Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments

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FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder - FDA Press Releases

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

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Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D. on efforts by the agency to address the impact of IV saline products and amino acids for injection shortages following the hurricane and update on FDA’s work in Puerto Rico

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Virginia Diner, Inc. Issues Allergy Alert on Undeclared Peanut Allergen in Chocolate Covered Cashews 10 oz. cans - FDA Safety Alerts & Drug Recalls

Virginia Diner, Inc. is voluntarily issuing a recall of 10 oz. cans of Plow & Hearth Chocolate Covered Cashews at Plow & Hearth’s locations and nationwide (Mail Order) as a precaution because they may contain peanuts and peanut allergens. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. A label mix up was discovered by a consumer who received and opened a Cashew Tower Set (3 individual cashew cans) of which one can, the 10 oz. Chocolate Covered Cashews, were found to have Salted Peanuts.

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FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers - FDA Press Releases

FDA/CMS parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries‎ sooner

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CMS releases its Measures Under Consideration List for 2018 pre-rulemaking - CMS Blog

By: Kate Goodrich, M.D., M.H.S., Director, Center for Clinical Standards & Quality, CMS Chief Medical Officer

Medicare and other payers are rapidly moving toward a healthcare system that rewards high quality care while spending more wisely. Foundational to the success of these efforts is having quality measures that are meaningful to patients, consumers, and providers alike.  CMS recently announced the “Meaningful Measures” initiative to identify the most impactful areas for quality measurement and improvement and reflect core issues that are most vital to high quality care and better individual outcomes. Each year, CMS publishes a list of quality and cost measures that are under consideration for Medicare quality reporting and value-based purchasing programs, and collaborates with the National Quality Forum (NQF) to get critical input from multiple stakeholders, including patients, families, caregivers, clinicians, commercial payers and purchasers, on the measures that are best suited for these programs. Ultimately, these measures may help patients choose the nursing home, hospital, or clinician that is best for them, and can help providers to provide the highest quality of care across care settings.

I am happy to announce that CMS posted the Measures under Consideration (MUC) List for 2018 pre-rulemaking on the CMS website and has sent it to NQF in preparation for multi-stakeholder input.

This year’s MUC List contains 32 measures that have the potential to drive improvement in quality across numerous settings of care, including clinician practices, hospitals, and dialysis facilities. CMS is considering new measures to help quantify healthcare outcomes and track the effectiveness, safety and patient-centeredness of the care provided.  At the same time, CMS is taking a new approach to coordinated implementation of meaningful quality measures focused on the most critical, highly impactful areas for improvement while reducing the burden of quality reporting on all providers so they can spend more time with their patients.  In addition to other factors, CMS evaluated the measures on the MUC list to ensure that measures considered for adoption in a CMS program through rulemaking as necessary, focus on clearly defined, meaningful measure priority areas that safeguard public health and improve patient outcomes.  For example, to generate this year’s MUC list, CMS considered 184 measures submitted by stakeholders during an open call for measures.  Considering the meaningful measurement areas, CMS narrowed the list to 32 measures (17% of the original submissions) which focus CMS efforts to achieve goals of high quality healthcare and meaningful outcomes for patients, while minimizing burden. CMS will continue to use the Meaningful Measures approach to strategically assess the development and implementation of quality measure sets that are the most parsimonious and least burdensome, that are well understood by external stakeholders, and are most likely to drive improvement in health outcomes.

This year, approximately 40% of measures on the MUC list are outcome measures, including patient-reported outcome measures, which will help empower patients to make decisions about their own healthcare and help clinicians to make continuous improvements in the care provided. In addition, this year there are eight episode-based cost measures proposed that were developed by incorporating the insight and expertise of clinicians and specialty societies.  CMS is committed to working with clinicians, consumers, and other stakeholders on the development and use of measures that are most meaningful to patients and clinicians and our programs.

We invite you to review the MUC List in detail and to participate in the public process. We believe it is critical to hear a wide range of voices in the selection of quality and efficiency measures that are used for accountability and transparency purposes and look forward to another successful pre-rulemaking season. For more information regarding the NQF Measure Applications Partnership public stakeholder review meeting purpose, meetings, 2017 MUC List deliberations and voting, visit the NQF website at http://ift.tt/IXUWWv.

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Nutra Labs Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Bull and Chao Jimengnan Tablets Due to Undeclared Active Pharmaceutical Ingredients - FDA Safety Alerts & Drug Recalls

Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH" - FDA Press Releases

FDA Commissioner Gottlieb provides testimony before the House Committee on Energy and Commerce on the agency’s implementation of the 21st Century Cures Act

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Stability and Change in Cognitive Status Classification of Black Older Adults - American Geriatric Society

Objectives

The purpose of this study was to determine whether stability and change in cognitive status are associated with sociodemographic characteristics and health function.

Design

Secondary analysis of data.

Setting

Baltimore Study of Black Aging—Patterns of Cognitive Aging.

Participants

Community-dwelling black adults (N = 407; mean age 68.6 ± 9.1).

Measurements

Baseline (n = 602) and 33-month follow-up (n = 450) assessments of cognition, health, and psychosocial function.

Results

For the present analyses, participants were grouped as being cognitively normal (n = 249), having stable mild cognitive impairment (MCI) (n = 32), or being MCI converters (n = 72; normal at baseline, MCI at follow-up) or reverters (n = 54; MCI at baseline, normal at follow-up). Multivariate analysis of variance showed that the groups differed significantly in education and lung function (P < .010). Post hoc analyses indicated that converters had fewer years of education than the other groups, whereas those who were cognitively normal had better lung function than converters and reverters (P < .050).

Conclusion

These results suggest that education and lung health are associated with patterns of cognitive status change and stability. Future research should account for sociodemographic and health factors when examining stability of cognitive status classifications.

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Farrell Farms, Inc. Issues allergy alert on undeclared milk in Dark Chocolate Almonds, Dark Chocolate Cashews, and Dark Chocolate Pecans - FDA Safety Alerts & Drug Recalls

Farrell Farms, Inc. of Goldsboro, NC is recalling 7 oz Dark Chocolate Almonds, 7 oz Dark Chocolate Cashews, and 7 oz Dark Chocolate Pecans, because these products 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 these products.

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Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria - Journal of Antibiotics

Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria

Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus <i>Halichondria</i>, Published online: 29 November 2017; doi:10.1038/ja.2017.145

Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria

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Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster - Journal of Antibiotics

Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster

Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster, Published online: 29 November 2017; doi:10.1038/ja.2017.146

Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster

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Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial - American Geriatric Society

Background/Objectives

Dementia-related behavioral symptoms and functional dependence result in poor quality of life for persons with dementia and their caregivers. The goal was to determine whether a home-based activity program (Tailored Activity Program; TAP-VA) would reduce behavioral symptoms and functional dependence of veterans with dementia and caregiver burden.

Design

Single-blind (interviewer), parallel, randomized, controlled trial (Clinicaltrials.gov: NCT01357564).

Setting

Veteran's homes.

Participants

Veterans with dementia and their family caregivers (N = 160 dyads).

Intervention

Dyads in TAP-VA underwent 8 sessions with occupational therapists to customize activities to the interests and abilities of the veterans and educate their caregivers about dementia and use of customized activity. Caregivers assigned to attention control received up to 8 telephone-based dementia education sessions with a research team member.

Measurements

Primary outcomes included number of behaviors and frequency of their occurrence multiplied by severity of occurrence; secondary outcomes were functional dependence, pain, emotional well-being, caregiver burden (time spent caregiving, upset with behaviors) and affect at 4 (primary endpoint) and 8 months.

Results

Of 160 dyads (n = 76 TAP-VA; n = 84 control), 111 completed 4-month interviews (n = 51 TAP-VA; n = 60 control), and 103 completed 8-month interviews (n = 50 TAP-VA; n = 53 control). At 4 months, compared to controls, the TAP-VA group showed reductions in number (difference in mean change from baseline = −0.68, 95% CI = −1.23 to −0.13) and frequency by severity (−24.3, 95% CI = −45.6 to −3.1) of behavioral symptoms, number of activities needing assistance with (−0.80, 95% CI = −1.41 to −0.20), functional dependence level (4.09, 95% CI = 1.06, 7.13), and pain (−1.18, 95% CI = −2.10 to −0.26). Caregivers of veterans in TAP-VA reported less behavior-related distress. Benefits did not extend to 8 months.

Conclusion

TAP-VA had positive immediate effects and no adverse events. Because TAP-VA reduces behavioral symptoms, slows functional dependence, and alleviates pain and caregiver distress, it is a viable treatment option for families.

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Leclerc Foods Issues Limited Voluntary Recall of Fit & Active Chocolatey Chip Protein Meal Bars – Due to Presence of Plastic Piece - FDA Safety Alerts & Drug Recalls

Leclerc Foods has initiated a limited voluntary recall of a single lot of Fit & Active Chocolatey Chip Protein Meal Bars packages with UPC Code 41498-18695 and only affected products with a “best by” date of May 24, 2018.

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Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity - American Geriatric Society

Objectives

To compare the effect of a 6-month community-based intervention with that of usual care on quality of life, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with type 2 diabetes mellitus (T2DM) and 2 or more comorbidities.

Design

Multisite, single-blind, parallel, pragmatic, randomized controlled trial.

Setting

Four communities in Ontario, Canada.

Participants

Community-dwelling older adults (≥65) with T2DM and 2 or more comorbidities randomized into intervention (n = 80) and control (n = 79) groups (N = 159).

Intervention

Client-driven, customized self-management program with up to 3 in-home visits from a registered nurse or registered dietitian, a monthly group wellness program, monthly provider team case conferences, and care coordination and system navigation.

Measurements

Quality-of-life measures included the Physical Component Summary (PCS, primary outcome) and Mental Component Summary (MCS, secondary outcome) scores of the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12). Other secondary outcome measures were the Generalized Anxiety Disorder Scale, Center for Epidemiologic Studies Depression Scale (CES-D-10), Summary of Diabetes Self-Care Activities (SDSCA), Self-Efficacy for Managing Chronic Disease, and healthcare costs.

Results

Morbidity burden was high (average of eight comorbidities). Intention-to-treat analyses using analysis of covariance showed a group difference favoring the intervention for the MCS (mean difference = 2.68, 95% confidence interval (CI) = 0.28–5.09, P = .03), SDSCA (mean difference = 3.79, 95% CI = 1.02–6.56, P = .01), and CES-D-10 (mean difference = −1.45, 95% CI = −0.13 to −2.76, P = .03). No group differences were seen in PCS score, anxiety, self-efficacy, or total healthcare costs.

Conclusion

Participation in a 6-month community-based intervention improved quality of life and self-management and reduced depressive symptoms in older adults with T2DM and comorbidity without increasing total healthcare costs.

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Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination - FDA Safety Alerts & Drug Recalls

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

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Transformation of a Geriatric Department in China - American Geriatric Society

China has the world's largest elderly population, and the oldest-old population, with a current disability rate greater than 50%, will triple in the next 35 years. The field of geriatrics is young, because almost all geriatric departments were established after 2000, and so faces many challenges. Management of diseases and hospital care is the focus. Senior physicians were trained in other subspecialties, such as pulmonary or cardiology, and junior physicians entered geriatrics departments as masters or doctorate students after medical school. The inadequacy of post-acute and long-term care facilities has caused long hospital stays. There are no national systematic geriatric training programs, national board examinations, or qualifications in geriatrics. These challenges were used as a framework for guiding changes in the Department of Geriatrics at West China Hospital, Sichuan University. These changes have included international experiences and collaboration for physicians and nurses, revision of departmental conferences, and special training for a unique group of caregivers called hugong (untrained caregivers hired by families to be at the bedside of hospitalized individuals). The most significant yet challenging part of the transformation has been to develop and modify Western-based geriatric models of care (e.g., Acute Care of the Elderly unit, delirium prevention and management models, palliative care). Lastly, the department established Tianxia (in the sky) Doctors, an internet-based platform to connect the department's interdisciplinary team to other hospitals, nursing institutions, home-based care service stations, community health service centers, and pharmacies throughout the region.

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Prevalence of Frailty and Associated Factors in the Community-Dwelling Population of China - American Geriatric Society

Background/Objectives

Frailty in older adults predicts dependence and mortality and is a major challenge for healthcare systems in countries with rapidly aging populations. Little is known about frailty in China. We investigated the prevalence and associated risk factors of frailty in older adults in China.

Design

Cross-sectional.

Setting

Data were obtained from the China Comprehensive Geriatric Assessment Study, conducted in 2011–12, which was the first uniform comprehensive assessment system adopted in China.

Participants

Older adults from 7 cities were selected based on well-established cluster, stratification, and random selection statistical sampling techniques (N = 5,844).

Measurements

The Comprehensive Geriatric Assessment-Frailty Index was measured based on demographic characteristics, physical health, physical function, living behavior and social function, mental health, and cognitive function.

Results

The overall weighted prevalence of frailty was 9.9%: 12.7% in southwestern China, 11.0% in northern China, 5.9% in northwestern China, 5.0% in south-central China, 2.5% in eastern China, and 2.3% in northeastern China. The prevalence of frailty increased with age and was significantly higher in women and those living in rural areas. After adjusting for sex, age, area, region, and education, activity of daily living impairment was the strongest risk factor for frailty. Chronic diseases, depression, poor lifestyle, and geriatric syndromes were also independent risk factors.

Conclusion

Our study provides epidemiological characteristics and the risk factors of frailty in China; the findings indicate greater regional disparities. Efforts to promote physical, psychological, and social health in older adults are a core objective of health policy, especially in women and those living in rural areas.

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Cost-Effectiveness of a Care Transitions Program in a Multimorbid Older Adult Cohort - American Geriatric Society

Background/Objectives

Facing penalties for preventable 30-day hospital readmissions, many provider groups have implemented programs to remedy this problem, but the cost efficacy and value of such programs are not well delineated. The objective was to compare total cost of care over 30 days of individuals enrolled in the Mayo Clinic Care Transitions (MCCT) program and individuals not enrolled.

Design

Retrospective cohort study using secondary data analysis of a previously published cohort study.

Setting

Mayo Clinic, Rochester, Minnesota.

Participants

MCCT participants (n = 363) and individuals in a propensity-matched referent cohort (n = 365).

Intervention

MCCT program enrollment.

Measurements

The primary outcome was total cost of care over 30 days after hospital discharge. A 2-part modeling strategy was used to analyze 30-day costs: whether individuals had non-zero costs during the 30 days after discharge and a generalized linear model for individuals who incurred costs. Potential heterogeneous effects of the MCCT program were examined according to decile of 30-day costs using quantile regression.

Results

Mean age was 83 in both groups. Adjusted mean 30-day cost after hospitalization was $3,363 (95% confidence interval (CI) = $2,512−4,213) in the MCCT group and $4,161 (95% CI = $3,096−5,226) in the control group (P = .25). Cost savings of $2,744 (P = .008) at the eighth decile and $3,388 (P = .20) at the ninth decile were demonstrated. Thus, the only statistically significant differences were in the post hoc subgroup analysis in the highest-cost subgroups.

Conclusion

We did not find a difference in overall mean costs between the MCCT group and the control group, although intervention participants in the upper deciles of costs appeared to experience lower costs than controls. A larger study cohort might better determine the value of the intervention.

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Food Co. Issues Allergy Alert on Undeclared Allergen (E.G. Milk) in Product - FDA Safety Alerts & Drug Recalls

Colorado Nut Company of Denver, CO is recalling Cashew Cranberry Cherry Jubilee, Oat Bran Nutty Crunch, Honey Nutty Granola, Peanut Delight, and Frontier Trail Mix, 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 these products.

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FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients - FDA Press Releases

FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.

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Medicaid Cost Savings of a Preventive Home Visit Program for Disabled Older Adults - American Geriatric Society

Background/Objectives

Little is known about cost savings of programs that reduce disability in older adults. The objective was to determine whether the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) program saves Medicaid more money than it costs to provide.

Design

Single-arm clinical trial (N = 204) with a comparison group of individuals (N = 2,013) dually eligible for Medicaid and Medicare matched on baseline geographic and demographic characteristics, chronic conditions, and healthcare use. We used finite mixture model regression estimates in a Markov model.

Setting

Baltimore, MD

Participants

Individuals aged 65 and older with reported difficulty with at least one activity of daily living.

Intervention

CAPABLE is a 5-month program to reduce the health effects of impaired physical function in low-income older adults by addressing individual capacity and the home environment. CAPABLE uses an interprofessional team (occupational therapist, registered nurse, handyman) to help older adults attain self-identified functional goals.

Measurements

Monthly average Medicaid expenditure and likelihood of high- or low-cost use of eight healthcare service categories.

Results

Average Medicaid spending per CAPABLE participant was $867 less per month than that of their matched comparison counterparts (observation period average 17 months, range 1–31 months). The largest differential reduction in expenditures were for inpatient care and long-term services and supports.

Conclusion

CAPABLE is associated with lower likelihood of inpatient and long-term service use and lower overall Medicaid spending. The magnitude of reduced Medicaid spending could pay for CAPABLE delivery and provide further Medicaid program savings due to averted services use.

Clinical trial registration

CAPABLE for Frail dually eligible older adults NCT01743495 http://ift.tt/2hV1wX4

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Targeting Function at Home in Older Adults: How to Promote and Disseminate Promising Models of Care? - American Geriatric Society

This editorial comments on the article by Szanton et al.

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Square Pegs; Round Holes: Our Healthcare System Is Failing Seriously Ill Older Americans in Their Last Years - American Geriatric Society

This editorial comments on the article by Thomas M. Gill et al.

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Frequency of Leaving the House and Mortality from Age 70 to 95 - American Geriatric Society

Objectives

To determine the association between frequency of leaving the house and mortality.

Design

Prospective follow-up of an age-homogenous, representative, community-dwelling birth cohort (born 1920–21) from the Jerusalem Longitudinal Study (1990–2015).

Setting

Home.

Participants

Individuals aged 70 (n = 593), 78 (n = 973), 85 (n = 1164), and 90 (n = 645), examined in 1990, 1998, 2005, and 2010, respectively.

Measurements

Frequency of leaving the house, defined as daily (6–7/week), often (2–5/week), and rarely (≤1/week); geriatric assessment; all-cause mortality (2010–15). Kaplan-Meier survival charts and proportional hazards models adjusted for social (sex, marital status, financial status, loneliness), functional (sex, self-rated health, fatigue, depression, physical activity, activity of daily living difficulty), and medical (sex, chronic pain, visual impairment, hearing impairment, diabetes mellitus, hypertension, ischemic heart disease, chronic kidney disease) covariates.

Results

At ages 70, 78, 85, and 90, frequency of going out daily was 87.0%, 80.6%, 65.6%, and 48.4%; often was 6.4%, 9.5%, 17.4%, and 11.3%; and rarely was 6.6%, 10.0%, 17.0%, and 40.3% respectively. Decreasing frequency of going out was associated with negative social, functional, and medical characteristics. Survival rates were lowest among those leaving rarely and highest among those going out daily throughout follow-up. Similarly, compared with rarely leaving the house, unadjusted mortality hazard ratios (HRs) were lowest among subjects leaving daily and remained significant after adjustment for social, functional and medical covariates. Among subjects leaving often, unadjusted HRs showed a similar effect of smaller magnitude, with attenuation of significance after adjustment in certain models. Findings were unchanged after excluding subjects dying within 6 months of follow-up.

Conclusion

In community-dwelling elderly adults aged 70 to 90, leaving the house daily was associated with lower mortality risk, independent of social, functional, or medical status.

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FDA approves first two-drug regimen for certain patients with HIV - FDA Press Releases

FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse - FDA Press Releases

FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse

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Cognitive Outcomes After Transcatheter Aortic Valve Implantation: A Metaanalysis - American Geriatric Society

Objectives

To quantitatively summarize changes in cognitive performance in individuals with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI).

Design

Metaanalysis.

Participants

Individuals undergoing TAVI (N = 1,065 (48.5% male) from 18 studies, average age ≥80).

Measurements

The MEDLINE, EMBASE, and Cochrane Central databases were searched for original peer-reviewed reports assessing cognitive performance using standardized cognitive tests before and after TAVI. Data were extracted for cognitive scores before TAVI; perioperatively (within 7 days after TAVI); 1, 3, and 6 months after TAVI, and 12 to 34 months after TAVI (over the long term). Standardized mean differences (SMDs) were generated using random-effects models for changes in cognition at each time point. Metaregression analyses were conducted to assess the association between population and procedural characteristics and cognitive outcomes. Risk of bias was assessed.

Results

There were no significant changes from baseline in perioperative cognitive performance (SMD = 0.05, 95% confidence interval (CI) = −0.08–0.18; z = 0.75, P = .46), although overall cognitive performance had improved significantly 1 month after TAVI (SMD = −0.33, 95% CI = −0.50 to −0.16; z = 3.83, P < .001). There were no differences in cognitive performance 3 and 6 months after TAVI or over the long term. Cognitive outcomes were not associated with any covariates in regression analyses.

Conclusion

Cognitive performance is preserved after TAVI, suggesting TAVI is not detrimental to cognition.

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Cognitive Function After Transcatheter Aortic Valve Replacement: Reassuring Findings For Now - American Geriatric Society

This editorial comments on the article by Khan et al.

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Goya Voluntary Recall of Adobo Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Goya de Puerto Rico is recalling 28 ounces Adobo with Cumin Seasoning and 28 ounces Adobo with Pepper Seasoning because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system.

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CMS announces a new user-centered resource to help improve alignment: the CMS Measures Inventory Tool (CMIT) - CMS Blog

By Kate Goodrich, MD
Director, CMS Center for Clinical Standards and Quality & CMS Chief Medical Officer

CMS is actively working to move the needle on improving quality in healthcare without additional burden to those providers on the frontlines. CMS recently launched a new initiative, ‘Meaningful Measures,’ which will streamline current measure sets – so providers can focus on the measures that are most impactful – and will move from process measures to outcome measures where possible. A great deal of attention has also been focused on alignment of quality measures within CMS and with commercial payers, and we are committed to working towards alignment of these measures to ensure delivery of high quality care to all Americans while minimizing burden on providers.

I am pleased to announce that CMS is deploying an innovative tool that provides all stakeholders improved visibility into the portfolio of CMS measures. The CMS Measures Inventory Tool (CMIT), an interactive web-based application that contains the same information that is currently included on the  Excel spreadsheet, provides a comprehensive list of measures that are currently under development, implemented for use, and have been removed from a CMS quality program or initiative.  The intuitive and user-friendly functions allow you to find measures quickly and to compile and refine sets of related measures. The tool increases transparency and can be used to identify measures across the continuum of care and will help coordinate measurement efforts across all conditions, settings, and populations.  We have expanded the information contained in the inventory to better answer questions we have heard from the public; the CMIT lists each measure by program, dates of measure consideration and implementation, and measure specifications including, but not limited to, numerator, denominator, exclusion criteria, measure type, and National Quality Forum (NQF) endorsement status.

CMIT is an innovative approach that will help to promote the goal of increased alignment across programs and with other payers.  We believe it is an easy to use valuable resource to various stakeholders, including commercial payers, clinicians, patients and measure developers.

For more information about CMIT and to access the tool, please visit the CMS.gov website.

Filed under: Uncategorized

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Reply to: Neutrophil to Lymphocyte Ratio As a Risk Stratification Tool for Older Adults with Pneumonia - American Geriatric Society

This letter comments on the letter by Karakonstantis et al.

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Neutrophil to Lymphocyte Ratio As a Risk Stratification Tool for Older Adults with Pneumonia - American Geriatric Society

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Nursing Home Regulations Redefined: Implications for Providers - American Geriatric Society

The Centers for Medicare and Medicaid Services (CMS) finalized a comprehensive update to nursing home requirements of participation in October 2016. Nearly 10,000 public comments were received regarding the proposed rule, and CMS made multiple modifications based on comments from providers, advocacy organizations, and others before issuing the final rule. The final rule describing nursing home requirements of participation modernizes nursing home regulation. It is being implemented in three phases—beginning in November 2016, November 2017, and November 2019. There are multiple provisions that have implications for clinicians caring for nursing home residents, particularly in terms of management of infections, medication prescribing and monitoring, and delegation of medical orders.

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Individualizing Prevention for Older Adults - American Geriatric Society

Prevention can help older adults avoid illness by identifying and addressing conditions before they cause symptoms, but prevention can also harm older adults if conditions that are unlikely to cause symptoms in the individual's lifetime are identified and treated. To identify older adults who preventive interventions are most likely to benefit (and most likely to harm), we propose a framework that compares an individual's life expectancy (LE) with the time to benefit (TTB) for an intervention. If LE is less than the TTB, the individual is unlikely to benefit but is exposed to the risks of the intervention, and the intervention should generally NOT be recommended. If LE is longer than the TTB, the individual could benefit, and the intervention should generally be recommended. If LE is similar to the TTB, the individual's values and preferences should be the major determinant of the decision. To facilitate the use of this framework in routine clinical care, we explored ways to estimate LE, identified the TTB for common preventive interventions, and developed strategies for communicating with individuals. We have synthesized these strategies and demonstrate how they can be used to individualize prevention for a hypothetical beneficiary in the setting of a Medicare annual wellness visit. Finally, we place prevention in the context of curative and symptom-oriented care and outline how prevention should be focused on healthier older adults, whereas symptom-oriented care should predominate in sicker older adults.

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Living with a Spouse or Others: Beneficial or Harmful in the Presence of Depressive Symptoms? - American Geriatric Society

This letter comments on the article by Nakamura et al.

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Identifying Sarcopenia in Female Long-Term Care Residents: A Comparison of Current Guidelines - American Geriatric Society

Objectives

To establish the prevalence of sarcopenia in a long-term care population, assess agreement among different consensus sarcopenia diagnostic criteria, and examine agreement of a self-reported questionnaire with consensus guidelines.

Design

Cross-sectional secondary analysis.

Setting

Long-term care communities in the greater Pittsburgh, Pennsylvania, area.

Participants

Women aged 65 and older (mean 83.6) undergoing eligibility screening for a fracture reduction trial (N = 141).

Measurements

We measured appendicular lean muscle mass using dual-energy X-ray absorptiometry. Hand grip strength and usual gait speed were also evaluated. Sarcopenia status was determined according to European Working Group on Sarcopenia in Older People (EWGSOP) and the Foundation for the National Institutes of Health (FNIH) Sarcopenia Project criteria and the SARC-F questionnaire.

Results

Eleven participants were sarcopenic (7.8%) according to the EWGSOP criteria, six (4.3%) according to FNIH conservative cut-point guidelines, and 32.6% (n = 46) according to FNIH intermediate cut-points. Only 2 of 141 participants met criteria for sarcopenia according to all three guidelines. Sarcopenia was identified in 30 (21.3%) participants according to the SARC-F questionnaire. Sensitivity of the SARC-F with consensus panel definitions ranged from 18.2% to 33.3%. Specificity ranged from 78.7% to 81.1%.

Conclusion

Current consensus criteria from the EWGSOP and FNIH Sarcopenia Project do not agree and have little overlap in older female long-term care residents. The SARC-F questionnaire is a simple tool that could be implemented in long-term care, but it has low sensitivity compared with current consensus guidelines in the identification of sarcopenic individuals.

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Interprofessional Teamwork in Acute Geriatric Care: Where Are the Pharmacists? - American Geriatric Society

See the Reply by Piers et al.

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Reply to: Interprofessional Teamwork in Acute Geriatric Care: Where Are the Pharmacists? - American Geriatric Society

This letter comments on the letter by Spinewine et al.

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Periventricular White Matter Hyperintensities and Functional Decline - American Geriatric Society

Background/Objectives

We previously showed that global brain white matter hyperintensity volume (WMHV) was associated with accelerated long-term functional decline. The objective of the current study was to determine whether WMHV in particular brain regions is more predictive of functional decline.

Design

Prospective population-based study.

Setting

Northern Manhattan magnetic resonance imaging (MRI) study.

Participants

Individuals free of stroke at baseline (N = 1,195; mean age 71 ± 9; n = 460 (39%) male).

Measurements

Participants had brain MRI with axial T1, T2, and fluid attenuated inversion recovery sequences. Volumetric WMHV distribution across 14 brain regions (brainstem; cerebellum; bilateral frontal, occipital, temporal, and parietal lobes; and bilateral anterior and posterior periventricular white matter (PVWM)) was determined using a combination of bimodal image intensity distribution and atlas-based methods. Participants had annual functional assessments using the Barthel Index (BI) (range 0–100) over a mean of 7.3 years and were followed for stroke, myocardial infarction (MI), and mortality. Because there were multiple collinear variables, least absolute shrinkage and selection operator (LASSO) regression–selected regional WMHV variables most associated with outcomes and adjusted generalized estimating equations models were used to estimate associations with baseline BI and change over time.

Results

Using LASSO regularization, only right anterior PVWM was found to meet criteria for selection, and each standard deviation greater WMHV was associated with accelerated functional decline of 0.95 additional BI points per year (95% confidence interval (CI) = −1.20 to −0.70) in an unadjusted model, −0.92 points per year (95% CI = −1.18 to −0.67) with baseline covariate adjustment, and −0.87 points per year (95% CI = −1.12 to −0.62) after adjusting for incident stroke and MI.

Conclusion

In this large population-based study with long-term repeated measures of function, periventricular WMHV was particularly associated with accelerated functional decline.

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Casa Sanchez Foods Extiende El Retiro Voluntario Del " Real Guacamole " Para Incluir “Spicy Guacamole” Del Mercado Por Causa De Posible Riesgo Para La Salud - FDA Safety Alerts & Drug Recalls

Casa Sanchez Foods de Hayward, California, está retirando todo su "Real Guacamole" y “Spicy Guacamole” del mercado, por precaución de acuerdo con el compromiso de la compañía para proteger la salud pública. La retirada fue necesaria por los resultados de pruebas positivas para Listeria monocytogenes en dos paquetes de muchas muestras recogidas para el programa de pruebas de muestras aleatorias de la Administración de Drogas y Alimentos de EE. UU.

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Expanded Voluntary Recall for Casa Sanchez Foods "Real Guacamole" and to also Include “Spicy Guacamole” Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Casa Sanchez Foods of Hayward, CA, is voluntarily recalling all "Real Guacamole" and “Spicy Guacamole” products out of an abundance of caution in keeping with the company’s commitment to protect the public health. The recall was necessitated by positive test results for Listeria monocytogenes on two packages out of many samples collected for the U. S. Food and Drug Administration random sample testing program.

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FDA approves first telehealth option to program cochlear implants remotely - FDA Press Releases

FDA approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts by the agency to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

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New Hope for Sarcopenia - American Geriatric Society

See the Reply by Rooks et al.

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Reply to: New Hope for Sarcopenia - American Geriatric Society

This letter comments on the letter by Kwang-il Kim.

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Greenstone Issues Voluntary Nationwide Recall of Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP Due to Possible Sub Potent and Super Potent Tablets - FDA Safety Alerts & Drug Recalls

For Immediate Release – PEAPACK, NJ, November 16, 2017 - Greenstone LLC, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent.

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Administrator’s Blog: National Rural Health Day (November 16, 2017) - CMS Blog

November 16, 2017

By: Seema Verma, CMS Administrator @SeemaCMS 

Today, CMS is celebrating National Rural Health Day by commemorating our partners who provide quality care to the nearly one in five Americans who reside in rural communities. CMS recognizes the unique challenges facing rural America, and we are taking action to improve access and quality for healthcare providers serving rural patients.

This fall, I have been visiting communities throughout the country to learn more about issues critical to improving access to rural healthcare. I travelled to Kansas City and visited the headquarters of the National Rural Health Association to talk with key leadership and stakeholders to hear how CMS can reduce the challenges rural communities face. CMS is committed to evaluating our policies and looking at each of them through a rural lens to ensure rural providers greater flexibility and less regulatory burden.

New technologies are emerging that have strong promise to address access issues in rural communities. CMS is trying to modernize the Medicare program so that beneficiaries can make use of the new technology. For example, CMS recently released new telehealth payment codes in Medicare so more services can be accessed in rural areas. This is only the beginning of our overall strategy to update our programs and improve access to high quality services.

Rural hospitals also face challenges in recruiting physicians. CMS is addressing this challenge by placing a two-year moratorium on the direct supervision requirement for outpatient therapeutic services at Critical Access Hospitals and small rural hospitals. This policy helps to ensure access to outpatient therapeutic services for Medicare beneficiaries living in rural communities and provides regulatory relief to America’s small rural hospitals. In Medicare Advantage plans, we are working to ensure network standards offer the flexibility needed to provide greater health care plan choices to rural beneficiaries. These reforms are in line with our focus on improving the beneficiary experience.

In response to feedback received from Critical Access Hospitals and other rural stakeholders, CMS recently announced that Critical Access Hospitals should no longer expect to receive medical record reviews related to the 96-hour certification requirement absent concerns of probable fraud, waste, or abuse. 

We are also now providing technical assistance and greater flexibilities to small and rural clinicians to help facilitate their participation in the Quality Payment Program (QPP). These efforts are aligned with our goal of reducing regulatory burden so clinicians are able to spend more time on patient care and healthier outcomes, and less time on paperwork. One way we have done this is to provide free and customized technical assistance to support small and rural clinicians every step of the way, as well as assistance through our Service Center, Regional Offices, and the QPP page on cms.gov.

We have finalized several policies to reduce burdens and help clinicians in small practices successfully participate in the QPP program. Some of these include:

• Increasing the “low volume threshold,” which is the maximum amount of Medicare revenue and the maximum number of Medicare patients that a clinician can have while being excluded from the new requirements, to exclude more small practices from QPP.
• Adding an option for clinicians to come together in “virtual groups” to report data together and share the burden of meeting the new requirements.
• Continuing to award small practices a minimum of three points for quality measures, recognizing that small practices may not be able to pull together the amount of data as easily as large practices.
• Providing small practices with a new hardship exception to some of the EHR reporting requirements.
• Adding five bonus points to the final performance score for small practices.

In our effort to consider a new direction that promotes patient-centered care and test market-driven reforms, the CMS Innovation Center is currently seeking suggestions on improving rural healthcare by way of a recently released Request for Information (RFI). The opportunity to provide recommendations for the new direction closes November 20 and if you have not already, we hope you will share your thoughts.

CMS has also developed a number of resources to help rural providers and other stakeholders.  To improve the customer experience and further empower our rural providers, we are centralizing rural healthcare resources into a single website which you can find here.

And finally, CMS does not operate in a vacuum.  We work closely with other federal partners including the Health Resources and Services Administration, the Office of the National Coordinator, and the Centers for Disease Control and Prevention, among others, to ensure our efforts to improve care in rural America are consistent with those agencies’ rural initiatives. CMS will continue to listen to, work with, and value the input from rural stakeholders.  Together, we can improve care in rural America.  Happy National Rural Health Day!

# # # #

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Lipari Foods, LLC. Issues Voluntary Product Recall of Specific Dark Chocolate Products Due to Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls

Lipari Foods, LLC has issued a voluntary recall of specific dark chocolate products packaged by sister company JLM due to an undeclared milk allergen. 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. The products are safe for consumption by those who do not have an allergy or severe sensitivity to milk.

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FDA expands approval of Sutent to reduce the risk of kidney cancer returning - FDA Press Releases

FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.

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FDA approves new treatment to prevent bleeding in certain patients with hemophilia A - FDA Press Releases

FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors.

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Giant/Martin’s Alerts Customers to Voluntary Recall of Store Brand Frozen Whole Kernel Sweet Corn - FDA Safety Alerts & Drug Recalls

GIANT Food Stores, LLC and MARTIN’S Food Markets announced it removed from sale GIANT/MARTIN’S Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination.

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Giant Food Alerts Customers to Voluntary Recall of Store Brand Frozen Whole Kernel Sweet Corn - FDA Safety Alerts & Drug Recalls

Giant Food, LLC announced it removed from sale Giant Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination.

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Stop & Shop Alerts Customers to Voluntary Recall of Store Brand Frozen Whole Kernel Sweet Corn - FDA Safety Alerts & Drug Recalls

The Stop & Shop Supermarket Company LLC announced it removed from sale Stop & Shop Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health - FDA Press Releases

Commissioner statement on FDA’s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy

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FDA announces comprehensive regenerative medicine policy framework - FDA Press Releases

FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.

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Primary Thromboprophylaxis in Individuals without Cancer Admitted to a Geriatric Palliative Care Unit - American Geriatric Society

Background/Objectives

The prevalence of individuals with advanced noncancer disease is increasing on palliative care units (PCUs), but there are no current guidelines to direct venous thromboembolism (VTE) prophylaxis decisions in these individuals. The aim of this study was to compare primary VTE prophylaxis in elderly adults with advanced noncancer diagnoses with that of those with advanced cancer on a dedicated geriatric PCU.

Design

Single-center retrospective chart review.

Setting

Baycrest Health Sciences PCU, Toronto, Ontario, Canada.

Participants

All 317 individuals admitted to and discharged in 2015 were included in the initial analysis.

Results

Three hundred sixteen individuals were included in the final analysis, 56 (17.7%) of whom had a noncancer diagnosis. VTE prophylaxis was administered in 31.8% of participants with cancer and 26.8% of those without (P = .28). Two hundred eleven (66.6%) participants were admitted from the hospital, and 96 (30.3%) were admitted from home. Participants admitted from the hospital were more likely to receive VTE prophylaxis (39.8% vs 13.7%; P < .05). Mean admission PPS score was 31.4 for participants without cancer and 36.0 for those with cancer (P < .05). Length of stay was shorter for participants with a PPS score less than 30 (18.6 vs 33.6 days; P < .05). The rate of VTE prophylaxis in participants who were bedbound was similar to that in those who were ambulatory (29.8% vs 32.2%; P = .36).

Conclusion

VTE prophylaxis rates were similar in participants with and without cancer on a geriatric PCU. The rate was not significantly less for nonambulatory participants. Further research would help to better guide VTE prophylaxis decisions and minimize suffering at the end of life.

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Accelerometer-Measured Physical Activity and Mortality in Women Aged 63 to 99 - American Geriatric Society

Objectives

To prospectively examine associations between accelerometer-measured physical activity (PA) and mortality in older women, with an emphasis on light-intensity PA.

Design

Prospective cohort study with baseline data collection between March 2012 and April 2014.

Setting

Women's Health Initiative cohort in the United States.

Participants

Community-dwelling women aged 63 to 99 (N = 6,382).

Measurements

Minutes per day of usual PA measured using hip-worn triaxial accelerometers, physical functioning measured using the Short Physical Performance Battery, mortality follow-up for a mean 3.1 years through September 2016 (450 deaths).

Results

When adjusted for accelerometer wear time, age, race-ethnicity, education, smoking, alcohol, self-rated health, and comorbidities, relative risks (95% confidence intervals) for all-cause mortality across PA tertiles were 1.00 (referent), 0.86 (0.69, 1.08), 0.80 (0.62, 1.03) trend P = .07, for low light; 1.00, 0.57 (0.45, 0.71), 0.47 (0.35, 0.61) trend P < .001, for high light; and, 1.00, 0.63 (0.50, 0.79), 0.42 (0.30, 0.57) trend P < .001, for moderate-to-vigorous PA (MVPA). Associations remained significant for high light-intensity PA and MVPA (P < .001) after further adjustment for physical function. Each 30-min/d increment in light-intensity (low and high combined) PA and MVPA was associated, on average, with multivariable relative risk reductions of 12% and 39%, respectively (P < .01). After further simultaneous adjusting for light intensity and MVPA, the inverse associations remained significant (light-intensity PA: RR = 0.93, 95% CI = 0.89–0.97; MVPA: RR = 0.67, 95% CI = 0.58–0.78). These relative risks did not differ between subgroups for age or race and ethnicity (interaction, P ≥ .14, all).

Conclusion

When measured using accelerometers, light-intensity and MVPA are associated with lower mortality in older women. These findings suggest that replacing sedentary time with light-intensity PA is a public health strategy that could benefit an aging society and warrants further investigation.

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Casa Sanchez Foods Recalls "Real Guacamole" Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Casa Sanchez Foods of Hayward, CA, is recalling its 9-ounce containers of "Real Guacamole" 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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Yorgo’s Foods Inc Is Recalling All Flavored and Unflavored Food Products (Hommus; Tahini Sauces; Yogurt Dip, Salads, Tzatziki, Grape Leaves; Taboule) Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Yorgo’s Foods Inc. of Manchester NH, a family-owned company, started in 1993, is recalling all Greek-style food products it manufactures, out of an abundance of caution, as they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people, those with weakened immune systems and in unborn fetuses. 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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CMS’s 2017 Medicare Fee-For-Service improper payment rate is below 10 percent for the first time since 2013 - CMS Blog

 CMS Blog
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November 15, 2017
By Kimberly Brandt, Principal Deputy Administrator for Operations (@cms.hhs.gov)

The Centers for Medicare & Medicaid Services (CMS) is committed to reducing improper payments in all of its programs, as evidenced by improper payment reduction efforts contained in the Fiscal Year 2018 President’s Budget. CMS’s new leadership is re-examining existing corrective actions and exploring new and innovative approaches to reducing improper payments, while minimizing burden for its partners. Due to the successes of actions we’ve put into place to reduce improper payments, the Medicare Fee-For-Service (FFS) improper payment rate decreased from 11.0 percent in 2016 to 9.5 percent in 2017, representing a $4.9 billion decrease in estimated improper payments. The 2017 Medicare FFS estimated improper payment rate represents claims incorrectly paid between July 1, 2015 and June 30, 2016. This is the first time since 2013 that the Medicare FFS improper payment rate is below the 10 percent threshold for compliance established in the Improper Payments Elimination and Recovery Act of 2010.

Improper payments are not always indicative of fraud, nor do they necessarily represent expenses that should not have occurred.  For example, instances where there is insufficient or no documentation to support the payment as proper are cited as improper payments under current Office of Management and Budget guidance.  The majority of Medicare FFS improper payments are due to documentation errors where CMS could not determine whether the billed items or services were actually provided, were billed at the appropriate level, and/or were medically necessary. A smaller proportion of Medicare FFS improper payments are payments for claims CMS determined should not have been made or should have been made in a different amount, representing a known monetary loss to the program.

Figure 1 provides information on Medicare FFS improper payments that are a known “monetary loss” to the program (i.e. medical necessity, incorrect coding, and other errors). The estimated known “monetary loss” improper payment rate is 3.0 percent, representing an estimated known monetary loss of $11.3 billion out of the total estimated improper payments of $36.2 billion.  In the figure, “unknown” represents payments where there was no or insufficient documentation to support the payment as proper or a known monetary loss. In other words, when payments lack the appropriate supporting documentation, their validity cannot be determined.  These are payments where more documentation is needed to determine if the claims were payable or if they should be considered monetary losses to the program.

Figure 1: FY 2017 Medicare FFS Improper Payments (in Millions) and Percentage of Improper Payments by Monetary Loss and Type of Error

 

CMS continues to implement tools and work with law enforcement partners and other key stakeholders to help focus on prevention, early detection, and data sharing to prevent and reduce improper payments in Medicare FFS.  Although documentation errors are the largest cause of improper payments, CMS employs multi-layered efforts to target all root causes of improper payments, with an emphasis on prevention-oriented activities.

CMS is pleased to have achieved this reduction in the improper payment rate, but we still have work to do.  We remain committed to collaborating across CMS and with stakeholders to address potential vulnerabilities and continuing to strengthen our program integrity efforts, while minimizing burden for our partners.

###
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FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action - FDA Press Releases

Newly authorized test detects genetic cancer mutations in 468 unique genes

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FDA approves treatment for rare genetic enzyme disorder - FDA Press Releases

FDA approves treatment for rare genetic enzyme disorder

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FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal - FDA Press Releases

FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal

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Valgamicin C, a novel cyclic depsipeptide containing the unusual amino acid cleonine, and related valgamicins A, T and V produced by Amycolatopsis sp. ML1-hF4 - Journal of Antibiotics

Valgamicin C, a novel cyclic depsipeptide containing the unusual amino acid cleonine, and related valgamicins A, T and V produced by Amycolatopsis sp. ML1-hF4

Valgamicin C, a novel cyclic depsipeptide containing the unusual amino acid cleonine, and related valgamicins A, T and V produced by <i>Amycolatopsis</i> sp. ML1-hF4, Published online: 15 November 2017; doi:10.1038/ja.2017.135

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Quadoctomycin, a 48-membered macrolide antibiotic from Streptomyces sp. MM168-141F8 - Journal of Antibiotics

Quadoctomycin, a 48-membered macrolide antibiotic from Streptomyces sp. MM168-141F8

Quadoctomycin, a 48-membered macrolide antibiotic from <i>Streptomyces</i> sp. MM168-141F8, Published online: 15 November 2017; doi:10.1038/ja.2017.140

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Baxter Issues A Voluntary Nationwide Recall For One Lot of Nexterone Injection Due To Presence Of Particulate Matter - FDA Safety Alerts & Drug Recalls

Baxter International Inc. announced today it is voluntarily recalling one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. The particulate matter may have entered the solution during the manufacturing process.

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FDA warns about illegal use of injectable silicone for body contouring and associated health risks - FDA Press Releases

FDA issues safety communication about illegal use of injectable silicone for body contouring and associated health risks

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Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom - FDA Press Releases

A botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.

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Diagnostic Accuracy of the Chinese Version of the Trail-Making Test for Screening Cognitive Impairment - American Geriatric Society

Background/Objectives

The Trail-Making Test (TMT), which is commonly used to measure executive function, consists of two components (TMT-A and TMTB). There is a lack of normative TMT data for Chinese elderly adults. This study aimed to evaluate the validity of the TMT in screening for cognitive impairment.

Design

2,294 Chinese-speaking adults aged 50 to 85: 1,026 with normal cognition (NC), 462 with mild cognitive impairment (MCI), 108 with Alzheimer's disease (AD), 113 with vascular mild cognitive impairment (VaMCI), 121 with vascular dementia (VaD), 282 with uncertain types of dementia, and 15 with mixed dementia. Receiver operating characteristic curve analysis was performed to test the ability of TMT scores to differentiate between NC and cognitive impairment.

Results

Age, education, and sex were significantly associated with TMT completion time. The TMT-A exhibited sensitivity of 77.8% and specificity of 92.0% with cut-off value of 98.5 seconds for discriminating AD from NC. The TMT-B had sensitivity of 83.3% and specificity of 91.8% with a cut-off value of 188.5 seconds for discriminating AD from NC. The TMT-A had sensitivity of 85.7% and specificity of 81.6% for discriminating NC from VaD with a cut-off value of 77.5 seconds, and the TMT-s had sensitivity of 81.6% and specificity of 83.9% with a cut-off value of 147.5 seconds. The TMT had less sensitivity distinguishing MCI from NC.

Conclusion

The Chinese version of the TMT is reliable for detecting AD or VaD but poor at distinguishing MCI from NC.

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Hepatitis C Virus Clearance in Older Adults - American Geriatric Society

Objectives

To determine whether older adults with the hepatitis C virus (HCV) achieve a sustained viral response (SVR) after treatment with direct-acting antiviral therapy.

Participants

Individuals aged 80 and older with chronic HCV infection (N = 253; n = 213 with cirrhosis, n = 40 with advanced fibrosis).

Measurements

We investigated the efficacy, safety, and global clinical effect of treatment with different combinations of direct antiviral agents (DAAs). Participants with cirrhosis were staged according to Child-Pugh-Turcotte class, Model for End-Stage Liver Disease score, and the D'Amico staging system. The type and number of comorbidities at baseline and hepatic and nonhepatic events during follow-up were registered.

Results

Ninety-five percent of participants with cirrhosis and 95% of those with advanced fibrosis attained SVR. The rate was independent of sex, HCV genotype, and treatment schedule. During a mean follow-up of 14 ± 4 months (range 5–23 months), 34 events occurred in 27 participants: 10 hepatocellular carcinomas, 12 hepatic decompensations, 9 nonhepatic events, 3 deaths. Multivariate analysis of risk factors for experiencing adverse events during follow up showed that participants in D'Amico Stages 4 and 5, with a baseline serum albumin level of 3.5 mg/dL or less, and 3 or more comorbidities were the most at risk.

Conclusion

In a real-world setting, DAAs are safe and effective in older adults with HCV-related advanced fibrosis or cirrhosis. Individuals with preserved albumin synthesis and fewer than 3 comorbidities at baseline have the most to gain from long-term DAA therapy.

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Proton Pump Inhibitor Use and Dementia Risk: Prospective Population-Based Study - American Geriatric Society

Objectives

To determine whether higher cumulative proton pump inhibitor (PPI) exposure is associated with greater dementia risk.

Design

Prospective population-based cohort study.

Setting

Kaiser Permanente Washington, an integrated healthcare delivery system in Seattle, Washington.

Participants

Individuals aged 65 and older without dementia at study entry (N = 3,484).

Measurements

Participants were screened for dementia every 2 years, and those who screened positive underwent extensive evaluation. Dementia outcomes were determined using standard diagnostic criteria. Time-varying PPI exposure was determined from computerized pharmacy data and consisted of total standardized daily doses (TSDDs) dispensed to an individual in the prior 10 years. We also assessed duration of use. Multivariable Cox regression was used to estimate the association between PPI exposure and time to dementia or Alzheimer's disease (AD).

Results

Over a mean follow-up of 7.5 years, 827 participants (23.7%) developed dementia (670 with possible or probable AD). PPI exposure was not associated with risk of dementia (P = .66) or AD (P = .77). For dementia, the risk for specific levels of cumulative exposure compared to no use was: 365 TSDDs (HR 0.87, 95% CI 0.65–1.18), 1,095 TSDDs (HR 0.99, CI 0.75–1.30) and 1,825 TSDDs (HR 1.13, CI 0.82–1.56). These TSDD levels represent approximately 1, 3 and 5 years of daily use respectively. Duration of PPI use was not associated with dementia outcomes either.

Conclusion

Proton pump inhibitor use was not associated with dementia risk, even for people with high cumulative exposure. Although there are other safety concerns with long-term PPI use, results from our study do not support that these medications should be avoided out of concern about dementia risk.

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Proton Pump Inhibitor Therapy and Dementia: What Is the Evidence? - American Geriatric Society

This editorial comments on the article by Gray et al.

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FDA approves pill with sensor that digitally tracks if patients have ingested their medication - FDA Press Releases

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

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Seattle Gourmet Foods Issues Allergy Alert on Undeclared Almonds In 5 Pound Bags of Dilettante Chocolates Espresso Blend - FDA Safety Alerts & Drug Recalls

Seattle Gourmet Foods of Kent, Washington is recalling 127 cases of Costco item # 2335, Dilettante Chocolates Espresso Blend, Espresso Beans in Semisweet, Milk and White Chocolate, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product.

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Nestle USA Initiates Voluntary Recall of Hot Pockets® Four Cheese Pizza Snack Bites Due to Undeclared Allergens - FDA Safety Alerts & Drug Recalls

Nestlé USA has initiated a recall of Hot Pockets® Four Cheese Pizza Snack Bites due to misbranding and undeclared allergens. The product was donated to a charitable organization in Missouri and was not sold in retail. The product contain the known allergens egg, milk, soy, and wheat, which are not declared. People who have an allergy or severe sensitivity to eggs, milk, soy or wheat run the risk of serious or life-threatening allergic reaction if they consume this product.

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Deaths from Resident-to-Resident Aggression in Australian Nursing Homes - American Geriatric Society

Objectives

To describe the frequency and nature of deaths from resident-to-resident aggression (RRA) in nursing homes in Australia.

Design

National population-based retrospective cohort study.

Setting

Accredited nursing homes in Australia.

Participants

Residents whose deaths resulted from RRA and were reported to the coroner between July 1, 2000, and December 31, 2013.

Measurements

Cases were identified using the National Coronial Information System, and data on individual, interpersonal, organizational, and societal factors were collected through review of the paper-based coroners' files.

Results

This research identified 28 deaths from RRA over a 14-year study period (0.004 per 100,000 bed days). Most exhibitors of aggression were male (n = 24, 85.7%), and risk of death from RRA was twice as high for male as for female nursing home residents (relative risk (RR) = 2.13, 95% confidence interval (CI) = 0.93–4.80, P = .05). Almost 90% of residents involved in RRA had a diagnosis of dementia, and three-quarters had a history of behavioral problems, including wandering and aggression. Dyad analysis showed that exhibitors of aggression were often younger and more recently admitted to the nursing home than targets. RRA incidents commonly occurred in communal areas and during the afternoon and involved a “push and fall.” Seven (25%) RRA deaths had a coronial inquest; criminal charges were rarely filed.

Conclusion

This is the first national study in Australia, and the largest internationally, to examine RRA deaths using medicolegal data. This generates hypotheses for future research on the effect of environmental and organizational factors on the frequency and preventability of RRA.

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Thank You For Your Service - CMS Blog

CMS BLOG
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November 9, 2017
By:  Seema Verma, CMS Administrator

Thank You for Your Service

We’ve all heard the stories of bravery and sacrifice, or have personally experienced the inspiring dedication to service of our US Military veterans, but for me their heroism was made real on a visit to Normandy.

Early in the morning on D-Day, June 6, 1944, Army Rangers climbed the cliffs of Point-du-Hoc to the west of Omaha Beach to destroy a battery of 155mm German cannons on top of the cliff. As I stood there, viewing these cliffs as a tourist, I couldn’t help but imagine the fear that must’ve been going through their minds as they scaled those massive, rocky cliffs under heavy German fire, only to reach the top and face even heavier opposition. How, in the face of what they must have considered certain death, they pressed on knowing the importance of their mission, and that their actions would save countless American and foreign lives.

I then went to see the cemetery where those lost on D-Day, including the Army Rangers who died while taking that hill, were buried. While looking at that field of graves, I found myself emotionally overwhelmed thinking about how these men died for the freedom and safety of people they didn’t know and would never meet.

As a public servant, on this day and every day, I think about the sacrifices of America’s Veterans, both dead and living, that inspire me to also make sacrifices so that others can live better lives. When I think about the work we do at CMS, I think about those Rangers, I think about the price they paid for our freedoms, and I think about the fact that their sacrifice should be honored by making sure that we serve our country in a manner worthy of their heroism.

America’s veterans are heroes. CMS currently employs 591 veterans, comprising 10% of our workforce. Last year we hired 38 veterans, and will continue to recruit and retain veterans within our ranks because they not only bring a wealth of knowledge and skill, but a profound sense of honor and dedication to public service that is an important quality in all CMS employees.

To America’s veterans, thank you for your service, and your devotion to our country. We at CMS will never take for granted what you have done for us and for this country. On behalf of myself, my family, and CMS employees currently serving all across our country, I hope you have a great Veterans Day, you’ve earned it.

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Filed under: Uncategorized

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Transcranial Doppler and Lower Extremity Function in Older Adults: Einstein Aging Study - American Geriatric Society

Objectives

To determine whether transcranial Doppler ultrasound (TCD) measures of mean blood flow velocity (MBFV) in the major cerebral arteries are associated with measures of lower extremity function in community-dwelling older adults.

Design

Cross-sectional study.

Setting

Community sample.

Participants

Individuals aged 70 and older (mean 79.5, 54% female) without dementia participating in the Einstein Aging Study (N = 200).

Measurements

All participants underwent TCD assessments and tests of lower extremity function at an annual clinic visit. Average MBFV for anterior (left and right anterior and middle cerebral arteries (MCAs)) and posterior (vertebral (VA) and basilar (BA) artery) circulation was measured using a standardized TCD protocol. Lower extremity function was characterized according to gait speed (cm/s) measured using an instrumented walkway, balance according to unipedal stance time (UPST, seconds), and lower extremity strength according to timed repeated chair rise (seconds).

Results

Multiple regression models adjusted for age, sex, race, education, and medical comorbidities showed that lower MBFV in the MCA was associated with slower gait speed and chair rise time but not with UPST. Ordinal regression models showed that lower MBFV in the VA and BA is associated with shorter UPST.

Conclusion

Low MBFV in the anterior and posterior cerebral circulation was associated with worse lower extremity function and balance in older adults. This might be indicative of the importance of age-related changes in cerebral hemodynamics in the function of brain regions involved in specific aspects of physical performance.

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Reply to: Systolic Blood Pressure and Mortality: Role of Reverse Causation - American Geriatric Society

This letter comments on the Letter by Supiano et al.

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