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https://www.readbyqxmd.com/read/28425687/patient-protection-and-affordable-care-act-market-stabilization-final-rule
#1
(no author information available yet)
This rule finalizes changes that will help stabilize the individual and small group markets and affirm the traditional role of State regulators. This final rule amends standards relating to special enrollment periods, guaranteed availability, and the timing of the annual open enrollment period in the individual market for the 2018 plan year; standards related to network adequacy and essential community providers for qualified health plans; and the rules around actuarial value requirements.
April 18, 2017: Federal Register
https://www.readbyqxmd.com/read/28425681/schedules-of-controlled-substances-temporary-placement-of-six-synthetic-cannabinoids-5f-adb-5f-amb-5f-apinaca-adb-fubinaca-mdmb-chmica-and-mdmb-fubinaca-into-schedule-i-temporary-scheduling-order
#2
(no author information available yet)
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule six synthetic cannabinoids: methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA] and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA], and their optical, positional, and geometric isomers, salts, and salts of isomers into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act...
April 10, 2017: Federal Register
https://www.readbyqxmd.com/read/28375593/va-dental-insurance-program-final-rule
#3
(no author information available yet)
This document revises Department of Veterans Affairs (VA) medical regulations to reflect the codification of the authority for the VA Dental Insurance Program (VADIP), a program through which VA contracts with private dental insurers to offer premium-based dental insurance to enrolled veterans and certain survivors and dependents of veterans. The VA Dental Insurance Reauthorization Act of 2016 codified the authority of the VADIP, and this final rulemaking accordingly revises the authority citation in the VA medical regulations that implement VADIP...
April 4, 2017: Federal Register
https://www.readbyqxmd.com/read/28375590/medicaid-program-disproportionate-share-hospital-payments-treatment-of-third-party-payers-in-calculating-uncompensated-care-costs-final-rule
#4
(no author information available yet)
This final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act (Act), and the application of such limitation in the annual DSH audits required under section 1923(j) of the Act, by clarifying that the hospital-specific DSH limit is based only on uncompensated care costs. Specifically, this rule makes explicit in the text of the regulation, an existing interpretation that uncompensated care costs include only those costs for Medicaid eligible individuals that remain after accounting for payments made to hospitals by or on behalf of Medicaid eligible individuals, including Medicare and other third party payments that compensate the hospitals for care furnished to such individuals...
April 3, 2017: Federal Register
https://www.readbyqxmd.com/read/28355050/release-of-va-records-relating-to-hiv-final-rule
#5
(no author information available yet)
The Department of Veterans Affairs (VA) is amending its medical regulations governing the release of VA medical records. Specifically, VA is eliminating the restriction on sharing a negative test result for the human immunodeficiency virus (HIV) with veterans' outside providers. HIV testing is a common practice today in healthcare and the stigma of testing that may have been seen in the 1980s when HIV was first discovered is no longer prevalent. Continuing to protect negative HIV tests causes delays and an unnecessary burden on veterans when VA tries to share electronic medical information with the veterans' outside providers through electronic health information exchanges...
March 23, 2017: Federal Register
https://www.readbyqxmd.com/read/28355049/schedules-of-controlled-substances-placement-of-fda-approved-products-of-oral-solutions-containing-dronabinol-delta-9-transtetrahydrocannabinol-delta-9-thc-in-schedule-ii-interim-final-rule-with-request-for-comments
#6
(no author information available yet)
On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. Thereafter, the Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation that would result in Syndros (and other oral solutions containing dronabinol) being placed in schedule II of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA...
March 23, 2017: Federal Register
https://www.readbyqxmd.com/read/28355048/medical-devices-neurological-devices-classification-of-the-vibratory-counter-stimulation-device-final-order
#7
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation 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 vibratory counter-stimulation 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.
March 14, 2017: Federal Register
https://www.readbyqxmd.com/read/28355047/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-high-throughput-genomic-sequence-analyzer-for-clinical-use-final-order
#8
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use 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 classification of the high throughput genomic sequence analyzer for clinical use device. 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...
March 14, 2017: Federal Register
https://www.readbyqxmd.com/read/28355046/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-continuous-glucose-monitor-secondary-display-final-order
#9
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display 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 continuous glucose monitor secondary display’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.
March 14, 2017: Federal Register
https://www.readbyqxmd.com/read/28355045/schedules-of-controlled-substances-placement-of-brivaracetam-into-schedule-v-final-rule
#10
(no author information available yet)
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on May 12, 2016. The Drug Enforcement Administration is placing the substance brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) (including its salts) into schedule V of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015...
March 9, 2017: Federal Register
https://www.readbyqxmd.com/read/28355044/schedules-of-controlled-substances-placement-of-10-synthetic-cathinones-into-schedule-i-final-rule
#11
(no author information available yet)
With the issuance of this final rule, the Drug Enforcement Administration places 10 synthetic cathinones: 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha-pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone, bk-MBDB e); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone, bk-MBDP); 4-fluoro-N-methylcathinone (4-FMC, flephedrone); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone); alpha-pyrrolidinobutiophenone ([alpha]-PBP) and their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act...
March 1, 2017: Federal Register
https://www.readbyqxmd.com/read/28355043/gastroenterology-urology-devices-manual-gastroenterology-urology-surgical-instruments-and-accessories-final-rule-technical-amendment
#12
(no author information available yet)
The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures ("specialized surgical instrumentation for use with urogynecologic surgical mesh"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh...
March 1, 2017: Federal Register
https://www.readbyqxmd.com/read/28150924/schedules-of-controlled-substances-extension-of-temporary-placement-of-thj-2201-ab-pinaca-and-ab-chminaca-in-schedule-i-of-the-controlled-substances-act-temporary-order
#13
(no author information available yet)
The Administrator of the Drug Enforcement Administration is issuing this temporary order to extend the temporary schedule I status of three synthetic cannabinoids pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: [1-(5-Fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201); N-1-Amino-3-methyl-1-oxo-2-butanyl]-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA); N-[1-Amino-3-methyl-1-oxo-2-butanyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), including their optical, positional and geometric isomers, salts, and salts of isomers...
January 27, 2017: Federal Register
https://www.readbyqxmd.com/read/28106360/federal-policy-for-the-protection-of-human-subjects-final-rule
#14
(no author information available yet)
The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight...
January 19, 2017: Federal Register
https://www.readbyqxmd.com/read/28106359/control-of-communicable-diseases-final-rule
#15
(no author information available yet)
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments have been made to aid public health responses to outbreaks of new or re-emerging communicable diseases and to accord due process to individuals subject to Federal public health orders. In response to public comment received, the updated provisions in this final rule clarify various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate...
January 19, 2017: Federal Register
https://www.readbyqxmd.com/read/28106358/national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-table-final-rule
#16
(no author information available yet)
On July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by proposing revisions to the Vaccine Injury Table (Table). The Secretary based the Table revisions primarily on the 2012 Institute of Medicine (IOM) report, "Adverse Effects of Vaccines: Evidence and Causality," the work of nine HHS workgroups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' (ACCV) recommendations...
January 19, 2017: Federal Register
https://www.readbyqxmd.com/read/28106357/possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-of-the-list-of-select-agents-and-toxins-and-enhanced-biosafety-requirements-final-rule
#17
(no author information available yet)
In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records...
January 19, 2017: Federal Register
https://www.readbyqxmd.com/read/28103000/fertility-counseling-and-treatment-for-certain-veterans-and-spouses-interim-final-rule
#18
(no author information available yet)
The Department of Veterans Affairs (VA) amends its regulation regarding fertility counseling and treatment available to certain veterans and spouses. VA currently provides certain infertility services other than in vitro fertilization (IVF) to veterans as part of the medical benefits package. IVF is the process of fertilization by manually fertilizing an egg, and then transferring the embryo to the uterus. This interim final rulemaking adds a new section authorizing IVF for a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment...
January 19, 2017: Federal Register
https://www.readbyqxmd.com/read/28102999/recognition-of-tribal-organizations-for-representation-of-va-claimants-final-rule
#19
(no author information available yet)
The Department of Veterans Affairs (VA) is amending its regulations concerning recognition of certain national, State, and regional or local organizations for purposes of VA claims representation. Specifically, this rulemaking allows the Secretary to recognize tribal organizations in a similar manner as the Secretary recognizes State organizations. The final rule allows a tribal organization that is established and funded by one or more tribal governments to be recognized for the purpose of providing assistance on VA benefit claims...
January 19, 2017: Federal Register
https://www.readbyqxmd.com/read/28102997/confidentiality-of-substance-use-disorder-patient-records-final-rule
#20
(no author information available yet)
The Department of Health and Human Services (HHS) is issuing this final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations and facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. These modifications also help clarify the regulations and reduce unnecessary burden.
January 18, 2017: Federal Register
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