urgent care visits during the day. Elements of this model were incorporated into the design of the Oncology Care Model.

• The High-Risk Children’s Clinic at the University of Texas Health Science Center at Houston’s (HRCC) offered dedicated outpatient services (primary, specialty, post-acute, chronic disease management) and around-the-clock phone access for extremely fragile and complex chronically ill children enrolled in Medicaid. Every family in the HRCC has an assigned clinician who involves the parent in all health assessments, empowering parents as experts in their child’s health condition and educating families on exacerbating symptoms. The evaluation found that the program significantly reduced emergency department visits and hospital admissions, which drove savings in medical and hospital cost of care for participating children. In addition, the report finds that the patient and family centered approach appears to have resulted in improved patient and family caregiver experience.

• Welvie is a program that offers education, health information, and decision-making resources regarding preference-sensitive surgeries to Medicare beneficiaries. Welvie conducts regularly scheduled, population-based outreach well before treatment decisions need to be made. Program administrators also review regional health care utilization patterns and mail outreach materials to arrive before periods of increased surgery utilization so that beneficiaries can recall and access the resources when needed. The program has enrolled over 181,000 beneficiaries in Ohio and almost 54,000 beneficiaries in Texas. Enrollees in Ohio had a statistically significant decrease in mortality as well as indications of a reduction in hospital readmissions following surgery-related hospital admissions for the Medicare FFS beneficiaries. The program was also associated with reductions in various surgery-related categories of expenditures among Medicare Advantage beneficiaries.

Diabetes Prevention Program

We recently announced that a round one Health Care Innovation Awards project — the Diabetes Prevention Program – is eligible for expansion under Medicare. The National Council of Young Men’s Christian Associations of the United States of America (Y-USA) enrolled eligible Medicare beneficiaries at high risk for diabetes in a program that could decrease their risk for developing serious diabetes-related illnesses. Beneficiaries in the program attended weekly meetings with a lifestyle coach who trained participants in strategies for long-term dietary change, increased physical activity, and behavior changes to control their weight and decrease their risk of type 2 diabetes. After the initial weekly training sessions, participants could attend monthly follow-up meetings to help maintain healthy behaviors. The main goal of the program was to improve participants’ health through improved nutrition and physical activity, targeting at least a five percent weight loss for each individual.

The independent CMS Office of the Actuary certified that expansion of the Diabetes Prevention Program would reduce net Medicare spending. The expansion was also determined to improve the quality of patient care without limiting coverage or benefits. This is the first time that a preventive service model from the CMS Innovation Center has become eligible for expansion into the Medicare program.

Health Care Innovation Awards Background

In July 2012, the CMS Innovation Center awarded 107 cooperative agreements through round one of the Health Care Innovation Awards to implement the most compelling ideas that aimed to deliver better care while spending health care dollars more wisely. Up to $1 billion were awarded to organizations that tested projects across the country that worked to achieve better quality of care and save money for people enrolled in Medicare, Medicaid and the Children’s Health Insurance Program. The evaluation reports are divided into large topical areas:

• Behavioral health and substance abuse;
• Complex and high risk patient targeting;
• Community resource planning and prevention;
• Disease specific;
• Hospital interventions;
• Primary care redesign; and
• Shared decision making/medication management

The first annual evaluation reports were released in April 2015 and provided qualitative findings largely focusing on the implementation experience covering the period from the award date through summer 2014. The reports released today synthesize findings from additional rounds of interviews and site visits conducted from the award date through summer 2015, preliminary estimates of impacts on four core measures (cost, hospitalizations, readmissions, emergency room visits) depending on the intervention and data availability, and results from select surveys of providers focusing on workforce and primary care.

While the results of the awards are wide-ranging, the evaluation of round one of the Health Care Innovation Awards is still ongoing and future reports will add to the current results. There is still much to learn, and we hope that other public and private entities will continue to invest in initiatives and efforts that improve the health care system in this country.

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Motor Vehicle Crashes and Dementia: A Population-Based Study - American Geriatric Society

Objectives

To compare the frequency of motor vehicle crashes of drivers aged 50 and older with a diagnosis of dementia with that of a group without dementia in the 3 years before and 3 years after an index hospital admission using the Western Australian Data Linkage System (WADLS).

Design

Retrospective population-based study.

Setting

De-identified data were obtained from Western Australian Hospital Morbidity Data System and the Western Australian Death Registrations using the WADLS from 2004 to 2010. The Integrated Road Information System was used to identify individuals involved in a crash as the driver from 2001 to 2013.

Participants

Individuals with dementia with an index hospital admission (n = 1,666, 34%) and individuals without dementia (n = 3,636, 66%) who had been involved in at least one motor vehicle crash as the driver from 2001 to 2013.

Measurements

Involvement in a police-reported crash as the driver.

Results

The occurrence of one or more crashes as the driver in the dementia group (43% had a crash as the driver) was higher in the 3 years before the index hospitalization than in the comparison group (30% had a crash as the driver). The risk of a crash was 93% less for those with dementia in the 3 years after an index hospital admission with dementia than for those without dementia (incidence rate ratio = 0.07, 95% confidence interval = 0.06–0.09) compared to the previous 3 years, after adjusting for relevant confounders.

Conclusion

Although older drivers may give up driving after a diagnosis of dementia, they may be at greater risk of crashing before diagnosis or in the early stages of dementia. Better methods are needed to identify at-risk drivers with early dementia and prevent crashes.

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Publix Recalls Cranberry Nut And Seed Mix Due To Possible Health Risk - FDA Safety Alerts & Drug Recalls

Publix Super Markets is issuing a voluntary recall for cranberry nut and seed mix because it may be adulterated with Listeria monocytogenes. Publix received notification of the potential contamination from the walnut supplier, Woodstock Farms, after routine testing was completed.

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Whole Foods Market Issues Allergy Alert on Undeclared Peanut and Coconut in Korean BBQ Sauce - FDA Safety Alerts & Drug Recalls

Whole Foods Market is voluntarily recalling one batch of Whole Foods Market Korean BBQ Sauce because the product contains Peanut Coconut Sauce and therefore includes peanut and treenut (coconut) allergens that were not declared on product packaging. People who have an allergy or severe sensitivity to peanuts and or tree nuts (coconut) run the risk of serious or life-threatening allergic reaction if they consume these products.

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Vending Nut Co. recalls Sunflower Kernel Products Because Of Possible Health Risks - FDA Safety Alerts & Drug Recalls

Vending Nut Company is voluntarily recalling a limited number of sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Medicaid: Keeping Moms Healthy - CMS Blog

By: Patrick Conway, M.D., Principal Deputy Administrator and CMS Chief Medical Officer and Vikki Wachino CMS Deputy Administrator and Director for the Center for Medicaid and CHIP Services (CMSCS)

More than any other health insurance program, Medicaid plays a key role in promoting the health of new mothers. Covering roughly half of births, Medicaid is there for new moms and their babies right from the beginning. We’re excited to showcase two ways that Medicaid can help get new moms and their babies off to the best possible start.

Help at the Right Time

Welcoming a new baby into the family is typically a time of great joy. But for some mothers it can also be a time in which they experience the “baby blues,” or in more serious cases, postpartum depression. Maybe you or someone you know has struggled with feelings of depression, detachment or even fear after the birth of a child.

Maternal depression presents a significant early risk to proper child development, the mother-infant bond, and the family. Children raised by clinically depressed mothers may perform lower on cognitive, emotional and behavioral assessments than children of non-depressed caregivers, and are at risk for later mental health problems, social adjustment difficulties, and difficulties in school. That’s why screening for and treating maternal depression is such an important tool to help prevent these adverse effects on a child’s development.

This is where Medicaid can help. Medicaid covers maternal depression screenings for mothers of Medicaid-eligible children performed by a pediatrician, often as part of a well-child exam, helping moms and their babies get the care they need.

For example, Colorado, Illinois, North Dakota and Virginia are helping moms get these screenings by making it easier for providers, including pediatricians, to have the tools they need to conduct the screenings and bill Medicaid appropriately. Making sure pediatricians have the tools they need is key, as they not only play a pivotal role in assessing the health and wellbeing of both moms and their babies, but may also be the health care practitioner most often interacting with a new mother.

Screenings represent a valuable opportunity for timely identification of issues; they are also a pathway to effective treatment. Based on the results of her screening, the pediatrician can refer the mother to diagnostic and treatment services as part of her needed follow-up care, which Medicaid will cover if she’s eligible for and enrolled in the program.

Today’s Informational Bulletin describes how Medicaid can pay for services that are for the direct benefit of the child, but that may also include the mother. 

Helping Families with Home Visitation

Home visiting programs are another way to get new moms and babies off to a great start in life. Home visiting programs do much more than simply promote health – they encourage positive parenting, promote school readiness, and prevent child abuse and neglect.

While not part of today’s Informational Bulletin, combining maternal depression screenings and treatment with home visitation programs is a winning combination. That’s why we wanted to highlight the Federal Home Visiting Program guidance we released in March in partnership with the Health Resources and Services Administration (HRSA).

This guidance includes examples of how states can design a home visitation program for pregnant women and families with young children, and walks through the typical components of such programs, such as developmental and social screenings for both moms and their babies, case management and referrals to needed treatments, and the provision of activities including family support and counseling services and parent/caregiver skills training. These home visitation programs keep moms and their babies at the heart of delivering effective, efficient and quality care.

In addition, our work with HRSA closely aligns with another way Medicaid supports the health of moms and their babies: Medicaid’s Maternal and Infant Health Initiative. This initiative focuses on increasing the rate and content of postpartum visits, as well as increasing the rate of intended pregnancies through the use of effective contraception. Last month, we released an Informational Bulletin describing how states can knock down barriers for women, including new moms, in accessing effective contraception, which has been shown to help reduce the risk of low-weight and/or premature birth while helping a woman’s physical and emotional well-being.

Together, these guidance documents provide information that we hope will be helpful to states, providers, advocates and beneficiaries in understanding the resources that are available to give families the best start possible.

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The consequences of reservoir host eradication on disease epidemiology in animal communities

The consequences of reservoir host eradication on disease epidemiology in animal communities

Emerging Microbes & Infections 5, e46 (May 2016). doi:10.1038/emi.2016.46

Authors: Farah Al-Shorbaji, Benjamin Roche, Rodolphe Gozlan, Robert Britton & Demetra Andreou

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Serologic assays for the detection and strain identification of Pteropine orthoreovirus

Serologic assays for the detection and strain identification of Pteropine orthoreovirus

Emerging Microbes & Infections 5, e44 (May 2016). doi:10.1038/emi.2016.35

Authors: Harpal Singh, Masayuki Shimojima, Shuetsu Fukushi, Aiko Fukuma, Hideki Tani, Tomoki Yoshikawa, Satoshi Taniguchi, Ming Yang, Masami Sugamata, Shigeru Morikawa & Masayuki Saijo

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Predominance and high antibiotic resistance of the emerging Clostridium difficile genotypes NAPCR1 and NAP9 in a Costa Rican hospital over a 2-year period without outbreaks

Predominance and high antibiotic resistance of the emerging Clostridium difficile genotypes NAPCR1 and NAP9 in a Costa Rican hospital over a 2-year period without outbreaks

Emerging Microbes & Infections 5, e42 (May 2016). doi:10.1038/emi.2016.38

Authors: Diana López-Ureña, Carlos Quesada-Gómez, Mónica Montoya-Ramírez, María del Mar Gamboa-Coronado, Teresita Somogyi, César Rodríguez & Evelyn Rodríguez-Cavallini

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Mortality Risk of Antipsychotic Dose and Duration in Nursing Home Residents with Chronic or Acute Indications - American Geriatric Society

Objectives

To examine disease-specific associations between antipsychotic dose and duration and all-cause mortality.

Design

Retrospective cohort study.

Setting

A 5% random sample of Medicare beneficiaries who had a Minimum Data Set 2.0 clinical assessment completed between 2007 and 2009.

Participants

Three mutually exclusive cohorts of new antipsychotic users with evidence of severe mental illness (SMI, n = 5,621); dementia with behavioral symptoms (dementia + behavior) without SMI (n = 1,090); or delirium only without SMI or dementia + behavior (n = 2,100) were identified.

Measurements

Dose and duration of therapy with antipsychotics were assessed monthly with a 6-month look-back. Dose was measured as modified standardized daily dose (mSDD), with a mSDD of 1 or less considered below or at recommended maximum geriatric dose. Duration was categorized as 30 or fewer, 31 to 60, 61 to 90, and 91 to 184 days for SMI and dementia + behavior and 7 or fewer, 8 to 30, 31 to 90, and 91 to 184 days for delirium. Complementary log-log models with mSDD and duration as time-dependent variables were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for mortality.

Results

In all three groups, new antipsychotic users with a mSDD of 1 or less had significantly lower mortality risk (HR_SMI = 0.77, 95% CI = 0.67–0.88; HR_{dementia+behavior} = 0.52, 95% CI = 0.36–0.76; HR_delirium = 0.61, 95% CI = 0.44–0.85) than peers with a mSDD greater than 1. Individuals with longer duration of antipsychotic use (91–184 days for SMI and delirium) had significantly lower mortality than those with a short duration of use (≤30 days for SMI; ≤7 days for delirium). The interaction between dose and duration was statistically significant in the SMI cohort (P < .001).

Conclusion

Lower mortality was observed with within-recommended dose ranges for dementia + behavior, SMI, and delirium and with long duration of antipsychotic use for the latter two disease groups. Prescribers should monitor antipsychotic dosage throughout the course of antipsychotic treatment and customize dose and duration regimens to an individual's indications.

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United Natural Trading LLC Announces Voluntary Recall of Walnuts - FDA Safety Alerts & Drug Recalls

United Natural Trading LLC, d/b/a Woodstock Farms Manufacturing, Edison, NJ, is voluntarily recalling a limited number of lots of conventional walnuts and walnut-containing products (see attachment for products and lot numbers) that were purchased from Gibson Farms and sold under the Nature’s Promise, Woodstock, Market Basket, and Woodfield Farms brands due to a possible health risk from Listeria monocytogenes.

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Frontier Co-op Initiates Voluntary Recall of Organic Hojicha Tea Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Frontier Co-op is voluntarily recalling its Organic Hojicha Tea due to potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Acting Administrator Slavitt Speech at Datapalooza - CMS Blog

Below are the prepared remarks of CMS Acting Administrator Andy Slavitt at Datapalooza on May 10, 2016. Follow Andy on Twitter, @aslavitt. 

There’s a bit of a checklist for speaking at Datapalooza. Thank Niall. Mention Todd Park. Remark at how big the event has gotten compared to last year. Recap how much progress has been made. Refer to yourself as a “data geek” . Also, have in my notes “Good not to follow Farzad or Aneesh” . Perhaps even make some news with an announcement or grant or contest. Several of my colleagues did this and I share their excitement.

But I’m not going to make news. Instead, I’m going to relay a bit of my personal experience with health care innovation and technology as my goal is to leave this job with nothing really left unsaid. Twitter, by the way, seems to be helping with that.

Lately, we’ve been contemplating a significant transformation of the Medicare program by implementing the bi-partisan MACRA legislation. Legislation to make a wholesale change in the Medicare payment system to pay for quality. This has caused me to begin an obsession with the plight of independent physicians, knowing as we all do that if we don’t invest in primary care, we’ll invest double or triple when people get unnecessarily sick. And as a steward of programs where people with the lowest incomes and in the most remote locations get care, I know that without access, it will be people that can afford it the least that suffer first and most.

Starting in January, we began an unprecedented effort to engage and listen to physicians and patients and close the gap between policy-making and front line care. We had more than 6,000 conversations with physicians, with patients, with innovators in local communities, in their office, in focus groups and in workshops — collecting stories and seeking criticism we could act on. I’ve listened to a number of stories of doctors who feel burned out and eager to retire, but who hang in there only for their patients.

We have had extraordinary learnings. Learnings that come only when you spend months and months listening to thousands of physicians, patients and other clinicians all over the country. With many hours of observations, what became clear was that the combination of technology, regulation and measurement took time away from patients and provided nothing or little back in return. Among other things, physicians are baffled by what feels like the “physician data paradox.” They are overloaded on data entry and yet rampantly under-informed. And physicians don’t understand why their computer at work doesn’t allow them to track what happens when they refer a patient to a specialist when their computer at home connects them everywhere.

Through these conversations, one thing became very clear. As we move to a system based on quality measurement, we need to radically simplify and support physicians and patients with technology that works for them. What we call “interoperability” at this point would not be considered an impressive achievement by physicians. At best, it would count as making the technology work. A specialist in Chicago told us, “I think that the one thing that this really could’ve added to patient care is the one thing that hasn’t happened. The systems don’t talk to each other. It’s actually the opposite. With one of the EMRs I used, I can’t even access it at the hospital because of the firewall. I can’t even get into the EMR at the hospital to look at patient records.”

Discouraging? I have a hopeful experience with technology that started out . . . discouraging.

I arrived in Washington two-and-a-half years ago and the occasion for my arrival was that technology was putting national health reform at risk. Health reform that we had waited so long for. Tens of millions of Americans needed health coverage and we waited for the technology of HC.gov to deliver. Once again, technology was the problem.

Until it wasn’t. After a while, except for some aftermath stories, you never heard about the technology again and next thing you know, we had 20 million new people covered with health insurance.

What you didn’t hear was that within months after we had technology functioning, for the first time across the country, we were using technology to do things that had never been done before and redefining the very value proposition of health insurance.

• Using complex analytics, and a real time data hub, we were signing people up for coverage in real time when up until then, in Medicaid, for example families and children had to wait months to find out if they were even eligible.

• By last year, technology had redefined the way health care is offered and purchased in America. The easy comparison of plans has brought down prices and created more service offerings. People who shopped and switched plans saved an average of $500/month and many “direct services” are now offered outside of a deductible to lure consumers.

• And consumers changed the way they shopped. On a daily basis, gov crawls the websites of all the health plans for their provider directories and formularies. So instead of looking for a health plan, consumer can search for a prescriptions drug they needed or a doctor or hospital they want to see and the technology will match them with a plan.

• Last year, in a single day, we watched as 500,000 people, many using mobile devices, signed up for coverage.

Health insurance costs less and offers more services because information was put to work for people. Just like it has in so many areas of people’s lives, like buying a car or getting same day shipping, technology has made our lives better and made a system work better.

What was responsible for the shift? A relentless focus on getting the customer what they wanted and making it a clear national focus. 

I relay this as I stand here today with eight-and-a-half months left in Washington because I can’t help but reflect on the parallel set of circumstances as it relates to technology and innovation in care delivery. Like the major change we went through as we improved access to coverage, we are now on the cusp of an equally transformative change in quality and affordability– paying physicians and hospitals for providing the right care. Yet now, while technology supports us in getting coverage, it is failing us in the care experience.

Health care is actually full of the same tasks over and over– getting a referral, getting discharged from a hospital, scheduling a follow up appointment. Yet the system treats us as if we’re doing everything for the first time and seems remarkably surprised by our activities. Robots can perform your mom’s surgery. But reminding her to fill her prescription? No! Telling her primary care doc how the surgery went and arranging a follow up? Seems to be too hard.

And guess what we know: all those things that happen to her after the surgery can be just as important as what happens during the surgery. Technology isn’t doing the things we know it can– help us make smarter decisions, reduce our wasted time, help us communicate or understand what to expect next.

I have the same feeling we faced two-and-a-half years ago as we turned around healthcare.gov. Physicians may be more skeptical now about the promise of IT than anyone was at that time. But just as we did then, we must re-focus on our customer and we must rise above our proprietary interests to make this a national priority. Having seen it happen, I know we can get this right.

So what are we doing about it?

This leads back to the MACRA implementation and the opportunity it gave us to re-think Meaningful Use. We may have surprised people with the changes we began to discuss, but it wasn’t discouragement, but confidence, that caused us to make this move. Confidence that if we worked closely with patients, clinicians, and the private sector, we could change the focus from payments and measurements and programs and a fragmented experience back to supporting patient-centered care. We committed to taking a page out of the consumer technology playbook and taking a user-centered approach to designing policy.

What we learned in all of our listening reinforces our effort around five significant strategic steps we have been undertaking:

1. The massive, unprecedented release of data which this conference has been all about.
2. Changing incentives through the CMS Innovation Center to pay physicians and hospitals more for practicing quality and coordinating care.
3. The creation of a single set of “core” quality measures across all payers so physicians can just do it one way for all their patients.
4. Advancing interoperability, requiring Open APIs and exposing data blocking practices so data can follow a patient and new apps can become plug and play.
5. And, a proposed replacement of Meaningful Use and streamlining of quality measures to put the needs of the users — clinicians and patients — back in the center.

These steps are designed to make it easier for you to innovate, to open up competition, and to move the focus from designing around regulations to allowing you to design around patients and physician’s needs. So, as I speak here for the final time as the CMS Administrator, the opportunity for you to transform health care into an information industry has never been more ripe… or more urgent. No new inventions needed. Just three things I ask you to think about.

1. Take stock of where you are in history. 

It’s time to think bigger. If it’s true that change breeds opportunity, as we implement MACRA to fully change Medicare payments to pay for quality, we are in the midst of the biggest change in our health care system since the 1960s and the beginnings of Medicare and Medicaid. Twenty million new people are accessing coverage; a boom generation is turning 70 and the 85+ generation is set to double in the next few years, taxing families and the system like never before. The affordability of health care and prescription drugs in specific is a top-tier issue for consumers by almost any study. And disaffection among physicians is significant, overloaded by change, lacking in support and fearful that their profession and independence is under assault.

For all of these macro changes, very little technology has yet to be created to make this change work. In short, it’s the perfect time to be an innovator. You can help change the course of history. We must learn how to take care of people better in their own homes and communities. We need to empower physicians so that technology improves their morale, not saps it. An entirely new operating system for health care will be needed to support it.

2. Second, find those out-ahead physicians that can define the needs for everyone else.

I sat down with a physician from Vanguard Medical Group, a primary care practice in New Jersey to listen to input on the roll out of the Quality Payment Program. Dr. McCarrick told me that since his practice became a medical home and was given the incentives and freedom to take care of patients the way they wanted to, his office has exploded with innovation. He told me that now that payments have caught up with the way they wanted to practice medicine, he can focus entirely on caring for his patients. He’s found new ways to reach his aging and increasingly lonely and isolated patients. He’s creating Skype “villages” for elder, disabled, homebound patients so they can now not only talk to their physician once a week, but their sister across the country, their granddaughter in college, and other people in their same situation.

Dr. Bevill in rural Arkansas, who is also an early participant in a payment model rolling out now across the country, told me that unlike most physicians he talks to, he has figured out how technology can help him spend more time with patients when they visit. All his patients are risk stratified and a care coordinator leaves an iPad in the exam room displaying everything he needs to know on it, including all prevention and screening recommendations. He says he leaves it lying flat so it doesn’t get in the way of the conversation with the patient.

These physicians that are already in medical home models and bundles are at the leading edge of a huge wave. Already roughly 11 million patients are in a Medicare ACO. We’ve just launched the largest medical home model in history. As of April, approximately half of all hip and knee replacements are being paid for in a bundled payment requiring inpatient and outpatient collaboration. And next year, as the new Quality Payment Program that is introduced by MACRA, every Medicare physician will be in a program that rewards quality and coordinated care in some form.

Physicians don’t need to get “pushed” into using technology with incentives to show they’re clicking. They are “pulled” in because they need collaboration tools. The purpose of new payment models is to give care providers the freedom to do what they think is right. Your opportunity is to allow it to happen. Go find them and talk to them– design for them.

3. Finally, with respect to some important business practices: it’s time to lead, follow or get out of the way.

At CMS we oversee the care needs of 140 million Americans in Medicare, Medicaid, CHIP and Marketplace plans. When you microscope their lives, almost all have moderate or fixed incomes and face a fragmented, mystifying health care system at their most vulnerable time– finding a nursing home for a parent, waiting on a biopsy, traveling by bus to a dialysis center, caring for a child with a disability. All of the handoff points are where the avoidable complications kick in.

If you want to lead the way with innovations that help consumers, great.

If you want to follow by using established standards for data and measurement and technology, also great.

If you have a business model which relies on silo-ing data, not using standards, or not allowing data to follow the needs of patients, pick a new business model or pick a new business. What Vice President Biden said should stick with us– as taxpayers, we did not spend $35 billion so companies could build their own silos.

There are a set of patient-friendly business practices everyone should follow:

• Eliminate language from contracts that slows down the ability of the system to plug and play.
• Make all your data machine readable and put it on an edge server so it can be securely and easily called to answer questions.
• Provide physicians with data on their patients in real time and with feeds into their workflow, not your portal.
• Use open APIs to be sure your technology is plug and play and with that, break the lock that early EHR decisions have placed on the physician desktop.

At this stage, there is no room for business practices that don’t match the need of patients.

Without better connected and easier to use technology, I worry most about the people with the least access to care. I worry about the independent physician practice. I worry about our country’s Cancer Moonshot. But mostly I worry that the moral underpinnings of our public-private health care system won’t support where we need to go. And that will mean our chances of any meaningful success will be held up, not because we can’t do it, but because we won’t do it.

When we put our minds to it, I have seen how much technology can radically improve health care and how fast. MACRA is the burning platform for progress in care delivery, just as the ACA was in health care coverage. Together, we can make the system radically better.

My job, like all of yours is filled with moments. Moments of human interaction that stand out. Some have snapped me to attention and action, like the time I spent at a dialysis center with people whose kidneys were slowly failing. Or when I met with Denis Heaphy, a young man living with disabilities in Boston, but who flew down to meet with me in D.C. because there was something I could do to help make sure he could continue to live independently. Letters from people whose lives were saved because they got insurance for the first time.

I had a moment last week that I will always remember, especially with my drive to simplify for medical practices. It was the last few minutes I spent with Dr. Bevill from Sama Healthcare in Arkansas– the one with the iPad and the focus on prevention. He showed me a photo of the entire office staff who wear t-shirts that say “Team Sama” and patients coming in to see him who say “the atmosphere feels electric.” Then he leaned over and confessed to me that his partner had been planning to retire, but now that he was free to practice medicine, he plans to practice until at least 70. As I looked at the picture, I noticed a quote from the Sama practice manager Pete Atkinson that made it all make sense in a way I know Vice President Biden will appreciate. It’s simple– “We find a stage 1 cancer rather than a stage 3 cancer.”

Let’s go help everyone do that.

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