Graceleigh, Inc. d/b/a Sammy’s Milk is recalling all lots of Sammy’s Milk Baby Food because of possible presence of Cronobacter, a bacteria that can cause severe and sometimes fatal blood infections or meningitis in infants and it may not provide adequate nutritional levels of iron.
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Friday, September 30, 2016
FDA warns against the use of homeopathic teething tablets and gels - FDA Press Releases
The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.
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Fall Risk Assessment Predicts Fall-Related Injury, Hip Fracture, and Head Injury in Older Adults - American Geriatric Society
Objectives
To investigate the role of a fall risk assessment, using the Downton Fall Risk Index (DFRI), in predicting fall-related injury, fall-related head injury and hip fracture, and death, in a large cohort of older women and men residing in Sweden.
Design
Cross sectional observational study.
Setting
Sweden.
Participants
Older adults (mean age 82.4 ± 7.8) who had a fall risk assessment using the DFRI at baseline (N = 128,596).
Measurements
Information on all fall-related injuries, all fall-related head injuries and hip fractures, and all-cause mortality was collected from the Swedish Patient Register and Cause of Death Register. The predictive role of DFRI was calculated using Poisson regression models with age, sex, height, weight, and comorbidities as covariates, taking time to outcome or end of study into account.
Results
During a median follow-up of 253 days (interquartile range 90–402 days) (>80,000 patient-years), 15,299 participants had a fall-related injury, 2,864 a head injury, and 2,557 a hip fracture, and 23,307 died. High fall risk (DFRI ≥3) independently predicted fall-related injury (hazard ratio (HR) = 1.43, 95% confidence interval (CI) = 1.39–1.49), hip fracture (HR = 1.51, 95% CI =1.38–1.66), head injury (HR = 1.12, 95% CI = 1.03–1.22), and all-cause mortality (HR = 1.39, 95% CI = 1.35–1.43). DFRI more strongly predicted head injury (HR = 1.29, 95% CI = 1.21–1.36 vs HR = 1.08, 95% CI = 1.04–1.11) and hip fracture (HR = 1.41, 95% CI = 1.30–1.53 vs HR = 1.08, 95% CI = 1.05–1.11) in 70-year old men than in 90-year old women (P < .001).
Conclusion
Fall risk assessment using DFRI independently predicts fall-related injury, fall-related head injury and hip fracture, and all-cause mortality in older men and women, indicating its clinical usefulness to identify individuals who would benefit from interventions.
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Fresh Express Announces Precautionary Recall of a Limited Quantity of 11 oz. American Salad due to Possible Allergen Exposure - FDA Safety Alerts & Drug Recalls
Fresh Express Incorporated of Orlando, Florida, is voluntarily conducting a precautionary recall of 480 cases of 11 oz. Fresh Express American Salad with a Product Code of G264A12A and Use-By Date of October 5, due to possible exposure to undeclared allergens (egg, milk, wheat, anchovy). Fresh Express representatives are coordinating with retail stores to ensure removal of the recalled product from store shelves where distributed in primarily southern states.
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Thursday, September 29, 2016
The Medicare Current Beneficiary Survey: Celebrating Our 25th Anniversary and a Bright Future Ahead - CMS Blog
By Niall Brennan, Chief Data Officer, CMS
This year marks the 25th anniversary and the one millionth beneficiary interview for the Medicare Current Beneficiary Survey (MCBS), a survey that the Centers for Medicare & Medicaid Services (CMS) first fielded in 1991. This in-person survey of 15,000 Medicare beneficiaries collects valuable information about aspects of the Medicare program that cannot be analyzed based on CMS administrative data alone. In particular, the MCBS gathers information on self-reported health status, satisfaction with care, and functional limitations. The MCBS also collects information on beneficiaries that is key to understanding patient-centered care. Beneficiary’s out-of-pocket spending and source of payment for medical services received outside the Medicare program provides a window into the “invisible” and missed costs of health care. One unique aspect of the MCBS is that it includes beneficiaries who reside in institutional settings, such as a nursing home, as well as those in the community.
The MCBS is used across CMS to provide important insights that support internal program analyses. For example, over the past several years, the MCBS has become a key resource for evaluating the impact of CMS Innovation Center demonstration models as well as for approving Medicare Advantage and Prescription Drug Plan benefits.
The MCBS also serves as the foundation for thousands of health policy analyses across a diverse external user community. To date, we know of more than 1,000 peer-reviewed papers based on MCBS data in leading publications such as the New England Journal of Medicine, the Journal of the American Medical Association, Journal of Health Economics, and the Journal of the American Geriatrics Society.
Today, I want to acknowledge a number of important efforts CMS has undertaken to ensure the MCBS remains a valuable resource for the agency and external stakeholders. We have made the data more accessible, releasing the first ever MCBS public use file in May of this year. While MCBS data files have always been available for a relatively nominal fee, we heard that this fee was a barrier to entry for certain users such as students. We believe that increased access through this freely available public resource will expand the MCBS user community, and thus help cement its importance as a critical tool in the evaluation of systemic changes in the US health care delivery system.
We are also implementing changes to the MCBS questionnaire and survey design. Revising and improving the survey questions is underway. We have added new relevant content including an updated dental utilization module, a module on care coordination, and new questions on food security. Enhancing the sampling methodology to include newly enrolled beneficiaries in the first year of their Medicare enrollment, conducting an oversample of Hispanic beneficiaries, and, beginning in 2017, conducting an oversample of low-income beneficiaries increase our ability to conduct disparities research and improve our survey estimates.
We are also committed to a more rapid data release schedule, with improved user documentation and file structure. The 2015 MCBS files will be the first to have many of the improvements discussed above. We anticipate releasing the 2015 data file in the 2nd quarter of 2017, more than one year earlier than the previous file release schedule. The release of the 2015 data will also include improved chart books to accompany data releases and more intuitive naming conventions and file layouts with modern file formats for SAS, Stata, and R use. However, to accommodate these long overdue innovations, we had to make the difficult decision not to release 2014 data files.
As we celebrate our 25th anniversary of the MCBS, we are renewing our commitment to providing the most useful and relevant information about the Medicare program and, more importantly, the health and satisfaction of its beneficiaries.
We hope that you’ll visit us on our MCBS webpage at http://ift.tt/2cEytTU where you can also subscribe for important updates and announcements.
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FDA Statement from Todd Simpson, FDA Chief Information Officer (CIO) on GAO Report Regarding FDA’s IT Security Program - FDA Press Releases
Information security and the protection of industry and public health information are among the FDA’s highest priorities and we do not take lightly the recommendations provided by the GAO in its June 2016 report.
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Periodontitis as a Modifiable Risk Factor for Dementia: A Nationwide Population-Based Cohort Study - American Geriatric Society
Objectives
To determine whether periodontitis is a modifiable risk factor for dementia.
Design
Prospective cohort study.
Setting
National Health Insurance Research Database in Taiwan.
Participants
Individuals aged 65 and older with periodontitis (n = 3,028) and an age- and sex-matched control group (n = 3,028).
Measurements
Individuals with periodontitis were compared age- and sex-matched controls with for incidence density and hazard ratio (HR) of new-onset dementia. Periodontitis was defined according to International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes 523.3–5 diagnosed by dentists. To ensure diagnostic validity, only those who had concurrently received antibiotic therapies, periodontal treatment other than scaling, or scaling more than twice per year performed by certified dentists were included. Dementia was defined according to ICD-9-CM codes 290.0–290.4, 294.1, 331.0–331.2.
Results
After adjustment for confounding factors, the risk of developing dementia was calculated to be higher for participants with periodontitis (HR = 1.16, 95% confidence interval = 1.01–1.32, P = .03) than for those without.
Conclusion
Periodontitis is associated with greater risk of developing dementia. Periodontal infection is treatable, so it might be a modifiable risk factor for dementia. Clinicians must devote greater attention to this potential association in an effort to develop new preventive and therapeutic strategies for dementia.
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Change in Quality of Life and Its Association with Oral Health and Other Factors in Community-Dwelling Elderly Adults—A Prospective Cohort Study - American Geriatric Society
Objectives
To determine whether changes in oral health status were associated with decline in quality of life (QoL).
Design
Prospective cohort study.
Setting
Carlos Barbosa, southern Brazil.
Participants
A random sample of 872 community-dwelling individuals aged 60 and older was evaluated in 2004. The current study population consisted of 389 participants available for follow-up in 2012.
Measures
Change in QoL was assessed through the use of the short version of the World Health Organization QoL Assessment tool (WHOQOL-BREF) at baseline and follow-up. Each WHOQOL domain generates a score, with changes being calculated for each domain. Individuals with the same or higher scores at follow-up were categorized as having improved QoL, and those with lower scores were categorized as having a decline in QoL. Sociodemographic and health variables were assessed in an interview, and tooth loss, use of dental prostheses, and satisfaction with chewing ability and oral appearance were verified through oral examinations. Interviews and examinations were repeated. Risk ratios (RRs) relative to the outcome and independent variables were estimated using Poisson regression with a robust variance estimator.
Results
Tooth loss was a risk factor for decline in the psychological domain of QoL (RR = 1.04, 95% confidence interval (CI) = 1.02–1.06). Improvement in satisfaction with chewing ability was a protective factor for decline in this same domain (RR = 0.69, 95% CI = 0.50–0.97). Greater satisfaction with oral appearance was a protective factor against decline in social (RR = 0.84, 95% CI = 0.72–0.98) and environmental (RR = 0.77, 95% CI = 0.61–0.97) domain scores.
Conclusion
Preventing tooth loss and recognizing and properly addressing concerns about chewing and dental appearance can affect the general well-being of community-dwelling elderly adults.
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Trends in Incidence of Disability in Activities of Daily Living in Chinese Older Adults: 1993–2006 - American Geriatric Society
Objectives
To investigate time trends in incidence of activity of daily living (ADL) disability of Chinese older adults and to explore factors potentially contributing to trends.
Design
Population-based prospective study using a multistage, randomized, cluster sampling process.
Setting
Nine provinces of China.
Participants
Three consecutive cohorts of people aged 60 and older from the China Health and Nutrition Survey: cohort 1993–2000 (n = 831), cohort 1997–2004 (n = 1,091), cohort 2000–2006 (n = 1,152).
Measurements
Disability in ADLs was defined as inability to perform at least one of five self-care activities (transferring, dressing, toileting, bathing, feeding). Data were analyzed using Cox and generalized estimating equation models.
Results
The incidence (per 1,000 person-years) of ADL disability decreased significantly from 35.3 in 1993–2000 and 28.9 in 1997–2004 to 24.3 in 2000–2006 in Chinese older adults (Ptrend < .001). The incidence of ADL disability decreased significantly in men and women, in young-old adults (aged 60–74), and in those living in rural areas (all Ptrend ≤ .02) after controlling for multiple potential influential factors. Of the five ADL items, decline in incidence of disability was significant in transferring (Ptrend < .001) and bathing (Ptrend = .002) and marginally significant in toileting (Ptrend = .06) but stable in dressing (Ptrend = .38) and feeding (Ptrend = .26).
Conclusion
The incidence of ADL disability decreased from 1993 to 2006 in older adults in China, especially in transferring and bathing, independent of sociodemographic, lifestyle, and chronic health conditions.
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Wednesday, September 28, 2016
Caring for Older Adults with the Human Immunodeficiency Virus - American Geriatric Society
Increasing proportions of older adults are living with the human immunodeficiency virus (HIV). It is estimated that more than 50% of individuals with HIV in the United States are aged 50 and older. Part of this group consists of individuals who have aged with chronic HIV infection, but a large proportion also results from new HIV diagnosis, with approximately 17% of new HIV diagnoses in 2013 occurring in individuals aged 50 and older. Although many of the recommendations on management of HIV infection are not age-specific, individuals with HIV aged 50 and older differ from their younger counterparts in many aspects, including immune response to antiretroviral therapy, multimorbidity, antiretroviral toxicities, and diagnostic considerations. This article outline these differences, offers a strategy on how to care for this unique population, and provides special considerations for problem-based management of individuals with HIV aged 50 and older.
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Updated Recall Information: McCain Foods USA, Inc. Issues Expanded Allergy Alert on Undeclared Milk in Frozen Onion Rings Sold and Distributed Under Private Label Retailer Brands - FDA Safety Alerts & Drug Recalls
McCain Foods USA, Inc. of Lisle, IL, today announced it is expanding its voluntarily recall of retail, frozen onion rings to include two (2) additional private label retail branded products due to the use of incorrect packaging that does not declare milk as one of the 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 these products.
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Commitment to Person-Centered Care for Long-Term Care Facility Residents - CMS Blog
By: Andy Slavitt, Acting Administrator and Kate Goodrich, M.D., M.H.S., Director, Center for Clinical Standards & Quality, CMS
Commitment to Person-Centered Care for Long-Term Care Facility Residents
It’s an experience millions of Americans go through each year, the difficult decisions we face when considering a long-term care facility for a loved one. We want to know that our family member will be safe, properly cared for, and receive the highest quality of care.
We are committed to doing everything we can to increase the knowledge and power that can help families undergo these transitions, particularly with regard to the rights of residents to high quality safety and care. Last year, CMS began offering consumers and families the ability to easily compare facilities based on successful discharges, unplanned emergency visits, and re-hospitalizations through a five-star website. However, the rules of the road for long-term care facilities haven’t had a comprehensive update since 1991. Today, we are pleased to announce that we have finalized new rules to protect and empower residents of long-term care facilities.
Today’s rules are a major step forward to improve the care and safety of the nearly 1.5 million residents in the more than 15,000 long-term care facilities that participate in the Medicare and Medicaid programs. These new rules set high standards for quality and safety, while providing facilities with important flexibilities that will assist with the preservation of quality of life and quality of care, and are grounded in the concepts of person-centered care. These changes are an integral part of CMS’s commitment to transform our health system to deliver better quality care and spend our health care dollars in a smarter way, setting high standards for quality and safety in long-term care facilities.
Since proposing to update these rules in July 2015, as part of the White House Conference on Aging, we have received and reviewed nearly 10,000 comments from the public. Many of the comments highlighted an important topic: concern about the use of required binding arbitration agreements that many prospective residents must sign before they are admitted to a long-term care facility. We took all of the comments into careful consideration as we developed the final rule we released today.
Protecting Residents Rights
The rule makes important changes to strengthen the rights of residents and families in the event that a dispute arises with a facility. Historically, many facilities require residents to agree to binding arbitration clauses when they are admitted to these facilities. These clauses require the resident to settle any dispute that may arise using arbitration rather than the court system. Effective November 28, 2016, our final rule will prohibit the use of pre-dispute binding arbitration agreements. This means that facilities may not require residents to sign pre-dispute arbitration agreements as a condition of admission to that long-term care facility.
Facilities and residents will still be able to use arbitration on a voluntary basis at the time a dispute arises. Even then, these agreements will need to be clearly explained to residents, including the understanding that these arbitration agreements are voluntary, and that these agreements should not prevent or discourage residents and families from talking to authorities about quality of care concerns.
This is part of our ongoing commitment at CMS to making sure that health care becomes more person-centered for Medicare and Medicaid beneficiaries and their family members. These changes further that goal by protecting the health and safety of residents, particularly during vulnerable and critical times like when moving into a long-term care facility. Together, the new requirements in today’s final rule set high standards for quality and safety in long-term care facilities and will provide residents – and their families – with greater protections.
For more information on today’s announcement, please visit the CMS website at: http://ift.tt/2d5v66L.
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FDA approves first automated insulin delivery device for type 1 diabetes - FDA Press Releases
The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.
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Koffee Kup Bakery, Inc. Voluntarily Recalls Bread Products Due to Possible Presence of Plastic Pieces in Product - FDA Safety Alerts & Drug Recalls
Koffee Kup Bakery, Inc. has voluntarily recalled approximately 99,000 packages of its bread products due to the possibility that there may be clear plastic pieces in some products. The product recall is limited to the bread products listed below and only those identified by the “use by” dates 9/30/16, 10/1/16, 10/2/16 or 10/3/16, which are printed on the closure tags of each package.
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Tuesday, September 27, 2016
Café Valley Inc. Issues Allergy Alert on Undeclared (Walnuts) In 12ct Banana Nut Mini Muffins Labeled as 12ct Lemon Poppy Seed Mini Muffins - FDA Safety Alerts & Drug Recalls
Café Valley of Marion, Indiana is recalling 543 cases of Banana nut mini muffins labeled as Lemon poppy seed mini muffins, because they may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.
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How Does Aging Affect Presentation and Management of Biliary Stones? - American Geriatric Society
Common bile duct (CBD) stones are common in elderly adults, but the effect of aging on the presentation of CBD stones remains to be evaluated. Recent studies have demonstrated that the clinical presentation of CBD stones may vary with age. Younger adults may present with classical biliary colic symptoms, whereas elderly adults may have no unapparent clinical features. Younger adults with CBD stones were significantly more likely to have abnormal liver function tests than those without. The sensitivity and accuracy of transabdominal ultrasound scans in screening for CBD stones increases with age. Antibiotic agents should be promptly administered to individuals with CBD stones complicated by cholangitis, but the effects of pharmacotherapy on renal function should be considered in elderly adults. Endoscopic retrograde cholangiopancreatography (ERCP) is considered to be first-line treatment for CBD stones, and endoscopic biliary sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD) along with ERCP is an adequate biliary drainage method in individuals with CBD stones. EPBD has a lower bleeding risk but higher post-ERCP risk of pancreatitis than EST. Longer-duration (>1 minute) EPBD may be preferred over EST because it is associated with a comparable risk of pancreatitis but a lower rate of overall complications, although recurrent cholangitis or unfavorable outcomes will increase during CBD dilation or in the presence of residual CBD stones.
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Effects of Prefracture Depressive Illness and Postfracture Depressive Symptoms on Physical Performance After Hip Fracture - American Geriatric Society
Objectives
To compare the effect of prefracture depressive illness and postfracture depressive symptoms on changes in physical performance after hip fracture.
Design
Longitudinal observational cohort.
Setting
Baltimore metropolitan area.
Participants
Older adults with hip fracture (N = 255).
Measurements
Prefracture depressive illness (from medical records) at baseline and postfracture depressive symptoms at 2 months (using the Center for Epidemiologic Studies Depression Scale) were measured. Physical performance was measured 2, 6, and 12 months after fracture using the Short Physical Performance Battery (SPPB), a composite metric of functional status with a score ranging from 0 to 12. Weighted estimating equations were used to assess mean SPPB over time, comparing participants with and without prefracture depressive illness and subjects with and without postfracture depressive symptoms.
Results
Participants with prefracture depressive illness had an SPPB increase of 0.4 units (95% confidence interval (CI) = −0.5–1.3) from 2 to 6 months, smaller than the increase of 1.0 SPPB unit (95% CI = 0.4–1.6) in those without prefracture depressive illness. Participants with postfracture depressive symptoms had an SPPB increase of 0.2 units (95% CI = −1.0–1.5) from 2 to 12 months, and those without postfracture depressive symptoms had a larger increase of 1.2 units (95% CI = 0.6–1.8) over the same period. Nevertheless, prefracture depressive illness and postfracture depressive symptoms were not significantly associated with SPPB.
Conclusions
Neither prefracture depressive illness nor postfracture depressive symptoms were significantly associated with changes in physical performance after hip fracture, but the magnitude of estimates suggested possible clinically meaningful effects on functional recovery.
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Association Between Social Participation and 3-Year Change in Instrumental Activities of Daily Living in Community-Dwelling Elderly Adults - American Geriatric Society
Objectives
To investigate whether social participation (SP) in older adults is associated with ability to perform instrumental activities of daily living (IADLs).
Design
Prospective cohort study.
Setting
Two local municipalities of Nara, Japan.
Participants
Individuals aged 65 to 96 (n = 2,774 male, n = 3,586 female) free of IADL disability at baseline.
Measurements
SP and IADLs were assessed using self-administered questionnaires. SP was categorized into five types and assessed using the number and type of social activities. IADLs were evaluated using the Tokyo Metropolitan Institute of Gerontology Index of Competence. Logistic regression analysis stratified according to sex was used to examine change in IADLs according to SP, with nonparticipation as a reference.
Results
During the 3-year follow-up, 13.6% of men and 9.0% of women reported IADL decline. After adjusting for age, family structure, body mass index, pension, occupation, medical treatment, self-rated health, drinking, smoking, depression, cognitive function, and activities of daily living, participation in various social activities was inversely associated with change in IADLs in women but not men. Participation in the following types of social activities had significant inverse associations with IADL disability: hobby clubs (odds ratio (OR) = 0.68, 95% confidence interval (CI) = 0.49–0.94) for men and local events (OR = 0.68, 95% CI = 0.48–0.95), hobby clubs (OR = 0.53, 95% CI = 0.36–0.79), senior citizen clubs (OR = 0.74, 95% CI = 0.56–0.97), and volunteer groups (OR = 0.56, 95% CI = 0.32–0.99) for women.
Conclusion
Participation in a variety of different types of social activities was associated with change in IADLs over the 3 years of this study in women, and participation in hobby clubs was associated with change in IADLs in men and women. Recommending that community-dwelling elderly adults participate in social activities appropriate for their sex may promote successful aging.
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Effects of Longitudinal Glucose Exposure on Cognitive and Physical Function: Results from the Action for Health in Diabetes Movement and Memory Study - American Geriatric Society
Objectives
To test whether average long-term glucose exposure is associated with cognitive and physical function in middle-aged and younger-old adults with type 2 diabetes mellitus.
Design
Prospective cohort study.
Setting
Data obtained as part of the Action for Health in Diabetes (Look AHEAD) trial (NCT00017953) and Look AHEAD Movement and Memory ancillary study (NCT01410097).
Participants
Overweight and obese individuals with type 2 diabetes mellitus aged 45 to 76 at baseline (N = 879).
Measurements
Glycosylated hemoglobin (HbA1c) was measured at regular intervals over 7 years, and objective measures of cognitive function (Trail-Making Test, Modified Stroop Color-Word Test, Digit Symbol-Coding, Rey Auditory Verbal Learning Test, Modified Mini-Mental State Examination) and physical function (Short Physical Performance Battery, expanded Physical Performance Battery, 400-m and 20-m gait speed) and strength (grip and knee extensor strength) were assessed at the Year 8 or 9 follow-up examination.
Results
Average HbA1c exposure was 7.0 ± 1.1% (53 ± 11.6 mmol/mol), with 57% of participants classified as having HbA1c levels of less than 7% (<53 mmol/mol), 27% having levels of 7% to 8% (53–64 mmol/mol), and 16% having levels of greater than 8% (>64 mmol/mol). After adjustment for age, sex, race, education, smoking status, alcohol intake, knee pain, physical fitness, body mass index, diabetes mellitus medication and statin use, ancillary year visit, and study arm and site, higher HbA1c was associated with worse physical but not cognitive function. Further adjustment for prevalent diabetes mellitus–related comorbidities made all associations nonsignificant. Results did not differ when stratified according to participant baseline age (<60 vs ≥ 60).
Conclusion
Results presented here suggest that, in the absence of diabetes mellitus–related complications, longitudinal glucose exposure is not associated with future cognitive and physical function. Optimal management of diabetes mellitus–related comorbidities may prevent or reduce the burden of disability associated with type 2 diabetes mellitus.
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Effect of Visual Impairment on Physical and Cognitive Function in Old Age: Findings of a Population-Based Prospective Cohort Study in Germany - American Geriatric Society
Objectives
To examine how visual impairment affects physical and cognitive function in old age.
Design
A longitudinal population-based prospective cohort study.
Setting
General practitioner offices at six study centers in Germany. They were observed every 1.5 years over four waves.
Participants
Individuals aged 77–101 at follow-up Wave 2 (N = 2,394).
Measurements
Physical and cognitive function were assessed using an adapted scale that had been previously developed, and visual impairment was rated on a Likert scale (none, mild, severe or profound).
Results
Adjusting for sociodemographic factors and comorbidity, linear fixed-effects regression showed that the onset of severe visual impairment was associated with a decline in physical function score in the total sample (β = −0.15, P = .01) and in women (β = −.15, P = .03). Moreover, the onset of severe visual impairment was associated with decline in cognitive function score in the total sample (β = −0.38, P < .001) and in women (β = −0.38, P < .001) and men (β = −0.37, P = .001).
Conclusion
Visual impairment affects physical and cognitive function in old age. Interventional strategies to postpone visual impairment may contribute to maintaining physical and cognitive function.
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A Novel Approach to Proactive Primary Care–Based Case Finding and Multidisciplinary Management of Falls, Syncope, and Dizziness in a One-Stop Service: Preliminary Results - American Geriatric Society
National and international evidence and guidelines on falls prevention and management in community-dwelling elderly adults recommend that falls services should be multifactorial and their interventions multicomponent. The way that individuals are identified as having had or being at risk of falls in order to take advantage of such services is far less clear. A novel multidisciplinary, multifactorial falls, syncope, and dizziness service model was designed with enhanced case ascertainment through proactive, primary care–based screening (of individual case notes of individuals aged ≥60) for individual fall risk factors. The service model identified 4,039 individuals, of whom 2,232 had significant gait and balance abnormalities according to senior physiotherapist assessment. Significant numbers of individuals with new diagnoses ranging from cognitive impairment to Parkinson's disease to urgent indications for a pacemaker were discovered. More than 600 individuals were found who were at high risk of osteoporosis according to World Health Association Fracture Risk Assessment Tool score, 179 with benign positional paroxysmal vertigo and 50 with atrial fibrillation. Through such screening and this approach, Comprehensive Geriatric Assessment Plus (Plus falls, syncope and dizziness expertise), unmet need was targeted on a scale far outside the numbers seen in clinical trials. Further work is needed to determine whether this approach translates into fewer falls and decreases in syncope and dizziness.
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High Prevalence of Medication Discrepancies Between Home Health Referrals and Centers for Medicare and Medicaid Services Home Health Certification and Plan of Care and Their Potential to Affect Safety of Vulnerable Elderly Adults - American Geriatric Society
Objectives
To describe the prevalence of discrepancies between medication lists that referring providers and home healthcare (HH) nurses create.
Design
The active medication list from the hospital at time of HH initiation was compared with the HH agency's plan of care medication list. An electronic algorithm was developed to compare the two lists for discrepancies.
Setting
Single large hospital and HH agency in the western United States.
Participants
Individuals referred for HH from the hospital in 2012 (N = 770, 96.3% male, median age 71).
Measurements
Prevalence was calculated for discrepancies, including medications missing from one list or the other and differences in dose, frequency, or route for medications contained on both lists.
Results
Participants had multiple medical problems (median 16 active problems) and were taking a median of 15 medications (range 1–93). Every participant had at least one discrepancy; 90.1% of HH lists were missing at least one medication that the referring provider had prescribed, 92.1% of HH lists contained medications not on the referring provider's list, 89.8% contained medication naming errors. 71.0% contained dosing discrepancies, and 76.3% contained frequency discrepancies.
Conclusion
Discrepancies between HH and referring provider lists are common. Future work is needed to address possible safety and care coordination implications of discrepancies in this highly complex population.
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Effects of Functional Disability and Depressive Symptoms on Mortality in Older Mexican–American Adults with Diabetes Mellitus - American Geriatric Society
Objectives
To examine the effect of co-occurring depressive symptoms and functional disability on mortality in older Mexican–American adults with diabetes mellitus.
Design
Longitudinal cohort study.
Setting
Hispanic Established Populations for the Epidemiological Study of the Elderly (HEPESE) survey conducted in the southwestern United States (Texas, Colorado, Arizona, New Mexico, California).
Participants
Community-dwelling Mexican Americans with self-reported diabetes mellitus participating in the HEPESE survey (N = 624).
Measurements
Functional disability was assessed using a modified version of the Katz activity of daily living scale. Depressive symptoms were measured using the Center for Epidemiologic Studies Depression Scale. Mortality was determined by examining death certificates and reports from relatives. Cox proportional hazards regression analyses were used to examine the hazard of mortality as a function of co-occurring depressive symptoms and functional disability.
Results
Over a 9.2-year follow-up, 391 participants died. Co-occurring high depressive symptoms and functional disability increased the risk of mortality (hazard ratio (HR) = 3.02, 95% confidence interval (CI) = 2.11–4.34). Risk was greater in men (HR = 8.11, 95% CI = 4.34–16.31) than women (HR = 2.21, 95% CI = 1.42–3.43).
Conclusion
Co-occurring depressive symptoms and functional disability in older Mexican–American adults with diabetes mellitus increases mortality risk, especially in men. These findings have important implications for research, practice, and public health interventions.
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Home-Based Exercise Supported by General Practitioner Practices: Ineffective in a Sample of Chronically Ill, Mobility-Limited Older Adults (the HOMEfit Randomized Controlled Trial) - American Geriatric Society
Objectives
To evaluate the effects a home-based exercise program delivered to ill and mobility-limited elderly individuals on physical function, physical activity, quality of life, fall-related self-efficacy, and exercise self-efficacy.
Design
Randomized controlled trial (ISRCTN Registry, Reg.-No. ISRCTN17727272).
Setting
Fifteen general practitioner (GP) practices and participants' homes.
Participants
Chronically ill and mobility-limited individuals aged 70 and older (N = 209).
Interventions
An exercise therapist delivered the experimental intervention—a 12-week multidimensional home-based exercise program integrating behavioral strategies—in individual counseling sessions at the GPs' practices and over the telephone. The control intervention focused on promoting light-intensity activities of daily living. Interventions took place between February 2012 and March 2013.
Measurements
The primary outcome was functional lower body strength (chair-rise test). Secondary outcomes were physical function (battery of motor tests), physical activity (step count), health-related quality of life (Medical Outcomes Study 8-item Short-Form Survey), fall-related (Falls Efficacy Scale—International Version), and exercise self-efficacy (Selbstwirksamkeit zur sportlichen Aktivitaet (SSA) scale). Postintervention differences between the groups were tested using analysis of covariance (intention to treat; adjusted for baseline value and GP practice; significance level P ≤ .05).
Results
Participants had a mean age ± standard deviation of 80 ± 5, 74% were female, 87% had three or more chronic diseases, and 54% used a walking aid. The difference (intention to treat; experimental minus control) between adjusted postintervention chair-rise times was −0.1 (95% confidence interval = −1.8–1.7). Differences for all secondary outcomes were also nonsignificant.
Conclusion
The program was ineffective in the target population. Possibilities for improving the concept will have to be evaluated.
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Unrecognized Cognitive Impairment and Its Effect on Heart Failure Readmissions of Elderly Adults - American Geriatric Society
Objectives
To determine whether 30-day readmissions were associated with presence of cognitive impairment more in elderly adults with heart failure (HF) than in those with other diagnoses and whether medical teams recognized cognitive impairment.
Design
One-year prospective cohort quality improvement program of cognitive screening and retrospective chart review of documentation and outcomes.
Setting
Academic tertiary care hospital medical unit with a cardiovascular focus and an enhanced discharge program of individualized patient education.
Participants
Individuals aged 70 and older screened before home discharge (241 admission encounters; 121 with HF as a primary diagnosis, 120 without). The HF cohort included individuals with preserved and reduced ejection fraction. Individuals who had undergone transplantation, ventricular assist device implantation, or hemodialysis or who had a primary oncology diagnosis or hospice referral were excluded.
Measurements
Mini-Cog administered 48 hours or less before discharge, 30-day all-cause readmission rates, documentation of dementia or cognitive impairment, and caregiver education.
Results
Mini-Cog scores were less than 4 (indicating cognitive impairment) in 157 encounters (82 (67.7%) with HF, 75 (62.5%) without). Mini-Cog scores were similar in rate and distribution between groups. Individuals with HF and cognitive impairment had a significantly higher 30-day readmission rate than did the other groups (26.8% vs 13.2%; P = .01; HF, no cognitive impairment, 12.8%; no HF, no cognitive impairment, 13.3%; cognitive impairment, no HF, 13.3%). In individuals with HF and cognitive impairment, those with documented caregiver education had lower readmission rates than those without (14.3% vs 36.2%; P = .03). Fewer than 9% had documentation of cognitive impairment in the medical record.
Conclusion
Cognitive impairment, which is frequently undocumented, may indicate greater risk of readmission for individuals with HF than those without. Screening for cognitive impairment, adapting discharge for it, and involving family and caregivers in discharge education may help reduce readmissions.
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Exploring Home Care Interventions for Frail Older People in Belgium: A Comparative Effectiveness Study - American Geriatric Society
Objectives
To examine the effects of home care interventions for frail older people in delaying permanent institutionalization during 6 months of follow-up.
Design
Longitudinal quasi-experimental research study, part of a larger study called Protocol 3.
Setting
Community care in Belgium.
Participants
Frail older adults who received interventions (n = 4,607) and a comparison group of older adults who did not (n = 3,633). Organizations delivering the interventions included participants provided they were aged 65 and older, frail, and at risk of institutionalization. A comparison group was established consisting of frail older adults not receiving any interventions.
Intervention
Home care interventions were identified as single component (occupational therapy (OT), psychological support, night care, day care) or multicomponent. The latter included case management (CM) in combination with OT and psychological support or physiotherapy, with rehabilitation services, or with OT alone.
Measurements
The interRAI Home Care (HC) was completed at baseline and every 6 months. Data from a national database were used to establish a comparison group. Relative risks of institutionalization and death were calculated using Poisson regression for each type of intervention.
Results
A subgroup analysis revealed that 1,999 older people had mild impairment, and 2,608 had moderate to severe impairment. Interventions providing only OT and interventions providing CM with rehabilitation services were effective in both subpopulations.
Conclusion
This research broadens the understanding of the effects of different types of community care interventions on the delay of institutionalization of frail older people. This information can help policy-makers to plan interventions to avoid early institutionalization.
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An Interim Analysis of an Advance Care Planning Intervention in the Nursing Home Setting - American Geriatric Society
Objectives
To describe processes and preliminary outcomes from the implementation of a systematic advance care planning (ACP) intervention in the nursing home setting.
Design
Specially trained project nurses were embedded in 19 nursing homes and engaged in ACP as part of larger demonstration project to reduce potentially avoidable hospitalizations.
Setting
Nursing homes.
Participants
Residents enrolled in the demonstration project for a minimum of 30 days between August 2013 and December 2014 (n = 2,709) and residents currently enrolled in March 2015 (n = 1,591).
Measurements
ACP conversations were conducted with residents, families, and the legal representatives of incapacitated residents using a structured ACP interview guide with the goal of offering ACP to all residents. Project nurses reviewed their roster of currently enrolled residents in March 2015 to capture barriers to engaging in ACP.
Results
During the initial implementation phase, 27% (731/2,709) of residents had participated in one or more ACP conversations with a project nurse, resulting in a change in documented treatment preferences for 69% (504/731). The most common change (87%) was the generation of a Physician Orders for Scope of Treatment form. The most frequently reported barrier to ACP was lack of time.
Conclusion
The time- and resource-intensive nature of robust ACP must be anticipated when systematically implementing ACP in the nursing home setting. The fact that these conversations resulted in changes over 2/3 of the time reinforces the importance of deliberate, systematic ACP to ensure that current treatment preferences are known and documented so that these preferences can be honored.
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Knowledge Gaps in Cardiovascular Care of Older Adults: A Scientific Statement from the American Heart Association, American College of Cardiology, and American Geriatrics Society: Executive Summary - American Geriatric Society
The incidence and prevalence of most cardiovascular disorders increase with age, and cardiovascular disease (CVD) is the leading cause of death and major disability in adults aged 75 and older. Despite the effect of CVD on quality of life, morbidity, and mortality in older adults, individuals aged 75 and older have been markedly underrepresented in most major cardiovascular trials, and virtually all trials have excluded older adults with complex comorbidities, significant physical or cognitive disabilities, frailty, or residence in nursing homes and assisted living facilities. As a result, current guidelines are unable to provide evidence-based recommendations for diagnosis and treatment of older adults typical of those encountered in routine clinical practice. The objectives of this scientific statement are to summarize current guideline recommendations as they apply to older adults, identify critical gaps in knowledge that preclude informed evidence-based decision-making, and recommend future research to close existing knowledge gaps. To achieve these objectives, a detailed review was conducted of current American College of Cardiology/American Heart Association (ACC/AHA) and American Stroke Association (ASA) guidelines to identify content and recommendations that explicitly targeted older adults. A pervasive lack of evidence to guide clinical decision-making in older adults with CVD was found, as well as a paucity of data on the effect of diagnostic and therapeutic interventions on outcomes that are particularly important to older adults, such as quality of life, physical function, and maintenance of independence. Accordingly, there is a critical need for a multitude of large population-based studies and clinical trials that include a broad spectrum of older adults representative of those seen in clinical practice and that incorporate relevant outcomes important to older adults in the study design. The results of these studies will provide the foundation for future evidence-based guidelines applicable to older adults and enhance person-centered care of older individuals with CVD in the United States and around the world.
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Winners of the 2015 JA Medals for excellence - Journal of Antibiotics
Winners of the 2015 JA Medals for excellence
The Journal of Antibiotics 69, 657 (September 2016). doi:10.1038/ja.2016.96
Author: Minoru Yoshida
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Distribution of PASTA domains in penicillin-binding proteins and serine/threonine kinases of Actinobacteria - Journal of Antibiotics
Distribution of PASTA domains in penicillin-binding proteins and serine/threonine kinases of Actinobacteria
The Journal of Antibiotics 69, 660 (September 2016). doi:10.1038/ja.2015.138
Author: Hiroshi Ogawara
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Effect of different agents with potential antibiofilm activity on antimicrobial susceptibility of biofilms formed by Staphylococcus spp. isolated from implant-related infections - Journal of Antibiotics
Effect of different agents with potential antibiofilm activity on antimicrobial susceptibility of biofilms formed by Staphylococcus spp. isolated from implant-related infections
The Journal of Antibiotics 69, 686 (September 2016). doi:10.1038/ja.2016.9
Authors: Diana Molina-Manso, Gema Del-Prado, Enrique Gómez-Barrena, Jose Cordero-Ampuero, Ricardo Fernandez-Roblas & Jaime Esteban
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Antimicrobial potency of single and combined mupirocin and monoterpenes, thymol, menthol and 1,8-cineole against Staphylococcus aureus planktonic and biofilm growth - Journal of Antibiotics
Antimicrobial potency of single and combined mupirocin and monoterpenes, thymol, menthol and 1,8-cineole against Staphylococcus aureus planktonic and biofilm growth
The Journal of Antibiotics 69, 689 (September 2016). doi:10.1038/ja.2016.10
Authors: Domagoj Kifer, Vedran Mužinić & Maja Šegvić Klarić
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Enantioselective total synthesis of naturally occurring eushearilide and evaluation of its antifungal activity - Journal of Antibiotics
Enantioselective total synthesis of naturally occurring eushearilide and evaluation of its antifungal activity
The Journal of Antibiotics 69, 697 (September 2016). doi:10.1038/ja.2015.146
Authors: Takayuki Tonoi, Ryo Kawahara, Takehiko Inohana & Isamu Shiina
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Cladosporinone, a new viriditoxin derivative from the hypersaline lake derived fungus Cladosporium cladosporioides - Journal of Antibiotics
Cladosporinone, a new viriditoxin derivative from the hypersaline lake derived fungus Cladosporium cladosporioides
The Journal of Antibiotics 69, 702 (September 2016). doi:10.1038/ja.2016.11
Authors: Yang Liu, Tibor Kurtán, Chang Yun Wang, Wen Han Lin, Raha Orfali, Werner EG Müller, Georgios Daletos & Peter Proksch
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JBIR-76 and JBIR-77, modified naphthoquinones from Streptomyces sp. RI-77 - Journal of Antibiotics
JBIR-76 and JBIR-77, modified naphthoquinones from Streptomyces sp. RI-77
The Journal of Antibiotics 69, 707 (September 2016). doi:10.1038/ja.2015.135
Authors: Keiichiro Motohashi, Miho Izumikawa, Noritaka Kagaya, Motoki Takagi & Kazuo Shin-ya
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Oxysporizoline, an antibacterial polycyclic quinazoline alkaloid from the marine-mudflat-derived fungus Fusarium oxysporum - Journal of Antibiotics
Oxysporizoline, an antibacterial polycyclic quinazoline alkaloid from the marine-mudflat-derived fungus Fusarium oxysporum
The Journal of Antibiotics 69, 709 (September 2016). doi:10.1038/ja.2015.137
Authors: Viviane Nenkep, Keumja Yun & Byeng Wha Son
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Genome-based survey of nonribosomal peptide synthetase and polyketide synthase gene clusters in type strains of the genus Microtetraspora - Journal of Antibiotics
Genome-based survey of nonribosomal peptide synthetase and polyketide synthase gene clusters in type strains of the genus Microtetraspora
The Journal of Antibiotics 69, 712 (September 2016). doi:10.1038/ja.2015.139
Authors: Hisayuki Komaki, Natsuko Ichikawa, Tomohiko Tamura, Akio Oguchi, Moriyuki Hamada & Nobuyuki Fujita
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Euvesperins A and B, new circumventors of arbekacin resistance in MRSA, produced by Metarhizium sp. FKI-7236 - Journal of Antibiotics
Euvesperins A and B, new circumventors of arbekacin resistance in MRSA, produced by Metarhizium sp. FKI-7236
The Journal of Antibiotics 69, 719 (September 2016). doi:10.1038/ja.2015.140
Authors: Mayu Shiina, Takuya Suga, Yukihiro Asami, Kenichi Nonaka, Masato Iwatsuki, Satoshi Omura & Kazuro Shiomi
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Monday, September 26, 2016
McCain Foods USA, Inc. Announces a Product Recall Impacting Frozen Onion Rings Sold and Distributed Under Four Separate Private Label Retail Brands - FDA Safety Alerts & Drug Recalls
McCain Foods USA, Inc. today announced it is voluntarily recalling retail, frozen onion ring products due to the use of incorrect packaging that does not declare milk as one of the 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 these products.
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Mt Kisco Smokehouse Recalls Smoked Salmon Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Mt Kisco Smokehouse of Mt Kisco, NY, is voluntarily recalling two types of smoked salmon 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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Sunday, September 25, 2016
Racial Differences in the Incidence of Cardiovascular Risk Factors in Older Black and White Adults - American Geriatric Society
Objectives
To describe the incidence of cardiovascular risk factors, or race-related disparities in incidence, across the age spectrum in adults.
Design
Longitudinal cohort.
Setting
National sample.
Participants
Community-dwelling black and white adults recruited between 2003 and 2007.
Measurements
Incident hypertension, diabetes mellitus, dyslipidemia and atrial fibrillation over 10 years of follow-up in 10,801 adults, stratified according to age (45–54, 55–64, 65–74, ≥75).
Results
There was no evidence (P ≥ .68) of an age-related difference in the incidence of hypertension for white men (average incidence 38%), black men (48%), or black women (54%), although for white women incidence increased with age (45–54, 27%; ≥75, 40%). Incidence of diabetes mellitus was lower at older ages for white men (45–54, 15%; ≥75, 8%), black men (45–54, 29%; ≥75, 13%), and white women (45–54, 11%; ≥75, 4%), although there was no evidence (P = .11) of age-related changes for black women (average incidence 21%). For dyslipidemia, incidence for all race–sex groups was approximately 20% for aged 45 to 54 but approximately 30% for aged 54 to 64 and 65 to 74 and approximately 22% for aged 75 and older. Incidence of atrial fibrillation was low at age 45 to 54 (<5%) but for aged 75 and older was approximately 20% for whites and 11% for blacks. The incidence of hypertension, diabetes mellitus, and dyslipidemia was higher in blacks across the age spectrum but lower for atrial fibrillation.
Conclusion
Incidence of risk factors remains high in older adults. Blacks have a higher incidence of hypertension, diabetes mellitus, and dyslipidemia after age 45, underscoring the ongoing importance of prevention of all three conditions in mid- to later life.
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Limited Number of Canned Vegetable Products, Primarily Non-Retail, Recalled for Possible Allergen Risk - FDA Safety Alerts & Drug Recalls
Sager Creek Foods, Inc. of Walnut Creek, CA a subsidiary of Del Monte Foods, Inc., announced a recall of approximately 15,000 shipped cases of FIELD PEAS WITH SNAPS and GREEN BEAN PRODUCTS, primarily non-retail, which may have the potential for trace amounts of shellfish contamination. A customer alerted Sager Creek to the incident.
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Friday, September 23, 2016
Urgent Allergy Alert: “Vrindavan” Cow Ghee Recall due to Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls
This voluntary recall has been initiated on September 9th, 2016 due to an undeclared milk allergen on VRINDAVAN COW GHEE labeling. Consumers who are allergic to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.
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Waymouth Farms, Inc. Issues an Allergy Alert on Undeclared Pecans, Walnuts, Milk and Soy in Good Sense Cranberries ‘N More - FDA Safety Alerts & Drug Recalls
Waymouth Farms, Inc has initiated a voluntary recall of Good Sense Cranberries 'N More 6 oz (170g) with a Freshest if used by date of 8/16/2017 A 15:00 through Freshest if used by 8/16/2017 A 23:00 after discovering that inadvertently other allergens were packed into the Good Sense Cranberries 'N More package. Only 2640 packages were impacted.
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FDA approves expanded indications for Ilaris for three rare diseases - FDA Press Releases
The U.S. Food and Drug Administration today approved three new indications for Ilaris (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients:
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FDA approves Amjevita, a biosimilar to Humira - FDA Press Releases
The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
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Thursday, September 22, 2016
Krishna Food Corp. Recalls Bikaju Chowpati Bhelpuri Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Krishna Food Corp of Neshanic Station, New Jersey is recalling 16 cartons of BIKAJI Chowpati BHELPURI, NET WT: 300g 10.58 OZ Batch no 2016 F97 Best Before June 2017, 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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Affordable Care Act has strengthened Medicare Advantage and Prescription Drug Program - CMS Blog
By Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare
Medicare Advantage is yet another area where the promise of the Affordable Care Act – saving money and improving care – has been fulfilled. When Congress passed the landmark Affordable Care Act six years ago, some critics claimed the law had fatally undermined the Medicare Advantage program. Yet, each year since then, the Centers for Medicare & Medicaid Services (CMS) has reported data showing this doom and gloom scenario was wrong. In spending taxpayers’ and beneficiaries’ dollars more wisely, the Affordable Care Act’ reforms resulted in a rejuvenated Medicare Advantage program that has grown every year while premiums have been stable and quality has improved.
First, the Affordable Care Act stopped the systematic excessive payments to Medicare Advantage plans. Before the Affordable Care Act, Medicare Advantage plans were being paid 114 percent of Original Medicare costs on average. This translated into an extra $1,280 of spending per Medicare Advantage enrollee or $14 billion in higher aggregate payments in 2009. The Affordable Care Act gradually reduced these payments but offered Medicare Advantage plans an opportunity to earn additional funding by improving the care they provided to Medicare beneficiaries through the Quality Bonus Payment program.
Rather than resulting in the demise of Medicare Advantage, these changes sparked a resurgence in the program. Enrollment in Medicare Advantage has increased every year since the Affordable Care Act passed and next year is expected to reach an all-time high of about 18.5 million, a 60 percent increase from 2010. In 2017, one-third of all Medicare enrollees will be in a Medicare Advantage plan. And these beneficiaries are receiving better care. In 2009, only about 17 percent of Medicare beneficiaries were in four and five star plans; in 2016, over 70 percent are enrolled in four and five star plans.
Access to the Medicare Advantage program remains strong, with 99 percent of Medicare beneficiaries having access to a Medicare health plan, which has remained relatively constant since 2010. And in every county of the United States, seniors can choose to remain in Original Medicare.
This improved quality, increased enrollment, and stable plan availability has been accomplished while maintaining stable – or even lower Medicare Advantage premiums paid by enrollees. The average Medicare Advantage premium in 2017 is projected to be 13 percent lower than the average Medicare Advantage premium prior to passage of the Affordable Care Act. In 2017, Medicare estimates that the average Medicare Advantage monthly premium will decrease by 4 percent compared to 2016.
Other key improvements the law made to Medicare Advantage and the Part D prescription drug program are:
- Closing the Medicare Part D “donut hole” over time. Because of this improvement to the law, people with Medicare are seeing reduced costs through savings on both covered brand-name and generic drugs. Through July 2016, more than 11 million seniors and people with disabilities have received savings and discounts in the coverage gap of over $23.5 billion on prescription drugs, an average of $2,127 per beneficiary.
- Adding coverage of an annual wellness visit and eliminating coinsurance and the Part B deductible for certain recommended preventive services covered by Medicare, including many cancer screenings and other important benefits. Medicare Advantage plans are required to cover all services that Original Medicare provides. By making certain preventive services available with no cost sharing under Original Medicare, the Affordable Care Act removed barriers to prevention, helping Americans take charge of their own health and helping individuals and their providers better prevent illness, detect problems early when treatment works best, and monitor health conditions. CMS extended that zero-cost-sharing protection to enrollees in Medicare Advantage plans after passage of the Affordable Care Act.
- An estimated 39.2 million people with Medicare (including those enrolled in Medicare Advantage) took advantage of at least one preventive service with no copays or deductibles in 2015.
- Nearly 9 million Medicare beneficiaries (including those enrolled in Medicare Advantage) took advantage of an annual wellness visit in 2015.
- Requiring that all Medicare Advantage plans spend at least 85 percent of revenue on quality and care delivery and not on overhead, profit or administrative costs. This means that 85 cents of every dollar earned by Medicare Advantage plans must be used on quality and care delivery. Enrolled seniors and individuals with disabilities will get more value and better benefits as plans spend more on health care. This requirement keeps Medicare Advantage in line with private insurance.
As CMS works to further strengthen the Medicare Advantage and Part D prescription drug programs for current and future Medicare beneficiaries, the Affordable Care Act’s reforms have built a foundation that will continue to provide greater protections for beneficiaries and value for taxpayers.
###
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Filed under: Uncategorized
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Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls
Ocala, Florida - Wells Pharmacy Network ("WPN") is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, 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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Blue Bell Ice Cream Recalls Select Products Containing Chocolate Chip Cookie Dough Pieces Purchased From Outside Supplier Aspen Hills Due To Possible Health Risk - FDA Safety Alerts & Drug Recalls
Blue Bell Ice Cream is voluntarily recalling select products produced in its Sylacauga, Alabama, plant because they were made with a chocolate chip cookie dough ingredient supplied by a third party supplier Aspen Hills, Inc., due to the potential for it to contain Listeria monocytogenes.
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Relationship Between Frailty and Oral Function in Community-Dwelling Elderly Adults - American Geriatric Society
Objectives
To determine the standard values of and age-related changes in objective oral function of healthy older people; compare oral function of robust, prefrail, and frail older people; and determine the association between oral function and frailty.
Design
Cross-sectional analysis.
Setting
General community.
Participants
Elderly adults (≥65) from the Obu Study of Health Promotion for the Elderly were included and assigned to the robust, prefrail, and frail groups (N = 4,720).
Measurements
Each participant underwent detailed physical testing to assess frailty. The frailty phenotype was defined according to the presence of limitations in three or more of the following five domains: mobility, strength, endurance, physical activity, and nutrition. The numbers of present teeth and functional teeth were counted, and occlusal force, masseter muscle thickness, and oral diadochokinesis (ODK) rate were measured, along with sociodemographic and functional status, comorbidities, and blood chemistry.
Results
The number of present teeth, occlusal force, masseter muscle thickness, and ODK rate decreased with age. The frail group had significantly fewer present teeth (women aged ≥70), lower occlusal force (women aged ≥70; men aged ≥80), lower masseter muscle thickness, and lower ODK rate than the robust group. Multivariate analysis indicated that age, Geriatric Depression Scale score, skeletal muscle mass index, Mini-Mental State Examination score, hypertension, diabetes mellitus, albumin and triglyceride levels, and oral function were significantly associated with frailty.
Conclusion
Age-related differences in oral function were found in older adults. Moreover, frail older individuals had significantly poorer oral function than prefrail and robust individuals. The risk of frailty was associated with lower occlusal force, masseter muscle thickness, and ODK rate.
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Constitutional Symptoms Trigger Diagnostic Testing Before Antibiotic Prescribing in High-Risk Nursing Home Residents - American Geriatric Society
Objectives
To evaluate the use of diagnostic testing before treating an infection in nursing home (NH) residents suspected of having a urinary tract infection (UTI) or pneumonia.
Design
Prospective longitudinal study nested within a randomized trial, using data from control sites.
Setting
Six NHs in southeast Michigan.
Participants
NH residents with an indwelling urinary catheter, enteral feeding tube, or both (N = 162) with 695 follow-up visits (189 (28%) visits with an infection).
Measurements
Clinical and demographic data—including information on incident infections, antibiotic use, and results of diagnostic tests—were obtained at study enrollment, after 14 days, and monthly thereafter for up to 1 year.
Results
One hundred (62%) NH residents had an incident infection requiring antibiotics, with substantial variations between NHs. In addition to presence of infection-specific symptoms, change in function was a significant predictor of ordering a chest X-ray to detect pneumonia (odds ratio (OR) = 1.7, P = .01). Similarly, change in mentation was a significant predictor of ordering a urinalysis (OR = 1.9, P = .02), chest X-ray (OR = 3.3, P < .001), and blood culture (OR = 2.3, P = .02). Antibiotics were used empirically, before laboratory results were available, in 50 of 233 suspected cases of UTI (21.5%) and 16 of 53 (30.2%) suspected cases of pneumonia. Antibiotics were used in 17% of visits without documented clinical or laboratory evidence of infection.
Conclusion
Constitutional symptoms such as change in function and mentation commonly lead to diagnostic testing and subsequent antibiotic prescribing. Antibiotic use often continues despite negative test results and should be a target for future interventions.
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Wednesday, September 21, 2016
Zika virus-associated brain damage: animal models and open issues
Zika virus-associated brain damage: animal models and open issues
Emerging Microbes & Infections 5, e106 (September 2016). doi:10.1038/emi.2016.103
Authors: Giovanni Di Guardo, Patrícia Baleeiro Beltrão Braga & Jean Pierre Schatzmann Peron
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Molecular epidemiology of human enterovirus 71 at the origin of an epidemic of fatal hand, foot and mouth disease cases in Cambodia
Molecular epidemiology of human enterovirus 71 at the origin of an epidemic of fatal hand, foot and mouth disease cases in Cambodia
Emerging Microbes & Infections 5, e104 (September 2016). doi:10.1038/emi.2016.101
Authors: Veasna Duong, Channa Mey, Marc Eloit, Huachen Zhu, Lucie Danet, Zhong Huang, Gang Zou, Arnaud Tarantola, Justine Cheval, Philippe Perot, Denis Laurent, Beat Richner, Santy Ky, Sothy Heng, Sok Touch, Ly Sovann, Rogier van Doorn, Thanh Tan Tran, Jeremy J Farrar, David E Wentworth, Suman R Das, Timothy B Stockwell, Jean-Claude Manuguerra, Francis Delpeyroux, Yi Guan, Ralf Altmeyer & Philippe Buchy
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Kidney Function and Disability-Free Survival in Older Women - American Geriatric Society
Objectives
To examine the prospective association between kidney function and three outcomes: survival to age 85 with functional independence, survival to age 85 with disability, and death before age 85.
Design
Prospective study.
Setting
Women's Health Initiative, conducted at 40 U.S. clinical centers.
Participants
Postmenopausal women enrolled between 1993 and 1998 with baseline biomarker assessments who had the potential to reach age 85 before September 2013 (N = 7,178).
Measurements
Kidney function was measured according to estimated glomerular filtration rate (eGFR) calculated from serum creatinine collected at baseline. Outcomes were survival to age 85 with functional independence, survival with disability, or death before age 85. Disability was defined as mobility or activity of daily living limitations measured by questionnaire.
Results
eGFR was greater than 90 mL/min per 1.73 m2 in 22.7% of women, 60 to 89 mL/min per 1.73 m2 in 66.5%, 45 to 59 mL/min per 1.73 m2 in 8.7%, and less than 45 mL/min per 1.73 m2 in 2.0%. Median follow-up was 15 years. Of 4,953 survivors, 3,155 reported no physical disability at age 85. Two thousand two hundred twenty-five participants died before age 85. Women with an eGFR of 90 mL/min per 1.73 m2 or greater had 2.71 times greater odds of survival to age 85 with functional independence than of dying before 85 (95% confidence interval (CI) = 1.62–4.51) than those with an eGFR less than 45 mL/min per 1.73 m2, women with an eGFR of 60 to 89 mL/min per 1.73 m2 had 3.04 times (95% CI = 1.85–5.00) greater odds, and women with an eGFR of 45 to 59 mL/min per 1.73 m2 had 2.22 times (95% CI = 1.31–3.76) greater odds. Similar, but slightly weaker odds were seen for survival to age 85 with disability. Better kidney function was not significantly associated with greater likelihood of survival to age 85 with independent function than of surviving with disability.
Conclusion
Better kidney function was associated with greater likelihood of survival to age 85 with and without disability.
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A Simple Tool to Predict Development of Delirium After Elective Surgery - American Geriatric Society
Objectives
To identify a quick clinical tool to assess the risk of delirium after elective surgery.
Design
Prospective observational study.
Setting
Preoperative assessment clinic at the Veterans Affairs Portland Health Care System.
Participants
Community-living veterans aged 65 and older scheduled for elective surgery requiring general or major anesthesia.
Measurements
Confusion Assessment Method (CAM) or Family Confusion Assessment Method (FAM-CAM). Data on education, medications, substance use, Patient Health Questionnaire (PHQ-9), Study of Osteoporotic Fractures Frailty, Mini-Cog, and Charlson-Deyo score were collected preoperatively.
Results
Of 114 veterans who agreed to participate, 76 completed the final delirium assessment. Ten of the 76 (13%) developed delirium in the 72 hours after surgery as assessed using the CAM or FAM-CAM. In bivariate analysis, factors that increased the odds of delirium at least three times were low education; poor PHQ-9, clock draw, word recall, Mini-Cog, and poor preoperative orientation scores; alcohol use; and higher comorbidities as measured using Charlson-Deyo index. Scoring the Mini-Cog from 0 to 5 had a higher predictive power (area under the receiving operating characteristic curve = 0.77) than other approaches to scoring the Mini-Cog. Other models did not significantly improve prediction of postoperative delirium risk and would be complicated to use in a clinical setting.
Conclusion
In this sample of veterans who had elective surgery with major anesthesia, Mini-Cog score predicted likelihood of postoperative delirium.
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Development of a Nonparametric Predictive Model for Readmission Risk in Elderly Adults After Colon and Rectal Cancer Surgery - American Geriatric Society
Objectives
Primary objective: to use advanced nonparametric techniques to determine risk factors for readmission after colorectal cancer surgery in elderly adults. Secondary objective: to compare this methodology with traditional parametric methods.
Design
Using data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), nonparametric techniques were used to evaluate the risk of readmission in elderly adults undergoing surgery for colorectal cancer in 2011 and 2012.
Setting
More than 200 hospitals participating in the NSQIP database.
Participants
Individuals aged 65 and older who underwent surgery for colorectal cancer in 2011 and 2012 (N = 2,117).
Measurements
Age-stratified robust nonparametric predictive model (classification and regression tree (CART) analysis) of 30-day readmission for elderly adults undergoing surgery for colorectal cancer.
Results
Recent chemotherapy was the most important predictor of readmission in participants aged 65 to 74, with 20% of those with recent chemotherapy and 11% of with no recent chemotherapy being readmitted. Participants aged 75 to 84 who had recently undergone chemotherapy had a readmission rate of 23%, whereas those with no chemotherapy had a readmission rate of 9%. Being underweight was the greatest predictor of readmission (30%) in participants aged 85 and older. These methods were found to be more robust than traditional logistic regression.
Conclusion
Specific age-related preoperative factors help predict readmission in elderly adults undergoing colorectal cancer surgery. Results of the nonparametric CART analysis are better than traditional regression analysis and help physicians to clinically stratify based on age. This model may help identify individuals in whom intervention may be helpful in reducing readmission after surgery.
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Tuesday, September 20, 2016
Apple Tree Goat Dairy Recalls Four Goat Cheeses Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Apple Tree Goat Dairy of Richfield, PA is recalling Feta cheese aged 60 days lot #836, Gouda Cheese aged 60 days Lot#426 Pasturized chevre Lot #816, in 5 lb. or 8 oz. and French Herb Chevre Lot #736 in 8 oz. Or 5 lb. 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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Monday, September 19, 2016
Mei Shun Noodle, Inc. Issues Allergy Alert on Undeclared Shellfish and Soy in Rice Noodles - FDA Safety Alerts & Drug Recalls
Mei Shun Noodle, Inc. of Chicago, IL, is recalling its 12 ounce packages of 6毛FIVE branded Rice Noodles. During inspection by the Illinois Department of Public Health, we found that some of the product was mislabeled. The products may contain dried, salted shrimp and soy, which are not included on the label.
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Kellogg Company Recalls Limited Number of Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls
Kellogg Company is voluntarily recalling approximately 10,000 cases of Kellogg’s® Eggo® Nutri-Grain® Whole Wheat Waffles because they have the potential to be contaminated with Listeria monocytogenes. No other Eggo products are impacted by this recall.
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Ferrara Candy Issues Allergy Alert on Undeclared Peanuts and Wheat in Almond Supremes with a Best by Date of 4/22/2017 - FDA Safety Alerts & Drug Recalls
Ferrara Candy Company has initiated a voluntary recall of Brach’s® 5 ounce Almond Supremes with a best by date of 4/22/2017 after discovering that some Brach’s® Almond Supremes packages may include Brach’s® Bridge Mix, a product that contains peanuts and wheat. No other Ferrara Candy Company products are affected.
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Censea, Inc. Recalls Shrimp Product Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Censea, Inc. is recalling its A-PAC 8/12 count Headless Shell on Black Tiger Shrimp, 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. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
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FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths - FDA Press Releases
The U.S. Food and Drug Administration today announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.
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Delivering coordinated, high quality care for patients - CMS Blog
By Dr. Patrick Conway, Acting Principal Deputy Administrator and Chief Medical Officer
In July 2016, CMS proposed new bundled payment models that continue the Administration’s progress to shift Medicare payments from rewarding quantity to rewarding quality by creating strong incentives for hospitals and clinicians to deliver better care to patients at a lower cost. These proposed new bundled payment models focus on heart attacks, heart bypass surgery, and hip fracture surgery. They would reward hospitals that work together with physicians and other providers to avoid complications, prevent hospital readmissions, and speed recovery. This proposal follows the implementation of the Comprehensive Care for Joint Replacement Model that begin earlier this year, which introduced bundled payments for certain hip and knee replacements.
Patients want the peace of mind that comes with knowing they will receive high quality, coordinated care from the minute they are admitted to the hospital through their recovery. Bundling payments for services that patients receive across a single episode of care – such as a heart bypass surgery or hip replacement – encourages better care coordination among hospitals, doctors, and other health care providers. Providers participating in bundled payments must work together when patients are in the hospital as well as after they are discharged, which should improve their recovery and avoid preventable complications and costs by keeping people healthy and at home.
Doctors, patient advocates, and health care experts across the country support these models because they have seen firsthand their potential for delivering better quality and more cost-effective care. Public and private-sector bundled payment models have already shown promise in improving patient outcomes while lowering costs, including for cardiac and orthopedic care. In Medicare, more than 1,400 providers are currently participating in bundles through the Bundled Payments for Care Improvement initiative. Early results are encouraging: orthopedic surgery bundles, in particular, have shown promising results on cost and quality in the first two years of the initiative. These models keep the patient at the center of care delivery and focus on well-coordinated, high quality care.
Today, CMS is releasing the second annual evaluation report for Models 2-4 of the Bundled Payments for Care Improvement initiative, which include both retrospective and prospective bundled payments that may or may not include the acute inpatient hospital stay for a given episode of care. This report describes the characteristics of the participants and includes quantitative results from the first year of the initiative. Future evaluation reports will have greater ability to detect changes in payment and quality due to larger sample sizes and the recent growth in participation of the initiative, which generally is not reflected in this report. Key highlights include:
- 11 out of the 15 clinical episode groups analyzed showed potential savings to Medicare. Future evaluation reports will have more data to analyze individual clinical episodes within these and additional groups;
- Orthopedic surgery under Model 2 hospitals showed statistically significant savings of $864 per episode while showing improved quality as indicated by beneficiary surveys. Beneficiaries who received their care at participating hospitals indicated that they had greater improvement after 90 days post-discharge in two mobility measures than beneficiaries treated at comparison hospitals; and
- Cardiovascular surgery episodes under Model 2 hospitals did not show any savings yet but quality of care was preserved. Over the next year, we will have significantly more data available, enabling us to better estimate effects on costs and quality.
While there is more work to be done, CMS continues to move forward to achieving the Administration’s goal to have 50 percent of traditional Medicare payments tied to alternative payment models by 2018. The 2016 goal of tying 30 percent of Medicare payments to alternative payment models was met eleven months ahead of schedule, and we are committed to keeping that momentum. Bundled payments – including the ongoing Comprehensive Care for Joint Replacement Model – continue to be an integral part of transforming our health care system by creating innovative care delivery models that support hospitals, doctors, and other providers in their efforts to deliver better care for patients while spending taxpayer dollars more wisely.
To view the evaluation report, please visit the CMS Innovation Center website at: http://ift.tt/1SHmSQv.
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