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https://www.readbyqxmd.com/read/27920134/hhs-expands-rules-for-clinical-trial-reporting
#1
(no author information available yet)
The HHS and NIH have adopted new policies aimed at clarifying and expanding the reporting requirements for clinical trials and more quickly disseminating data to researchers and the public. Among the changes: requiring registration of trials that test experimental and early-stage therapies, and posting results for trials of unapproved drugs. The policies take effect January 18, 2017.
December 2016: Cancer Discovery
https://www.readbyqxmd.com/read/27919807/a-cryptic-species-produced-by-autopolyploidy-and-subsequent-introgression-involving-medicago-prostrata-fabaceae
#2
J S Eriksson, J L Blanco-Pastor, F D Sousa, Y J K Bertrand, B E Pfeil
Although hybridisation through genome duplication is well known, hybridisation without genome duplication (homoploid hybrid speciation, HHS) is not. Few well-documented cases have been reported. A possible instance of HHS in Medicago prostrata Jacq. was suggested previously, based on only two genes and one individual. We tested whether this species was formed through HHS by sampling eight nuclear loci and 22 individuals, with additional individuals from related species, using gene capture and Illumina sequencing...
December 2, 2016: Molecular Phylogenetics and Evolution
https://www.readbyqxmd.com/read/27914663/outcome-of-alternative-approach-to-displaced-acetabular-fractures
#3
K S Park, C K Chan, G W Lee, H W Ahn, T R Yoon
INTRODUCTION: Anatomical reduction of displaced acetabular fracture is not without its' limitations and complications. This study is conducted to assess clinical and radiological outcomes as well as complications of treating displaced acetabular fractures with emphasis on anatomical reduction in weight-bearing area, mainly the posterior column, and imperfect reduction of the anterior column is acceptable. However, stability of both columns is mandatory. METHODS: It was a retrospective study carried out in a Level 1 arthroplasty and trauma centre...
November 27, 2016: Injury
https://www.readbyqxmd.com/read/27911455/functional-outcomes-of-infected-hip-arthroplasty-a-comparison-of-different-surgical-treatment-options
#4
Benjamin V Herman, Mark Nyland, Lyndsay Somerville, Steven J MacDonald, Brent A Lanting, James L Howard
BACKGROUND: Periprosthetic joint infection (PJI) following total hip arthroplasty (THA) can be treated with irrigation and debridement with head and polyethylene exchange (IDHPE) or 2-stage revision (2SR). Few studies have compared patient-reported outcome measures (PROMs) in patients managed with these treatments. METHODS: A retrospective review identified 137 patients who had an infected primary THA between 1986-2013. Control cohorts were matched according to age and Charlton Comorbidity Index (CCI)...
November 28, 2016: Hip International: the Journal of Clinical and Experimental Research on Hip Pathology and Therapy
https://www.readbyqxmd.com/read/27906537/medicaid-and-children-s-health-insurance-programs-eligibility-notices-fair-hearing-and-appeal-processes-for-medicaid-and-other-provisions-related-to-eligibility-and-enrollment-for-medicaid-and-chip-final-rule
#5
(no author information available yet)
This final rule implements provisions of the Affordable Care Act that expand access to health coverage through improvements in Medicaid and coordination between Medicaid, CHIP, and Exchanges. This rule finalizes most of the remaining provisions from the "Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing; Proposed Rule" that we published in the January 22, 2013, Federal Register...
November 30, 2016: Federal Register
https://www.readbyqxmd.com/read/27906534/food-and-drug-administration-review-and-action-on-over-the-counter-time-and-extent-applications-final-rule
#6
(no author information available yet)
The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.
November 23, 2016: Federal Register
https://www.readbyqxmd.com/read/27906532/medical-gas-containers-and-closures-current-good-manufacturing-practice-requirements-final-rule
#7
(no author information available yet)
The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements...
November 18, 2016: Federal Register
https://www.readbyqxmd.com/read/27906531/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions-to-part-b-for-cy-2017-medicare-advantage-bid-pricing-data-release-medicare-advantage-and-part-d-medical-loss-ratio-data-release-medicare-advantage-provider-network
#8
(no author information available yet)
This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans...
November 15, 2016: Federal Register
https://www.readbyqxmd.com/read/27906530/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment-systems-and-quality-reporting-programs-organ-procurement-organization-reporting-and-communication-transplant-outcome-measures-and-documentation-requirements-electronic
#9
(no author information available yet)
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system...
November 14, 2016: Federal Register
https://www.readbyqxmd.com/read/27905888/medicare-program-end-stage-renal-disease-prospective-payment-system-coverage-and-payment-for-renal-dialysis-services-furnished-to-individuals-with-acute-kidney-injury-end-stage-renal-disease-quality-incentive-program-durable-medical-equipment-prosthetics-orthotics
#10
(no author information available yet)
This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP...
November 4, 2016: Federal Register
https://www.readbyqxmd.com/read/27905815/medicare-program-merit-based-incentive-payment-system-mips-and-alternative-payment-model-apm-incentive-under-the-physician-fee-schedule-and-criteria-for-physician-focused-payment-models-final-rule-with-comment-period
#11
(no author information available yet)
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs)...
November 4, 2016: Federal Register
https://www.readbyqxmd.com/read/27905814/medicare-and-medicaid-programs-cy-2017-home-health-prospective-payment-system-rate-update-home-health-value-based-purchasing-model-and-home-health-quality-reporting-requirements-final-rule
#12
(no author information available yet)
This final rule updates the Home Health Prospective Payment System (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor; effective for home health episodes of care ending on or after January 1, 2017. This rule also: Implements the last year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates; updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 2nd-year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014; finalizes changes to the methodology used to calculate payments made under the HH PPS for high-cost "outlier" episodes of care; implements changes in payment for furnishing Negative Pressure Wound Therapy (NPWT) using a disposable device for patients under a home health plan of care; discusses our efforts to monitor the potential impacts of the rebasing adjustments; includes an update on subsequent research and analysis as a result of the findings from the home health study; and finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model, which was implemented on January 1, 2016; and updates to the Home Health Quality Reporting Program (HH QRP)...
November 3, 2016: Federal Register
https://www.readbyqxmd.com/read/27905813/family-violence-prevention-and-services-programs-final-rule
#13
(no author information available yet)
This rule will better prevent and protect survivors of family violence, domestic violence, and dating violence, by clarifying that all survivors must have access to services and programs funded under the Family Violence Prevention and Services Act. More specifically, the rule enhances accessibility and non-discrimination provisions, clarifies confidentiality rules, promotes coordination among community-based organizations, State Domestic Violence Coalitions, States, and Tribes, as well as incorporates new discretionary grant programs...
November 2, 2016: Federal Register
https://www.readbyqxmd.com/read/27905700/use-of-ozone-depleting-substances-direct-final-rule
#14
(no author information available yet)
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as "essential uses" under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation...
October 26, 2016: Federal Register
https://www.readbyqxmd.com/read/27904218/core-decompression-or-quadratus-femoris-muscle-pedicle-bone-grafting-for-nontraumatic-osteonecrosis-of-the-femoral-head-a-randomized-control-study
#15
Deqiang Li, Ming Li, Peilai Liu, Yuankai Zhang, Liang Ma, Fei Xu
BACKGROUND: The traditional management for osteonecrosis of the femoral head (ONFH) includes core decompression (CD) and quadratus femoris muscle pedicle bone graft (QF-MPBG). The aim of this study was to investigate the effects of CD and QF-MPBG on the patients with nontraumatic ONFH in an early stage. MATERIALS AND METHODS: 39 patients (47 hips) with ONFH in an early stage (Ficat Stage I or II) were randomly divided into two groups according to random number table method...
November 2016: Indian Journal of Orthopaedics
https://www.readbyqxmd.com/read/27902171/treatment-of-mixed-type-femoroacetabular-impingement-using-safe-surgical-hip-dislocation-in-adults
#16
Ulukan İnan, Selim Harmanşa, Hakan Ömeroğlu
OBJECTIVES: This study aims to assess the experience gained in a single institution in the treatment of mixed type femoroacetabular impingement (FAI) using safe surgical hip dislocation (SSHD) technique. PATIENTS AND METHODS: In this study, 22 hips of 21 patients (7 males, 14 females; mean age 33.8±10.6 years; range 19-52 years) treated by SSHD technique in our clinic between October 2009 and October 2014 were retrospectively evaluated. Preoperative and final Harris hip scores (HHS) and alpha angles were compared...
December 2016: Eklem Hastalıkları Ve Cerrahisi, Joint Diseases & related Surgery
https://www.readbyqxmd.com/read/27901563/medical-devices-ear-nose-and-throat-devices-classification-of-the-eustachian-tube-balloon-dilation-system-final-order
#17
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the Eustachian tube balloon dilation system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
October 24, 2016: Federal Register
https://www.readbyqxmd.com/read/27901560/medical-devices-physical-medicine-devices-classification-of-the-upper-extremity-prosthesis-including-a-simultaneously-powered-elbow-and-or-shoulder-with-greater-than-two-simultaneous-powered-degrees-of-freedom-and-controlled-by-non-implanted-electrical-components
#18
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' classification...
October 18, 2016: Federal Register
https://www.readbyqxmd.com/read/27901558/medical-devices-cardiovascular-devices-classification-of-the-apical-closure-device-final-order
#19
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
October 17, 2016: Federal Register
https://www.readbyqxmd.com/read/27900509/conversion-of-hip-fusion-to-total-hip-arthroplasty-clinical-radiological-outcomes-and-complications-in-40-hips
#20
Mustafa Celiktas, Ozkan Kose, Adil Turan, Ferhat Guler, Cagri Ors, Emre Togrul
OBJECTIVE: The purpose of this retrospective study is to report the clinical and radiological outcome of total hip arthroplasty in patients with previous hip arthrodesis. PATIENTS AND METHODS: We retrospectively reviewed 28 (40 hips) prospectively followed patients in whom ankylosed hips were converted to total hip arthroplasty (THA) between 2010 and 2014 in our institution. The average age at the time of the conversion operation was 40.8 ± 9.8 years (range 24-62)...
November 29, 2016: Archives of Orthopaedic and Trauma Surgery
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