Out of an abundance of caution, Hampton Creek is undertaking a voluntary recall of 6 SKU's of baking mixes that contain the Native Forest Coconut Milk Powder. The ingredient, which makes up less than 1.31% of the mixes, tested positive for Salmonella in a company-initiated testing program.
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Sunday, July 31, 2016
Friday, July 29, 2016
Updated: Additional Package Codes Of Watts Brothers Farms Organic Mixed Vegetables, Organic Super Sweet Corn, and Organic Peas Recalled Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
ConAgra Foods of Chicago, Illinois, is voluntarily recalling additional package codes of Watts Brothers Farms Organic Mixed Vegetables, Organic Super Sweet Corn (Yellow/Gold), and Organic Peas due to the potential for these products to be contaminated with Listeria monocytogenes.
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SM Fish Corp Recalls Select Ossie's Ready To Eat Herring Salads Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
SM Fish Corp. of Far Rockaway, NY, is voluntarily recalling OSSIE’S brand ready-to-eat Herring Salads 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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Chapel Hill Creamery Recalls Cheese Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Chapel Hill Creamery in Chapel Hill, NC, has announced a voluntary recall of all Chapel Hill Creamery cheese products because of a potential association with an outbreak of Salmonella infections. Health officials have identified recent cases of Salmonella infection in persons who consumed Chapel Hill Creamery products.
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Thursday, July 28, 2016
Gel Spice, Inc. Issues Alert on Elevated Lead Levels in One Lot of Fresh Finds Ground Turmeric Powder - FDA Safety Alerts & Drug Recalls
Gel Spice, Inc. is recalling one lot of Fresh Finds Ground Turmeric Powder because the product contains elevated lead levels.
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Statement from Peter Marks, M.D., Ph.D., Director, FDA’s Center for Biologics Evaluation and Research - FDA Press Releases
The FDA is tasked with taking important steps to respond to the emerging Zika virus outbreak. One of the agency’s key public health responsibilities is to help ensure the safety of the nation’s blood supply.
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An Interprofessional Approach to Reducing the Risk of Falls Through Enhanced Collaborative Practice - American Geriatric Society
Falls are the leading cause of accidental deaths in older adults and are a growing public health concern. The American Geriatrics Society (AGS) and British Geriatrics Society (BGS) published guidelines for falls screening and risk reduction, yet few primary care providers report following any guidelines for falls prevention. This article describes a project that engaged an interprofessional teaching team to support interprofessional clinical teams to reduce fall risk in older adults by implementing the AGS/BGS guidelines. Twenty-five interprofessional clinical teams with representatives from medicine, nursing, pharmacy, and social work were recruited from ambulatory, long-term care, hospital, and home health settings for a structured intervention: a 4-hour training workshop plus coaching for implementation for 1 year. The workshop focused on evidence-based strategies to decrease the risk of falls, including screening for falls; assessing gait, balance, orthostatic blood pressure, and other medical conditions; exercise including tai chi; vitamin D supplementation; medication review and reduction; and environmental assessment. Quantitative and qualitative data were collected using chart reviews, coaching plans and field notes, and postintervention structured interviews of participants. Site visits and coaching field notes confirmed uptake of the strategies. Chart reviews showed significant improvement in adoption of all falls prevention strategies except vitamin D supplementation. Long-term care facilities were more likely to address environmental concerns and add tai chi classes, and ambulatory settings were more likely to initiate falls screening. The intervention demonstrated that interprofessional practice change to target falls prevention can be incorporated into primary care and long-term care settings.
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FDA approves Adlyxin to treat type 2 diabetes - FDA Press Releases
The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
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Wednesday, July 27, 2016
Helping Consumers Make Care Choices through Hospital Compare - CMS Blog
By: Kate Goodrich, MD, MHS, Director of Center for Clinical Standards and Quality
When individuals and their families need to make important decisions about health care, they seek a reliable way to understand the best choice for themselves or their loved ones. That’s why over the past decade, the Centers for Medicare & Medicaid Services (CMS) has published information about the quality of care across the five different health care settings that most families encounter.[1] These easy-to-understand star ratings are available online and empower people to compare and choose across various types of facilities from nursing homes to home health agencies. Today, we are updating the star ratings on the Hospital Compare website to help millions of patients and their families learn about the quality of hospitals, compare facilities in their area side-by-side, and ask important questions about care quality when visiting a hospital or other health care provider.
Today’s ratings include the Overall Hospital Quality Star Rating that reflects comprehensive quality information about the care provided at our nation’s hospitals. The new Overall Hospital Quality Star Rating methodology takes 64 existing quality measures already reported on the Hospital Compare website and summarizes them into a unified rating of one to five stars. The rating includes quality measures for routine care that the average individual receives, such as care received when being treated for heart attacks and pneumonia, to quality measures that focus on hospital-acquired infections, such as catheter-associated urinary tract infections. Specialized and cutting edge care that certain hospitals provide such as specialized cancer care, are not reflected in these quality ratings.
We have received numerous letters from national patient and consumer advocacy groups supporting the release of these ratings because it improves the transparency and accessibility of hospital quality information. In addition, researchers found that hospitals with more stars on the Hospital Compare website have tended to have lower death and readmission rates.[2],[3]
Prior to publishing the Overall Hospital Quality Star Rating, we paused to give hospitals additional time to better understand our methodology and data. In response, we delayed the release of the ratings. Since then, we have conducted significant outreach and education to hospitals to understand their concerns and directly answered their questions, including:
- Hosting two National Provider Calls with over 4,000 hospital representatives. During the calls, we walked through the Overall Hospital Quality Star Rating data and the methodology in detail while responding to questions that the attendees raised.
- Providing specialized assistance to hospitals. We held numerous meetings with the hospital associations and individual hospitals to explain their data and answer questions.
- Posting an evaluation of the national distributions of the Overall Hospital Quality Star Rating based on hospital characteristics. The analysis shows that all types of hospitals have both high performing and low performing hospitals.
- Subjecting the measures used to calculate the Overall Hospital Quality Star Rating to rigorous scientific review and risk adjustment. All of the measures used to calculate the Overall Hospital Quality Star Rating are based on clinical guidelines and have undergone a rigorous scientific review and testing. The vast majority are endorsed by the National Quality Forum. Most of these quality measures are already adjusted for clinical co-morbidities to account for the illness-burden of the population. Some hospitals have raised the question of making additional adjustments to account for the sociodemographic characteristics of the patients they serve. We continue to work closely with the National Quality Forum and the Assistant Secretary for Planning and Evaluation (ASPE), who is required by the IMPACT Act to study the effect of socioeconomic status on quality measures and payment programs based on measures. We will work with ASPE and determine what next steps, if any, should be taken to adjust our measures based on the recommendations in the report.
CMS will continue to analyze the star rating data and consider public feedback to make enhancements to the scoring methodology as needed. The star rating will be updated quarterly, and will incorporate new measures as they are publicly reported on the website as well as remove measures retired from the quality reporting programs.
Today, we are taking a step forward in our commitment to transparency by releasing the Overall Hospital Quality Star Rating. We have been posting star ratings for different for facilities for a decade and have found that publicly available data drives improvement, better reporting, and more open access to quality information for our Medicare beneficiaries. We will continue to work closely with hospitals and other stakeholders to enhance the Overall Hospital Quality Star Rating based on feedback and experience.
These star rating programs are part of the Administration’s Open Data Initiative which aims to make government data freely available and useful while ensuring privacy, confidentiality, and security.
For more information please see http://ift.tt/2a9xmaO.
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[1] CMS Compare websites include: Nursing Home Compare; Physician Compare; Medicare Plan Finder; Dialysis Compare; and Home Health Compare.
[2] Wang DE, Tsugawa Y, Figueroa JF, Jha AK. Association Between the Centers for Medicare and Medicaid Services Hospital Star Rating and Patient Outcomes. JAMA Intern Med. 2016;176(6):848-850. doi:10.1001/jamainternmed.2016.0784. http://ift.tt/1Q4FV1H
[3] Trzeciak, S. Gaughan, J. Mazzarelli, A. Association Between Medicare Summary Star Ratings and Clinical Outcomes in US Hospitals. Journal of Patient Experience. 2016 vol. 3 no. 1 2374373516636681 doi: 10.1177/2374373516636681 http://ift.tt/2awN3fx
Filed under: Uncategorized
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Exploring the diversification mechanism of skeletal construction in representative natural product families - Journal of Antibiotics
Exploring the diversification mechanism of skeletal construction in representative natural product families
The Journal of Antibiotics 69, 471 (July 2016). doi:10.1038/ja.2016.69
Authors: Hideaki Oikawa & Yi Tang
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Nature as organic chemist - Journal of Antibiotics
Nature as organic chemist
The Journal of Antibiotics 69, 473 (July 2016). doi:10.1038/ja.2016.55
Author: David E Cane
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General base-general acid catalysis by terpenoid cyclases - Journal of Antibiotics
General base-general acid catalysis by terpenoid cyclases
The Journal of Antibiotics 69, 486 (July 2016). doi:10.1038/ja.2016.39
Authors: Travis A Pemberton & David W Christianson
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Insights into polyketide biosynthesis gained from repurposing antibiotic-producing polyketide synthases to produce fuels and chemicals - Journal of Antibiotics
Insights into polyketide biosynthesis gained from repurposing antibiotic-producing polyketide synthases to produce fuels and chemicals
The Journal of Antibiotics 69, 494 (July 2016). doi:10.1038/ja.2016.64
Authors: Satoshi Yuzawa, Jay D Keasling & Leonard Katz
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Recent advances of Diels–Alderases involved in natural product biosynthesis - Journal of Antibiotics
Recent advances of Diels–Alderases involved in natural product biosynthesis
The Journal of Antibiotics 69, 500 (July 2016). doi:10.1038/ja.2016.67
Authors: Atsushi Minami & Hideaki Oikawa
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Recognition of acyl carrier proteins by ketoreductases in assembly line polyketide synthases - Journal of Antibiotics
Recognition of acyl carrier proteins by ketoreductases in assembly line polyketide synthases
The Journal of Antibiotics 69, 507 (July 2016). doi:10.1038/ja.2016.41
Authors: Matthew P Ostrowski, David E Cane & Chaitan Khosla
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Actinoquinolines A and B, anti-inflammatory quinoline alkaloids from a marine-derived Streptomyces sp., strain CNP975 - Journal of Antibiotics
Actinoquinolines A and B, anti-inflammatory quinoline alkaloids from a marine-derived Streptomyces sp., strain CNP975
The Journal of Antibiotics 69, 511 (July 2016). doi:10.1038/ja.2016.56
Authors: Hossam M Hassan, Chollaratt Boonlarppradab & William Fenical
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Chemical diversity of labdane-type bicyclic diterpene biosynthesis in Actinomycetales microorganisms - Journal of Antibiotics
Chemical diversity of labdane-type bicyclic diterpene biosynthesis in Actinomycetales microorganisms
The Journal of Antibiotics 69, 515 (July 2016). doi:10.1038/ja.2015.147
Authors: Yuuki Yamada, Mamoru Komatsu & Haruo Ikeda
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Biosynthetic potential of sesquiterpene synthases: product profiles of Egyptian Henbane premnaspirodiene synthase and related mutants - Journal of Antibiotics
Biosynthetic potential of sesquiterpene synthases: product profiles of Egyptian Henbane premnaspirodiene synthase and related mutants
The Journal of Antibiotics 69, 524 (July 2016). doi:10.1038/ja.2016.68
Authors: Hyun Jo Koo, Christopher R Vickery, Yi Xu, Gordon V Louie, Paul E O'Maille, Marianne Bowman, Charisse M Nartey, Michael D Burkart & Joseph P Noel
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Using quantum chemical computations of NMR chemical shifts to assign relative configurations of terpenes from an engineered Streptomyces host - Journal of Antibiotics
Using quantum chemical computations of NMR chemical shifts to assign relative configurations of terpenes from an engineered Streptomyces host
The Journal of Antibiotics 69, 534 (July 2016). doi:10.1038/ja.2016.51
Authors: Q Nhu N Nguyen & Dean J Tantillo
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Genome mining of the sordarin biosynthetic gene cluster from Sordaria araneosa Cain ATCC 36386: characterization of cycloaraneosene synthase and GDP-6-deoxyaltrose transferase - Journal of Antibiotics
Genome mining of the sordarin biosynthetic gene cluster from Sordaria araneosa Cain ATCC 36386: characterization of cycloaraneosene synthase and GDP-6-deoxyaltrose transferase
The Journal of Antibiotics 69, 541 (July 2016). doi:10.1038/ja.2016.40
Authors: Fumitaka Kudo, Yasunori Matsuura, Takaaki Hayashi, Masayuki Fukushima & Tadashi Eguchi
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New conjugates of polyene macrolide amphotericin B with benzoxaboroles: synthesis and properties - Journal of Antibiotics
New conjugates of polyene macrolide amphotericin B with benzoxaboroles: synthesis and properties
The Journal of Antibiotics 69, 549 (July 2016). doi:10.1038/ja.2016.34
Authors: Anna N Tevyashova, Alexander M Korolev, Aleksey S Trenin, Lyubov G Dezhenkova, Alexander A Shtil, Vladimir I Polshakov, Oleg Yu Savelyev & Evgenia N Olsufyeva
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New natural products isolated from Metarhizium robertsii ARSEF 23 by chemical screening and identification of the gene cluster through engineered biosynthesis in Aspergillus nidulans A1145 - Journal of Antibiotics
New natural products isolated from Metarhizium robertsii ARSEF 23 by chemical screening and identification of the gene cluster through engineered biosynthesis in Aspergillus nidulans A1145
The Journal of Antibiotics 69, 561 (July 2016). doi:10.1038/ja.2016.54
Authors: Hiroki Kato, Yuta Tsunematsu, Tsuyoshi Yamamoto, Takuya Namiki, Shinji Kishimoto, Hiroshi Noguchi & Kenji Watanabe
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Methyltransferases excised from trans-AT polyketide synthases operate on N-acetylcysteamine-bound substrates - Journal of Antibiotics
Methyltransferases excised from trans-AT polyketide synthases operate on N-acetylcysteamine-bound substrates
The Journal of Antibiotics 69, 567 (July 2016). doi:10.1038/ja.2016.66
Authors: D Cole Stevens, Drew T Wagner, Hannah R Manion, Bradley K Alexander & Adrian T Keatinge-Clay
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Biosynthesis of the α-nitro-containing cyclic tripeptide psychrophilin - Journal of Antibiotics
Biosynthesis of the α-nitro-containing cyclic tripeptide psychrophilin
The Journal of Antibiotics 69, 571 (July 2016). doi:10.1038/ja.2016.33
Authors: Muxun Zhao, Hsiao-Ching Lin & Yi Tang
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Design and synthesis of 15-deoxyspergualin–biotin conjugates as novel binding probes for target protein screening - Journal of Antibiotics
Design and synthesis of 15-deoxyspergualin–biotin conjugates as novel binding probes for target protein screening
The Journal of Antibiotics 69, 574 (July 2016). doi:10.1038/ja.2016.32
Authors: Masahiko Morioka, Kuniki Kato & Kazuo Umezawa
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Tuesday, July 26, 2016
Let's Do Lunch, Inc., dba Integrated Food Service, Expands Voluntary Recall - FDA Safety Alerts & Drug Recalls
Let’s Do Lunch, Inc., dba Integrated Food Service (IFS)of Gardena, CA, is expanding the scope of their June 19, 2016, voluntarily recall of certain ready-to-eat sandwiches because they have the potential to be contaminated with Listeria monocytogenes. No illnesses have been reported to date.
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Meijer Recalls Fresh Salad Products Due to Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls
Meijer is announcing a recall of select fresh salads and sandwiches due to a potential risk of Salmonella contamination. The Markets of Meijer Salads and Sandwiches were sold in Meijer stores from 7/20/16 to 7/25/16. There have been no known illnesses reported to Meijer from the product affected by this recall.
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General Mills Expands Retail Flour Recall - FDA Safety Alerts & Drug Recalls
Due to four new confirmed illnesses, General Mills is adding additional flour production dates to the previously announced U.S. retail flour recall that was originally announced on May 31, 2016. The illnesses reported to health officials continue to be connected with consumers reporting that they ate or handled uncooked dough or ate uncooked batter made with raw flour.
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FDA updates warnings for fluoroquinolone antibiotics - FDA Press Releases
The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.
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The Geriatric Day Hospital: Preliminary Data on an Innovative Model of Care in Brazil for Older Adults at Risk of Hospitalization - American Geriatric Society
Older adults have a greater risk of experiencing functional decline and iatrogenic complications during hospitalization than younger individuals. Geriatric day hospitals (GDHs) have been implemented mainly for rehabilitation. The goal of the current study was to expand the GDH spectrum of care to prevent hospital admissions in this population. This study details an innovative model of GDH care that offers short-term, nonrehabilitative treatment to older adults who have experienced an acute event, those with a decompensated chronic disease, or those in need of a minor procedure that would be unattainable in a regular outpatient setting. During the 6-hour visits made weekly for up to 2 months, participants receive integrated evaluations of their various health domains, education, and rapid access to examinations and procedures based on a multidisciplinary approach. In the first 6 years, 2,322 individuals attended the GDH. The analysis of a representative sample (n = 645) revealed that 81% were treated in the GDH without the need for another type of hospital care. This percentage was high for the different reasons for referral (infection, 71%; delirium, 73%; decompensated chronic disease, 81%). Between baseline and discharge, participants maintained their functional status, and their self-reported health improved. This study represents the first step in describing the role of the GDH as a possible alternative to emergency department use or hospitalization for older adults. Future studies are needed to determine the optimal individual for this model of care and to ensure its cost-effectiveness.
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Aggressiveness of End-of-Life Care for Hospitalized Individuals with Cancer with and without Dementia: A Nationwide Matched-Cohort Study in France - American Geriatric Society
Objectives
To compare the aggressiveness of end-of-life care in hospitalized individuals with cancer with and without dementia in France.
Design
Nationwide register-based matched-cohort study.
Setting
Hospital facilities in France.
Participants
All individuals with cancer aged 65 and older with a diagnosis of dementia who died between January 1, 2010 and December 31, 2013, matched one-to-one with individuals with cancer without dementia (n = 26,782 matched pairs).
Results
Older individuals with cancer with dementia were less likely to receive aggressive treatment in their last month of life than those who were not diagnosed with dementia. Dementia was associated with significantly greater likelihood of receiving chemotherapy (2.8% vs 8.5%, P < .001, adjusted odds ratio (aOR) = 0.33, 95% confidence interval (CI) = 0.31–0.36) in the month before death. Individuals with dementia were also less likely to receive radiation therapy (aOR = 0.49, 95% CI = 0.43–0.56), blood transfusions (aOR = 0.67, 95% CI = 0.64–0.70), artificial nutrition (aOR = 0.79, 95% CI = 0.73–0.85), and invasive ventilation (aOR = 0.62, 95% CI = 0.57–0.68), although they were more likely to remain hospitalized over their entire last month of life (aOR = 1.42, 95% CI = 1.37–1.48) and to have more than one emergency department visit (aOR = 1.22, 95% CI = 1.12–1.34).
Conclusion
Older hospitalized adults with cancer with dementia are less likely to receive aggressive cancer treatment near the end of life than those without dementia. This discrepancy raises important ethical questions for clinicians and healthcare policy-makers.
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Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial - American Geriatric Society
Objectives
To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care.
Design
Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up.
Setting
Primary care setting, 39 general practices in the Netherlands.
Participants
Community-dwelling people aged 60 and older (N = 3,092).
Interventions
A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care.
Measurements
Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0–15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality.
Results
The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77–1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80–1.96; control group, 2.03, 95% CI = 1.92–2.13; P = .03). No differences in quality of life were observed.
Conclusion
Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results.
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Saturday, July 23, 2016
Friday, July 22, 2016
Voluntary Recall for 30 Bakery Products - FDA Safety Alerts & Drug Recalls
Weis Markets of Sunbury, PA, is issuing a voluntary recall for 30 bakery products including muffins, cookies, shortbread and baked bread items due to the potential presence of small metal fragments (2-9mm) in the sugar topping used on these products.
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Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with trace peanuts - FDA Safety Alerts & Drug Recalls
Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of peanuts. Consumers who are allergic to peanuts may run the risk of serious or life-threatening allergic reactions if they consume this product. On July 21, 2016 Kwik Trip, Inc. became aware of this situation and have removed all Kitchen Cravings Strawberry and Mixed Berry Parfaits from their Retail location due to the undeclared allergen.
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Talon Compounding Pharmacy Issues Voluntary Nationwide Recall of HCG and Sermorelin Due to Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls
Talon Compounding Pharmacy ("TCP") of San Antonio, Texas, is voluntarily recalling all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to the Food and Drug Administration's ("FDA") concern over a lack of sterility assurance
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Remarks by Andy Slavitt before the American Osteopathic Association - CMS Blog
Chicago, Illinois
Mr. President and Members of the American Osteopathic Association, I’m honored to be invited to address your annual business meeting. Hello and good morning. Thank you for hosting me. I want to give special thanks to:
- Doctor John Becher, the President of the AOA [congratulations on your service to the AOA],
- Doctor Boyd Buser, the President-elect of the AOA [congratulations on your new role],
- Ms. Adrienne White-Faines, the AOA CEO,
- Joseph Giaimo, Member of Board of Trustee, Chair of our Department of Governmental Relations,
- All members of the American Osteopathic Association, and
- Perhaps most of all, the DOs who serve our beneficiaries and consumers everyday, especially in rural and underserved areas.
I want to start by recognizing your long history as osteopathic physicians who lead the nation to where we need to be on health care. Your focus on treating people, not symptoms; on prevention, not illness; in the link between physical and mental health and in all the things that surround a healthy lifestyle so people can live their lives, heal, and age in comfortable settings. In particular, I want to begin by thanking you for your commitment to serving Americans in rural and underserved communities. With all that surrounds health care as a system, it’s reassuring to see your profession focus on what matters most.
Cornerstone is an example of your philosophy in action. A philosophy, while over a century-old, feels very modern today. We’ve just celebrated 50 years of the Medicare program and as we think about how we springboard into the future, it’s very clear that if our health care system continues to center on our big medical institutions, our testing machinery, our pharmaceutical pipelines — and not the people at the center of care, then we will not succeed– either by our beneficiaries or by our country. With 10,000 beneficiaries turning 65 every day, the baby boom population headed into their 70s, and the prevalence of chronic disease where one in four Americans has multiple chronic conditions, and a confusing, fragmented medical system, we won’t have enough taxpayers to support the kind of system we have.
So it’s clear that for the next 50 years of Medicare we need to do things differently – do things more in the Cornerstone way. Here’s how we’re beginning that change:
- Making primary care and prevention a bigger part of people’s lives so that treating illness can be a smaller part of our system. We will be paying for community-based diabetes prevention across Medicare beginning in 2018. And yesterday we were pleased to announce the participation of 20,000 practitioners in our Million Hearts model which focuses on prevention of strokes and heart attacks. I’m happy to note DOs from around the country like the Philadelphia College of Osteopathic Medicine are participating. Paying physicians not just to test or write a prescription, but to actually listen and explain and heal– a move we furthered with our actions in Advanced Care Directives and recent proposals to reward cognitive care;
- Coordinating the care a patient receives so the entanglement of prescriptions, referrals, care instructions, and interpretations can be made simpler and clearer and so patients and families can lead their lives, not spiral around a system feeling worse and feeling more confused;
- Moving towards helping people stay in their homes or in comfortable settings in their communities as they age and recover instead of institutions;
- And, finally, we need technology and information to support us like it does in the rest of our lives, wrapping around the needs of patients and clinicians and how they use the health care systems, not residing in the silos of health IT companies.
But this is really what MACRA is about. It is the opportunity to change how Medicare pays for care, but also the opportunity to achieve something bigger: to support the kind of care that patients want– with physicians able to anticipate and focus on their needs.
While we are talking about how we pay for care in America, payment systems are not intended to be finely calibrated models that we expect to be performed to the test. In all my years, I have never met, nor do I hope to meet, a physician who makes her decision on how to treat a patient based on how she gets paid. She does what she thinks is right for the patient and hopes that the system will support her. Our job in implementing MACRA is to design policies that support the Cornerstones of the world in providing the care they think is best.
Goals for the Quality Payment Program
When Congress passed, and the President signed, the bipartisan Medicare Access and CHIP Reauthorization Act, we finally ended– permanently– the Sustainable Growth Rate (SGR) formula and brought the potential for long-term stability and reliability to the Medicare program.
With MACRA, we answered one question and opened up a set of others that are now ours to begin to address. So how did Congress approach the tough task of sustaining the Medicare program and how will we carry it out? What do you really need to know about the program? And what new sets of requirements are there to participate?
While any change can be distracting, the goal of the program is to return the focus to patient care, not spend time learning a new program. Medicare will still pay for services as it always has, but every physician will have the opportunity to be paid more for better care and for making investments that support patients — like having a staff member follow up with patients at home. MACRA also allows us to end the patchwork of alphabet-soup measurement programs like PQRS, VM, and MU and replaces them with a new single framework that can provide the basis for a more flexible, relevant and ultimately simpler-to-use system.
The new program brings changes intended to promote coordinated care at reasonable costs through a uniform merit-based system. It is defined in the statute to focus on quality– both standard measures of care and practice-based initiatives of a physician’s choosing and encourage the use of technology. Physicians and other clinicians who wish to go further will receive additional bonuses and will be able to join more advanced approaches to care for patients like medical homes, specialty models, and team-based models that improve quality and manage costs.
Implementation Approach and Priorities
Given the size of this change, we decided to engage more with patients and physicians than we ever had to figure out the best path to implementation.
Even with all the promise of MACRA, adding new regulations to an already busy health care system without improving how the pieces fit together just will not work. So, we adopted a new outside-in approach we label “user-driven policy design.” This approach calls on us to conduct an unprecedented effort of intensive listening and learning. And my first commitment is that we do this in as open, transparent, and iterative way possible.
Policy cannot be written from behind our desks. So, we asked our staff to put down their pens and take the unique opportunity to go into the field, meet with physicians, and listen. Starting with me, our career staff and our regions have been tasked with connecting us closer and closer to where care actually happens. And in May, we launched a listening tour across the country so that we could hear firsthand physician thoughts and concerns about the proposal to implement the Quality Payment Program.
Thanks to all of you, this listening tour has been incredibly valuable, and thousands of individuals have provided feedback on the initial proposal for the new Quality Payment Program. Whether you formally submitted one of the nearly 4,000 comments we received, or were one of over 64,000 attendees at one of our outreach sessions, there have been record levels of engagement in this implementation. These conversations are grounding our priorities and we are hearing some hard, but important truths.
To start with, many are frustrated at the overwhelming amount of paperwork they have to do and about measures the become exercise in compliance, instead of quality improvement; about how technology has often distracted instead of supported patient care; and how an accumulation of many small things imposed from afar add up to the feeling that we just don’t get it. This gives us all a place to start thinking about a new framework and the drive to develop a roadmap that not only improves patient care, but does it by beginning to address some of the very real causes of physician burnout.
For all of you who care deeply about serving Medicare patients and are contributing to making the health care system work better, this is a step toward a valuable partnership. And, while we can’t act on every suggestion—your voices as caregivers have been heard and your partnership is having a very real effect on the implementation of this program.
All of this feedback falls into priority areas for us.
First Area of Feedback – Impact on patients.
First of all, you should know that patients, consumers, and families are overwhelmingly supportive of a payment system that pays more for what works and supports the delivery of better care. And physicians and clinicians agree and tell us, in the words of one physician, “Let us practice medicine, and not practice documentation and bureaucracy. We don’t have it in us. We are caregivers. Let us do our job.”
This is the first area of input: to keep the focus on patients.
We must create a system that sharpens the focus on paying for what helps your patients get and stay healthy, rewards collaboration and gives physicians back more time to spend on patients. Fifteen minutes spent tapping at a keyboard is 15 minutes that can’t be spent on patient care. So we have included fewer metrics and more flexibility and a menu of activities that physicians can choose from that are patient-centered– such as expanding office hours, developing specific care plans, or using evidence-based aids that help support shared decision-making. And rather than more documentation, all physicians will need to do in many cases is select an activity and attest to it.
Second Area of Feedback – Simplified reporting and feedback.
The second major area is to do everything we can to reduce the reporting requirements, simplify the scoring, and clarify the rules. Physicians also expressed interest in moving towards a quality improvement program– with more frequent, useful feedback, and away from a compliance program.
We started by reducing by one-third the number of quality metrics that need to be reported and we have aligned the measures across categories to end repetitive reporting. We got rid of technology measures that hindered usability, and moved the focus from “clicking” to care provision and collaboration. Part of reducing burden is becoming more flexible. If physicians already report using a registry or as part of an ACO, we will accept that.
It’s also time to ask a lot more of the technology and technology vendors. Most technology doesn’t adapt to our workflow– we adapt to the technology. And this is particularly true in the area of what many call interoperability– but which most physicians describe as allowing data to move back and forth between systems so they can follow the movement of a patient after they make a referral.
The burden needs to be on the technology, not the user. EHR vendors and hospitals that use them will now be required to open their APIs– so data can move in and out of an application safely and securely– and technology can become plug and play. Today’s data silos are more a function of business practices than technology capability and we cannot tolerate it any longer. This will not only help you track referrals, but serve another purpose– to eliminate the “desktop lock” that occurred based on early EHR purchases.
Third Area of Feedback – Impact on small and rural practices.
Paperwork is one thing if you practice here at Northwestern or Rush, but quite another if you’re a small or solo practice without much, if any, back office staff. Our third focal area is on the impact of this program on small and rural practices to make sure we have a level playing field. This has been an important part of many of our conversations as we travelled the country, including strong feedback from this Association.
We know from experience that small practices can be just as successful as larger practices if the bar to participating isn’t too administratively burdensome. We are working directly with physician user groups to listen to how we can design additional ways to make that easier. Even more exciting are opportunities to join new medical home models like our CPC+ model for smaller practices, which will provide fewer reporting requirements, innovative telemedicine opportunities, and qualify for a 5 percent bonus.
I should also mention that to help smaller and rural practices, we will be deploying technical assistance through a network of learning collaboratives that are already on the ground in local markets. We will spend $100 million over the next 5 years on those efforts to support small practices.
Fourth Area of Feedback – Pathway for Advanced Alternative Payment Models
We heard directly from many physicians, and specialists in particular, that a one-size-fits-all program just won’t work. That’s why our fourth area of focus is to create and offer more approaches and more pathways to models like our medical home model, which qualify for what we call Advanced APMs.
These are models that pay a 5 percent bonus for participation. For example, Accountable Care Organizations that believe their ability to improve care and lower costs enough to take on financial risk. Or, payment approaches like we have launched for cancer care and kidney care.
We have an innovation center that is launching or improving on new payment approaches, so that over the next few years, physicians have more options to participate in something that’s right for their practice and right for their patients. There’s a special advisory committee set up by Congress expressly for the purpose of working with the physician community to develop these new approaches.
Fifth Area of Feedback – Physician readiness for new program.
Finally, we have listened to feedback from physicians who want to make sure they are prepared for all the changes to come. We are committed to making the start as smooth as possible.
Most physicians participate today in many of the elements of MACRA, but we are getting a lot of good points that we must find ways to make sure physicians feel set up for success.
Some of the things that are on the table include alternative start dates, looking at whether shorter periods could be used, and finding other ways for physicians to get experience with the program before the impact of it really begins.
Looking Ahead
This insight– around patient-benefits, simplicity, flexibility and support– are the things that will make the difference between a set of goals from policymakers and something that actually works. And it’s how we will begin to move Medicare and the rest of the health care system forward and anticipate the next 50 years of Medicare beneficiaries.
But after listening to many patients and clinicians, personally visiting practices and hearing the concerns expressed by many, I have no illusions that the changes we all see as so important can happen overnight. I also know that even with good changes, no one will be happy with all the details and that change creates uncertainty. There are always unintended consequences of new laws and regulations and we will need to work through those changes as well. So I’m asking for your ongoing collaboration over the next several years, so that we can implement, receive feedback, iterate, and progress.
I made a comment earlier this year that we lost the hearts and minds of physicians. We won’t win them back with empty promises of quick fixes. We win them back by listening, by making progress even in small steps, and by calling attention to where the system remains dysfunctional. We don’t have the option of running from the challenges we face– because it’s at the very heart of the care we get, that our family gets, that our country gets. With 140 million people in the Medicare, Medicaid, Insurance exchange, and Children’s Health Insurance Program, many on fixed and modest incomes, we will always rely on you on the front lines in taking care of these Americans and allowing them to live their fullest lives.
Conclusion
We must use every opportunity to commit to the quadruple aim as the key to defining a new future for the health care system. I have also seen what happens when the tide turns and so have many of you. For example, a physician in New Jersey told me that as part of a Medical Home, he is setting up Skype Villages to connect his elderly patients to each other. Another in Oregon fulfilled her vision of being able to coordinate real-time mental health handoffs as a game changer for her community. A physician in Arkansas told me that, once ready to retire early, he was extending retirement to 70 because how he was getting paid caught up to how he wanted to practice. And places like Cornerstone become bedrocks of their communities.
In several short years, our nation has brought access to health to 20 million new Americans. Many didn’t think we would get this done. But through hard work, listening, and adjusting we are on our way to fulfilling our country’s promise to provide care to all Americans.
It is now time to turn our attention to the underpinnings of the care system. And when all of us — policy makers, physicians, patients, hospitals, and innovators– focus with a unified purpose, we can make the significant progress that I believe is ahead of us. We can do it. It’s our responsibility to do it. We have no choice, but to do it, and we will if we rally around patient care first and foremost. I look forward to taking on these challenges together.
Thank you for your having me today. And thank you for bringing your gifts to heal our country when we need it most. I look forward to our continued work together.
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Starway Inc. Issues Allergy Alert on Undeclared Milk and Unallowed Color Ponceau 4R (E124) in Peony Mark Brand Biscuits - FDA Safety Alerts & Drug Recalls
Starway Incorporated, located at 137 Grattan Street, Brooklyn, NY, 11237, is recalling Peony Mark Brand Biscuits because the product contains undeclared milk and unallowed color Ponceau 4R (E124). People who have severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume this product.
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Treatment for Multiple Acute Cardiopulmonary Conditions in Older Adults Hospitalized with Pneumonia, Chronic Obstructive Pulmonary Disease, or Heart Failure - American Geriatric Society
Objectives
To determine how often hospitalized older adults principally diagnosed with pneumonia, chronic obstructive pulmonary disease (COPD), or heart failure (HF) are concurrently treated for two or more of these acute cardiopulmonary conditions.
Design
Retrospective cohort study.
Setting
368 U.S. hospitals in the Premier research database.
Participants
Individuals aged 65 and older principally hospitalized with pneumonia, COPD, or HF in 2009 or 2010.
Measurements
Proportion of diagnosed episodes of pneumonia, COPD, or HF concurrently treated for two or more of these acute cardiopulmonary conditions during the first 2 hospital days.
Results
Of 91,709 diagnosed pneumonia hospitalizations, 32% received treatment for two or more acute cardiopulmonary conditions (18% for HF, 18% for COPD, 4% for both). Of 41,052 diagnosed COPD hospitalizations, 19% received treatment for two or more acute cardiopulmonary conditions (all of which involved additional HF treatment). Of 118,061 diagnosed HF hospitalizations, 38% received treatment for two or more acute cardiopulmonary conditions (34% for pneumonia, 9% for COPD, 5% for both).
Conclusion
Hospitalized older adults diagnosed with pneumonia, COPD, or HF are frequently treated for two or more acute cardiopulmonary conditions, suggesting that clinical syndromes often fall between traditional diagnostic categories. Research is needed to evaluate the risks and benefits of real-world treatment for the many older adults whose presentations elicit diagnostic uncertainty or concern about coexisting acute conditions.
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Thursday, July 21, 2016
Hy-Vee Voluntarily Recalls a Limited Quantity of Its No-Salt-Added Black Beans Due to Potential Presence of Foreign Material - FDA Safety Alerts & Drug Recalls
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling a limited quantity of Hy-Vee No-Salt-Added Black Beans across its eight-state region due the potential presence of plastic and/or metal pieces within the product. The presence of small pieces of plastic and/or metal has the potential to cause a choking hazard and may cause adverse health consequences, including injury.
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Wednesday, July 20, 2016
Krispak, Inc. Issues Allergy Alert on Undeclared Treenuts - Pecans In GFS Honey Roasted Peanuts Received From Supplier Trophy Nut Co. - FDA Safety Alerts & Drug Recalls
Krispak, Inc. of Grand Rapids, MI, is recalling a small quantity of Honey Roasted Peanuts packed under the GFS label because they may contain undeclared Tree Nuts - Pecans. People who have allergies to Tree Nuts - Pecans run the risk of serious or life-threatening allergic reaction if they consume this product.
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$42 Billion Saved in Medicare and Medicaid Primarily Through Prevention - CMS Blog
By Shantanu Agrawal, M.D. Deputy Administrator and Director, Center for Program Integrity
Today, CMS released a report showing that investments made in program integrity activities – which include stamping out fraud and deterring and reducing other improper payments – pay off for taxpayers and beneficiaries. From October 1, 2012 through September 30, 2014 (Fiscal Year (FY) 2013 and FY 2014), every dollar invested in CMS’ Medicare program integrity efforts saved $12.40 for the Medicare program.
This means that all our efforts – making sure health care providers enrolled in our programs are properly screened; using predictive analytics to prevent fraud, waste, and abuse; and coordinating our anti-fraud efforts with our federal and external partners – have resulted in billions of dollars saved in Medicare and Medicaid over the two-year period.
CMS is dedicated to promoting better care, protecting patient safety, reducing health care costs, and providing people with access to the right care, when and where they need it. This includes continually strengthening and improving Medicare and Medicaid programs that provide vital services to millions of Americans. We take our responsibility to deliver better care at a better value seriously.
An important part of this mission is to ensure that the resources the nation devotes to health program is used to keep our nation’s seniors and low-income families healthy. This is why CMS has a comprehensive and robust program integrity strategy that addresses and prevents potentially fraudulent and improper payments in Medicare and Medicaid. Enhancing program integrity; reducing fraud, waste, and abuse; and tackling all types of improper payments ultimately helps protect current beneficiaries and also protects these programs for future generations.
Medicare and Medicaid Program Integrity Report to Congress
The report highlights CMS’s significant achievements in reducing potentially fraudulent and improper payments. Total savings from program integrity efforts were nearly $42 billion over the two-year period covered by the report. This equates to an average savings of $12.40 for each dollar spent on Medicare program integrity alone. These savings represent funds that remain available to provide needed health care to Medicare, Medicaid, and Children’s Health Insurance Program beneficiaries nationwide and reflect the increasing success of CMS’ efforts to proactively prevent improper payments.
CMS has achieved this impact by using a multifaceted approach, ranging from provider enrollment and screening standards, to use of enforcement authorities, to use of advanced analytics such as predictive modeling. We have previously reported on various outcomes tied to specific programs, some of which can be found here.
More importantly, CMS’s efforts to proactively prevent potentially fraudulent and improper payments from being made have been increasingly effective, moving our efforts away from the “pay-and-chase” method of recovering payments after they had already been made. In fiscal year 2013, savings from prevention activities represented about 68 percent of total savings. In fiscal year 2014, the portion of savings from preventing potentially fraudulent and improper payments rose to nearly 74 percent. This development means that more taxpayer dollars intended to care for the beneficiaries are not being paid at all, avoiding the need to recover improperly paid amounts from health care providers and suppliers. Preliminary information from FY 2015 indicates that CMS’s program integrity efforts continue to accrue savings of this magnitude and that the portion attributed to prevention continues to increase. CMS will release FY 2015 numbers later this year.
CMS collaborates with various partners when implementing efforts to prevent or reduce potentially fraudulent payments and to correct improper payments in Medicare and Medicaid. Assistance from our contractors, state Medicaid agencies, and law enforcement partners are also instrumental in this effort when potentially fraudulent and improper payments result from intentionally fraudulent activities.
CMS remains committed to implementing a robust program integrity strategy to protect beneficiaries from harm and further safeguard taxpayer funds by paying only for appropriate health care items and services. To this end, CMS continuously evaluates and updates its program integrity strategy. We welcome input from beneficiaries, providers, suppliers, and others to inform possible future enhancements to our program integrity strategy. Please contact us at 1-800-MEDICARE (1-800-633-4227) or TTY: 877-486-2048 with your thoughts or to report potentially improper billing.
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Agave Dream Recalls Cappuccino Ice Cream Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Agave Dream of Palos Verdes Peninsula, CA is recalling 389 cases Cappuccino Ice Cream 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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Vaccines and immunization strategies for dengue prevention
Vaccines and immunization strategies for dengue prevention
Emerging Microbes & Infections 5, e77 (July 2016). doi:10.1038/emi.2016.74
Authors: Yang Liu, Jianying Liu & Gong Cheng
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EV-A71 vaccine licensure: a first step for multivalent enterovirus vaccine to control HFMD and other severe diseases
EV-A71 vaccine licensure: a first step for multivalent enterovirus vaccine to control HFMD and other severe diseases
Emerging Microbes & Infections 5, e75 (July 2016). doi:10.1038/emi.2016.73
Authors: Qunying Mao, Yiping Wang, Lianlian Bian, Miao Xu & Zhenglun Liang
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Molecular characterization of H6 subtype influenza viruses in southern China from 2009 to 2011
Molecular characterization of H6 subtype influenza viruses in southern China from 2009 to 2011
Emerging Microbes & Infections 5, e73 (July 2016). doi:10.1038/emi.2016.71
Authors: Shumei Zou, Rongbao Gao, Ye Zhang, Xiaodan Li, Wenbing Chen, Tian Bai, Libo Dong, Dayan Wang & Yuelong Shu
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Intense circulation of A/H5N1 and other avian influenza viruses in Cambodian live-bird markets with serological evidence of sub-clinical human infections
Intense circulation of A/H5N1 and other avian influenza viruses in Cambodian live-bird markets with serological evidence of sub-clinical human infections
Emerging Microbes & Infections 5, e70 (July 2016). doi:10.1038/emi.2016.69
Authors: Srey Viseth Horm, Arnaud Tarantola, Sareth Rith, Sowath Ly, Juliette Gambaretti, Veasna Duong, Phalla Y, San Sorn, Davun Holl, Lotfi Allal, Wantanee Kalpravidh, Philippe Dussart, Paul F Horwood & Philippe Buchy
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Tuesday, July 19, 2016
ConAgra Foods Expands Recall of P.F. Chang’s Home Menu Brand Meals Available in Grocery Retailers Due to Potential Presence of Foreign Material ConAgra Foods Does Not Make Meals for P.F. Chang’s Restaurants - FDA Safety Alerts & Drug Recalls
ConAgra Foods is expanding a voluntary recall of P.F. Chang’s Home Menu Brand products due to the potential presence of small metal fragments (2-9mm) in the sugar used in the sauce. This voluntary action is being undertaken because of impacted sugar from a supplier.
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Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of No-Salt-Added Black Beans (Frijoles Negros Bajo En Sodio, Frijoles Negros, Frijol Negro Sin Sal) Due to the Potential Presence of Foreign Material - FDA Safety Alerts & Drug Recalls
Faribault Foods, Inc. of Faribault, MN, is initiating a voluntary recall of a limited number of 15 ounce No-Salt-Added Black Beans due to the potential presence of plastic and/or metal pieces within the product.
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Federal court orders Minnesota sprout and noodle company to cease operations due to unsanitary conditions - FDA Press Releases
On July 15, 2016, the U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction between the United States and Kwong Tung Foods, Inc., doing business as Canton Foods; its president and owner, Vieta “Victor” C. Wang; and its vice-president, Juney H. Wang, for significant and ongoing violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The business, located in Minneapolis, Minnesota, sells rice and wheat noodles, and mung bean and soy bean sprouts.
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Monday, July 18, 2016
Theo Chocolate Issues Allergy Alert on Undeclared Milk in Salted Almond 70% Dark Chocolate - FDA Safety Alerts & Drug Recalls
Theo Chocolate of Seattle, Washington is voluntarily recalling 3 ounce Salted Almond 70% Dark Chocolate bars because they may contain 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 this product.
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Friday, July 15, 2016
Update: Tippin’s Gourmet Pies, LLC Announces the Recall of Tippin’s Key Lime Pie for the Presence of Undeclared Peanut Residue Due to Supplier Recall - FDA Safety Alerts & Drug Recalls
Tippin’s Gourmet Pies, LLC today is voluntarily recalling select Key Lime Pies because they may contain flour with undeclared peanut residue. Tippin’s initiated the recall after we became aware that our supplier, Kellogg Company, was conducting a recall of graham cracker crumbs because they may contain undeclared peanut residue. The graham cracker crumbs were used to make the crust for our Key Lime Pies identified below.
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PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination - FDA Safety Alerts & Drug Recalls
PharmaTech LLC of Davie, FL, the manufacturer of the Rugby®- branded product, is voluntarily recalling all lots within the expiry of Diocto Liquid, a docusate sodium solution due to a risk of product contamination with Burkholderia cepacia. Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
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FDA approves first intraocular lens with extended range of vision for cataract patients - FDA Press Releases
The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.
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Is This Broken Bone Because of Abuse? Characteristics and Comorbid Diagnoses in Older Adults with Fractures - American Geriatric Society
Objectives
To examine the relationship between individual characteristics and potential correlates of elder abuse in older adults who present with fractures.
Design
Cross-sectional analysis of deidentified data extracted from medical records.
Setting
Academic medical center.
Participants
Individuals aged 65 and with a primary diagnosis of any fracture admitted to an outpatient department or emergency department (ED) in a single southern California medical center over a 36-month period (N = 652).
Measurements
Participant characteristics included demographic characteristics, number of medical visits, and point of service. Corresponding International Classification of Diseases, Ninth Revision (ICD-9) codes, E-codes, and V-codes were extracted to identify cause, location, and type of fracture. The presence of 13 potential correlates of abuse as captured by ICD-9 codes were extracted and summed. Descriptive statistics and regression models were used for analyses.
Results
Mean age of participants was 77.2, 58% were female (58%), 60% were white (60%), and 46% had one or more potential correlates of abuse. In bivariate analyses, older age (≥80), dementia, seeking care in the ED (vs inpatient or outpatient clinics), only one visit to a medical facility (vs multiple visits) in the 36-month study period, cause of fracture as something other than a fall, and fractures of the head or face were more likely to have at least one correlate of abuse. In logistic regression, dementia (B = 0.794, standard error (SE) = 0.280); seeking care in the ED (vs outpatient or outpatient clinics) (B = 1.86, SE = 0.302); at least two visits to a medical facility (vs multiple visits) (B = −0.585, SE = 0.343); and fracture of the back (B = 0.730, SE = 0.289), head (B = 1.22, SE = 0.333), and face (B = 1.28, SE = 0.474) were associated with the presence of at least one correlate of abuse.
Conclusion
Certain characteristics in older adults with fracture are associated with potential correlates of abuse. Medical practitioners should have a heightened awareness when these signs are present.
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Thursday, July 14, 2016
Monogram Appetizers Issues Allergy Alert On Undeclared (Egg) In Poppers Brand Mozzarella Cheese Sticks - FDA Safety Alerts & Drug Recalls
Monogram Appetizers of Plover, Wisconsin is recalling approximately 5000 cases of Poppers Brand Mozzarella Cheese Sticks, because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.
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Wednesday, July 13, 2016
International Commissary Corporation Issues Voluntary Recall of Marie Callender's Cheese Biscuit Mix Due To Possible Health Risk - FDA Safety Alerts & Drug Recalls
International Commissary Corporation (ICC) has issued a voluntary recall of certain lots of two retail products: Marie Callender's 7oz & 14oz Cheese Biscuit Mix. The 7 oz recalled product has Best By dates of 3/22/17 and 5/17/17 and was sold in retail stores in the following states - AL, CA, WA, UT, and TX. The 14 oz recalled product has a Best Buy date of 6/17/17 and was sold only in Stockton, CA.
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Kerry Inc. Recalls Golden Dipt® Jalapeño Breaders Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Kerry Inc. of Beloit, WI is recalling two lots of Golden Dipt Jalapeno Breader that were sold to foodservice distributors because one of our suppliers recalled an ingredient used in our mix for the potential presence of E. coli O121. Kerry Inc. was notified by our supplier that two of their products, a red bell pepper nugget and a jalapeno nugget, were made with a small percentage of affected flour which was recalled by General Mills because it may be contaminated with E. coli O121.
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IKEA N.A. Services, LLC Voluntarily Issues Expanded Recall and Allergy Alert on Undeclared Milk, Almond, and/or Hazelnut on Certain IKEA Chocolate Products - FDA Safety Alerts & Drug Recalls
CHOKLAND MORK, CHOKLAND MORK 70%, CHOKLAD LINGON & BLABAR, CHOKLAD NOT, GODIS CHOKLADKROKANT, GODIS CHOKLADRAN and CHOKLAD LJUS, are being recalled due to undeclared Milk, Hazelnuts and/or Almond. "All Best Before Dates," Sold from April 30, 2015 to July 1, 2016.
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Baptista's Bakery Issues Allergy Alert on Undeclared Milk in Snack Factory® Original Pretzel Crisps® - FDA Safety Alerts & Drug Recalls
Baptista's Bakery, Inc. announced a voluntary recall of a limited number of 30 oz. Snack Factory Original Pretzel Crisps packages because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected product.
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A fatal yellow fever virus infection in China: description and lessons
A fatal yellow fever virus infection in China: description and lessons
Emerging Microbes & Infections 5, e69 (July 2016). doi:10.1038/emi.2016.89
Authors: Zhihai Chen, Lin Liu, Yanning Lv, Wei Zhang, Jiandong Li, Yi Zhang, Tian Di, Shuo Zhang, Jingyuan Liu, Jie Li, Jing Qu, Wenhao Hua, Chuan Li, Peng Wang, Quanfu Zhang, Yanli Xu, Rongmeng Jiang, Qin Wang, Lijuan Chen, Shiwen Wang, Xinghuo Pang, Mifang Liang, Xuejun Ma, Xingwang Li, Quanyi Wang, Fujie Zhang & Dexin Li
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Tuesday, July 12, 2016
Two Flavors of Betty Crocker Cake Mix Recalled - FDA Safety Alerts & Drug Recalls
MINNEAPOLIS - Out of an abundance of caution, two flavors of Betty Crocker cake mix sold in the U.S. and one flavor sold in Canada have been added to General Mills' previously announced flour recall from July 1, 2016. No illnesses reported to date have been connected to cake mix.
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Alere to Initiate Voluntary Withdrawal of the Alere INRatio and INRatio2 PT/INR Monitor System - FDA Safety Alerts & Drug Recalls
WALTHAM, Mass. - Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc. (NYSE:ALR) will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.
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FDA approves new medication for dry eye disease - FDA Press Releases
The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved by the FDA for dry eye disease.
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Monday, July 11, 2016
General Mills Voluntarily Recalls a Limited Quantity of Frozen Beyond Meat Vegetarian Indian Curry with Beyond Chicken - FDA Safety Alerts & Drug Recalls
General Mills today announced a voluntary recall of a limited quantity of frozen Beyond Meat Vegetarian Indian Curry with Beyond Chicken, produced over seven days in April 2016. This product is available exclusively at Whole Foods.
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FDA approves first MRI-guided focused ultrasound device to treat essential tremor - FDA Press Releases
The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.
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Saturday, July 9, 2016
Continental Mills Recalls Blueberry Pancake Mix Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Continental Mills has issued a recall affecting only retail Krusteaz Blueberry Pancake Mix, which involves product manufactured between April 2016 and June 2016. The company was notified by our supplier that their product, a blueberry nugget, is made with a small percentage of affected flour which was recalled by General Mills because it may be contaminated with E. coli O121.
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Kroger Recalls Deluxe S'mores Ice Cream Due to Undeclared Allergens - FDA Safety Alerts & Drug Recalls
The Kroger Co. (NYSE: KR) has recalled Kroger Deluxe S'mores Ice Cream (48 oz, tub) sold in its retail stores because the product may contain peanuts not listed on the label. Kroger initiated the recall when a supplier, Grain Craft, indicated a raw ingredient may have become contaminated with low levels of peanut residue.
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Does the Shoe Fit? Ethical, Legal, and Policy Considerations of Global Positioning System Shoes for Individuals with Alzheimer's Disease - American Geriatric Society
As the overall incidence of Alzheimer's disease rises, the burden on caregivers and law enforcement institutions will increase to find individuals who wander. As such, technological innovations that could reduce this burden will become increasingly important. One such innovation is the GPS Shoe. As with any innovation involving the transfer of personal data to third parties, potential pitfalls with respect to loss of privacy and inadequate consent counterbalance the substantial promise of GPS shoes. To some extent, advance planning can mitigate these concerns, wherein individuals willingly elect to be monitored before their impairments progress to a stage that makes such authorization impractical. Nonetheless, tension may arise between the peace of mind of caregivers and family members and other important considerations at the intersection of autonomy, privacy, dignity, and consent. Ultimately, confronting ethical, legal, and policy considerations at the front end of product development and deployment will help ensure that new technologies are used wisely and that their lifesaving potential is realized.
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Friday, July 8, 2016
Hearn Kirkwood Recalls "Evie's Cheddar Potato Salad" Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Hearn Kirkwood is initiating a voluntary recall of "Evie's Cheddar Potato Salad" 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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FDA approves Differin Gel 0.1% for over-the-counter use to treat acne - FDA Press Releases
The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
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Thursday, July 7, 2016
Focusing on Primary Care for Better Health - CMS Blog
By Andy Slavitt, CMS Acting Administrator (@aslavitt) and
Patrick Conway, MD, MSc, CMS Acting Principal Deputy Administrator and Chief Medical Officer
In the United States, we have historically invested far more in treating sickness than we do in maintaining health. The result of this imbalance is not only poorer health, but more money spent in institutions, hospitals, and nursing homes.
The road to a better health care system means correcting this imbalance. We should reinvest in what we value — primary care — as a practice, as a profession, and as an abundant resource for patients. In recent years, we have begun taking a number of meaningful steps to begin this reinvestment process. Today, we are proposing significant actions to improve how we pay primary care physicians, mental health specialists, geriatricians, and other clinicians. By better valuing primary care and care coordination, we help beneficiaries access the services they need to stay well. In addition to keeping people healthy, health care costs are lower when people have a primary care provider and team of doctors and clinicians overseeing and coordinating their care.
There are four parts to our strategy to emphasize primary care:
- We are improving how we pay for care that we value. Today, through the Medicare physician fee schedule proposed rule, we are announcing an important set of changes that would improve how Medicare pays for primary care, care coordination, and mental health care. We conservatively estimate that these changes would result in approximately $900 million in additional funding in 2017 to physicians and practitioners providing these services. Over time, if the practitioners qualified to provide these services were to fully provide these services to all eligible beneficiaries, the increase could be as much as $5 billion in additional funding for care coordination and patient-centered care. These changes build on the work we’ve done to improve access to care in Medicaid by finalizing long-anticipatedrules that help support state delivery system reform efforts, and strengthening new policies to align payment with better, more cost-effective care and ensure that access to care is sufficient in key specialties.
- We are providing more opportunities for primary care providers to practice the way they think is best. Medicare is transitioning to policies that reduce burden on both patients and clinicians by better rewarding coordinated, quality care. We’ve recently launched a new advanced primary care Medical Home model called CPC+, which will be broadly available across the country and will support primary care doctors’ and clinicians’ efforts to spend more time with patients, serve patients’ needs outside of the office visit, and better coordinate care with specialists.
- We are finding ways to reduce practice expenses associated with operating a primary care or other small practice. We have been convening meetings with physician practices across the country to find ways to reduce reporting and compliance burdens, while at the same time increasing support to their practices. This spring, we proposed to streamline how Medicare pays for quality and value through the new Quality Payment Program, which includes features intended to reduce the reporting burden for clinicians. Through this new program, we’ve moved beyond meaningful use to the new Advancing Care Information category, which supports the vision of providers leveraging health IT to promote efficiency and clinical effectiveness based on their unique needs. In addition, the Transforming Clinical Practice Initiative supports more than 140,000 clinicians in sharing, adapting, and further developing their comprehensive quality improvement strategies.
- We are exploring and encouraging far-reaching innovations to connect people with primary care in new ways. We have included telemedicine in a number of care models. The Rural Health Council is also helping to promote a strategic focus on access, economics, and innovation issues across rural America.
Today’s Proposals for Primary Care Payments in the Physician Fee Schedule
With today’s primary care payment proposals, Medicare continues to move toward a health care system that encourages teams of doctors to work together and collaborate in order to provide more personalized care for their patients. Doctors will be compensated for spending more time with their patients, serving their patients’ needs outside of the office visit, and better coordinating care. These changes will deliver improved health outcomes that matter to the patient. Some examples of today’s proposals include:
- Increasing payments for routine office visits for treating patients with mobility-related disabilities. Currently, Medicare pays approximately $73 for these visits, even though the patient might need to spend more time with the physician or require more physical and staff support during the visit. Under today’s proposal, Medicare would pay approximately $119 for the visit.
- Increasing payments to geriatricians or family practice physicians – specialists who provide core services for the Medicare program. Under our conservative assumptions, we anticipate that these clinicians could receive a two percent increase in their payments for providing the care we propose to recognize under the Physician Fee Schedule. Over time, if all of the practitioners that can provide these services provide them to all eligible patients, we estimate that the payment increase could be as much as 30 and 37 percent respectively to these specialties.
- Proposing to pay for care using the behavioral health Collaborative Care Model. The Collaborative Care model supports mental and behavioral health through a team-based, coordinated approach involving a psychiatric consultant, a behavioral health care manager, and the primary care clinician and which extends beyond the scope of an office visit. Payment for care using this model will help address access issues for behavioral health and improve care for patients. This model, increasingly used by primary care practices, has demonstrated benefits in a variety of settings to improve patient outcomes. CMS is also proposing to pay for other approaches to behavioral health integration.
Strengthening Primary Care Beyond Medicare
As more people age into the Medicare program, we know that access to primary care is an essential tool for their health and wellbeing. We know that effective primary care, care coordination and planning, mental health care, substance use disorder treatment, and care for patients with cognitive and functional impairments can improve outcomes and result in smarter spending. Today’s efforts aim to better value primary care to ensure continued – and strengthened – beneficiary access to these valuable services.
We expect to see the impact of this proposal far beyond Medicare beneficiaries and hope that it will help strengthen the fabric of primary care throughout the country.
For more information, please visit: http://ift.tt/29xYkLa.
Filed under: Uncategorized
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FDA approves first HPV test for use with SurePath Preservative Fluid - FDA Press Releases
The U.S. Food and Drug Administration today approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.
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Homebound Patient and Caregiver Perceptions of Quality of Care in Home-Based Primary Care: A Qualitative Study - American Geriatric Society
Objectives
To assess patient and caregiver perceptions of what constitutes quality care in home-based primary care (HBPC).
Design
Cross-sectional qualitative design; semistructured interview study.
Setting
Academic home-based primary care program.
Participants
Homebound patients (n = 13) and 10 caregivers (n = 10) receiving HBPC.
Measurements
Semistructured interviews explored experiences with a HBPC program and perceptions of quality care. Interviews were audio-recorded and transcribed. Qualitative content analysis was performed to identify major themes.
Results
Five major themes emerged related to participant perceptions of quality care: access, affordability, competency, care coordination, goal attainment. Participants felt that reliable, consistent access provided “peace of mind” and reduced hospital and emergency department use. Insurance coverage of program costs and coordinated care provided by an interdisciplinary team were positively regarded. Interpersonal skills and technical abilities of providers influenced patient perception of provider competency. Assessing and helping patients attain care goals contributed to a perception of quality care.
Conclusion
Patients and caregivers associate high-quality HBPC with around-the-clock access to affordable interdisciplinary providers with strong interpersonal skills and technical competency. These results expand on prior research and are concordant with HBPC goals of around-the-clock access to multidisciplinary teams with the goals of reduced emergency department and hospital use. HBPC programs should be structured to optimize access, affordability, coordinated care, and goal ascertainment and alignment. Quality indicators should be created and validated with these patient and caregiver views of care quality in mind.
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Using Electronic Health Record Data to Measure Care Quality for Individuals with Multiple Chronic Medical Conditions - American Geriatric Society
Objectives
To inform the development of a data-driven measure of quality care for individuals with multiple chronic conditions (MCCs) derived from an electronic health record (EHR).
Design
Qualitative study using focus groups, interactive webinars, and a modified Delphi process.
Setting
Research department within an integrated delivery system.
Participants
The webinars and Delphi process included 17 experts in clinical geriatrics and primary care, health policy, quality assessment, health technology, and health system operations. The focus group included 10 individuals aged 70–87 with three to six chronic conditions selected from a random sample of individuals aged 65 and older with three or more chronic medical conditions.
Measurements
Through webinars and the focus group, input was solicited on constructs representing high-quality care for individuals with MCCs. A working list was created of potential measures representing these constructs. Using a modified Delphi process, experts rated the importance of each possible measure and the feasibility of implementing each measure using EHR data.
Results
High-priority constructs reflected processes rather than outcomes of care. High-priority constructs that were potentially feasible to measure included assessing physical function, depression screening, medication reconciliation, annual influenza vaccination, outreach after hospital admission, and documented advance directives. High-priority constructs that were less feasible to measure included goal setting and shared decision-making, identifying drug–drug interactions, assessing social support, timely communication with patients, and other aspects of good customer service. Lower-priority domains included pain assessment, continuity of care, and overuse of screening or laboratory testing.
Conclusion
High-quality MCC care should be measured using meaningful process measures rather than outcomes. Although some care processes are currently extractable from electronic data, capturing others will require adapting and applying technology to encourage holistic, person-centered care.
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Interprofessional Collaboration to Improve Discharge from Skilled Nursing Facility to Home: Preliminary Data on Postdischarge Hospitalizations and Emergency Department Visits - American Geriatric Society
An interprofessional collaborative practice model was established at Hennepin County Medical Center to improve discharge management from the transitional care unit of the skilled nursing facility (SNF) to home. The practice model involves a geriatrician, nurse practitioner, and pharmacist who care for individuals at a community-based SNF. Before SNF discharge, the pharmacist conducts a chart and in-person medication review and collaborates with the nurse practitioner to determine the discharge medication regimen. The pharmacist's review focuses on assessing the indication, safety, effectiveness, and convenience of medications. The pharmacist provides follow-up in-home or over the telephone 1 week after SNF discharge, focusing on reviewing medications and assessing adherence. Hospitalizations and emergency department (ED) visits 30 days after SNF discharge of individuals who received care from this model was compared with those of individuals who received usual care from a nurse practitioner and geriatrician. From October 2012 through December 2013, the intervention was delivered to 87 individuals, with 189 individuals serving as the control group. After adjusting for age, sex, race, and payor, those receiving the intervention had a lower risk of ED visits (odds ratio (OR) = 0.46, 95% confidence interval (CI) = 0.22–0.97), although there was no significant difference in hospitalizations (OR = 0.47, 95% CI = 0.21–1.08). The study suggests that an interprofessional approach involving a pharmacist may be beneficial in reducing ED visits 30 days after SNF discharge.
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