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( (Sec. use at least two years of diagnostic data, provide separate adjustments for individuals dually eligible for Medicare and Medicaid, and. 5004) The bill revises Medicare payments for infusion medications delivered through durable medical equipment. 2062) HHS must: (1) continue to conduct or support research on vector-borne diseases, (2) establish the Tick-Borne Disease Working Group to review HHS efforts regarding tick-borne diseases. 17002) The CMS must annually report on specified Medicare enrollment data. The COVID-19 pandemic has put research evidence and its use in health policy-making under a new spotlight.1 Faced with the need for immediate action, as most recently shown with vaccination roll-out strategies,2 many politicians and other leaders have publicly stressed the need to follow the ‘science’. In taking an interdisciplinary approach, these two volumes target a broad audience and fill a gap in the existing reference literature for a general guide to the core concepts that inform qualitative research practices. The FDA's documented rationale for a significant decision regarding a medical device must include a statement on how the least burdensome means requirements were considered and applied. (Sec. 3042) The FDA may, at the request of the drug's sponsor, approve an antibiotic or antifungal drug for use in a limited population if the drug is intended to treat a serious infection in a limited population of patients with unmet medical needs. Each institute must coordinate activities applicable to a major disease area among the FDA centers that review products. (Sec. 14004) DOJ may award grants for: (1) pretrial mental health screening of defendants and supervision of defendants on pretrial release, and (2) criminal justice system behavioral health assessments and intervention programs. The Department of Health and Human Services (HHS) must include in its biennial reports detailed accounting for each system. 13004) The GAO must report on the extent to which group health plans, health insurers, Medicaid managed care organizations, and Children's Health Insurance Program (CHIP) health plans comply with parity requirements. (Sec. 5006) A state must publish and annually update a directory of physicians participating in its Medicaid program if the program provides assistance on a fee-for-service basis or through a primary care case-management system. The transferable voucher entitles the holder to have an application for a new medication acted upon by the FDA within six months. (Sec. 14024) DOJ grants to improve law enforcement response to mentally ill offenders may be used to support academy training and other programs that teach law enforcement personnel. You consent to Dun & Bradstreet (D&B) using this data for marketing and analytical purposes, and to D&B emailing you or using an autodialer or pre-recorded voice to text or call you at the number you provide with marketing or other offers. Subtitle H--Medical Countermeasures Innovation. assign staff to address questions by institutional review committees concerning investigational use of the device. 14023) Justice and Mental Health Collaboration Program implementation grants may be used to support multidisciplinary teams that address frequent users of crisis services. 5001) The bill increases the funds available to the Medicare Improvement Fund for services provided during and after FY2021. (Sec. Background and History. The Associated Press offers an update on the standoff between the US and Iran over the Joint Comprehensive Plan of Action (JCPOA), also known as the Iran deal, from which Donald Trump as president spectacularly withdrew the US in 2018.. Trump committed an act of pure will, with no serious legal argument related to the terms of the agreement. ), Array 2011) HHS is encouraged to carry out a Precision Medicine Initiative to address disease prevention, diagnosis, and treatment. 3056) The bill eliminates the requirement for the Institutional Review Board supervising the clinical testing of an investigational or humanitarian medical device to be local. Qualitative research is designed to explore the human elements of a given topic, while specific qualitative methods examine how individuals see and experienc (Sec. (Sec. Decision-making process is a reasoning process based on assumptions of values, preferences and beliefs of the decision-maker. 9004) The bill revises and extends through FY2022 block grants for transition from homelessness. To rely upon submitted information, the sponsor must have developed, or have a right of reference to, the information. (Sec. (Sec. 9014) This bill amends the Protecting Access to Medicare Act of 2014 to extend through FY2022 a pilot program for assisted outpatient treatment programs for individuals with serious mental illness. ( (Sec. 3057) The FDA must revise the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.”, (Sec. Priority for these grants is given to programs that are administered cooperatively by law enforcement personnel and mental health and substance abuse professionals. [chamberOfAction] => Senate 3024) Clinical testing of investigational medical devices and drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk to the subjects and includes safeguards. Coverage and payments under a qualified HRA are excluded from gross income, unless the employee does not have minimum essential coverage for the month in which the medical care was provided. (Sec. 6003) The bill creates the position of Chief Medical Officer within SAMHSA. 14027) The bill revises priority considerations for Justice and Mental Health Collaboration Program grants to prioritize applications that: (1) propose interventions that reduce recidivism, and (2) target certain offenders with a moderate or high risk of recidivism and a need for treatment and services. (Sec. 3024) Clinical testing of investigational medical devices and drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk to the subjects and includes safeguards. (Sec. 14025) Regarding response to individuals with mental illness, DOJ must provide direction and guidance on: (1) training programs for federal first responders and tactical units, and (2) systems to provide timely information to federal law enforcement agencies and criminal justice agencies. 6022) This bill amends the Protection and Advocacy for Individuals with Mental Illness Act to require state protection and advocacy systems to publish their annual reports. (Sec. 14015) Data prepared by, or submitted to, the DOJ or the Federal Bureau of Investigation on homicides, law enforcement officers killed, seriously injured, and assaulted, or individuals killed or seriously injured by law enforcement officers must include data on the involvement of mental illness in the incident. ), Blog – In Custodia Legis: Law Librarians of Congress, House - Science, Space, and Technology | Senate - Commerce, Science, and Transportation, 12/13/2016 Became Public Law No: 114-255. (Sec. 2031) NIH must publish a strategic plan that addresses research, training, the biomedical workforce, and collaboration with other agencies. (Sec. [chamberOfAction] => [description] => Became Law (Sec. limit annual payments and reimbursements to specified dollar amounts. In awarding grants, SAMHSA must give special consideration to entities proposing to support services for veterans. Public consultation on National Statement content. (Sec. (Sec. [description] => Passed Senate (Sec. (Sec. Qualitative research projects are informed by a wide range of methodologies and theoretical frameworks. (Sec. It allows you to rapidly generate reports with action items, photos, notes, and other details. The ONC may require health IT certification criteria support certain usability features. 13002) HHS must convene stakeholders to produce an action plan for improved federal and state coordination regarding enforcement of parity requirements. We help clients ensure that brand value can be measured and exploited to its full potential. 15008) The bill removes certain hospitals specializing in neoplastic disease from their classification as LTCHs for purposes of Medicare payment. (Sec. (Sec. 3058) The FDA must ensure that employees who review premarket submissions of medical devices receive training on least burdensome means requirements. 3075) The bill revises provisions regarding: (1) FDA screening of the Adverse Event Reporting System, and (2) evaluation of elements to assure safe use of drugs. In psychology, decision-making (also spelled decision making and decisionmaking) is regarded as the cognitive process resulting in the selection of a belief or a course of action among several possible alternative options, it could be either rational or irrational. Before a national research institute awards a grant for a research project (R-series grant) the director of the institute must review and approve the award. (Sec. (Sec. Advisory council reports must include certain demographic data for clinical research subjects. take into account an MA enrollee's total number of diseases or conditions. 9022) HHS must establish a training demonstration program for mental and substance use disorders to award grants for: (1) training medical residents and fellows to practice psychiatry and addiction medicine in underserved, community-based settings with integrated care; (2) training other providers to provide services in such settings; and (3) academic units or programs that train students or faculty or develop practices or recommendations for the design of such units or programs. 2053) The results of NIH-funded clinical trials that include women and minorities must be submitted to NIH's clinical trial data bank. [externalActionCode] => 14000 (Sec. [externalActionCode] => 20000 The Medicare Payment Advisory Commission must report on the effect of extending this instruction on: (1) Medicare beneficiaries, and (2) hospital staffing needs. (Sec. 9021) The bill revises and extends through FY2022 mental and behavioral health education and training grants. Upon a sponsor's request, the FDA must determine whether a device meets the criteria for designation as a breakthrough device. (Sec. 3091) The Advisory Committee on Immunization Practices must: (1) consider the use of newly licensed vaccines at each regularly scheduled meeting, and (2) make timely recommendations for vaccines designated as breakthrough therapies and vaccines that could be used in a public health emergency. The ONC must issue guidance on the secure exchange of electronic health information. priority review of qualified infectious disease products, use of clinical investigation data from outside the United States, and. 3087) The Paperwork Reduction Act does not apply to voluntary collection of information during a public health emergency or while determining whether there is a public health emergency. A qualified small employer HRA is offered by employers that have fewer than 50 full-time employees and do not offer group health plans to any of their employees.

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