Lee Seed Company, Inc. Issues Allergy Alert on Undeclared Milk in Yogurt Super Soynuts - FDA Safety Alerts & Drug Recalls

Lee Seed Company, Inc. of Inwood, Iowa is recalling Yogurt Super Soynuts because the product contains undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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Food Bank Recalls Canned Mandarin Oranges Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Duquesne,PA - Greater Pittsburgh Community Food Bank is announcing a voluntary recall of one lot of Imperial Choice Mandarin Oranges Broken Segments in Light Syrup because some of the cans from this lot may leak, bulge or burst open. The product may be contaminated by spoilage organisms or pathogens, which could lead to serious or life-threatening illness if consumed.

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R.W. Baker Co. Issues Allergy Alert on Undeclared Peanuts in "Meijer Plain Knot Rolls" "Assorted Dinner Rolls 128 ct." - FDA Safety Alerts & Drug Recalls

R.W. Bakers Co. of Muskegon, MI, is recalling its 8 ct. packages of "Meijer Plain Knot Rolls" and 8 ct. packages of “Assorted Dinner Rolls 128 ct.” because they may contain trace amounts of undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Flowers Foods Issues Allergy Alert and Voluntary Recall on Cobblestone Bread Co. Wheat English Muffins in CT, DE, KY, ME, MD, MA, NH, NJ, NY, NC, OH, PA, RI, SC, TN, VT, VA, DC, and WV - FDA Safety Alerts & Drug Recalls

Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Cobblestone Bread Co. Wheat English Muffins with the UPC # 0 72250 01316 1 and best by dates of October 28, 2015 through April 10, 2016 because they contain undeclared milk. People who have allergies to dairy products run the risk of serious or life-threatening allergic reaction if they consume these products.

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The Marketplace Risk Adjustment Program: Promoting Access, Quality, and Choice for Consumers - CMS Blog

By Kevin Counihan, CEO of the Health Insurance Marketplaces
Dr. Patrick Conway, CMS Acting Principal Deputy Administrator

This week, CMS brings together health care stakeholders and experts to discuss an esoteric sounding, yet important, topic: the individual and small group market risk adjustment programs created by the Affordable Care Act (ACA).  Risk adjustment is critical to making the ACA’s better-known market reforms work well for insurers and consumers. By reducing incentives for issuers to try to design products that attract a healthy risk pool, risk adjustment lets issuers compete on quality, price, and products that meet the needs of all consumers, protecting consumers’ access to a range of robust options.

Risk adjustment is a longstanding and important part of the Medicare Advantage and Medicare Prescription Drug Programs and has proven effective in making these programs work well for seniors.  Likewise, the ACA’s risk adjustment program is already delivering on its promise of affordable coverage that meets consumers’ needs. But, there is always room for improvement.

That’s why CMS recently released a white paper (http://ift.tt/1pI9eBW) that evaluates our experience with the risk adjustment formula to date and analyzes possible changes. The white paper provides data and analysis about how the program has operated in the past, so that information, best practices, and ideas for improvement can be shared. And that’s why we’re bringing a broad range of stakeholders together to discuss these issues.

As we consider comments and feedback in our meeting on Thursday, March 31, on the future of the ACA’s risk adjustment program, we will keep in mind key principles to simultaneously make improvements while staying true to the goals of the program.

Promoting Access, Quality, and Choice for Consumers with Diverse Health Care Needs

Before the ACA, Americans with pre-existing medical conditions were often left out of the health insurance market. Now, because of the ACA, Americans with pre-existing condition can no longer be charged more or denied coverage just because they’ve been sick.

This means that insurance companies have had to adapt to a new way of working.  Instead of “medical underwriting” – a practice where an insurance company requires you to disclose your health status to determine whether to offer you coverage, at what price, and with what exclusions – insurance companies must offer you coverage regardless of your health status and can’t charge you more for being sick.

Risk adjustment is an essential part of making the individual and small group markets work well under a system where everyone, including people with pre-existing conditions, can buy high-quality coverage.

Through risk adjustment, insurance companies with sicker-than-average enrollees receive payments from other health insurance companies with healthier-than-average enrollees. That means that issuers make or lose money based on the characteristics of the products they offer, rather than how sick or healthy their enrollees are. This, in turn, lets issuers compete in the market by designing products that meet the needs of all consumers, rather than designing products to be unattractive to those who are sick.

For example, thanks to risk adjustment, it can make financial sense for issuers to develop specialized care management programs to meet the needs of people with chronic or other conditions. If such plans attract more expensive enrollees, issuers know they will be compensated by risk adjustment.

We are already seeing some Marketplace plans innovate in this area to meet the needs of consumers with challenging health issues, for example by offering plans that focus on diabetes management and other chronic illnesses. Risk adjustment may also help new or smaller businesses participate in the market without fear of attracting a large number of sick enrollees in any particular year.

Assessing the Marketplace Risk Adjustment Program

The risk adjustment methodology was designed with input from trade associations, insurance companies, actuaries, clinicians, economists, and other members of the public. It was implemented through rulemaking with a public notice and comment period. CMS worked closely with health insurance companies to ensure that the risk adjustment program uses the best available data. And all insurance companies – large and small, new or established – play by the same rules.

The first finding of the CMS white paper is that the risk adjustment program has largely worked as intended to date. For the 2014 benefit year, the formula successfully transferred $4.6 billion from issuers with healthier enrollees to issuers with sicker enrollees.  Our data and an outside independent analysis (http://ift.tt/1MTQVz2) found that the main determinant of whether an issuer received a payment is the relative health of their enrollees, which is a sign of health for the program.

These analyses also show that the formula hasn’t favored large plans over small plans, or the reverse, indicating no bias by the size of the plan or insurance company. We expect performance of the program to improve with experience. Accurate risk adjustment payments depend on issuers accurately collecting, managing, and submitting data on their population’s health. While the ACA-compliant individual and small group markets are still relatively new, these core capabilities appear to have worked well in 2014 and we expect will contribute to successful health plan operation even in a market without risk adjustment.

What’s Next?

We have recently made and announced a number of changes to risk adjustment. In response to issuers’ requests for earlier information, we distributed risk adjustment data reports to insurance companies earlier this month to help them with setting their 2017 rates. These early reports rely on the information insurance companies report to CMS, and so they are only available in markets where sufficient issuers had submitted their data, and they are only as accurate as the data provided. This is why it is important that the companies focus on data management to fully and accurately report their experience and try to do so as early in the year as feasible.

We have also made some other adjustments to the methodology for the 2017 plan year including using more recent data, updating medical and drug trends, and incorporating preventive services into companies’ risk adjustment calculations.

As we contemplate making additional changes, we want to get more input from the public. And that’s the purpose of the public meeting on risk adjustment. As outlined in more detail in the white paper, some of the ideas we want to discuss include: whether and how to account for partial year enrollment in the model; whether and how to develop a prescription drug model, accounting for newer high-cost medications; whether and how to pool high risk enrollees; and whether and how to recalibrate the model based on data for the individual and small group populations, instead of a commercial dataset drawn from the employer market.

We look forwarding to hearing feedback from the public about these and other possible changes to the risk adjustment program.

We will continue to listen and learn to make sure we operate this vital program to maximum effect. We will take feedback and suggestions through April 22, 2016, and will keep the public informed as we consider proposals to change and improve the risk adjustment program in 2018 to serve the goals of providing affordable coverage and better care for millions of Americans.

Filed under: Uncategorized

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CMS Invites Quality Innovation Network-Quality Improvement Organizations to Submit Special Innovation Projects to Expand Their Reach in Improving Care Delivery - CMS Blog

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

Kate Goodrich, MD MHS
Director
Center for Clinical Standards and Quality

Jean Moody-Williams, RN, MPP
Deputy Director
Center for Clinical Standards and Quality

Dennis Wagner, MPA
Director, Quality Improvement and Innovation Group
Center for Clinical Standards and Quality

The Centers for Medicare & Medicaid Services’ (CMS) Quality Improvement Organization (QIO) Program is constantly evolving to help ensure that Medicare beneficiaries receive better care, better health, and greater value. Today, CMS is announcing the program’s next evolution: two projects focused on supporting and scaling quality improvement innovations.

With this announcement, Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs) can collaborate with health care providers and/or partners to compete for 28 Special Innovation Project (SIP) awards that fall within two topic categories totaling $8 million.

SIPs are two-year quality improvement projects that align with the goals of the CMS Quality Strategy (http://ift.tt/1LajAlI) and emphasize the power of partnerships. There are two categories of SIPs for QIN-QIOs to consider:

1. “Innovations that Advance Local Efforts for Better Care and Smarter Spending,” which will address healthcare quality issues that occur within specific QIN-QIO regions.

2. “Interventions that are Ripe for Spread and Scalability,” which will focus on expanding the scope and national impact of a quality improvement project that has experienced proven but limited success. The expectation is that similar benefits would be experienced on a large scale if spread throughout the greater health care community.

The scalability category aligns with the CMS Strategic Innovation Engine (SIE) (http://ift.tt/1RJzOnN), a new endeavor launched in August of 2015. The SIE is working to rapidly move innovative, evidence-based quality practices from research to implementation through the QIO Program. In consultation with the SIE Executive Leadership Council, CMS is seeking projects that:

• Streamline patient flow in various health care settings, including hospital units, outpatient clinics, primary care offices, ambulatory surgical centers, and cancer centers resulting in efficiencies, improved satisfaction, decreased mortality, better care, healthier people, and smarter spending.
• Work with health plans and/or care coordination providers to deploy an integrated approach to post-acute care that results in enhanced care management, safe transitions from one care setting to another, improved health outcomes, and reductions in harms.
• Increase value, patient affordability, and appropriate use of specialty drugs by applying evidenced based criteria to prescribing practices and by monitoring effectiveness when providers have a choice(s) among equally effective drugs with differing costs.

• Address acute pain management. For example, more is needed to assist sickle cell patients: from accurate identification of their illness to education of emergency department staff on sickle cell disease while addressing the cultural stigmas often associated with the disease.

• Utilize big data analytics to reduce preventable harm in healthcare.

We encourage those in the larger healthcare community who are leading quality work in these areas, with interventions and proven results, to reach out and explore potential partnerships with QIN-QIOs. Through collaboration with healthcare providers, patients, families, and other key stakeholders, QIN-QIOs have tremendous potential to take those interventions to the national level and improve the health care delivery system by tapping into new settings of care and building upon the knowledge gained by people working on the front line of providing quality health care.

The QIN-QIOs selected to carry out these SIPs will leverage their data-driven approach, extensive partnerships, and the voices of patients and families to positively impact Medicare beneficiaries in their communities and nationwide.

The QIO Program’s 14 QIN-QIOs work with providers, community partners and beneficiaries on multiple data-driven quality improvement initiatives to improve patient safety, reduce harm, engage patients and families, improve clinical care and reduce healthcare disparities. For more information about the CMS QIO Program and for a complete list of QIN-QIOs, please visit the QIO Program website (http://ift.tt/1M0KMpR).

Filed under: Uncategorized

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FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow - FDA Press Releases

The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition.

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FDA allows use of investigational test to screen blood donations for Zika virus - FDA Press Releases

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.

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B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Lot J5J706, 5% Dextrose Injection USP in PAB Container Due to Leakage and/or Particulate Matter Identified To Be Microbial Growth - FDA Safety Alerts & Drug Recalls

B. Braun Medical Inc. of Irvine, CA is voluntarily recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog # S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth.

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Geriatrics Education Team Model Results in Sustained Geriatrics Training in 15 Residency and Fellowship Programs and Scholarship - American Geriatric Society

Caring for the growing elderly population will require specialty and subspecialty physicians who have not completed geriatric medicine fellowship training to participate actively in patient care. To meet this workforce demand, a sustainable approach to integrating geriatrics into specialty and subspecialty graduate medical education training is needed. This article describes the use of a geriatrics education team (GET) model to develop, implement, and sustain specialty-specific geriatrics curricula using a systematic process of team formation and needs assessment through evaluation, with a unique focus on developing curricular interventions that are meaningful to each specialty and satisfy training, scholarship, and regulatory requirements. The GET model and associated results from 15 specialty residency and fellowship training programs over a 4-year period include 93% curriculum sustainability after initial implementation, more than half of the programs introducing additional geriatrics education, and more than 80% of specialty GETs fulfilling their scholarship requirements through their curriculum dissemination. Win–wins and barriers encountered in using the GET model, along with the model's efficacy in curriculum development, sustainability, and dissemination, are summarized.

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Revised Press Release For: "Reliable Drug" Recall of all Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance - FDA Safety Alerts & Drug Recalls

Reliable Drug Pharmacy is voluntarily recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall.

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QFC Issues Allergy Alert on Undeclared Pecans, Wheat, and Soy in Cranberry Chicken Salad - FDA Safety Alerts & Drug Recalls

QFC said it had recalled its Fresh Food Market Cranberry Chicken Salad that is sold in QFC stores, located in Oregon and Washington. The product may be mislabeled and may contain pecans, wheat, and soy not listed on the label.

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"Reliable Drug" Recalls All Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance - FDA Safety Alerts & Drug Recalls

Reliable Drug Pharmacy is voluntarily recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California.

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Smallbatch Pets Inc. Voluntarily Recalls Frozen Dog Duckbatch Sliders Due to Possible Salmonella and Listeria Monocytogenes Health Risk - FDA Safety Alerts & Drug Recalls

Smallbatch Pets Inc. is voluntarily recalling one lot of frozen dog duckbatch sliders due to their potential to be contaminated with Salmonella and Listeria monocytogenes.

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Pyrrocidine A, a metabolite of endophytic fungi, has a potent apoptosis-inducing activity against HL60 cells through caspase activation via the Michael addition - Journal of Antibiotics

Pyrrocidine A, a metabolite of endophytic fungi, has a potent apoptosis-inducing activity against HL60 cells through caspase activation via the Michael addition

The Journal of Antibiotics 69, 133 (March 2016). doi:10.1038/ja.2015.103

Authors: Shota Uesugi, Nozomi Fujisawa, Jun Yoshida, Mitsuru Watanabe, Shingo Dan, Takao Yamori, Yoshihito Shiono & Ken-ichi Kimura

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Aspergillus mulundensis sp. nov., a new species for the fungus producing the antifungal echinocandin lipopeptides, mulundocandins - Journal of Antibiotics

Aspergillus mulundensis sp. nov., a new species for the fungus producing the antifungal echinocandin lipopeptides, mulundocandins

The Journal of Antibiotics 69, 141 (March 2016). doi:10.1038/ja.2015.105

Authors: Gerald F Bills, Qun Yue, Li Chen, Yan Li, Zhiqiang An & Jens C Frisvad

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Prevalence of mutations conferring resistance among multi- and extensively drug-resistant Mycobacterium tuberculosis isolates in China - Journal of Antibiotics

Prevalence of mutations conferring resistance among multi- and extensively drug-resistant Mycobacterium tuberculosis isolates in China

The Journal of Antibiotics 69, 149 (March 2016). doi:10.1038/ja.2015.106

Authors: Yan Chen, Bing Zhao, Hai-can Liu, Qing Sun, Xiu-qin Zhao, Zhi-guang Liu, Kang-lin Wan & Li-li Zhao

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Micromonospora lycii sp. nov., a novel endophytic actinomycete isolated from wolfberry root (Lycium chinense Mill) - Journal of Antibiotics

Micromonospora lycii sp. nov., a novel endophytic actinomycete isolated from wolfberry root (Lycium chinense Mill)

The Journal of Antibiotics 69, 153 (March 2016). doi:10.1038/ja.2015.109

Authors: Junwei Zhao, Lifeng Guo, Chongxi Liu, Yuejing Zhang, Xuejiao Guan, Jiansong Li, Shilin Xu, Wensheng Xiang & Xiangjing Wang

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Streptomyces hyaluromycini sp. nov., isolated from a tunicate (Molgula manhattensis) - Journal of Antibiotics

Streptomyces hyaluromycini sp. nov., isolated from a tunicate (Molgula manhattensis)

The Journal of Antibiotics 69, 159 (March 2016). doi:10.1038/ja.2015.110

Authors: Enjuro Harunari, Moriyuki Hamada, Chiyo Shibata, Tomohiko Tamura, Hisayuki Komaki, Chiaki Imada & Yasuhiro Igarashi

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Synthesis of Thienamycin methyl ester from 2-deoxy-d-ribose via Kinugasa reaction - Journal of Antibiotics

Synthesis of Thienamycin methyl ester from 2-deoxy-d-ribose via Kinugasa reaction

The Journal of Antibiotics 69, 164 (March 2016). doi:10.1038/ja.2015.108

Authors: Magdalena Soluch, Barbara Grzeszczyk, Olga Staszewska-Krajewska, Marek Chmielewski & Bartłomiej Furman

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Increased resistance rate to ceftazidime among blood culture isolates of ESBL-producing Escherichia coli in a university-affiliated hospital of China - Journal of Antibiotics

Increased resistance rate to ceftazidime among blood culture isolates of ESBL-producing Escherichia coli in a university-affiliated hospital of China

The Journal of Antibiotics 69, 169 (March 2016). doi:10.1038/ja.2015.100

Authors: Xiao-Yan Yuan, Dong-Ying Yu, Xue-Hong Qu, Xin-Qiang Xiao, Bo Bi, Sheng-Bo Sun, Ai-Ying Chang & Qi-bo Zhang

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Antimycobacterial activity of five efflux pump inhibitors against Mycobacterium tuberculosis clinical isolates - Journal of Antibiotics

Antimycobacterial activity of five efflux pump inhibitors against Mycobacterium tuberculosis clinical isolates

The Journal of Antibiotics 69, 173 (March 2016). doi:10.1038/ja.2015.101

Authors: Guilian Li, Jingrui Zhang, Chao Li, Qian Guo, Yi Jiang, Jianhao Wei, Yan Qiu, Xiuqin Zhao, Li-li Zhao, Jianxin Lu & Kanglin Wan

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Coccoquinones A and B, new anthraquinone derivatives produced by Staphylotrichum coccosporum PF1460 - Journal of Antibiotics

Coccoquinones A and B, new anthraquinone derivatives produced by Staphylotrichum coccosporum PF1460

The Journal of Antibiotics 69, 176 (March 2016). doi:10.1038/ja.2015.102

Authors: Daisuke Tatsuda, Masahide Amemiya, Ryuichi Sawa, Kengo Sumiyoshi, Takumi Watanabe, Isao Momose, Manabu Kawada, Akio Nomoto & Masakatsu Shibasaki

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Increasing antibiotic production yields by favoring the biosynthesis of precursor metabolites glucose-1-phosphate and/or malonyl-CoA in Streptomyces producer strains - Journal of Antibiotics

Increasing antibiotic production yields by favoring the biosynthesis of precursor metabolites glucose-1-phosphate and/or malonyl-CoA in Streptomyces producer strains

The Journal of Antibiotics 69, 179 (March 2016). doi:10.1038/ja.2015.104

Authors: Daniel Zabala, Alfredo F Braña, José A Salas & Carmen Méndez

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Antibacterial effects of nitric oxide on uropathogenic Escherichia coli during bladder epithelial cell colonization—a comparison with nitrofurantoin - Journal of Antibiotics

Antibacterial effects of nitric oxide on uropathogenic Escherichia coli during bladder epithelial cell colonization—a comparison with nitrofurantoin

The Journal of Antibiotics 69, 183 (March 2016). doi:10.1038/ja.2015.112

Authors: Ravi Vumma, Charlotte Sahlberg Bang, Robert Kruse, Kjell Johansson & Katarina Persson

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Curromycin A as a GRP78 downregulator and a new cyclic dipeptide from Streptomyces sp. - Journal of Antibiotics

Curromycin A as a GRP78 downregulator and a new cyclic dipeptide from Streptomyces sp.

The Journal of Antibiotics 69, 187 (March 2016). doi:10.1038/ja.2015.115

Authors: Yoichi Hayakawa, Minami Akimoto, Akari Ishikawa, Masumi Izawa & Kazuo Shin-ya

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Trader Joe's Issues Voluntary Allergy Alert on Undeclared Milk in Chocolate Orange Sticks and Chocolate Raspberry Sticks - FDA Safety Alerts & Drug Recalls

Trader Joe's of Monrovia, California is voluntarily recalling all codes of Trader Joe's Chocolate Orange Sticks (UPC 00847162) and Trader Joe's Chocolate Raspberry Sticks (UPC 00847122) because the products may contain more than the stated traces of milk on the label. All affected product has been removed from store shelves.

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American Gourmet Recalls American Gourmet Roasted/Salted Pistachios Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

American Gourmet of Vista, CA is recalling American Gourmet Roasted/Salted Pistachios because they may be contaminated with Salmonella. American Gourmet was informed by its Pistachio supplier to initiate a voluntary recall.

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Gerber is Voluntarily Recalling Two Batches of GERBER® Organic 2ND FOODS® Pouches Due to a Packaging Defect That May Result in Product Spoilage - FDA Safety Alerts & Drug Recalls

Gerber Products Company is voluntarily recalling specific Organic pouch products after identifying a packaging defect that may result in product spoilage during transport and handling. Because of our commitment to high quality, Gerber is working to retrieve from retailers and online stores the remaining pouches from the four affected batches of GERBER® Organic 2ND FOOD pouches that fail to meet our quality standards. We are offering replacement coupons for consumers who purchased the following products:

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FDA takes important step to increase the development of, and access to, abuse-deterrent opioids - FDA Press Releases

The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.

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AA USA Trading Inc. Issues Allergy Alert on Undeclared Sulfites in AA Brand Dried Ginger Slice - FDA Safety Alerts & Drug Recalls

AA USA Trading Inc. of South River, NJ is recalling ginger slice products packaged under the AA brand in 8-ounce plastic bags, because they may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA approves Cinqair to treat severe asthma - FDA Press Releases

The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

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Only a subset of C. canimorsus strains is dangerous for humans

Only a subset of C. canimorsus strains is dangerous for humans

Emerging Microbes & Infections 5, e29 (March 2016). doi:10.1038/emi.2016.43

Authors: Francesco Renzi, Melanie Dol, Alice Raymackers, Pablo Manfredi & Guy Richard Cornelis

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Mortality attributable to carbapenem-resistant Pseudomonas aeruginosa bacteremia: a meta-analysis of cohort studies

Mortality attributable to carbapenem-resistant Pseudomonas aeruginosa bacteremia: a meta-analysis of cohort studies

Emerging Microbes & Infections 5, e27 (March 2016). doi:10.1038/emi.2016.22

Authors: Yu Zhang, Xiao-Li Chen, Ai-Wei Huang, Su-Ling Liu, Wei-Jiang Liu, Ni Zhang & Xu-Zai Lu

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Alum: an old dog with new tricks

Alum: an old dog with new tricks

Emerging Microbes & Infections 5, e25 (March 2016). doi:10.1038/emi.2016.40

Authors: Yumei Wen & Yan Shi

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Enterovirus 71 induces dsRNA/PKR-dependent cytoplasmic redistribution of GRP78/BiP to promote viral replication

Enterovirus 71 induces dsRNA/PKR-dependent cytoplasmic redistribution of GRP78/BiP to promote viral replication

Emerging Microbes & Infections 5, e23 (March 2016). doi:10.1038/emi.2016.20

Authors: Jia-Rong Jheng, Shin-Chyang Wang, Chao-Rih Jheng & Jim-Tong Horng

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Antipsychotic Medication for Prevention and Treatment of Delirium in Hospitalized Adults: A Systematic Review and Meta-Analysis - American Geriatric Society

Objectives

To evaluate the effectiveness of antipsychotic medications in preventing and treating delirium.

Design

Systematic review and meta-analysis.

Setting

PubMed, EMBASE, CINAHL, and ClinicalTrials.gov databases were searched from January 1, 1988, to November 26, 2013.

Participants

Adult surgical and medical inpatients.

Intervention

Antipsychotic administration for delirium prevention or treatment in randomized controlled trials or cohort studies.

Measurements

Two authors independently reviewed all citations, extracted relevant data, and assessed studies for potential bias. Heterogeneity was considered as chi-square P < .1 or I² > 50%. Using a random-effects model (I² > 50%) or a fixed-effects model (I² < 50%), odds ratios (ORs) were calculated for dichotomous outcomes (delirium incidence and mortality), and mean or standardized mean difference for continuous outcomes (delirium duration, severity, hospital and intensive care unit (ICU) length of stay (LOS)). Sensitivity analyses included postoperative prevention studies only, exclusion of studies with high risk of bias, and typical versus atypical antipsychotics.

Results

Screening of 10,877 eligible records identified 19 studies. In seven studies comparing antipsychotics with placebo or no treatment for delirium prevention after surgery, there was no significant effect on delirium incidence (OR = 0.56, 95% confidence interval (CI) = 0.23–1.34, I² = 93%). Using data reported from all 19 studies, antipsychotic use was not associated with change in delirium duration, severity, or hospital or ICU LOS, with high heterogeneity among studies. No association with mortality was detected (OR = 0.90, 95% CI = 0.62–1.29, I² = 0%).

Conclusion

Current evidence does not support the use of antipsychotics for prevention or treatment of delirium. Additional methodologically rigorous studies using standardized outcome measures are needed.

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FDA approves new psoriasis drug Taltz - FDA Press Releases

The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis.

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FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death - FDA Press Releases

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

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NOW Health Group, Inc. Voluntarily Recalls Limited Quantity of Six Dietary Supplements Due to Mislabeling - FDA Safety Alerts & Drug Recalls

Bloomingdale, Ill. - NOW Health Group, Inc. is voluntarily recalling limited quantities of six dietary supplements that are mislabeled due to a printing error from the label supplier. The recall affects approximately 165 total units that were distributed nationally and sold in retail stores and online.

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H-E-B Issues Voluntary Recall: Select 5oz Hill Country Fare Chunk Light Tuna in Oil Recalled for Potential Health Risk - FDA Safety Alerts & Drug Recalls

H-E-B is voluntarily recalling 224 cases (10,752 cans) of Hill Country Fare brand 5 oz. Chunk Light Tuna in Oil. This recall has been initiated because the product, produced at a co-packer, may have been undercooked due to an equipment malfunction, which was uncovered during a routine inspection.

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Hospira Issues a Voluntary Recall for One Lot of Sodium Bicarbonate Injection, USP Due to the Presence of a Particulate - FDA Safety Alerts & Drug Recalls

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single-dose glass fliptop vial. The issue was identified through a confirmed complaint.

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FDA proposes ban on most powdered medical gloves - FDA Press Releases

Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.

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FDA approves new treatment for inhalation anthrax - FDA Press Releases

On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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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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Care-Delivery Interventions to Manage Agitation and Aggression in Dementia Nursing Home and Assisted Living Residents: A Systematic Review and Meta-analysis - American Geriatric Society

Objectives

To evaluate the efficacy of nonpharmacological care-delivery interventions (staff training, care-delivery models, changes to the environment) to reduce and manage agitation and aggression in nursing home and assisted living residents.

Design

Three bibliographic databases, references of systematic reviews, ClincalTrials.gov, and the International Controlled Trials Registry Platform were systematically searched for randomized controlled trials reporting behavioral outcomes for nonpharmacological care-delivery interventions in nursing homes and assisted living facilities. Five investigators independently assessed study eligibility, extracted data, rated risk of bias, and graded strength of evidence. Inclusion was limited to studies with low to moderate risk of bias.

Setting

Nursing homes and assisted living facilities.

Participants

Facility caregiving staff.

Measurements

Agitation, aggression, antipsychotic and other psychotropic use, general behavior.

Results

Nineteen unique studies met entry criteria, addressing several categories of facility caregiver training interventions: dementia care mapping (DCM; n = 3), person-centered care (PCC; n = 3), clinical protocols to reduce the use of antipsychotic and other psychotropic drugs (n = 3), and emotion-oriented care (n = 2). Eleven additional studies evaluated other unique interventions. Results were pooled for the effect of each type of intervention on agitation and aggression: DCM (standardized mean difference −0.12, 95% confidence interval (CI) = −0.66 to 0.42), PCC (standardized mean difference −0.15, 95% CI = −0.67 to 0.38), and protocols to reduce antipsychotic and other psychotropic use (Cohen-Mansfield Agitation Inventory mean difference −4.5, 95% C = −38.84 to 29.93). Strength of evidence was generally insufficient to draw conclusions regarding efficacy or comparative effectiveness.

Conclusion

Evidence was insufficient regarding the efficacy of nonpharmacological care-delivery interventions to reduce agitation or aggression in nursing home and assisted living facility residents with dementia.

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Managing Agitation and Aggression in Congregate Living Settings: Efficacy and Implementation Challenges - American Geriatric Society

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Anticholinergic Drug Burden in Persons with Dementia Taking a Cholinesterase Inhibitor: The Effect of Multiple Physicians - American Geriatric Society

Objectives

To explore the association between the number of physicians providing care and anticholinergic drug burden in older persons newly initiated on cholinesterase inhibitor therapy for the management of dementia.

Design

Population-based cross-sectional study.

Setting

Community and long-term care, Ontario, Canada.

Participants

Community-dwelling (n = 79,067, mean age 81.0, 60.8% female) and long-term care residing (n = 12,113, mean age 84.3, 67.2% female) older adults (≥66) newly dispensed cholinesterase inhibitor drug therapy.

Measurements

Anticholinergic drug burden in the prior year measured using the Anticholinergic Risk Scale.

Results

Community-dwelling participants had seen an average of eight different physicians in the prior year. The odds of high anticholinergic drug burden (Anticholinergic Risk Scale score ≥ 2) were 24% higher for every five additional physicians providing care to individuals in the prior year (adjusted odds ratio = 1.24, 95% confidence interval = 1.21–1.26). Female sex, low-income status, previous hospitalization, and higher comorbidity score were also associated with high anticholinergic drug burden. Long-term care facility residents had seen an average of 10 different physicians in the prior year. After a sensitivity analysis, the association between high anticholinergic burden and number of physicians was no longer statistically significant in the long-term care group.

Conclusion

In older adults newly started on cholinesterase inhibitor drug therapy, greater number of physicians providing care was associated with higher anticholinergic drug burden scores. Given the potential risks of anticholinergic drug use, improved communication among physicians and an anticholinergic medication review before prescribing a new drug are important strategies to improve prescribing quality.

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Effect of Structured Physical Activity on Respiratory Outcomes in Sedentary Elderly Adults with Mobility Limitations - American Geriatric Society

Objectives

To evaluate the effect of structured physical activity on respiratory outcomes in community-dwelling elderly adults with mobility limitations.

Design

Multicenter, randomized trial of physical activity vs health education, with respiratory variables prespecified as tertiary outcomes over an intervention period of 24–42 months. Physical activity included walking (goal of 150 min/week) and strength, flexibility, and balance training. Health education included workshops on topics relevant to older adults and upper extremity stretching exercises.

Setting

Lifestyle Interventions and Independence in Elders (LIFE) Study.

Participants

Community-dwelling persons aged 70–89 with Short Physical Performance Battery scores less than 10 (N = 1,635).

Measurements

Dyspnea severity (defined as moderate to severe according to a Borg index >2 immediately after a 400-m walk), forced expiratory volume in 1 second (FEV1) (<lower limit of normal (LLN) defined low breathing capacity), and maximal inspiratory pressure (MIP) (<LLN defined respiratory muscle weakness) were assessed at baseline and 6, 18, and 30 months. Hospitalization for exacerbation of obstructive airways disease (EOAD) and pneumonia was also ascertained over the 42-month follow-up period.

Results

The randomized groups were similar in baseline demographics, including mean age (79) and sex (67% female). The effect of physical activity on dyspnea severity, FEV1, and MIP was no different from that of health education but was associated with higher likelihood of respiratory hospitalization, significantly for EOAD (hazard ratio (HR) = 2.34, 95% confidence interval (CI) = 1.19–4.61, P = .01) and marginally for pneumonia (HR = 1.54, 95% CI = 0.98–2.42, P = .06).

Conclusion

In older persons with mobility limitations, physical activity was associated with higher likelihood of respiratory hospitalization than health education, but differences in dyspnea severity, FEV1, and MIP did not accompany this effect—indicating that higher hospital use could be attributable to greater participant contact.

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Association Between Small Decrease in Serum Sodium Concentration within the Normal Range and All-Cause and Cardiovascular Mortality in Elderly Adults over 5 Years - American Geriatric Society

Objectives

To determine the importance of a decrease in serum sodium concentration within the normal range in elderly adults.

Design

Prospective cohort.

Setting

The Korean Longitudinal Study on Health and Aging.

Participants

Randomly selected, community-based elderly population with a corrected serum sodium level between 135.0 and 145.0 mEq/L (N = 949).

Measurements

Survival status was determined during 63.3 ± 16.6 months of follow-up.

Results

Participants were divided into corrected sodium groups as follows: 73 (7.7%) in Group 1 (sodium 135.0–138.0 mEq/L), 635 (66.9%) in Group 2 (sodium 138.1–142.0 mEq/L), and 241 (25.4%) in Group 3 (sodium 142.1.0–145.0 mEq/L). There were 34 (46.6%) deaths in Group 1, 124 (19.5%) in Group 2, and 52 (21.6%) in Group 3 (P < .001). In a Cox proportional hazards analysis, a 2-mEq/L higher sodium level reduced the risk of death by 14.9% (95% confidence interval (CI) = 0.1–27.4%, P = .048). Group 1 had risk of mortality that was 2.7 times as high as that of Group 2 (95% CI = 1.76–4.11, P < .001). Participants with a measured sodium level of 138.0 mEq/L or less and a corrected sodium level greater than 138.0 mEq/L had a better survival rate than those with a measured sodium level of 138.0 mEq/L or less and a corrected sodium level of 138.0 mEq/L or less.

Conclusion

A slightly lower serum sodium concentration within the normal range was a major risk factor for mortality in elderly adults. Sodium level corrected according to serum glucose concentration was a more meaningful risk factor than measured sodium level.

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Functional Status and Quality of Life in Elderly Intensive Care Unit Survivors - American Geriatric Society

Objectives

To evaluate functional status and quality of life in elderly intensive care unit (ICU) survivors at 1-year follow-up.

Design

Prospective 18-month observational study.

Setting

University medical–surgical ICU.

Participants

ICU survivors aged 75 and older.

Measurements

Functional status at baseline (Barthel Index (BI)) was compared with that at hospital discharge and 1-year follow-up. Health-related quality of life (HRQL Spanish version of the Medical Outcomes Study 36-item Short-From Survey) was measured at 1-year follow-up and compared with that of the Spanish population of same age.

Results

Of 176 individuals admitted to the ICU, 110 (62.1%) were discharged alive from the hospital, and 94 (53.1%) were alive at 1-year follow-up. ICU admission was associated with significant clinical deterioration (median BI 100 points (interquartile range (IQR) 85–100) at baseline vs 85 (IQR 60–100) at hospital discharge, P < .001). Three months after discharge, there was a significant although modest improvement in functional status (BI 95 (IQR 80–100) P = .03). Baseline functional status was not recovered at 1-year follow-up (BI 95 (IQR 80–100) P < .001). More ICU survivors had moderate to severe dependence at the end of follow-up (20.3%) than at ICU admission (6.6%) (P < .001). Factors independently associated with poor functional recovery were low baseline BI and ICU stay longer than 4 days. At 1-year follow-up, 76.8% of participants who survived were living in their own homes. HRQL was similar to that of the Spanish population of the same age.

Conclusion

Elderly ICU survivors experienced significant deterioration in functional status, and although they recovered modestly during the following year, they never regained their baseline status. Good recovery was associated with short ICU stay and better baseline functional status.

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Efficacy and Safety of Canagliflozin in Individuals Aged 75 and Older with Type 2 Diabetes Mellitus: A Pooled Analysis - American Geriatric Society

Objectives

To compare the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor developed to treat type 2 diabetes mellitus (T2DM), in individuals younger than 75 and those aged 75 and older.

Design

Randomized Phase 3 studies.

Setting

International study centers.

Participants

Adults with T2DM.

Measurements

Changes from baseline in glycosylated hemoglobin (HbA_1c), fasting plasma glucose (FPG), blood pressure (BP), and body weight were measured. Efficacy was evaluated using pooled data from six randomized, double-blind, placebo-controlled studies (N = 4,158; n = 3,975 aged <75, n = 183 aged ≥75). Safety was assessed based on adverse event (AE) reports from eight randomized, double-blind, placebo- and active-controlled studies (N = 9,439; n = 8,949 aged <75, n = 490 aged ≥75).

Results

Canagliflozin 100 and 300 mg were associated with placebo-subtracted mean reductions in HbA_1c in participants younger than 75 (−0.69% and −0.85%, respectively) and aged 75 and older (−0.65% and −0.55%, respectively). Dose-related reductions in FPG, body weight, and BP were seen with canagliflozin 100 and 300 mg in participants in both age groups. Overall AE incidence was 67.1% with canagliflozin 100 mg, 68.6% with canagliflozin 300 mg, and 65.9% with non-canagliflozin (pooled group of comparators in all studies) in participants younger than 75, and 72.4%, 79.1%, and 72.3%, respectively, in those aged 75 and older, with a similar safety profile in both groups. The incidence of volume depletion–related AEs was 2.2%, 3.1%, and 1.4% in participants younger than 75 with canagliflozin 100 and 300 mg and non-canagliflozin, respectively, and 4.9%, 8.7%, and 2.6%, respectively, in those aged 75 and older.

Conclusion

Canagliflozin improved glycemic control, body weight, and BP in participants aged 75 and older. The overall incidence of AEs was high across treatment groups in participants aged 75 and older and higher than in those younger than 75. The safety profile of canagliflozin was generally similar in both age groups, with a higher incidence of AEs related to volume depletion observed with canagliflozin in participants aged 75 and older than in those younger than 75. These findings support canagliflozin, starting with the 100-mg dose, as an effective therapeutic option for older adults with T2DM.

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Relationship Between Circulating Thyroid-Stimulating Hormone, Free Thyroxine, and Free Triiodothyronine Concentrations and 9-Year Mortality in Euthyroid Elderly Adults - American Geriatric Society

Objectives

To determine the association between plasma thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels and all-cause mortality in older adults who had levels of all three hormones in the normal range.

Design

Longitudinal.

Setting

Community-based.

Participants

Euthyroid Invecchiare in Chianti study participants aged 65 and older (N = 815).

Measurements

Plasma TSH, FT3, and FT4 levels were predictors, and 9-year all-cause mortality was the outcome. Cox proportional hazards models adjusted for confounders were used to examine the relationship between TSH, FT3, and FT4 quartiles and all-cause mortality over 9 years of follow-up.

Results

During follow-up (mean person-years 8,643.7, range 35.4–16,985.0), 181 deaths occurred (22.2%). Participants with TSH in the lowest quartile had higher mortality than the rest of the population. After adjusting for multiple confounders, participants with TSH in the lowest quartile (hazard ratio = 2.22, 95% confidence interval = 1.19–4.22) had significantly higher all-cause mortality than those with TSH in the highest quartile. Neither FT3 nor FT4 was associated with mortality.

Conclusion

In elderly euthyroid subjects, normal-low TSH is an independent risk factor for all-cause mortality.

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Multifaceted Prospective Memory Intervention to Improve Medication Adherence - American Geriatric Society

Objectives

To test whether a multifaceted prospective memory intervention improved adherence to antihypertensive medications and to assess whether executive function and working memory processes moderated the intervention effects.

Design

Two-group longitudinal randomized control trial.

Setting

Community.

Participants

Individuals aged 65 and older without signs of dementia or symptoms of severe depression who were self-managing prescribed medication.

Measurements

After 4 weeks of initial adherence monitoring using a medication event monitoring system, individuals with 90% or less adherence were randomly assigned to groups.

Intervention

The prospective memory intervention was designed to provide strategies that switch older adults from relying on executive function and working memory processes (that show effects of cognitive aging) to mostly automatic associative processes (that are relatively spared with normal aging) for remembering to take medications. Strategies included establishing a routine, establishing cues strongly associated with medication taking actions, performing the action immediately upon thinking about it, using a medication organizer, and imagining medication taking to enhance encoding and improve cuing.

Results

There was significant improvement in adherence in the intervention group (57% at baseline to 78% after the intervention), but most of these gains were lost after 5 months. The control condition started at 68% and was stable during the intervention, but dropped to 62%. Executive function and working memory moderated the intervention effect, with the intervention producing greater benefit for those with lower executive function and working memory.

Conclusion

The intervention improved adherence, but the benefits were not sustained. Further research is needed to determine how to sustain the substantial initial benefits.

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Diagnosis and Disruption: Population-Level Analysis Identifying Points of Care at Which Transitions Are Highest for People with Dementia and Factors That Contribute to Them - American Geriatric Society

Objectives

To examine transitions that individuals with dementia experience longitudinally and to identify points of care when transitions are highest and the factors that contribute to those transitions.

Design

Population-based 10-year retrospective cohort study from 2000 to 2011.

Setting

General community.

Participants

All individuals aged 65 and older newly diagnosed with dementia in British Columbia, Canada.

Measurements

The frequency and timing of transitions over 10 years, participant characteristics associated with greater number of transitions, and the influence of recommended dementia care and high-quality primary care on number of transitions.

Results

Individuals experience a spike in transitions during the year of diagnosis, driven primarily by hospitalizations, despite accounting for end of life or newly moving to a long-term care facility (LTCF). This occurs regardless of survival time or care location. Regardless of survival time, individuals not in LTCFs experience a marked increase in hospitalizations in the year before and the year of death, often exceeding hospitalizations in the year of diagnosis. Receipt of recommended dementia care and receipt of high-quality primary care were independently associated with fewer transitions across care settings.

Conclusion

The spike in transitions in the year of diagnosis highlights a distressing period for individuals with dementia during which unwanted or unnecessary transitions might occur and suggests a useful target for interventions. There is an association between recommended dementia care and outcomes and evidence of the continued value of high-quality primary care in a complex population at a critical point when gaps in continuity are especially likely.

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Religious Involvement and Adaptation in Female Family Caregivers - American Geriatric Society

Objectives

To examine the relationship between religious involvement (RI) and adaptation of women caring for family members with severe physical or neurological disability.

Design

Two-site cross-sectional study.

Setting

Community.

Participants

A convenience sample of 251 caregivers was recruited. RI and caregiver adaptation (assessed by perceived stress, caregiver burden, and depressive symptoms) were measured using standard scales, along with caregiver characteristics, social support, and health behaviors. Bivariate and multivariate analyses were conducted to identify relationships and mediating and moderating factors.

Results

Religious involvement (RI) was associated with better caregiver adaptation independent of age, race, education, caregiver health, care recipient's health, social support, and health behaviors (B = −0.09, standard error = 0.04, t = −2.08, P = .04). This association was strongest in caregivers aged 58–75 and spouses and for perceived stress in blacks.

Conclusion

Religious involvement (RI) in female caregivers is associated with better caregiver adaptation, especially for those who are older, spouses of the care recipients, and blacks. These results are relevant to the development of future interventions that provide support to family caregivers.

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Prediction of Cognitive and Functional Decline Using the Telephone-Administered Minnesota Cognitive Acuity Screen - American Geriatric Society

Objectives

To examine whether a telephone-based cognitive assessment—the Minnesota Cognitive Acuity Screen (MCAS)—is effective in predicting cognitive and functional decline in older adults with mild cognitive impairment (MCI) and conversion to dementia.

Design

Longitudinal.

Setting

Academic medical center.

Participants

Individuals aged 60 to 84 with MCI (N = 61).

Measurements

An initial office visit consisting of a neurological examination, Clinical Dementia Rating Scale (CDR), and neuropsychological testing using the Dementia Rating Scale-2 (DRS-2), followed by the MCAS within 1 month. Participants completed up to three follow-up in-office neuropsychological assessments, originally scheduled 1 year apart. A multidisciplinary consensus group determined diagnosis (MCI, dementia) at each assessment.

Results

Higher baseline MCAS total scores emerged as a significant predictor of slower functional decline (P = .002) and dementia conversion (P = .02). An increase in score from 43 to 50 points (1st to 3rd quartile) was associated with a 0.59-point (95% confidence interval (CI) = 0.23–0.95) lower CDR score at follow-up, and a 71% (95% CI = 1.11–2.63) increase in median time to dementia conversion from 2 years to 3.5 years. Of the MCAS subscales, delayed word recall predicted functional decline alone (P < .001), whereas computation was nominally associated with cognitive (P = .01) and functional (P = .01) decline.

Conclusion

The brief telephone-administered MCAS provides valuable information about future cognitive and functional decline in older adults with MCI and predicted conversion from MCI to dementia. These findings provide additional support for use of MCAS in clinical and research settings. The instrument may be particularly valuable in settings in which an office visit is difficult.

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Hospital Readmission Penalties: Coming Soon to a Nursing Home Near You! - American Geriatric Society

The Protecting Access to Medicare Act of 2014 includes provisions for hospital readmission penalties for skilled nursing facilities (SNFs) starting in 2018. This presents an opportunity for care improvement but also raises several concerns regarding quality of care. The readmission measure for SNFs is similar to the current readmission measure for hospitals mandated under the Affordable Care Act, with the exception of adjustments made for sex. Because these measures for hospitals are similar, lessons can be learned from implementation of the existing hospital readmission penalties. In addition, there are three specific concerns that the authors relate to implementing the proposed measure in SNFs. There is poor communication and care coordination between care settings, including posthospitalization and post-SNF care in the current healthcare system. Adding readmission penalties to SNF regulations may create perverse incentives for prolonged SNF stays. The evidence base for the best means of caring for individuals after a brief stay in a SNF needs enrichment. These challenges need to be addressed as part of implementation of these new hospital readmission penalties for SNFs to improve care and prevent new unintended consequences.

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Diabetes Mellitus as a Risk Factor for Development of Depressive Symptoms in a Population-Based Cohort of Older Mexican Americans - American Geriatric Society

Objectives

To determine whether diabetes mellitus increases depressive symptoms in older Latinos in a population-based cohort.

Design

Prospective cohort study.

Participants

Individuals from the Sacramento Latino Study on Aging aged 60 and older in 1998–99 and followed annually until 2008 (N = 1,586).

Measurements

Diabetes mellitus was defined according to self-report, fasting blood glucose of 126 mg/dL or greater, glycosylated hemoglobin of 6.5% or greater, or diabetic medication use. Depressive symptoms were defined as Center for Epidemiologic Studies Depression Scale (CES-D) score of 16 or greater or use of antidepressant medication. Multistate Markov modeling was used to assess the effects of time-dependent diabetes mellitus on transitions between three states over time: low CES-D score (normal), high CES-D score or treated (depressed), and death. Bivariate analyses identified covariates significantly associated with any transition, including sex and baseline measures of age, education, body mass index, hypertension, and stroke.

Results

In a fully adjusted model, participants with diabetes mellitus had a 35% higher rate of developing depressive symptoms or starting treatment with an antidepressant (hazard ratio (HR) = 1.35, 95% confidence interval (CI) = 1.13–1.62). Time-dependent diabetes mellitus was associated with a lower rate of regression from depressed to normal (HR = 0.72, 95% CI = 0.59–0.88) and a 2.3 greater rate pf progression from depressed to death (HR = 2.31, 95% CI = 1.57–3.40).

Conclusion

Diabetes mellitus increased the risk of developing depressive symptoms in older Mexican Americans. Older Latinos with diabetes mellitus should be screened for depressive symptoms and prioritized for close follow-up, potentially through greater reliance on team-based models of care.

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MFA Incorporated issues recall on rabbit feed pellets (both bagged and bulk) in southwest Missouri due to excessive sodium - FDA Safety Alerts & Drug Recalls

MFA Incorporated today announced the recall of bagged and bulk MFA 16% and 17% rabbit feed. The product was distributed to MFA retail stores in southwest Missouri.

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Taxes and Health Care Coverage: Five Tips for Tax Filers - CMS Blog

By: Kevin Counihan, CEO of the Health Insurance Marketplaces, Centers for Medicare and Medicaid Services

Last year, millions of people purchased quality, affordable coverage through the Health Insurance Marketplace, and most benefitted from advance payments of the premium tax credit that lowered their monthly premiums. With the tax filing deadline a few weeks away, it’s a good time to remind everyone – both new and renewing consumers – about what they need to know when they file their taxes.

For those who returned to the Marketplace in 2015 to renew coverage or pick a different plan, the tax filing process is generally the same as last year. But, for the millions who signed up for Marketplace coverage in 2015 for the first time, the process may be a new one. By now, all Marketplace consumers should have received a statement in the mail from the Marketplace called a Form 1095-A. These statements include important information needed to complete and file a tax return.

Marketplace consumers who received advance payments of the premium tax credit are required to file a tax return to reconcile that financial assistance. This is similar to the reconciliation process for taxes withheld from wages during the year – consumers receive a larger or smaller refund depending on whether the appropriate taxes were withheld based on the tax filer’s actual income and other factors.

It’s extremely important that those who received advance payments of the premium tax credit reconcile these payments when they file their tax return. Individuals who do not do so will generally see their refunds delayed, and are not eligible to receive advance payments of the premium tax credit in future years.

Individuals with Marketplace or other types of health coverage may also have received additional forms called a Form 1095-B or 1095-C from their employer, insurance company, or the government program that provides their coverage, like Medicare or Medicaid. Taxpayers don’t need to attach this information to their return or wait to receive the form before filling their federal taxes, but should keep it in a safe place with other tax records.

An important reminder: Since most tax filers use a tax preparer or tax preparation software, most filers just need to answer questions when prompted.

We are here to help. Marketplace consumers having questions should contact the Marketplace Call Center (1-800-318-2596).  Additional resources and information for is also available at http://ift.tt/1C8SbJv or www.IRS.gov/aca.

Here’s summary of five helpful tips for both Marketplace consumers and other tax filers when it comes to filing taxes this year:

Five Tips for Tax Filers

1. Most people just need to check a box: The vast majority of tax filers have qualifying coverage (including employer coverage, Medicare, Medicaid, or other coverage) and will just need to check a box when they file their taxes to indicate that that everyone in their household had coverage for 2015. This year, many consumers will receive a new form called a Form 1095-B or a Form 1095-C in the mail from their employer, insurance company, or the government program that provides their coverage, like Medicare or Medicaid. Taxpayers don’t need to attach this information to their return or wait to receive the form before filling their taxes, but should keep it in a safe place with other tax records. For more information on all these forms, visit the IRS website at: http://ift.tt/1VIHw2J

2. Marketplace consumers must file a tax return to reconcile any advance payment of the premium tax credit they received in order to maintain eligibility for future help: By now, all Marketplace consumers should have received a statement in the mail from the Marketplace called a Form 1095-A. These statements include important information needed to complete and file a tax return. It’s extremely important that those who received advance payments of the premium tax credit reconcile these payments when they file their tax return. Individuals who do not do so will generally see their refunds delayed, and are not eligible for advance payment of premium tax credits in future years.

3. The fee for not having coverage is increasing. For those who could afford health insurance and chose not to get coverage, the fee for not having minimum essential coverage in 2015 has increased to 2 percent of household income or $325 per person. The fee is pro-rated based on how many months a person is uninsured. The fee goes up again for 2016. If someone doesn’t have coverage or an exemption in the 2016 calendar year, but could afford coverage, the fee increases to $695 per person or 2.5% of income, whichever is higher.

4. Some people who didn’t have health coverage in 2015 will qualify for an exemption: While those who can afford health coverage but chose not to enroll generally have to pay a fee, some people who couldn’t afford coverage or met other conditions can receive an exemption. You can find out more information online from the Marketplace or IRS at http://ift.tt/1RrfqEP or http://ift.tt/20h6rNg.

5. Help is available. If people have questions about Marketplace tax forms, qualifying for exemptions, or the fee, they should contact the Marketplace Call Center. The call center is open all day, every day at 1-800-318-2596. Additional resources and information for is also available at healthcare.gov/taxes or www.IRS.gov/aca

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Tri-Union Seafoods LLC Issues Precautionary, Voluntary Recall on Select 5 oz. Canned Chunk Light Tuna in Oil and 5 oz. Canned Chuck Light Tuna in Water - FDA Safety Alerts & Drug Recalls

Tri-Union Seafoods LLC is voluntarily recalling a 2,745 cases (equal to 107,280 cans) of Chicken of the Sea brand 5 oz. canned chunk light tuna in oil and 5 oz. canned chunk light tuna in water.

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Bumble Bee Foods, LLC Issues Voluntary Recall on 3 Production Codes of Canned Chunk Light Tuna Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

SAN DIEGO - Bumble Bee Foods, LLC announced today that it is voluntarily recalling 3 specific UPC codes of canned Chunk Light tuna due to process deviations that occurred in a co-pack facility not owned or operated by Bumble Bee. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed.

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Organic Raw Macadamia Nuts Recalled Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Ashland, Ore.-- Ashland Food Co-op is recalling Organic Raw Macadamia nuts because it has 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.

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CMS Strong Start for Mothers and Newborns Strategy II Initiative Second Annual Evaluation Report - CMS Blog

By Patrick Conway, M.D., CMS Principal Deputy Administrator and Chief Medical Officer

Today, we at the Centers for Medicare & Medicaid Services (CMS) are pleased to announce findings from the second annual evaluation report for the Strong Start for Mothers and Newborns Strategy II Initiative. As noted with the release of our first annual report, Strong Start Strategy II seeks to build on work conducted by the Partnership for Patients and Strong Start Strategy I to improve newborn health through a reduction in early elective deliveries. Babies are generally healthier and have better long-range outcomes when they are born full-term.  Strategy I contributed to a 64.5% nationwide drop in early elective deliveries from 2010 to 2013.

The Strong Start II (hereafter referred to as Strong Start) builds on this success through prenatal care enhancements addressing the psychosocial needs of pregnant women eligible for Medicaid and CHIP.  Strong Start is an important federal initiative geared toward testing innovative approaches to improve maternal and infant health outcomes in low-income families.

Research consistently shows that infants born preterm (before 37 completed weeks of gestation) have higher mortality risks and may endure a lifetime of developmental and health problems when compared to their counterparts born after 37 weeks’ gestation.

Prenatal care enhancements provided through Strong Start are designed to promote overall maternal and infant health and particularly to reduce incidence of preterm birth and low birth weight.  The second annual report presents the progress Strategy II has made since its inception.

Strong Start has continued its partnership with 27 organizations representing nearly 200 provider sites in 32 states, Washington, D.C., and Puerto Rico.  The program continues to provide enhanced services through three approaches:

• Group Care – Group prenatal care that incorporates peer-to-peer support in a facilitated setting for three components: health assessment, education, and support.
• Birth Centers – Comprehensive prenatal care facilitated by midwives and teams of health professionals, including peer counselors and doulas.
• Maternity Care Homes – Enhanced prenatal care at traditional prenatal sites with enhanced continuity of care and expanded access to care coordination, education, and other services.

Enrollment increased dramatically in the second year of program operations, with a total of 23,000 women enrolled from March 2013 to the end of the first calendar quarter of 2015. Enrollment is expected to continue to grow to more than 40,000 participants by the program’s end in February 2017.  Additionally, participants continue to express overwhelming satisfaction, with 90% stating that they were either very satisfied or extremely satisfied with their prenatal care.

In addition to their standard schedule of prenatal care visits, Strong Start participants receive enhanced care visits in accordance with their psychosocial needs.  Enhanced visits provide services such as care coordination, referrals to local resources, prenatal health education, and peer support.

Upon enrollment, Strong Start participants have several risk factors, including many pertaining to psychosocial needs:

• Depression upon enrollment (nearly a quarter of participants report being depressed at intake)
• Unstable housing
• Unemployment
• Unmet mental health and dental needs
• Food insecurity
• Unmarried or unpartnered status

Results from the second year evaluation indicate that, as was found in the first year, Strong Start participants have:

• Lower rates of cesarean section than national averages, though there is wide variation among and within models
• Higher rates of breastfeeding than national averages among similar populations

In addition, the new report finds that Strong Start participants have:

• Overall preterm birth rates similar to national averages despite the high-risk population served
• Lower preterm birth rates than national averages within racial-ethnic groups (Black , White, Hispanic)
• Vaginal birth after cesarean rates that are nearly twice the national average

Although findings must be interpreted with caution because they are descriptive, we are pleased with what we have found thus far. Substantial progress was made during the second evaluation year in developing resources, particularly obtaining state Medicaid claims linked to vital records, which will enable development of a control group and an analysis of costs.  The third annual report is anticipated to contain analysis of further participant-level data, case studies based on site visits, and an initial analysis of linked data from states.

Much work remains to be done to reduce significant risks and complications for pregnant women and infants, but these early results from the Strong Start evaluation show promise for improving pregnancy outcomes.  We remain committed to working together to deliver higher quality care, smarter spending, and better health outcomes for low-income pregnant women and their newborns.

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Comparative genomic analysis of pre-epidemic and epidemic Zika virus strains for virological factors potentially associated with the rapidly expanding epidemic

Comparative genomic analysis of pre-epidemic and epidemic Zika virus strains for virological factors potentially associated with the rapidly expanding epidemic

Emerging Microbes & Infections 5, e22 (March 2016). doi:10.1038/emi.2016.48

Authors: Zheng Zhu, Jasper Fuk-Woo Chan, Kah-Meng Tee, Garnet Kwan-Yue Choi, Susanna Kar-Pui Lau, Patrick Chiu-Yat Woo, Herman Tse & Kwok-Yung Yuen

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Texas Star Nut & Food Company is Expanding the Recall on Natural Pistachio Kernels and Products Containing Pistachio Kernels, Which Were Previously Voluntarily Recalled Due To Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

Texas Star Nut & Food Company expands the previous Recall issued on March 10, 2016, to include the following items and Best by Dates.

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Awareness Voluntary Recalls Boost Tea Due To Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

Awareness Corp. of Mesa, AZ, is recalling its 7.4 ounce container of Boost Tea because it may 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, nausea, vomiting and abdominal pain.

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Northern Tier Bakery LLC Issues Voluntary Recall Due to Allergy Alert on Undeclared Milk in Tuna Salad Wedge Sandwich - FDA Safety Alerts & Drug Recalls

Northern Tier Bakery LLC is voluntarily recalling 4.5 oz. Tuna Salad Sandwiches sold under the brand names SuperMom's Kitchen (763913801248), Take Away Cafe (763913107029), and Express Cafe (763913801248) due to mislabeling caused by a third party supplier. The product contains milk, an allergen, which is undeclared on the packaging label.

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JRZ Dairy, Inc., Selinsgrove, PA Recalls Whole Milk Yogurt and Low Fat Yogurt Because of a Possible Health Risk Due To Incomplete Pasteurization - FDA Safety Alerts & Drug Recalls

Inadequate pasteurization may allow for the survival of pathogens, which may cause serious or fatal infections after consumption. No illnesses have been reported to date.

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Keeping Consumers Covered - CMS Blog

By Health Insurance Marketplace CEO Kevin Counihan

The latest open enrollment period exceeded our expectations, with more than 12.7 million people signing up for coverage or automatically renewing their plans for 2016. To me, this success is confirmation that the Health Insurance Marketplace is providing a needed service to connect people to quality, affordable health care coverage. This year’s progress is also confirmation of the hard work that went into improving the consumer experience on HealthCare.gov to help people shop for the coverage that is right for them and their families.

Consumers are more engaged, savvier and better informed. New customers came in earlier, allowing them to have a full year of coverage, and 70 percent of returning customers actively selected a plan. And because of operational improvements, we have more precise enrollment data, so the 12.7 million already takes into account a larger share of cancellations that took place during Open Enrollment.

These are all good signs for consumers retaining coverage for the year to come. And now that Open Enrollment is over, we are focusing even more of our energy on helping consumers stay covered.

There are many reasons consumers choose to leave the Marketplace – perhaps the most common is that the consumer finds a new source of coverage outside of the Marketplace, including getting a job with employer coverage or becoming eligible for programs like Medicare and Medicaid. What we don’t want is for eligible consumers to lose their coverage because they have trouble navigating our processes. Below are some of the things we’re doing to make sure that consumers who are eligible for and need coverage throughout the year are able to stay covered.

Consumer Payment Experience

Some consumers who are just entering the Marketplace don’t pay their first bill. In some cases, a consumer changes their mind or has had a life change and no longer needs Marketplace coverage. But in others, it’s because they have trouble navigating the payment process, aren’t clear on when their payment is due, or simply forget to pay before it’s too late. If a consumer doesn’t pay their first bill, or what’s called their binder payment, their coverage is terminated by their insurance company.

We’re working to improve the consumer payment experience this year in a couple of different ways:

• We’ve made improvements to our Marketplace outreach, reminding consumers to make their first payment. We’re sending consumers additional reminders, sending them earlier in the process and providing clearer guidance on when their payment is due.
• We’re also working closely with insurance companies to reinstate consumers who had trouble during the payment process.

Data Matching

Another reason consumers may lose their coverage is if we don’t receive the information we need to confirm their eligibility. The law specifies that when we can’t verify key information like a Social Security number or income immediately through automatic checks against other Federal data, consumers can enroll in coverage for 90 or 95 days while we work with them to verify their eligibility. But after that, their coverage is cancelled or their financial assistance is adjusted or ended.

The fact that we cannot immediately confirm eligibility does not mean an individual is ineligible for coverage or financial help. It just means that the information a consumer provided can’t be instantly validated by our data sources. Reasons this occurs can be as simple as a Social Security number typo or a government database that has first and last names switched. For many consumers, the issue is a change in employment or wages since they filed their last tax return. That’s why the law gives consumers time to provide more information, and that’s why the majority of “data-matching” issues are resolved because consumers successfully submitted documentation that substantiates what they told us on the application. Nonetheless, in 2015, coverage was terminated or APTCs were adjusted due to data matching issues for about 1.7 million consumers.

As with other Marketplace rules, CMS is committed to both making sure the process works better and limiting access to coverage and financial assistance to those individuals who are indeed eligible. We’ve already made significant improvements that we believe will help to reduce the share of consumers who lose coverage or financial assistance due to data matching issues this year.

To help consumers avoid data matching issues during the enrollment process:

• We’ve made improvements to the online application that makes it clearer when a data matching issue is created and we encourage people to provide key information if they failed to do so initially, such as providing a Social Security number or an immigration document number to resolve the issue in real time.
• We added functionality that helps make sure consumers do not generate a new data matching issue if they have previously resolved that issue with the Marketplace. This keeps consumers from having to summit the same documentation year after year.
• Going forward, the 2017 payment notice allows CMS to establish more appropriate income verification thresholds next year for consumers.

And, to help consumers resolve data matching issues once they’ve been generated:

• As a result of working with advocates and assisters, we have made improvements to our notice language to more clearly explain what documents a consumer should submit to resolve data matching issues. And we are developing a new resource guide designed to both prevent income data matching issues and improve resolution of generated income data matching issues.
• Going forward, the FY 2017 budget proposes funding that would give CMS the ability to improve our outreach, including to consumers with data matching issues. The CMS team reaches out to consumers as many as 14 times to make sure consumers know what information they need to provide.

Because of these improvements, we’re starting to see promising signs, including a noticeable reduction in the rate of data matching issues, and consumers responding to our outreach efforts earlier and in larger numbers. While we won’t have final numbers for a couple of months, we are strongly encouraged by the progress we have made and hopeful that our progress will help consumers who need and are eligible for coverage stay covered all year.

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FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer - FDA Press Releases

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC.

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Teleflex Incorporated Announces Worldwide Recall of ARROW International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits - FDA Safety Alerts & Drug Recalls

Teleflex Incorporated announces worldwide recall of ARROW International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. The Arrow IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.

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Kanan Enterprises Conducts Nationwide Voluntary Recall of Natural in Shell Pistachios - FDA Safety Alerts & Drug Recalls

Kanan Enterprises announces the voluntary recall of natural in shell pistachios due to potential contamination with salmonella. Our third party supplier who makes this product has asked us to issue this recall because it has 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.

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