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https://www.readbyqxmd.com/read/29152721/perspectives-on-the-current-state-of-the-biosimilar-regulatory-pathway-in-the-united-states
#1
Michele K Dougherty, Issam Zineh, Leah Christl
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway in the United States that allows for the development and approval of biologic products shown to be biosimilar to or interchangeable with a US Food and Drug Administration (FDA)-licensed reference product (Table 1). Here we discuss implementation of the US biosimilar approval pathway and the role of various types of data, including clinical pharmacology data, in biosimilar development.
November 20, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29135882/early-effects-of-medicare-s-bundled-payment-for-care-improvement-bpci-program-for-lumbar-fusion
#2
Timothy S Carey, Darren DeWalt
No abstract text is available yet for this article.
November 10, 2017: Spine
https://www.readbyqxmd.com/read/28983220/similar-cost-savings-of-bundled-payment-initiatives-applied-to-lower-extremity-total-joint-arthroplasty-can-be-achieved-applying-both-models-2-and-3
#3
Allyson Alfonso, Lorraine Hutzler, Bill Robb, Chad Beste, André Blom, Joseph Bosco
BACKGROUND: In an effort to control cost and increase value, Medicare is transitioning from fee-for-service to value-based alternative payment models (APMs). The Bundled Payments for Care Improvement (BPCI) initiative represents one such voluntary APM. BPCI offers four different bundling options: model 1 covers all Diagnosis Related Groups (DRGs) and Models 2-4 cover 48 clinical episodes, including 186 separate DRGs. QUESTIONS/PURPOSES: The purpose of this investigation is to analyze and compare the cost savings achieved by two different BPCI program participants, provider A and provider B, enrolled in different models of BPCI (Models 2 and 3) for lower extremity joint replacements (LEJRs)...
October 2017: HSS Journal: the Musculoskeletal Journal of Hospital for Special Surgery
https://www.readbyqxmd.com/read/28885288/early-effects-of-medicare-s-bundled-payment-for-care-improvement-bpci-program-for-lumbar-fusion
#4
Brook I Martin, Jon D Lurie, Farrokh R Farrokhi, Kevin J McGuire, Sohail K Mirza
STUDY DESIGN: Retrospective analysis of Medicare claims linked to hospital participation in the Center for Medicare and Medicaid Innovation's episode-based Bundled Payment for Care Improvement (BPCI) program for lumbar fusion. OBJECTIVES: To describe the early effects of BPCI participation for lumbar fusion on 90-day reimbursement, procedure volume, reoperation, and readmission. SUMMARY OF BACKGROUND DATA: Initiated on January 1st, 2013, BPCI's voluntary bundle payment program provides a predetermined payment for services related to a Diagnosis Related Group-defined "triggering event" over a defined time period...
September 6, 2017: Spine
https://www.readbyqxmd.com/read/28752702/-synthesis-of-bodipy-photosensitizers-and-their-photodynamic-effect-on-cancer-cells
#5
Liu Xingang, W U Min, L I Suying, Li Zhongbao, H U Qinglian, Zhou Jun, Tang Guping
Objective: To design and synthesize photosensitizers with different substituents and to identify its physicochemical characteritics and photodynamic effect on cancer cells. Methods: Two kinds of BODIPY photosensitizers BPOI and BPCI were synthesized through condensation reaction between aldehyde and reactive hydrogen of pyrrole, followed with electrophilic substitution reaction. Physicochemical properties were characterized by (1)H NMR, FT-IR and UV-visible absorption spectra and fluorescence emission spectra...
March 25, 2017: Zhejiang da Xue Xue Bao. Yi Xue Ban, Journal of Zhejiang University. Medical Sciences
https://www.readbyqxmd.com/read/28741101/bundled-payments-in-total-joint-replacement-keeping-our-care-affordable-and-high-in-quality
#6
REVIEW
Alexander S McLawhorn, Leonard T Buller
PURPOSE OF REVIEW: The purpose of this review was to evaluate the literature regarding bundle payment reimbursement models for total joint arthroplasty (TJA). RECENT FINDINGS: From an economic standpoint, TJA are cost-effective, but they represent a substantial expense to the Centers for Medicare & Medicaid Services (CMS). Historically, fee-for-service payment models resulted in highly variable cost and quality. CMS introduced Bundled Payments for Care Improvement (BPCI) in 2012 and subsequently the Comprehensive Care for Joint Replacement (CJR) reimbursement model in 2016 to improve the value of TJA from the perspectives of both CMS and patients, by improving quality via cost control...
September 2017: Current Reviews in Musculoskeletal Medicine
https://www.readbyqxmd.com/read/28647442/the-impact-of-the-transition-from-volume-to-value-on-heart-failure-care-implications-of-novel-payment-models-and-quality-improvement-initiatives
#7
REVIEW
Dushyanth Srinivasan, Nihar R Desai
In response to wide variation in quality and outcomes as well as escalating health care costs, the U.S. health care system is moving away from a volume-based payment system to a quality- and value-based system. Medicare, the largest insurer and payer of health care, has accelerated the movement toward value-based care with the development and implementation of myriad alternate payment models and pay-for-performance programs as part of the Affordable Care Act. Given that heart failure affects a significant number of Medicare patients and that these patients account for a disproportionate amount of health care utilization and spending, heart failure has become a focal point for these initiatives...
June 21, 2017: Journal of Cardiac Failure
https://www.readbyqxmd.com/read/28583761/bundled-payments-for-care-improvement-boom-or-bust
#8
Brian M Curtin, Robert D Russell, Susan M Odum
BACKGROUND: As early implementors of the Centers for Medicare and Medicaid Services (CMS) Bundled Payments for Care Improvement (BPCI) initiative, our private practice sought to compare our readmission rates, post-acute care utilization, and length of stay for the first year under BPCI compared to baseline data. METHODS: We used CMS data to compare total expenditures of all diagnosis-related groups (DRGs). Medicare patients who underwent orthopedic surgery between 2009 and 2012 were defined as non-BPCI (n = 8415) and were compared to Medicare BPCI patients (n = 4757) who had surgery in 2015...
October 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28509721/bundled-payments-for-care-improvement-preparing-for-the-medical-diagnosis-related-groups
#9
Lauran Hardin, Adam Kilian, Elizabeth Murphy
BACKGROUND: The Centers for Medicare and Medicaid Services Innovation Center introduced the Bundled Payments for Care Improvement (BPCI) initiative in 2011 as 1 strategy to encourage healthcare organizations and clinicians to improve healthcare delivery for patients, both when they are in the hospital and after they are discharged. Mercy Health Saint Mary's, a large urban academic medical center, engaged in BPCI primarily with a group of medical diagnosis-related groups (DRGs). OBJECTIVES: In this article, we describe our experience creating a system of response for the diverse people and diagnoses that fall into the medical DRG bundles and specifically identify organizational factors for enabling successful implementation of bundled payments...
June 2017: Journal of Nursing Administration
https://www.readbyqxmd.com/read/28438453/effect-of-bundled-payments-and-health-care-reform-as-alternative-payment-models-in-total-joint-arthroplasty-a-clinical-review
#10
REVIEW
Ahmed Siddiqi, Peter B White, Jaydev B Mistry, Chukwuweike U Gwam, James Nace, Michael A Mont, Ronald E Delanois
BACKGROUND: In an effort to control rising healthcare costs, healthcare reforms have developed initiatives to evaluate the efficacy of alternative payment models (APMs) for Medicare reimbursements. The Center for Medicare and Medicaid Services Innovation Center (CMMSIC) introduced the voluntary Bundled Payments for Care Improvement (BPCI) model experiment as a means to curtail Medicare cost by allotting a fixed payment for an episode of care. The purpose of this review is to (1) summarize the preliminary clinical results of the BPCI and (2) discuss how it has led to other healthcare reforms and alternative payment models...
March 20, 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28433428/effect-of-risk-acceptance-for-bundled-care-payments-on-clinical-outcomes-in-a-high-volume-total-joint-arthroplasty-practice-after-implementation-of-a-standardized-clinical-pathway
#11
James R Kee, Paul K Edwards, Charles L Barnes
BACKGROUND: The Bundled Payments for Care Improvement (BPCI) initiative and the Arkansas Payment Improvement (API) initiative seek to incentivize reduced costs and improved outcomes compared with the previous fee-for-service model. Before participation, our practice initiated a standardized clinical pathway (CP) to reduce length of stay (LOS), readmissions, and discharge to postacute care facilities. METHODS: This practice implemented a standardized CP focused on patient education, managing patient expectations, and maximizing cost outcomes...
March 16, 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28412109/reengineering-valve-patients-postdischarge-management-for-adapting-to-bundled-payment-models
#12
Michael S Koeckert, Patricia A Ursomanno, Mathew R Williams, Michael Querijero, Elias A Zias, Didier F Loulmet, Kevin Kirchen, Eugene A Grossi, Aubrey C Galloway
BACKGROUND: Bundled Payments for Care Improvement (BPCI) initiatives were developed by Medicare in an effort to reduce expenditures while preserving quality of care. Payment model 2 reimburses based on a target price for 90-day episode of care postprocedure. The challenge for valve patients is the historically high (>35%) 90-day readmission rate. We analyzed our institutional cardiac surgical service line adaptation to this initiative. METHODS: On May 1, 2015, we instituted a readmission reduction initiative (RRI) that included presurgical risk stratification, comprehensive predischarge planning, and standardized postdischarge management led by cardiac nurse practitioners (CNPs) who attempt to guide any postdischarge encounters (PDEs)...
July 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28395006/association-between-hospitals-engagement-in-value-based-reforms-and-readmission-reduction-in-the-hospital-readmission-reduction-program
#13
Andrew M Ryan, Sam Krinsky, Julia Adler-Milstein, Cheryl L Damberg, Kristin A Maurer, John M Hollingsworth
Importance: Medicare is experimenting with numerous concurrent reforms aimed at improving quality and value for hospitals. It is unclear if these myriad reforms are mutually reinforcing or in conflict with each other. Objective: To evaluate whether hospital participation in voluntary value-based reforms was associated with greater improvement under Medicare's Hospital Readmission Reduction Program (HRRP). Design, Setting, and Participants: Retrospective, longitudinal study using publicly available national data from Hospital Compare on hospital readmissions for 2837 hospitals from 2008 to 2015...
June 1, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/28389136/bpci-everyone-wins-including-the-patient
#14
Paul K Edwards, Simon C Mears, C Lowry Barnes
BACKGROUND: Alternative payment models are becoming increasingly more common with the rising cost of the US health care. Bundled payment programs for elective hip and knee arthroplasty have shown promising results by improved outcomes and significant cost reduction. METHODS: All consecutive total joint arthroplasty with diagnosis-related group (DRG) 469/470 were included in this study. And 1427 episodes from 2009 to 2012 were defined as the baseline group; 461 episodes from October 2013 to September 2014 were defined as the Bundled Payments for Care Improvement (BPCI) group...
February 28, 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28375499/episode-based-payment-and-direct-employer-purchasing-of-healthcare-services-recent-bundled-payment-innovations-and-the-geisinger-health-system-experience
#15
Jonathan R Slotkin, Olivia A Ross, Eric D Newman, Janet L Comrey, Victoria Watson, Rachel V Lee, Megan M Brosious, Gloria Gerrity, Scott M Davis, Jacquelyn Paul, E Lynn Miller, David T Feinberg, Steven A Toms
One significant driver of the disjointed healthcare often observed in the United States is the traditional fee-for-service payment model which financially incentivizes the volume of care delivered over the quality and coordination of care. This problem is compounded by the wide, often unwarranted variation in healthcare charges that purchasers of health services encounter for substantially similar episodes of care. The last 10 years have seen many stakeholder organizations begin to experiment with novel financial payment models that strive to obviate many of the challenges inherent in customary quantity-based cost paradigms...
April 1, 2017: Neurosurgery
https://www.readbyqxmd.com/read/28060238/single-institution-early-experience-with-the-bundled-payments-for-care-improvement-initiative
#16
Richard Iorio, Joseph Bosco, James Slover, Yousuf Sayeed, Joseph D Zuckerman
The Centers for Medicare & Medicaid Services (CMS) implemented the Bundled Payments for Care Improvement (BPCI) initiative in 2011. Through BPCI, organizations enlisted into payment agreements that include both performance and financial accountability for episodes of care. To succeed, BPCI requires quality maintenance and care delivery at lower costs. This necessitates physicians and hospitals to merge interests. Orthopaedic surgeons must assume leadership roles in cost containment, surgical safety, and quality assurance to deliver cost-effective care...
January 4, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/28055062/cost-of-joint-replacement-using-bundled-payment-models
#17
Amol S Navathe, Andrea B Troxel, Joshua M Liao, Nan Nan, Jingsan Zhu, Wenjun Zhong, Ezekiel J Emanuel
Importance: Medicare launched the mandatory Comprehensive Care for Joint Replacement bundled payment model in 67 urban areas for approximately 800 hospitals following its experience in the voluntary Acute Care Episodes (ACE) and Bundled Payments for Care Improvement (BPCI) demonstration projects. Little information from ACE and BPCI exists to guide hospitals in redesigning care for mandatory joint replacement bundles. Objective: To analyze changes in quality, internal hospital costs, and postacute care (PAC) spending for lower extremity joint replacement bundled payment episodes encompassing hospitalization and 30 days of PAC...
February 1, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/28034906/fda-s-approach-to-regulating-biosimilars
#18
Steven J Lemery, M Stacey Ricci, Patricia Keegan, Amy E McKee, Richard Pazdur
The Biologics Price Competition and Innovation (BPCI) Act, enacted as part of the Affordable Care Act, created a new licensure pathway for biological products demonstrated to be biosimilar with or interchangeable with an FDA-licensed biological product (the "reference product"). The FDA's approach to the regulation of biosimilars is based on the requirements set forth in the BPCI Act. A biosimilar product is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between products in terms of safety, purity, and potency...
April 15, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28005410/results-of-a-medicare-bundled-payments-for-care-improvement-initiative-for-chronic-obstructive-pulmonary-disease-readmissions
#19
Surya P Bhatt, J Michael Wells, Anand S Iyer, deNay P Kirkpatrick, Trisha M Parekh, Lauren T Leach, Erica M Anderson, J Greg Sanders, Jessica K Nichols, Cindy C Blackburn, Mark T Dransfield
RATIONALE: Approximately 20% of Medicare beneficiaries hospitalized for acute exacerbations of chronic obstructive pulmonary disease (COPD) are readmitted within 30 days of discharge. In addition to implementing penalties for excess readmissions, the U.S. Centers for Medicare and Medicaid Services has developed Bundled Payments for Care Improvement (BPCI) initiatives to improve outcomes and control costs. OBJECTIVES: To evaluate whether a comprehensive COPD multidisciplinary intervention focusing on inpatient, transitional, and outpatient care as part of our institution's BPCI participation would reduce 30-day all-cause readmission rates for COPD exacerbations and reduce overall costs...
May 2017: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/27926675/improvement-in-total-joint-replacement-quality-metrics-year-one-versus-year-three-of-the-bundled-payments-for-care-improvement-initiative
#20
John M Dundon, Joseph Bosco, James Slover, Stephen Yu, Yousuf Sayeed, Richard Iorio
BACKGROUND: In January 2013, a large, tertiary, urban academic medical center began participation in the Bundled Payments for Care Improvement (BPCI) initiative for total joint arthroplasty, a program implemented by the Centers for Medicare & Medicaid Services (CMS) in 2011. Medicare Severity-Diagnosis Related Groups (MS-DRGs) 469 and 470 were included. We participated in BPCI Model 2, by which an episode of care includes the inpatient and all post-acute care costs through 90 days following discharge...
December 7, 2016: Journal of Bone and Joint Surgery. American Volume
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