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Delfo D'Alessandro, Giuseppe Perale, Mario Milazzo, Stefania Moscato, Cesare Stefanini, Gianni Pertici, Serena Danti
The ideal scaffold for bone regeneration is required to be highly porous, non-immunogenic, biostable until the new tissue formation, bioresorbable and osteoconductive. This study aimed at investigating the process of new bone formation in patients treated with granular SmartBone(®) for sinus augmentation, providing an extensive histologic analysis. Five biopsies were collected at 4-9 months post SmartBone(®) implantation and processed for histochemistry and immunohistochemistry. Histomorphometric analysis was performed...
October 18, 2016: International Journal of Pharmaceutics
Kun He, Huanyu Chen, Thomas Gwise, Sandra Casak, Steven J Lemery, Patricia Keegan, Richard Pazdur, Rajeshwari Sridhara
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) established an abbreviated approval pathway for biosimilar and interchangeable biological products that was intended to balance innovation and consumer interests. The US Food and Drug Administration has published several guidance documents to facilitate implementation of the BPCI Act. Here we discuss the role of comparative clinical studies in the assessment of clinically meaningful differences and illustrate the underlying scientific concepts with a hypothetical example of a clinical study comparing a product to US-licensed bevacizumab...
August 31, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Shaunak S Adkar, Ryan S Turley, Ehsan Benrashid, Sandhya Lagoo, Cynthia K Shortell, Leila Mureebe
OBJECTIVE: The initiation of bundled payment for care improvement (BPCI) by Centers for Medicare & Medicaid Services (CMS) has led to increased financial and performance accountability. As the majority of vascular surgery patients are elderly and reimbursed via CMS, improving their outcomes will be critical for durable financial stability. As a first step in forming a multi-disciplinary pathway for the elderly vascular patient, we sought to identify modifiable perioperative variables in geriatric patients undergoing lower extremity arterial bypass (LEB)...
August 12, 2016: Annals of Vascular Surgery
P Maxwell Courtney, Blair S Ashley, Eric L Hume, Atul F Kamath
BACKGROUND: Alternative payment models, such as the Centers for Medicare & Medicaid Services (CMS) Bundled Payment for Care Improvement (BPCI) initiative, aim to decrease overall costs for hip and knee arthroplasties. QUESTIONS/PURPOSES: We asked: (1) Is there any difference in the CMS episode-of-care costs, hospital length of stay, and readmission rate from before and after implementation of our bundled-payment program? (2) Is there any difference in reimbursements and resource utilization between revision THA and TKA at our institution? (3) Are there any independent risk factors for patients with high costs who may not be appropriate for a bundled-payment system for revision total joint arthroplasty (TJA)? METHODS: Between October 2013 and March 2015, 218 patients underwent revision TKA or THA in one health system...
June 29, 2016: Clinical Orthopaedics and related Research
A Seth Greenwald, Amy Bassano, Stephen Wiggins, Mark I Froimson
The Bundled Payments for Care Improvement (BPCI) initiative was begun in January 2013 by the U.S. Centers for Medicare & Medicaid Services (CMS) through its Innovation Center authority, which was created by the U.S. Patient Protection and Affordable Care Act (PPACA). The BPCI program seeks to improve health-care delivery and to ultimately reduce costs by allowing providers to enter into prenegotiated payment arrangements that include financial and performance accountability for a clinical episode in which a risk-and-reward calculus must be determined...
June 1, 2016: Journal of Bone and Joint Surgery. American Volume
Steven J Lemery, Francisco J Esteva, Martina Weise
Congress passed the Biologics Price Competition and Innovation Act (BPCI Act) as part of the Affordable Care Act on March 23, 2010. The BPCI Act authorized an approval pathway for biosimilar and interchangeable products. It defines biosimilarity to mean "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and that "there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product...
2016: American Society of Clinical Oncology Educational Book
William Ringwood, Tawnya Bosko
Healthcare providers that are assessing their readiness to assume financial risk for care delivery should understand the full range of risk options available to them. Available options fall into two broad categories: episode-based risk (e.g., the Medicare BPCI initiative and CJR model, commercial insurance models, and direct-to-employer models) and population-based risk (e.g., shared savings models and professional or institutional capitation models). Providers also require a deep understanding of both internal and market-based factors that are essential for success under any risk option being contemplated...
April 2016: Healthcare Financial Management: Journal of the Healthcare Financial Management Association
Stephen B Murphy, Nicholas J Bolz, David P Terry, Carl T Talmo, Michael N Fehm
BACKGROUND: There is significant need for physician innovation and leadership in health care as we adapt to bundled payment models of health care delivery. METHODS: We engaged a collective of 16 different private company orthopedic physician groups to apply to become episode initiators under BPCI models 2 and 3. The application process itself provided historical cost data, enabling each group to independently decide whether or not to proceed with the BPCI initiative...
May 2016: Journal of Arthroplasty
Andrew J Clair, Perry J Evangelista, Claudette M Lajam, James D Slover, Joseph A Bosco, Richard Iorio
BACKGROUND: The Bundled Payment for Care Improvement (BPCI) Initiative is a Centers for Medicare and Medicaid Services program designed to promote coordinated and efficient care. This study seeks to report costs of readmissions within a 90-day episode of care for BPCI Initiative patients receiving total knee arthroplasty (TKA) or total hip arthroplasty (THA). METHODS: From January 2013 through December 2013, 1 urban, tertiary, academic orthopedic hospital admitted 664 patients undergoing either primary TKA or THA through the BPCI Initiative...
September 2016: Journal of Arthroplasty
James P Doran, Alan H Beyer, Joseph Bosco, Peggy L Naas, Brian S Parsley, James Slover, Stephen J Zabinski, Joseph D Zuckerman, Richard Iorio
Although the Bundled Payments for Care Improvement (BPCI) Initiative began generating data in January 2013, it may be years before the data can determine if the BPCI Initiative enhances value without decreasing quality. Private insurers have implemented other bundled payment arrangements for the delivery of total joint arthroplasty in a variety of practice settings. It is important for surgeons to review the early results of the BPCI Initiative and other bundled payment arrangements to understand the challenges and benefits of healthcare delivery systems with respect to total joint arthroplasty...
2016: Instructional Course Lectures
Coleen Kivlahan, Janis M Orlowski, Jonathan Pearce, Jessica Walradt, Matthew Baker, Darrell G Kirch
The authors describe observations from the 27 teaching hospitals constituting the Association of American Medical Colleges (AAMC) cohort in the Center for Medicare and Medicaid Innovation (CMMI) Bundled Payments for Care Improvement (BPCI) initiative. CMMI introduced BPCI in August 2011 and selected the first set of participants in January 2013. BPCI participants enter into Medicare payment arrangements for episodes of care for which they take financial risk. The first round of participants entered risk agreements on October 1, 2013 and January 1, 2014...
July 2016: Academic Medicine: Journal of the Association of American Medical Colleges
Lena M Chen, Ellen Meara, John D Birkmeyer
OBJECTIVES: Aiming to encourage care coordination and cost efficiency, the Center for Medicare and Medicaid Innovation (CMMI) launched the Bundled Payments for Care Improvement (BPCI) initiative in 2013. To help gauge the program's potential impact and generalizability, we describe early and current participants. STUDY DESIGN: We examined the cross-sectional association between BPCI participation and providers' structural and cost characteristics. METHODS: Using data from October 2013 and June 2014, we quantified changes in BPCI participation...
November 2015: American Journal of Managed Care
Robert E Mechanic
In July, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule for a new Comprehensive Care for Joint Replacement (CCJR) program. The program would establish bundled payments for total hip and knee replacements, covering hospitalizations, professional fees, and all clinically..
October 2015: New England Journal of Medicine
Mukul Minocha, Jogarao Gobburu
Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be "biosimilar" if data show that, among other things, the product is "highly similar" to an already-approved biological product. Biosimilar insulins have the potential to reduce ever growing costs associated with insulin treatment by allowing competition. In this article, we describe the current drug development and regulatory paths for biosimilar insulins. Most likely basis of market approval for biosimilar insulins by the US Food and Drug Administration (FDA) and guidance for developing insulin biosimilars by European Medicines Agency (EMA) are discussed in detail...
January 1, 2014: Journal of Diabetes Science and Technology
Jun Wang, Shein-Chung Chow
Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval framework for biosimilar products, and WHO has published guidelines on the evaluation of biosimilars in order to facilitate the global harmonization. Based on EMA and WHO guidelines, many other countries such as Canada, Japan and Korea have also issued their own guidance for evaluating follow-on biologics...
2012: Pharmaceuticals
Kevin E Vowles, Lance M McCracken, Gail Sowden, Julie Ashworth
OBJECTIVE: The role of coping in chronic pain management is well established. One challenge to the coping approach, however, is in identifying forms of coping that reliably lead to better functioning. An emerging approach to coping is based on the notion of psychological flexibility, a response pattern entailing openness to experience, awareness of specific behavioral options in a given situation, and persistence or alteration of activity according to personally held values and goals...
April 2014: Clinical Journal of Pain
Begoña Calvo, Leyre Zuñiga
In the US, the Biologics Price Competition and Innovation Act (BPCI Act, 2009) provided the pathway to create an abbreviated licensure procedure for biologic products that are demonstrated to be biosimilar to or interchangeable with a Food and Drug Administration (FDA) licensed biologic product. In February 2012, the FDA issued three guidelines that list the requirements for biosimilar registration. The topics covered include scientific and quality considerations to demonstrate biosimilarity to a reference product and a guidance that clarifies the BPCI Act implementation...
December 1, 2012: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
A L Suman, B Biagi, G Biasi, G Carli, M Gradi, E Prati, M Bonifazi
OBJECTIVE: The aim of the present study was to investigate the long-term efficacy of a 3-week intensive residential multidisciplinary non-pharmacological treatment program (including individually prescribed and monitored aerobic exercise and cognitive behavioural therapy) on fibromyalgia symptoms and aerobic fitness. METHODS: Twenty-five women with fibromyalgia participated in six experimental sessions (pre-admission, immediately before and immediately after the treatment, and to 2, 5 and 12 months afterwards) in which they underwent clinical, psychophysical and psychological examinations: pain intensity (VAS), pain area (percentage of total body surface), deep pressure pain threshold at 18 tender point sites measured with a pressure algometer, an incremental step test with blood lactate determination and calculation of the individual intensity of exercise corresponding to 2 mM of lactate concentration (W2, index of aerobic fitness)...
January 2009: Clinical and Experimental Rheumatology
Michał Nowicki, Rafał Zwiech, Przemysław Dryja, Wiktor Sobański
AIM: Uremic neuropathy (UN) is a typical complication of long-term dialysis therapy and may manifest as distal, symmetric, and both senso-motoric and autonomic nerve dysfunction. Its clinical picture is highly variable and it is not known how the symptoms of UN reported by chronic dialysis patients correspond to positive results of clinical tests for autonomic dysfunction. The objective of this study was to compare the prevalence of self-reported symptoms of autonomic neuropathy (AN) revealed in patient questionnaires with the prevalence of findings from objective clinical tests...
April 2009: Clinical and Experimental Nephrology
Diana L Miglioretti, Rebecca Smith-Bindman, Linn Abraham, R James Brenner, Patricia A Carney, Erin J Aiello Bowles, Diana S M Buist, Joann G Elmore
BACKGROUND: Extensive variability has been noted in the interpretive performance of screening mammography; however, less is known about variability in diagnostic mammography performance. METHODS: We examined the performance of 123 radiologists who interpreted 35895 diagnostic mammography examinations that were obtained to evaluate a breast problem from January 1, 1996, through December 31, 2003, at 72 facilities that contribute data to the Breast Cancer Surveillance Consortium...
December 19, 2007: Journal of the National Cancer Institute
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