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https://www.readbyqxmd.com/read/29027769/moral-exemptions-and-accommodations-for-coverage-of-certain-preventive-services-under-the-affordable-care-act-interim-final-rules-with-request-for-comments
#1
(no author information available yet)
The United States has a long history of providing conscience protections in the regulation of health care for entities and individuals with objections based on religious beliefs or moral convictions. These interim final rules expand exemptions to protect moral convictions for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration, a component of the United States Department of Health and Human Services, to maintain the guidelines requiring contraceptive coverage where no regulatorily recognized objection exists...
October 13, 2017: Federal Register
https://www.readbyqxmd.com/read/29027768/religious-exemptions-and-accommodations-for-coverage-of-certain-preventive-services-under-the-affordable-care-act-interim-final-rules-with-request-for-comments
#2
(no author information available yet)
The United States has a long history of providing conscience protections in the regulation of health care for entities and individuals with objections based on religious beliefs and moral convictions. These interim final rules expand exemptions to protect religious beliefs for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration (HRSA), a component of the United States Department of Health and Human Services (HHS), to maintain the guidelines requiring contraceptive coverage where no regulatorily recognized objection exists...
October 13, 2017: Federal Register
https://www.readbyqxmd.com/read/29022599/findings-of-research-misconduct
#3
COMMENT
(no author information available yet)
No abstract text is available yet for this article.
October 4, 2017: Federal Register
https://www.readbyqxmd.com/read/28990746/medical-devices-gastroenterology-urology-devices-classification-of-the-high-intensity-ultrasound-system-for-prostate-tissue-ablation-final-order
#4
(no author information available yet)
The Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high intensity ultrasound system for prostate tissue ablation’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device...
October 2, 2017: Federal Register
https://www.readbyqxmd.com/read/28990743/drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulation-final-rule-further-delay-of-effective-date
#5
(no author information available yet)
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On August 21, 2017, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 39553)...
September 29, 2017: Federal Register
https://www.readbyqxmd.com/read/28990740/schedules-of-controlled-substances-removal-of-naldemedine-from-control-final-rule
#6
(no author information available yet)
With the issuance of this final rule, the Drug Enforcement Administration removes the substance naldemedine (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,7,9-trihydroxy-N-(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, naldemedine was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine...
September 29, 2017: Federal Register
https://www.readbyqxmd.com/read/28920639/protection-of-human-subjects
#7
(no author information available yet)
On January 19, 2017, the Federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the Common Rule) published a final rule amending the Common Rule. The Consumer Product Safety Commission (CPSC or Commission) adopts the Common Rule.
September 18, 2017: Federal Register
https://www.readbyqxmd.com/read/28805361/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care-hospital-prospective-payment-system-and-policy-changes-and-fiscal-year-2018-rates-quality-reporting-requirements-for-specific-providers-medicare
#8
(no author information available yet)
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these changes implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation...
August 14, 2017: Federal Register
https://www.readbyqxmd.com/read/28805360/medicare-program-fy-2018-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reporting-requirements-final-rule
#9
(no author information available yet)
This final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2018. Additionally, this rule includes new quality measures and provides an update on the hospice quality reporting program.
August 4, 2017: Federal Register
https://www.readbyqxmd.com/read/28805359/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities-for-fy-2018-snf-value-based-purchasing-program-snf-quality-reporting-program-survey-team-composition-and-correction-of-the-performance-period-for-the-nhsn-hcp
#10
(no author information available yet)
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also revises and rebases the market basket index by updating the base year from 2010 to 2014, and by adding a new cost category for Installation, Maintenance, and Repair Services. The rule also finalizes revisions to the SNF Quality Reporting Program (QRP), including measure and standardized resident assessment data policies and policies related to public display...
August 4, 2017: Federal Register
https://www.readbyqxmd.com/read/28857091/findings-of-research-misconduct
#11
COMMENT
(no author information available yet)
No abstract text is available yet for this article.
August 3, 2017: Federal Register
https://www.readbyqxmd.com/read/28805358/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal-year-2018-final-rule
#12
(no author information available yet)
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2018 as required by the statute. As required by section 1886(j)(5) of the Social Security Act (the Act), this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2018. This final rule also revises the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes that are used to determine presumptive compliance under the "60 percent rule," removes the 25 percent payment penalty for inpatient rehabilitation facility patient assessment instrument (IRF-PAI) late transmissions, removes the voluntary swallowing status item (Item 27) from the IRF-PAI, summarizes comments regarding the criteria used to classify facilities for payment under the IRF PPS, provides for a subregulatory process for certain annual updates to the presumptive methodology diagnosis code lists, adopts the use of height/weight items on the IRF-PAI to determine patient body mass index (BMI) greater than 50 for cases of single-joint replacement under the presumptive methodology, and revises and updates measures and reporting requirements under the IRF quality reporting program (QRP)...
August 3, 2017: Federal Register
https://www.readbyqxmd.com/read/28805357/schedule-for-rating-disabilities-dental-and-oral-conditions-final-rule
#13
(no author information available yet)
This document amends the Department of Veterans Affairs (VA) Schedule for Rating Disabilities by revising the portion of the schedule that addresses dental and oral conditions. The effect of this action is to ensure that the rating schedule uses current medical terminology and to provide detailed and updated criteria for evaluation of dental and oral conditions for disability rating purposes.
August 3, 2017: Federal Register
https://www.readbyqxmd.com/read/28753262/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-closed-loop-hysteroscopic-insufflator-with-cutter-coagulator-final-order
#14
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the closed loop hysteroscopic insufflator with cutter-coagulator 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 closed loop hysteroscopic insufflator with cutter-coagulator 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...
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28753261/medical-devices-neurological-devices-classification-of-cranial-motion-measurement-device-final-order
#15
(no author information available yet)
The Food and Drug Administration (FDA or Agency) is classifying the cranial motion measurement 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 cranial motion measurement 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.
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28753260/medical-devices-gastroenterology-urology-devices-classification-of-the-oral-removable-palatal-space-occupying-device-for-weight-management-and-or-weight-loss-final-order
#16
(no author information available yet)
The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss 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 oral removable palatal space occupying device for weight management and/or weight loss 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...
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28753259/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-cardiovascular-status-indicator-final-order
#17
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator 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 adjunctive cardiovascular status indicator'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.
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28753258/medicare-medicaid-and-children-s-health-insurance-programs-announcement-of-the-extension-of-temporary-moratoria-on-enrollment-of-part-b-non-emergency-ground-ambulance-suppliers-and-home-health-agencies-in-designated-geographic-locations-extension-of-temporary
#18
(no author information available yet)
This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states...
July 28, 2017: Federal Register
https://www.readbyqxmd.com/read/28749100/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter-final-order
#19
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter 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 balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
July 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28749099/medical-devices-immunology-and-microbiology-devices-classification-of-the-assayed-quality-control-material-for-clinical-microbiology-assays-final-order
#20
(no author information available yet)
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays 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 assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device...
July 27, 2017: Federal Register
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