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    1024px) { #styln-briefing-block { width. 100%. } } Latest Updates. The Coronavirus Outbreak 5m ago With a rule change and some unusual help from a private jet, Nick Saban coached the Crimson Tide to victory. 2h ago Scientists raise doubts about Britain’s plan to deliberately infect volunteers.

    2h ago Afghans seeking medical care in Pakistan are killed in a stampede. See more updates More live coverage. Markets A New York Times database has tracked clusters of at least 50 coronavirus cases in a dozen rural jails in Montana, Idaho, Utah and New Mexico during the pandemic. Among them. The Purgatory Correctional Center in Hurricane, Utah, with 166 infections.

    The jail in Twin Falls, Idaho, with 279. And, in New Mexico, the Cibola County Correctional Center, which has reported 357 cases.In Cascade County, infections at the jail make up about a quarter of all known virus cases in the county. Health authorities say that the jail’s outbreak, which began in mid-August, was not believed to be the main cause of the community’s recent surge, but that it had led to some cases. In the past two months, Mr. Krogue said, the jail released 29 people who were considered actively infected.Infections at the jail make up about a quarter of Cascade County’s known virus cases.Credit...Tailyr Irvine for The New York TimesGreat Falls, home to about 58,000 residents, is in the less mountainous part of Montana, with the Missouri River flowing through and a large oil refinery on its banks.

    The Cascade County Detention Center sits along a highway at the edge of town. Drive five miles in any direction and you are surrounded by wide-open plains.Montana requires that masks be worn inside businesses and indoor public spaces, and many people in Great Falls wear them when walking around downtown’s Central Avenue, where shops and cafes are still recovering from shutting down in the spring. Others go without masks, citing the open space and lack of crowds.Bob Kelly, the mayor, said people had not been overly worried about how the jail outbreak might affect the rest of town when it started.“I think that by the very definition of a jail, hopefully, the disease will be incarcerated, as well as the patients,” he said. €œIs there concern?. Sure, there’s concern.

    But is there overreaction?. No.”The mayor of Great Falls said that residents had considered the jail’s outbreak a distant concern at first.Credit...Tailyr Irvine for The New York TimesSome residents’ nonchalance about the risks of the virus, said Mr. Krogue, the jail’s medical director, can be traced to a spring and early summer when almost no one in Cascade County knew anyone who had been sickened.“We benefited from that early on,” he said. €œBut in some ways, I think it did us a disservice, too, because it also created a certain level of complacency.”That has quickly shifted now, he said, as cases have spiked.The number of active cases known to county officials on any given day has risen sharply to about 600, according to Trisha Gardner, Cascade County’s health officer. The county has seen 1,261 cases and six deaths during the pandemic, a Times database shows.

    Some of the cases have been tied to the jail outbreak, she said, and others have been connected to bars and restaurants. Even figuring out what has led to some cases has been complex, she said, as residents have been reluctant to cooperate with contact tracers.“Our hospitals are at capacity, our public health system is at capacity,” she said. €œIt’s not sustainable at this rate.”When the outbreak at the jail began, social distancing was impossible, the authorities said. Three inmates shared cells designed for two. At night, men slept on thin blue pads in every available space.

    On the floor in the day room, in shower stalls, in stairwells, in hallways outside of cells.Inmates did not receive masks until August, and jail officials said many have refused to wear them.In interviews with more than a dozen inmates and their family members, inmates described the jail during the outbreak as chaotic and unsanitary. They said their pleas for help often went unanswered by nurses and guards.Newly arriving inmates were not always quarantined from one another before their test results were known because of a lack of space, inmates and jail officials said.Owen Hawley, 30, said every inmate in his living area of 38 men had tested positive for the virus. He said he had been unable to eat for three days, had intensive body aches and suffered from a headache so powerful it felt as if it was “behind my eyes.”“After the fourth day of like, not eating and stuff, I just shut off, you know?. € he said.A jail area set aside for quarantining new inmates.Credit...Tailyr Irvine for The New York TimesAt one point, Mr. Hawley said, he and other prisoners protested the way the virus was being handled by refusing to leave their living areas and by blocking new inmates from entering.

    Everyone was ultimately tested, Mr. Hawley said, and each prisoner was given a disposable mask.Sierra Jasmine Wells, 25, another inmate, said women in her dormitory had grown ill, one after the next.“Everyone around me was getting sick and it was tough on me,” she said. €œBy then, I had already accepted the fact that I was going to get sick.”When she became infected, she said, she was given cough syrup and Tylenol.“I kind of was just left alone to deal with it,” she said.Jesse Slaughter, the county sheriff who oversees the jail, said that the jail’s medical staff was doing everything it could, and that he had been seeking health care assistance from other counties. Officials defended their handling of the outbreak, noting that all inmates received standard medications including Tylenol twice a day and were taken to area hospitals when they needed added care. Seven inmates, as well as some staff members, were hospitalized.

    No one from the jail has died from the virus, officials said.Sheriff Jesse Slaughter, who oversees the jail, said he had been seeking health care assistance from other counties.Credit...Tailyr Irvine for The New York TimesMr. Krogue said that since the start of the outbreak he had been working up to 16 hours each day and sleeping in his basement, away from his wife and children. He remains healthy but says he fears bringing the virus home. The virus has slowed some in the jail, and officials have moved some inmates to other facilities, but other prisons and jails in the state are now seeing outbreaks.“You can start to see what some of these other places experienced much earlier on, and we just didn’t have that experience, but it’s certainly happening now,” Mr. Krogue said.

    €œIt’s just real in a way that it wasn’t.”Lucy Tompkins reported from Great Falls, Maura Turcotte from Chicago and Libby Seline from Lincoln, Neb. Reporting was contributed by Izzy Colón from Columbia, Mo., Brendon Derr from Phoenix, Rebecca Griesbach from Tuscaloosa, Ala., Danya Issawi and Timothy Williams from New York, Ann Hinga Klein from Des Moines, K.B. Mensah from Silver Spring, Md., and Mitch Smith from Chicago.Start Preamble Federal Transit Administration (FTA), DOT. Notice of funding opportunity. The Coronavirus Disease 2019 (COVID-19) public health emergency Start Printed Page 63654has had a significant impact on transit operations.

    During a series of FTA listening sessions held over the last three months, transit agencies asked FTA to support research to identify solutions to address the operational challenges that they are facing as a result of COVID-19. In response, FTA makes available through this Notice of Funding Opportunity (NOFO) funding to support research demonstration grants to public transit agencies to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the COVID-19 public health emergency. Demonstration grants under this NOFO are authorized under FTA's Public Transportation Innovation Program (49 U.S.C. 5312). Eligible projects will demonstrate innovative solutions to improve the operational efficiencies of transit systems and enhance mobility for their communities in four major areas.

    (1) Vehicle, facility, equipment and infrastructure cleaning and disinfection. (2) exposure mitigation measures. (3) innovative mobility such as contactless payments. And (4) measures that strengthen public confidence in transit services. The total funding available for awards under this NOFO is $10,000,000.

    FTA may supplement this amount if additional funding becomes available. Applicants must submit completed proposals for funding opportunity FTA-2020-015-TRI through the GRANTS.GOV “APPLY” function by 11:59 p.m. Eastern Time on November 2, 2020. Prospective applicants should register as soon as possible on the GRANTS.GOV website to ensure they can complete the application process before the submission deadline. Application instructions are available on FTA's website at http://transit.dot.gov/​howtoapply and in the “FIND” module of GRANTS.GOV.

    FTA will not accept mail and fax submissions. Start Further Info Please send any questions on this notice to Jamel El-Hamri email. Jamel.El-Hamri@dot.gov phone. 2020-366-8985. A Telecommunication Device for the Deaf (TDD) is available for individuals who are deaf or hard of hearing at 1-800-877-8339.

    End Further Info End Preamble Start Supplemental Information Table of Contents A. Program Description B. Federal Award Information C. Eligibility Information D. Application and Submission Information E.

    Application Review Information F. Federal Award Administration Information G. Federal Awarding Agency Contact Information A. Program Description The Public Transportation COVID-19 Research Demonstration Grant Program is funded through the Public Transportation Innovation Program (49 U.S.C. 5312), with the goal to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the COVID-19 public health emergency.

    Eligible projects will propose to develop and deploy innovative solutions in four major areas. (1) Vehicle, facility, equipment and infrastructure cleaning and disinfection. (2) exposure mitigation measures. (3) innovative mobility such as contactless payments. And (4) measures that strengthen public confidence in transit.

    As required by 49 U.S.C. 5312(e)(4), projects funded under this NOFO must participate in an evaluation by an independent outside entity that will conduct a comprehensive evaluation of the success or failure of the projects funded under this subsection and any plan for broad-based implementation of the innovation promoted by successful projects. B. Federal Award Information FTA makes available $10,000,000 in fiscal year (FY) 2020 funds under the Public Transportation Innovation Program (49 U.S.C. 5312) to finance the Public Transportation COVID-19 Research Demonstration Grant Program.

    FTA may supplement the total funds available if additional funding becomes available at the time project selections are made. FTA will grant pre-award authority starting on the date of the project award announcement for selected projects and should be completed within 24 months from the date of award. Funds are available only for eligible expenses incurred after the announcement of project selections. C. Eligibility Information (1) Eligible Applicants Eligible applicants include State and local governmental authorities, direct recipients of Urbanized Area (49 U.S.C.

    5307) and Rural Area (49 U.S.C. 5311) formula funds, and Indian tribes. Eligible applicants are limited to FTA grantees or subrecipients who would be the primary beneficiaries of the innovative products and services that are developed—typically public transit agencies. Except for projects proposed by Indian tribes, proposals for projects in rural (non-urbanized) areas must be submitted as part of a consolidated State proposal. States and other eligible applicants also may submit consolidated proposals for projects in urbanized areas.

    The submission of the Statewide application will not preclude the submission and consideration of any application from other eligible recipients in an urbanized area in a State. Proposals may contain projects to be implemented by the recipient or its subrecipients. Eligible subrecipients include public agencies, private nonprofit organizations, and private providers engaged in public transportation. Eligible applicants may submit consolidated proposals for projects. (2) Cost Sharing or Matching The maximum Federal share of project costs is 100 percent.

    FTA may give additional consideration to applicants that propose a local share and may view these applicants as more competitive. The applicant must document the source(s) of the local match, if any, in the grant application. For any applicants proposing match, eligible local match sources include the following. Cash from non-Government sources other than revenues from providing public transportation services. Revenues derived from the sale of advertising and concessions.

    Revenues generated from value capture financing mechanisms. Funds from an undistributed cash surplus. Replacement or depreciation cash fund or reserve. New capital. Or in-kind contributions.

    (3) Eligible Projects Eligible projects will propose innovative solutions to improve operational efficiencies of transit agencies and enhance the mobility of transit users, through projects that demonstrate innovative solutions for. Vehicle, facility, equipment and infrastructure cleaning and disinfection. Exposure mitigation measures such a real-time notification of rail and bus passenger loads. New multi-modal payment innovative mobility systems such as contactless payments. And measures that strengthen public confidence in transit.

    Each applicant may only submit one proposal.Start Printed Page 63655 D. Application and Submission Information (1) Address and Form of Application Submission Applications must be submitted through GRANTS.GOV. Applicants can find general information for submitting applications through GRANTS.GOV at www.fta.dot.gov/​howtoapply, along with specific instructions for the forms and attachments required for submission. Mail and fax submissions will not be accepted. (2) Content and Form of Application Submission a.

    Proposal Submission A complete proposal submission consists of at least two forms. 1. The SF-424 Mandatory Form (downloadable from GRANTS.GOV) and 2. The supplemental form for the FY 2020 COVID-19 Demonstration Program (downloadable from GRANTS.GOV), which is available on FTA's website at (placeholder for FTA COVID-19 Demonstration Program). The application must include responses to all sections of the SF-424 mandatory form and the supplemental form unless a section is indicated as optional.

    FTA will use the information on the supplemental form to determine applicant and project eligibility for the program and to evaluate the proposal against the selection criteria described in part E of this notice. FTA will accept only one supplemental form per SF-424 submission. FTA encourages applicants to consider submitting a single supplemental form that includes multiple activities to be evaluated as a consolidated proposal. Applicants may attach additional supporting information to the SF-424 submission, including but not limited to letters of support, project budgets, or excerpts from relevant planning documents. Supporting documentation must be described and referenced by file name in the appropriate response section of the supplemental form, or it may not be reviewed.

    Information such as applicant name, Federal amount requested, local match amount, description of areas served, etc., may be requested in varying degrees of detail on both the SF-424 form and supplemental form. Applicants must fill in all fields unless stated otherwise on the forms. If applicants copy information into the supplemental form from another source, they should verify that the supplemental form has fully captured pasted text and that it has not truncated the text due to character limits built into the form. Applicants should use both the “Check Package for Errors” and the “Validate Form” validation buttons on both forms to check all required fields. Applicants should also ensure that the Federal and local amounts specified are consistent.

    Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage. Consistent with the R.O.U.T.E.S. Initiative, the Department encourages applicants to consider how the project will address the challenges faced by rural areas. B. Application Content The SF-424 Mandatory Form and the supplemental form will prompt applicants for the required information, including.

    I. Applicant Name ii. Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number iii. Key contact information (contact name, address, email address, and phone number) iv. Congressional district(s) where project will take place v.

    Project Information (title, executive summary, and type) vi. A detailed description of the need for the project vii. A detailed description of how the project will support the Program objectives viii. Evidence that the applicant can provide the local cost shares ix. A description of the technical, legal, and financial capacity of the applicant x.

    A detailed project budget xi. Details on the local matching funds xii. A detailed project timeline xiii. Whether the project impacts an Opportunity Zone (3) Unique Entity Identifier and System for Award Management (SAM) Each applicant is required to. (1) Be registered in SAM before submitting an application.

    (2) provide a valid unique entity identifier in its application. And (3) continue to maintain an active SAM registration with current information at all times during which the applicant has an active Federal award or an application or plan under consideration by FTA. These requirements do not apply if the applicant. (1) Is excepted from the requirements under 2 CFR 25.110(b) or (c). Or (2) has an exception approved by FTA under 2 CFR 25.110(d).

    FTA may not make an award until the applicant has complied with all applicable unique entity identifier and SAM requirements. If an applicant has not fully complied with the requirements by the time FTA is ready to make an award, FTA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a Federal award to another applicant. All applicants must provide a unique entity identifier provided by SAM. Registration in SAM may take as little as 3-5 business days, but there can be unexpected steps or delays. For example, the applicant may need to obtain an Employer Identification Number.

    FTA recommends allowing ample time, up to several weeks, to complete all steps. For additional information on obtaining a unique entity identifier, please visit www.sam.gov. (4) Submission Dates and Times Project proposals must be submitted electronically through GRANTS.GOV by 11:59 p.m. Eastern on November 2, 2020. Mail and fax submissions will not be accepted.

    FTA urges applicants to submit applications at least 72 hours prior to the due date to allow time to correct any problems that may have caused either GRANTS.GOV or FTA systems to reject the submission. Proposals submitted after the deadline will only be considered under extraordinary circumstances not within the applicant's control. Deadlines will not be extended due to scheduled website maintenance. GRANTS.GOV scheduled maintenance and outage times are announced on the GRANTS.GOV website. Within 48 hours after submitting an electronic application, the applicant should receive two email messages from GRANTS.GOV.

    (1) Confirmation of successful transmission to GRANTS.GOV. And (2) confirmation of successful validation by GRANTS.GOV. If the applicant does not receive confirmation of successful validation or receives a notice of failed validation or incomplete materials, the applicant must address the reason for the failed validation, as described in the email notice, and resubmit before the submission deadline. If making a resubmission for any reason, applicants must include all original attachments regardless of which attachments were updated and check the box on the supplemental form indicating this is a resubmission. Applicants are encouraged to begin the process of registration on the GRANTS.GOV site well in advance of the submission deadline.

    Registration is Start Printed Page 63656a multi-step process, which may take several weeks to complete before an application can be submitted. Registered applicants may still be required to update their registration before submitting an application. Registration in SAM is renewed annually and persons making submissions on behalf of the Authorized Organization Representative (AOR) must be authorized in GRANTS.GOV by the AOR to make submissions. (5) Funding Restrictions Funds may be used for post-award expenditures only. Funds under this NOFO cannot be used to reimburse projects for otherwise eligible expenses incurred prior to the date of project award announcements.

    (6) Other Submission Requirements FTA encourages applicants to identify scaled funding options in case insufficient funding is available to fund a project at the full requested amount. If an applicant indicates that a project is scalable, the applicant must provide an appropriate minimum funding amount that will fund an eligible project that achieves the objectives of the program and meets all relevant program requirements. The applicant must provide a clear explanation of how a reduced award would affect the project budget and scope. FTA may award a lesser amount whether or not the applicant provides a scalable option. E.

    Application Review Information (1) Project Evaluation Criteria Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage. Consistent with the R.O.U.T.E.S. Initiative, the Department will consider how the project will address the challenges faced by rural areas. In addition, the Department will review and consider applications for funding pursuant to this Notice in accordance with the President's September 2, 2020 memorandum, entitled Memorandum on Reviewing Funding to State and Local Government Recipients of Federal Funds that Are Permitting Anarchy, Violence, and Destruction in American Cities, consistent with guidance from the Office of Management and Budget and the Attorney General and with all applicable laws. FTA will evaluate proposals submitted according to the following criteria.

    (a) Project Innovation and Impact. (b) Project Approach. (c) National Applicability. (d) Commercialization and/or Knowledge Transfer. And (e) Technical, Legal and Financial Capacity.

    FTA encourages each applicant to demonstrate how a project supports all criteria with the most relevant information the applicant can provide, regardless of whether such information has been specifically requested or identified in this notice. A. Project Innovation and Impact i. Effectiveness of the project in achieving and demonstrating the specific objectives of this program. Ii.

    Demonstration of benefits in addressing the needs of the transit agency and industry and impacts to infrastructure, equipment, transit workforce, and riders. Iii. Degree of improvement over current and existing technologies, designs, and/or practices applicable to the transit industry. B. Project Approach i.

    Quality of the project approach such as existing partnerships, collaboration strategies and level of commitment of the project partners. Ii. Proposal is realistic in its approach to fulfill the milestones/deliverables, schedule and goals. C. National Applicability i.

    Degree to which the project could be replicated by other transit agencies regionally or nationally. Ii. Ability to evaluate technologies, designs and/or practices in a wide variety of conditions and locales. Iii. Degree to which the technology, designs and/or practices can be replicated by other transportation modes.

    D. Commercialization and/or Knowledge Transfer i. Demonstrates a realistic plan for moving the results of the project into the transit marketplace (patents, conferences, articles in trade magazines, webinar, site visits, etc.). Ii. How the project team plans to work with the industry on improving best practices, guidance and/or standards, if applicable.

    Iii. Demonstrate a clear understanding and robust approach to data collection, access and management. E. Technical, Legal and Financial Capacity Capacity of the applicant and any partners to successfully execute the project effort. There should be no outstanding legal, technical, or financial issues with the applicant that would make this a high-risk project.

    (2) Review and Selection Process An FTA technical evaluation committee will evaluate proposals based on the published project evaluation criteria. Members of the technical evaluation committee will rate the applications and may seek clarification about any statement in an application. The FTA Administrator will determine the final selection and amount of funding for each project after consideration of the findings of the technical evaluation committee. Geographic diversity, diversity of the project type, the amount of local match to be provided, and the applicant's receipt and management of other Federal transit funds may be considered in FTA's award decisions. Prior fare payment innovation efforts may receive priority consideration.

    The FTA Administrator will consider the following key DOT objectives. A. Utilizing alternative funding sources and innovative financing models to attract non-Federal sources of investment. B. Whether the project is located in or supports public transportation service in a qualified opportunity zone designated pursuant to 26.U.S.C.

    1400Z-1. And c. The extent to which the project addresses challenges specific to the provision of rural public transportation. (3) FAPIIS Review Prior to making a grant award, FTA is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System (FAPIIS) accessible through SAM. An applicant may review and comment on information about itself that a Federal awarding agency previously entered.

    FTA will consider any comments by the applicant, in addition to the other information in FAPIIS, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.205 Federal Awarding Agency Review of Risk Posed by Applicants. F. Federal Award Administration Information (1) Federal Award Notices FTA will announce the final project selections on the FTA website. Project recipients should contact their FTA Regional Office for additional information regarding allocations for Start Printed Page 63657projects. At the time project selections are announced, FTA will extend pre-award authority for the selected projects.

    There is no blanket pre-award authority for these projects before announcement. There is no minimum or maximum grant award amount, but FTA intends to fund as many meritorious projects as possible. FTA only will consider proposals from eligible recipients for eligible activities. Due to funding limitations, projects selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate that the proposed projects are still viable and can be completed with the amount awarded.

    (2) Administrative and National Policy Requirements a. Pre-Award Authority FTA will issue specific guidance to recipients regarding pre-award authority at the time of selection. FTA does not provide pre-award authority for competitive funds until projects are selected, and there are Federal requirements that must be met before costs are incurred. For more information about FTA's policy on pre-award authority, see the FY 2020 Apportionments Notice published on June 3, 2020, at https://www.govinfo.gov/​content/​pkg/​FR-2020-06-03/​pdf/​2020-11946.pdf. b.

    Grant Requirements Selected applicants will submit a grant application through FTA's electronic grant management system and adhere to the customary FTA grant requirements for research project (insert Circular name). All competitive grants, regardless of award amount, will be subject to the Congressional notification and release process. FTA emphasizes that third-party procurement applies to all funding awards, as described in FTA Circular 4220.1F, “Third Party Contracting Guidance.” However, FTA may approve applications that include a specifically identified partnering organization(s) (2 CFR 200.302(f)). When included, the application, budget, and budget narrative should provide a clear understanding of how the selection of these organizations is critical for the project and give sufficient detail about the costs involved. C.

    Planning FTA encourages applicants to engage the appropriate State Departments of Transportation, Regional Transportation Planning Organizations, or Metropolitan Planning Organizations in areas to be served by the project funds available under this program. D. Standard Assurances The applicant assures that it will comply with all applicable Federal statutes, regulations, executive orders, FTA circulars, and other Federal administrative requirements in carrying out any project supported by the FTA grant. The applicant acknowledges that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with FTA. The applicant understands that Federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project.

    The applicant agrees that the most recent Federal requirements will apply to the project unless FTA issues a written determination otherwise. The applicant must submit the Certifications and Assurances before receiving a grant if it does not have current certifications on file. E. Free Speech and Religious Liberty In connection with any program or activity conducted with or benefiting from funds awarded under this notice, recipients of funds must comply with all applicable requirements of Federal law, including, without limitation, the Constitution of the United States. Statutory, regulatory, and public policy requirements, including without limitation, those protecting free speech, religious liberty, public welfare, the environment, and prohibiting discrimination.

    The conditions of performance, non-discrimination requirements, and other assurances made applicable to the award of funds in accordance with regulations of the Department of Transportation.

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    Several years ago I made the difficult decision to no longer perform bedside nursing and become a nurse administrator. The biggest loss from my transition is the feeling that what I do matters to the patient. COVID-19 has forced a lot of us to rethink the role we play in health starlix and hypoglycemia care and what the real priority should be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a pandemic or prepare for the unknown future of, “When is our turn?.

    € For me, COVID-19 has reignited the feeling that what I do matters as virtual care has become a powerful tool on the forefront of care during this crisis. It has starlix and hypoglycemia also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be discarded permanently. When I became the director of virtual care at our organization in 2015 I knew nothing about telehealth. Sure, I had seen a stroke robot in some Emergency Departments, and I had some friends that told me their insurance company lets them FaceTime a doctor for free (spoiler alert.

    It’s not starlix and hypoglycemia FaceTime). I was tech-savvy from a consumer perspective and a tech novice from an IT perspective. Nevertheless, my team and I spent the next few years learning as we built one of the higher volume virtual care networks in the state of Michigan. We discovered a lot of barriers that keep virtual care from actually making the lives of patients and providers better and we starlix and hypoglycemia also became experts in working around those barriers.

    But, there were two obstacles that we could not overcome. Government regulation and insurance provider willingness to cover virtual visits. These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care starlix and hypoglycemia technologies to provide care outside of our brick-and-mortar facilities, most commonly in the patient home. The need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in place created instant demand for direct-to-consumer virtual care.

    In all honesty, I’ve always considered direct-to-consumer virtual care to be the flashy, must-have holiday gift of the year that organizations are convinced will be the way of the future. If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of starlix and hypoglycemia vendors that will sell them their app and their doctors and put the health system’s logo on it. What a health system will struggle with is to find is enough patient demand to cover the high cost. Remember my friends from earlier that told me about the app their insurance gave them?.

    Nearly all starlix and hypoglycemia of them followed that up by telling me they’ve never actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how can we provide care that our patients actually want and need from the doctors they want to see. Ironically, this fiscal year we had a corporate top priority around direct-to-consumer virtual care. We wanted to starlix and hypoglycemia expand what we thought were some successful pilots and perform 500 direct-to-consumer visits.

    This year has been one of the hardest of my leadership career because, frankly, up until a month ago I was about to fail on this top priority. With only four months left, we were only about halfway there. The biggest problem we ran into was that every great idea a starlix and hypoglycemia physician brought to me was instantly dead in the water because practically no insurance company would pay for it. There are (prior to COVID-19) a plethora of rules around virtual care billing but the simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health care facility.

    It is extremely limited what will be paid for in the patient home and most of it is so specific that the average patient isn’t eligible to get any in-home virtual care. Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the starlix and hypoglycemia physician to forgo reimbursement for a visit that would be covered if it happened in office. Add to that the massive capital and operating expenses it takes to build a virtual care network and you can see why these programs don’t exist. A month ago I was skeptical we’d have a robust direct-to-consumer program any time soon and then COVID-19 hit.

    When COVID-19 started starlix and hypoglycemia to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they would temporarily begin reimbursing for virtual visits conducted in the patient’s home for COVID-19 and non-COVID related visits. We were already frantically designing a virtual program to handle the wave of COVID-19 screening visits that were overloading our emergency departments and urgent cares. We were starlix and hypoglycemia having plenty of discussions around reimbursement for this clinic.

    Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community benefit and eat the cost?. The CMS waiver gave us hope that we would be compensated for diverting patients away from reimbursed visits to a virtual visit that is more convenient for the patient and aligns with the concept of social distancing. Realistically we starlix and hypoglycemia don’t know if we will be paid for any of this. We are holding all of the bills for at least 90 days while the industry sorts out the rules.

    I was excited by the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care barriers. However, I was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed starlix and hypoglycemia. I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, Facebook, Skype, etc.) that they use every day. The problem is nearly every app the consumer uses on a daily basis is banned by HIPAA because “it’s not secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet again gave me strep throat but apparently the concern is great enough to stifle the entire industry.

    Sure, not every health care discussion starlix and hypoglycemia is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten regulations surrounding specific health conditions. The idea that regulations change based on medical situation is not new. For example, in my home state of Michigan, adolescents are essentially considered emancipated starlix and hypoglycemia if it involves sexual health, mental health or substance abuse.

    Never mind that this same information is freely given over the phone by every office around the country daily without issue, but I digress. While my job is to innovate new pathways for care, our lawyer’s job is to protect the organization and he, along with IT security, rightfully shot down my consumer applications idea. A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use starlix and hypoglycemia discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications. The elimination of billing restrictions and HIPAA regulations changed what is possible for health care organizations to offer virtually.

    Unfortunately both changes are listed as temporary and will likely be removed when the pandemic ends. Six days after the HIPAA changes were announced, we launched starlix and hypoglycemia a centralized virtual clinic for any patient that wanted a direct-to-consumer video visit to be screened by a provider for COVID-19. It allows patients to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them. They don’t have to download an app, create an account or even be an established patient of our health system.

    It saw over 900 patients in the first 12 days it was open starlix and hypoglycemia. That is 900 real patients that received care from a physician or advanced practice provider without risking personal exposure and without going to an already overwhelmed ED or urgent care. To date, 70 percent of the patients seen by the virtual clinic did not meet CDC testing criteria for COVID-19. I don’t believe we could have reached even half of these patients had the starlix and hypoglycemia consumer application restrictions been kept.

    A program like this almost certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement in normal times. Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and payors being on the same page is what fueled this fire. During the virtual clinic’s first two weeks, my team turned its attention to getting over 300 starlix and hypoglycemia providers across 60+ offices virtual so they could see their patients at home. Imagine being an immunocompromised cancer patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist.

    Direct-to-consumer virtual care is the best way to safely care for these patients and without these temporary waivers it wouldn’t be covered by insurance even if you did navigate the clunky apps that are HIPAA compliant. Do we really think the immunocompromised cancer patient feels any more comfortable every starlix and hypoglycemia normal flu season?. Is it any more appropriate to ask them to risk exposure to the flu than it is to COVID-19?. And yet we deny them this access in normal times and it quite possibly will be stripped away from them when this crisis is over.

    Now 300 to 400 patients per day starlix and hypoglycemia in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits. Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use the software that connects us to the patient. Lastly, recall that prior to COVID-19, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. COVID-19 has starlix and hypoglycemia been a wake-up call to the whole country and health care is no exception.

    It has put priorities in perspective and shined a light on what is truly value-added. For direct-to-consumer virtual care it has shown us what is possible when we get out of our own way. If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first starlix and hypoglycemia place. HIPAA regulation cannot go back to its antiquated practices if we are truly going to shift the focus to patient wellness.

    CMS and private payors must embrace value-added direct-to-consumer virtual care and allow patients the access they deserve. COVID-19 has forced this industry forward, we cannot starlix and hypoglycemia allow it to regress and be forgotten when this is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of Michigan. The views and opinions expressed in this commentary are his own.When dealing with all of the aspects of diabetes, it’s easy to let your feel fall to the bottom of the list.

    But daily care and starlix and hypoglycemia evaluation is one of the best ways to prevent foot complications. It’s important to identify your risk factors and take the proper steps in limiting your complications. Two of the biggest complications with diabetes are peripheral neuropathy and ulcer/amputation. Symptoms of peripheral neuropathy include numbness, tingling and/or burning in your starlix and hypoglycemia feet and legs.

    You can slow the progression of developing neuropathy by making it a point to manage your blood sugars and keep them in the normal range. If you are experiencing these symptoms, it is important to establish and maintain a relationship with a podiatrist. Your podiatrist can make sure things are looking healthy and bring starlix and hypoglycemia things to your attention to monitor and keep a close eye on. Open wounds or ulcers can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation.

    If ulcerations do develop, it’s extremely important to identify the cause and address it. Ulcers can get worse quickly, so it’s necessary to seek immediate medical treatment if you find yourself or starlix and hypoglycemia a loved one dealing with this complication. Untreated ulcerations often lead to amputation and can be avoided if proper medical attention is sought right away. There are important things to remember when dealing with diabetic foot care.

    It’s very important to starlix and hypoglycemia inspect your feet daily, especially if you have peripheral neuropathy. You may have a cut or a sore on your feet that you can’t feel, so your body doesn’t alarm you to check your feet. Be gentle when bathing your feet. Moisturize your feet, but not between your toes.

    Do not treat calluses or corns on your own. Wear clean, dry socks. Never walk barefoot, and consider socks and shoes made specifically for patients with diabetes. Kristin Raleigh, D.P.M., is a podiatrist who sees patients at Foot &.

    Ankle Specialists of Mid-Michigan in Midland. Those who would like to make an appointment may contact her office at (989) 488-6355..

    The odds are it’s not available buy starlix online usa to you, and there is a reason for that. You may be hearing about how virtual care, often described as telehealth or telemedicine, is beneficial during COVID-19 and how health systems are offering virtual access like never before. There’s a reason for that, too. For the past few weeks I’ve seen Facebook posts daily from former nursing colleagues in metro Detroit, one of the buy starlix online usa hardest hit areas in the country, as they provide front-line care to patients with COVID-19. It makes me very proud to call these nurses my friends.

    As a former emergency department nurse, I recall the feeling of satisfaction knowing that I’ve helped someone on the worst day of their life. One of the best parts buy starlix online usa of being a nurse is knowing you matter to the only person in health care that truly matters. The patient. Several years ago I made the difficult decision to no longer perform bedside nursing and become a nurse administrator. The biggest loss from my transition is the feeling buy starlix online usa that what I do matters to the patient.

    COVID-19 has forced a lot of us to rethink the role we play in health care and what the real priority should be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a pandemic or prepare for the unknown future of, “When is our turn?. € For me, COVID-19 has reignited the feeling that what I do matters as virtual care has become a powerful tool on the buy starlix online usa forefront of care during this crisis. It has also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be discarded permanently. When I became the director of virtual care at our organization in 2015 I knew nothing about telehealth.

    Sure, I had seen a stroke robot in some Emergency Departments, and I had some friends that told me their buy starlix online usa insurance company lets them FaceTime a doctor for free (spoiler alert. It’s not FaceTime). I was tech-savvy from a consumer perspective and a tech novice from an IT perspective. Nevertheless, my team and I spent the next few years learning as we built one of the buy starlix online usa higher volume virtual care networks in the state of Michigan. We discovered a lot of barriers that keep virtual care from actually making the lives of patients and providers better and we also became experts in working around those barriers.

    But, there were two obstacles that we could not overcome. Government regulation and insurance provider willingness to cover virtual buy starlix online usa visits. These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care technologies to provide care outside of our brick-and-mortar facilities, most commonly in the patient home. The need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in place created instant demand for direct-to-consumer virtual care. In all honesty, I’ve always considered direct-to-consumer buy starlix online usa virtual care to be the flashy, must-have holiday gift of the year that organizations are convinced will be the way of the future.

    If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of vendors that will sell them their app and their doctors and put the health system’s logo on it. What a health system will struggle with is to find is enough patient demand to cover the high cost. Remember my friends from earlier that told me about the buy starlix online usa app their insurance gave them?. Nearly all of them followed that up by telling me they’ve never actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how can we provide care that our patients actually want and need from the doctors they want to see.

    Ironically, this fiscal year buy starlix online usa we had a corporate top priority around direct-to-consumer virtual care. We wanted to expand what we thought were some successful pilots and perform 500 direct-to-consumer visits. This year has been one of the hardest of my leadership career because, frankly, up until a month ago I was about to fail on this top priority. With only four months left, we buy starlix online usa were only about halfway there. The biggest problem we ran into was that every great idea a physician brought to me was instantly dead in the water because practically no insurance company would pay for it.

    There are (prior to COVID-19) a plethora of rules around virtual care billing but the simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health care facility. It is extremely limited what will be paid for in the patient home and most of it is so specific that the average patient isn’t eligible to get any in-home virtual buy starlix online usa care. Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the physician to forgo reimbursement for a visit that would be covered if it happened in office. Add to that the massive capital and operating expenses it takes to build a virtual care network and you can see why these programs don’t exist. A month ago I was skeptical we’d have buy starlix online usa a robust direct-to-consumer program any time soon and then COVID-19 hit.

    When COVID-19 started to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they would temporarily begin reimbursing for virtual visits conducted in the patient’s home for COVID-19 and non-COVID related visits. We were already buy starlix online usa frantically designing a virtual program to handle the wave of COVID-19 screening visits that were overloading our emergency departments and urgent cares. We were having plenty of discussions around reimbursement for this clinic. Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community benefit and eat the cost?.

    The CMS waiver gave us hope that we buy starlix online usa would be compensated for diverting patients away from reimbursed visits to a virtual visit that is more convenient for the patient and aligns with the concept of social distancing. Realistically we don’t know if we will be paid for any of this. We are holding all of the bills for at least 90 days while the industry sorts out the rules. I was excited by the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care buy starlix online usa barriers. However, I was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed.

    I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, Facebook, Skype, etc.) that they use every day. The problem is nearly every app the consumer uses on a daily basis is banned by HIPAA because “it’s not buy starlix online usa secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet again gave me strep throat but apparently the concern is great enough to stifle the entire industry. Sure, not every health care discussion is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten regulations surrounding specific health conditions. The idea that buy starlix online usa regulations change based on medical situation is not new.

    For example, in my home state of Michigan, adolescents are essentially considered emancipated if it involves sexual health, mental health or substance abuse. Never mind that this same information is freely given over the phone by every office around the country daily without issue, but I digress. While my job is to innovate buy starlix online usa new pathways for care, our lawyer’s job is to protect the organization and he, along with IT security, rightfully shot down my consumer applications idea. A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications. The elimination of billing restrictions and HIPAA regulations changed what is possible for health care organizations to offer virtually.

    Unfortunately both changes are listed as temporary and will likely be removed when buy starlix online usa the pandemic ends. Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any patient that wanted a direct-to-consumer video visit to be screened by a provider for COVID-19. It allows patients to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them. They don’t have to download an app, create an account or even be an established buy starlix online usa patient of our health system. It saw over 900 patients in the first 12 days it was open.

    That is 900 real patients that received care from a physician or advanced practice provider without risking personal exposure and without going to an already overwhelmed ED or urgent care. To date, 70 percent of buy starlix online usa the patients seen by the virtual clinic did not meet CDC testing criteria for COVID-19. I don’t believe we could have reached even half of these patients had the consumer application restrictions been kept. A program like this almost certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement in normal times. Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and buy starlix online usa payors being on the same page is what fueled this fire.

    During the virtual clinic’s first two weeks, my team turned its attention to getting over 300 providers across 60+ offices virtual so they could see their patients at home. Imagine being an immunocompromised cancer patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist. Direct-to-consumer virtual care is buy starlix online usa the best way to safely care for these patients and without these temporary waivers it wouldn’t be covered by insurance even if you did navigate the clunky apps that are HIPAA compliant. Do we really think the immunocompromised cancer patient feels any more comfortable every normal flu season?. Is it any more appropriate to ask them to risk exposure to the flu than it is to COVID-19?.

    And yet we deny them this access in normal buy starlix online usa times and it quite possibly will be stripped away from them when this crisis is over. Now 300 to 400 patients per day in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits. Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use the software that connects us to the patient. Lastly, recall that prior to COVID-19, buy starlix online usa our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. COVID-19 has been a wake-up call to the whole country and health care is no exception.

    It has put priorities in perspective and shined a light on what is truly value-added. For direct-to-consumer virtual care it has shown us what is possible when we get buy starlix online usa out of our own way. If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first place. HIPAA regulation cannot go back to its antiquated practices if we are truly going to shift the focus to patient wellness. CMS and private payors must embrace buy starlix online usa value-added direct-to-consumer virtual care and allow patients the access they deserve.

    COVID-19 has forced this industry forward, we cannot allow it to regress and be forgotten when this is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of Michigan. The views and opinions expressed in this commentary are his own.When dealing with all of the aspects of diabetes, it’s easy buy starlix online usa to let your feel fall to the bottom of the list. But daily care and evaluation is one of the best ways to prevent foot complications. It’s important to identify your risk factors and take the proper steps in limiting your complications.

    Two of the biggest complications with diabetes buy starlix online usa are peripheral neuropathy and ulcer/amputation. Symptoms of peripheral neuropathy include numbness, tingling and/or burning in your feet and legs. You can slow the progression of developing neuropathy by making it a point to manage your blood sugars and keep them in the normal range. If you are experiencing these symptoms, buy starlix online usa it is important to establish and maintain a relationship with a podiatrist. Your podiatrist can make sure things are looking healthy and bring things to your attention to monitor and keep a close eye on.

    Open wounds or ulcers can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation. If ulcerations do develop, it’s extremely buy starlix online usa important to identify the cause and address it. Ulcers can get worse quickly, so it’s necessary to seek immediate medical treatment if you find yourself or a loved one dealing with this complication. Untreated ulcerations often lead to amputation and can be avoided if proper medical attention is sought right away. There are important things to remember when dealing with buy starlix online usa diabetic foot care.

    It’s very important to inspect your feet daily, especially if you have peripheral neuropathy. You may have a cut or a sore on your feet that you can’t feel, so your body doesn’t alarm you to check your feet. Be gentle when bathing your feet buy starlix online usa. Moisturize your feet, but not between your toes. Do not treat calluses or corns on your own.

    How should I use Starlix?

    Take nateglinide tablets by mouth. Swallow the tablets with a drink of water. Do not chew the tablets. Nateglinide is usually taken three times a day with a meal. Each dose should be taken 1-30 minutes before each meal. If you skip a meal, do not take that dose of nateglinide. Do not take your medicine more often than directed. Do not take nateglinide without a meal. Do not stop taking except on your prescriber's advice.

    Contact your pediatrician or health care professional regarding the use of Starlix in children. Special care may be needed.

    Overdosage: If you think you have taken too much of Starlix contact a poison control center or emergency room at once.

    NOTE: Starlix is only for you. Do not share Starlix with others.

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    Health systems for years have been talking about patient- and consumer-centered care, trying to figure out new ways buy starlix without prescription to meet patients where they are, make their hospitals stays where can you buy starlix more enjoyable and more strongly engage them in clinical decisions.But as COVID-19 led more people to seek care from home and decreased touch points with patients even inside of hospitals, health systems needed new strategies to keep patients involved in care and provide them with resources—two core components of patient-centered care, according to Modern Healthcare’s Power Panel, a survey of top healthcare CEOs—even when providers couldn’t see them face-to-face.While COVID-19 created a new reality for healthcare in just a few months, it hasn’t sidetracked health systems from projects focused on patient-centered care and experience, according to their CEOs. In fact, for many, it accelerated digital efforts focused on patients.Roughly 87% of CEOs who participated in the Power Panel survey said their organization had implemented new digital tools related to consumerism during where can you buy starlix COVID-19.“A lot of what we do in the consumer experience is in person,” said David Entwistle, CEO of Stanford Health Care. €œBut despite all of that, I still think what we’ve been able to focus on and do has probably propelled us further than what we gave up, so to speak.”When COVID-19 hit, executives at Scripps Health knew they needed to figure out how care teams could reduce contact with patients who had the highly infectious disease, without where can you buy starlix losing the personal touch.“We wanted to be customer service-oriented and patient-centered, but we also wanted to protect our employees from going in and out of the rooms a lot,” said Chris Van Gorder, CEO of the San Diego-based health system.Their solution?. Installing baby monitors in patient rooms.It proved to be a low-cost way to let nurses communicate with COVID-19 patients—and have patients talk back—without necessarily having to go inside the patient’s room, Van Gorder said.It’s one example of how where can you buy starlix systems have developed new processes to keep patients engaged and employees safe.For ambulatory visits, health systems are overhauling entrenched processes, keeping patients outside of the facility as much as possible.Scripps Health recently rolled out an option for patients to automatically get checked in when they arrive at a clinic by enabling location tracking on their patient portal app. Then, patients get a text message when the exam room is prepped and the provider is ready to see them—meaning they can go directly to the exam room, bypassing registration and other steps.Sometimes, patients don’t even have to step foot into the hospital.

    Dartmouth-Hitchcock Health in Lebanon, N.H., has started drawing some labs while patients sit in where can you buy starlix their cars.These types of programs are part of a growing trend that Paddy Padmanabhan, founder and CEO of Damo Consulting, refers to as the “drive-through experience.”He compared the process to ordering a coffee from Starbucks. Patients schedule appointments, check in from the parking lot and then pay for services online, similar to how customers can place an order for where can you buy starlix coffee through an app and pick it up at a drive-through window.“If you have to go into a clinic for something, you go in and you go in for exactly what you need,” Padmanabhan explained, adding that the trend is still just emerging.But with health systems implementing whole new sets of processes—often with a quick rollout amid COVID-19—organizations are still assessing how well they’re working.Froedtert Health in Milwaukee launched a project during the pandemic to get feedback from patients about their experiences at the health system. Most data is collected through calling patients and sending emails, where can you buy starlix said Cathy Jacobson, Froedtert Health’s CEO. There’s a pretty quick turnaround, so executives and managers get that feedback on a weekly basis.Froedtert had planned to roll out the customer experience project a few months earlier but delayed it and retooled some questions to focus on patients’ perception of infection control and safety—such as getting patient feedback on masking policies.“We get that (feedback) back to our managers immediately,” Jacobson where can you buy starlix said. €œWe’re just now starting to tap the insights from that.”Carilion Clinic in Roanoke, Va., had been planning to roll out a multipronged digital front door strategy over the next 24 months.

    But as COVID-19 cases mounted in the spring, executives realized they needed to move faster.Executives in healthcare for years have been discussing the so-called “digital front door,” wanting to use new where can you buy starlix technologies to engage patients outside a facility’s walls. But with many health systems compelled to restrict patients from walking into their actual physical front doors at the height of the COVID-19 pandemic, executives had to revisit those plans, pushing out new chatbot symptom checkers and at-home virtual visits.COVID-19 “hasn’t changed our thinking” where can you buy starlix about patient-centered care, said Nancy Agee, Carilion Clinic’s CEO. But it has accelerated “how far and how fast” the system moved toward implementing tasks already on its to-do where can you buy starlix list.Agee is in good company. Seventy-three percent of CEOs in Modern Healthcare’s Power Panel survey said their focus on consumerism increased amid COVID-19, with the remaining 27% saying their focus stayed the same.At Carilion Clinic, that included expanding the roster of tools that patients use to connect with the system where can you buy starlix online, such as rolling out options to self-schedule appointments and pay bills. And Carilion is developing an app, dubbed MyCarilion, which will centralize where patients access those services as well as educational videos, directions to facilities and on-demand telehealth.Across the board, telehealth has played a major role in how health systems are keeping patients outside of the hospital, but still connected to their care team.All CEOs who responded to Modern Healthcare’s Power Panel survey indicated they’d increased their telehealth investments during the pandemic.

    CEOs are chosen to participate in the survey.Dartmouth-Hitchcock Health in Lebanon, N.H., was averaging just three telehealth visits per where can you buy starlix week before COVID-19 hit. At the height of the pandemic, it was conducting up to 2,000 where can you buy starlix virtual visits a day. To make sure patients were prepared for a telehealth visit, medical assistants called patients the day before their appointment to http://www.amisdepasteur.fr/how-do-i-get-starlix/ walk them through the process and how to use the technology.Even if telehealth use slows as the pandemic subsides, as some experts predict will happen, it’ll still be where can you buy starlix a powerful option for patients, said Dr. Joanne Conroy, Dartmouth-Hitchcock Health’s CEO where can you buy starlix. In the health system’s territory in New Hampshire and Vermont, telehealth could prove a useful tool to avoid missed patient appointments during snow storms, she said.“People appreciated the importance of virtual everything during the pandemic,” she said.

    €œI don’t think all of that is going to go away.”Moving forward, Dartmouth-Hitchcock sees where can you buy starlix telehealth as a market opportunity. The health where can you buy starlix system is working to create a direct-to-consumer urgent-care telehealth program, which could help to attract new patients, according to Conroy. The program, which is still being developed, will initially roll out where can you buy starlix to the health system’s employees, who will provide feedback.As telehealth use soared this past spring, health systems were confronted with a problem. Not all patients have access to high-quality internet.It’s not a new problem, but it took on newfound importance as health systems were forced to shift more and more patient appointments online.It’s frustrating to be “in the middle of a telehealth visit and it drops or you can’t hear someone,” said where can you buy starlix David Entwistle, CEO of Palo Alto, Calif.-based Stanford Health Care. For some patient populations, that could go beyond frustration and become an issue of access to care.“What I do worry about is that there’s some socio-economic demographics that are not going to have access to (this) technology,” Entwistle added.Health systems are still grappling with how to address that challenge.During the pandemic, clinicians have been able to replace some appointments with audio-only telephone visits.

    However, payment for those services from CMS might expire with where can you buy starlix the public health emergency.Dr. R. Lawrence Moss, CEO of Jacksonville, Fla.-based Nemours Children’s Health System, suggested that internet access could be the next social determinant of health that health systems target. All CEOs in Modern Healthcare’s Power Panel survey said their organizations need to address patient issues beyond traditional healthcare, including social determinants. That typically includes addressing access to food or transportation, but not internet.Internet access is one of many social factors that Nemours is considering, Moss said.“Just like I believe the health system needs to play a role with partners in ensuring that every child has access to high-quality food, every child also needs access to high-quality digital connectivity,” Moss said.

    €œA decade ago we wouldn’t have said that, but it’s a different world now.”Roughly 6.5% of Americans lacked access to wired broadband that met the Federal Communications Commission’s speed benchmark in 2017, according to a report the agency released last year. About 26.4% of rural Americans lack that access, an issue that HHS, the FCC and the Agriculture Department said they’ll tackle as part of a new Rural Telehealth Initiative.Even if patients do have internet access, they might need help learning to use health systems’ emerging digital tools.Carilion Clinic in Roanoke, Va., is working to stand up Apple Genius Bar-style technology support stations in its surrounding community, as part of a program to better answer patients’ questions about using the health system’s tech tools and encourage them to adopt the capabilities, said Nancy Agee, Carilion’s CEO. The system hopes to open the first station in a few months.Given COVID-19, Agee said Carilion is working on possibilities for creating a “virtual” tech bar. The health system is planning to use a new patient education program, which it’s already using to let clinicians assign short educational videos to patients about some conditions and procedures. A set of videos on how to use Carilion’s digital tools, such as its apps, could fit into that resource, Agee said..

    Health systems http://www.amisdepasteur.fr/best-online-starlix/ for years have been talking about patient- and consumer-centered care, trying to figure out new ways to meet patients where they are, make their hospitals buy starlix online usa stays more enjoyable and more strongly engage them in clinical decisions.But as COVID-19 led more people to seek care from home and decreased touch points with patients even inside of hospitals, health systems needed new strategies to keep patients involved in care and provide them with resources—two core components of patient-centered care, according to Modern Healthcare’s Power Panel, a survey of top healthcare CEOs—even when providers couldn’t see them face-to-face.While COVID-19 created a new reality for healthcare in just a few months, it hasn’t sidetracked health systems from projects focused on patient-centered care and experience, according to their CEOs. In fact, for many, it accelerated digital buy starlix online usa efforts focused on patients.Roughly 87% of CEOs who participated in the Power Panel survey said their organization had implemented new digital tools related to consumerism during COVID-19.“A lot of what we do in the consumer experience is in person,” said David Entwistle, CEO of Stanford Health Care. €œBut despite all of that, I still think what we’ve been able to focus on and do has probably propelled us further than buy starlix online usa what we gave up, so to speak.”When COVID-19 hit, executives at Scripps Health knew they needed to figure out how care teams could reduce contact with patients who had the highly infectious disease, without losing the personal touch.“We wanted to be customer service-oriented and patient-centered, but we also wanted to protect our employees from going in and out of the rooms a lot,” said Chris Van Gorder, CEO of the San Diego-based health system.Their solution?. Installing baby monitors in buy starlix online usa patient rooms.It proved to be a low-cost way to let nurses communicate with COVID-19 patients—and have patients talk back—without necessarily having to go inside the patient’s room, Van Gorder said.It’s one example of how systems have developed new processes to keep patients engaged and employees safe.For ambulatory visits, health systems are overhauling entrenched processes, keeping patients outside of the facility as much as possible.Scripps Health recently rolled out an option for patients to automatically get checked in when they arrive at a clinic by enabling location tracking on their patient portal app. Then, patients get a text message when the exam room is prepped and the provider is ready to see them—meaning they can go directly to the exam room, bypassing registration and other steps.Sometimes, patients don’t even have to step foot into the hospital.

    Dartmouth-Hitchcock Health in Lebanon, N.H., has started drawing some labs while patients sit in their cars.These types of programs are part of a buy starlix online usa growing trend that Paddy Padmanabhan, founder and CEO of Damo Consulting, refers to as the “drive-through experience.”He compared the process to ordering a coffee from Starbucks. Patients schedule appointments, check buy starlix online usa in from the parking lot and then pay for services online, similar to how customers can place an order for coffee through an app and pick it up at a drive-through window.“If you have to go into a clinic for something, you go in and you go in for exactly what you need,” Padmanabhan explained, adding that the trend is still just emerging.But with health systems implementing whole new sets of processes—often with a quick rollout amid COVID-19—organizations are still assessing how well they’re working.Froedtert Health in Milwaukee launched a project during the pandemic to get feedback from patients about their experiences at the health system. Most data is collected through calling patients and sending emails, said buy starlix online usa Cathy Jacobson, Froedtert Health’s CEO. There’s a pretty quick turnaround, so executives and managers get that feedback on a weekly basis.Froedtert had planned to roll out the customer experience project a few months earlier but delayed it and retooled some questions to focus on patients’ perception of infection control and safety—such as getting patient feedback on masking policies.“We get that (feedback) back to our managers immediately,” Jacobson said buy starlix online usa. €œWe’re just now starting to tap the insights from that.”Carilion Clinic in Roanoke, Va., had been planning to roll out a multipronged digital front door strategy over the next 24 months.

    But as COVID-19 cases mounted in the spring, executives realized they needed to move faster.Executives in healthcare for years have been discussing the so-called “digital front door,” wanting to use new technologies to engage patients outside buy starlix online usa a facility’s walls. But with many health systems compelled to restrict patients from walking into their actual physical front doors at the buy starlix online usa height of the COVID-19 pandemic, executives had to revisit those plans, pushing out new chatbot symptom checkers and at-home virtual visits.COVID-19 “hasn’t changed our thinking” about patient-centered care, said Nancy Agee, Carilion Clinic’s CEO. But it has accelerated “how far buy starlix online usa and how fast” the system moved toward implementing tasks already on its to-do list.Agee is in good company. Seventy-three percent of CEOs in Modern Healthcare’s Power Panel survey said their focus on consumerism increased amid COVID-19, with the remaining 27% saying their focus stayed the same.At Carilion Clinic, that included expanding the roster of tools that patients use to connect with the system online, such as rolling buy starlix online usa out options to self-schedule appointments and pay bills. And Carilion is developing an app, dubbed MyCarilion, which will centralize where patients access those services as well as educational videos, directions to facilities and on-demand telehealth.Across the board, telehealth has played a major role in how health systems are keeping patients outside of the hospital, but still connected to their care team.All CEOs who responded to Modern Healthcare’s Power Panel survey indicated they’d increased their telehealth investments during the pandemic.

    CEOs are chosen to participate in the survey.Dartmouth-Hitchcock Health in Lebanon, N.H., was averaging buy starlix online usa just three telehealth visits per week before COVID-19 hit. At the height of the buy starlix online usa pandemic, it was conducting up to 2,000 virtual visits a day. To make sure patients buy starlix online usa were prepared for a telehealth visit, medical assistants called patients the day before their appointment to walk them through the process and how to use the technology.Even if telehealth use slows as the pandemic subsides, as some experts predict will happen, it’ll still be a powerful option for patients, said Dr. Joanne Conroy, Dartmouth-Hitchcock buy starlix online usa Health’s CEO. In the health system’s territory in New Hampshire and Vermont, telehealth could prove a useful tool to avoid missed patient appointments during snow storms, she said.“People appreciated the importance of virtual everything during the pandemic,” she said.

    €œI don’t think all of that buy starlix online usa is going to go away.”Moving forward, Dartmouth-Hitchcock sees telehealth as a market opportunity. The health system is working to create a direct-to-consumer urgent-care telehealth program, which could help to attract new patients, buy starlix online usa according to Conroy. The program, which is still being developed, will initially roll out to the health system’s employees, who will provide feedback.As telehealth use soared this past spring, buy starlix online usa health systems were confronted with a problem. Not all patients have access to high-quality internet.It’s not a new problem, but buy starlix online usa it took on newfound importance as health systems were forced to shift more and more patient appointments online.It’s frustrating to be “in the middle of a telehealth visit and it drops or you can’t hear someone,” said David Entwistle, CEO of Palo Alto, Calif.-based Stanford Health Care. For some patient populations, that could go beyond frustration and become an issue of access to care.“What I do worry about is that there’s some socio-economic demographics that are not going to have access to (this) technology,” Entwistle added.Health systems are still grappling with how to address that challenge.During the pandemic, clinicians have been able to replace some appointments with audio-only telephone visits.

    However, payment for those services from CMS might expire with the public health emergency.Dr buy starlix online usa. R. Lawrence Moss, CEO of Jacksonville, Fla.-based Nemours Children’s Health System, suggested that internet access could be the next social determinant of health that health systems target. All CEOs in Modern Healthcare’s Power Panel survey said their organizations need to address patient issues beyond traditional healthcare, including social determinants. That typically includes addressing access to food or transportation, but not internet.Internet access is one of many social factors that Nemours is considering, Moss said.“Just like I believe the health system needs to play a role with partners in ensuring that every child has access to high-quality food, every child also needs access to high-quality digital connectivity,” Moss said.

    €œA decade ago we wouldn’t have said that, but it’s a different world now.”Roughly 6.5% of Americans lacked access to wired broadband that met the Federal Communications Commission’s speed benchmark in 2017, according to a report the agency released last year. About 26.4% of rural Americans lack that access, an issue that HHS, the FCC and the Agriculture Department said they’ll tackle as part of a new Rural Telehealth Initiative.Even if patients do have internet access, they might need help learning to use health systems’ emerging digital tools.Carilion Clinic in Roanoke, Va., is working to stand up Apple Genius Bar-style technology support stations in its surrounding community, as part of a program to better answer patients’ questions about using the health system’s tech tools and encourage them to adopt the capabilities, said Nancy Agee, Carilion’s CEO. The system hopes to open the first station in a few months.Given COVID-19, Agee said Carilion is working on possibilities for creating a “virtual” tech bar. The health system is planning to use a new patient education program, which it’s already using to let clinicians assign short educational videos to patients about some conditions and procedures. A set of videos on how to use Carilion’s digital tools, such as its apps, could fit into that resource, Agee said..

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    Start Preamble http://www.amisdepasteur.fr/how-do-i-get-starlix/ Centers for cheap starlix online canada Medicare &. Medicaid Services (CMS), HHS. Final rule cheap starlix online canada. Correction.

    In the August 4, 2020 issue of the Federal Register, we published a final rule entitled “FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)”. The August 4, 2020 final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided cheap starlix online canada by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access hospital. In addition, we adopted more recent Office of Management and Budget (OMB) statistical area delineations, and applied a 2-year transition for all providers negatively impacted by wage index changes. This correction document corrects the statement of cheap starlix online canada economic significance in the August 4, 2020 final rule.

    This correction is effective October 1, 2020. Start Further Info The IPF Payment Policy mailbox at IPFPaymentPolicy@cms.hhs.gov for general information. Nicolas Brock, cheap starlix online canada (410) 786-5148, for information regarding the statement of economic significance. End Further Info End Preamble Start Supplemental Information I.

    Background In FR Doc cheap starlix online canada. 2020-16990 (85 FR 47042), the final rule entitled “FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)” (hereinafter referred to as the FY 2021 IPF PPS final rule) there was an error in the statement of economic significance and status as major under the Congressional Review Act (5 U.S.C. 801 et seq.). Based on an estimated total impact of $95 million in increased transfers from the federal government to IPF providers, we cheap starlix online canada previously stated that the final rule was not economically significant under Executive Order (E.O.) 12866, and that the rule was not a major rule under the Congressional Review Act.

    However, the Office of Management and Budget designated this rule as economically significant under E.O. 12866 and major under cheap starlix online canada the Congressional Review Act. We are correcting our previous statement in the August 4, 2020 final rule accordingly. This correction is effective October 1, 2020.

    II. Summary of Errors On page 47064, in the third column, the third full paragraph under B. Overall Impact should be replaced entirely. The entire paragraph stating.

    €œWe estimate that this rulemaking is not economically significant as measured by the $100 million threshold, and hence not a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.” should be replaced with. €œWe estimate that the total impact of this final rule is close to the $100 million threshold. The Office of Management and Budget has designated this rule as economically significant under E.O.

    12866 and a major rule under the Congressional Review Act (5 U.S.C. 801 et seq.). Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.” III. Waiver of Proposed Rulemaking and Delay in Effective Date We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C.

    553(b)). However, we can waive this notice and comment procedure if the Secretary of the Department of Human Services finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice. This correction document does not constitute a rulemaking that would be subject to these requirements because it corrects only the statement of economic significance included in the FY 2021 IPF PPS final rule. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies and payment methodologies that were adopted and subjected to notice and comment procedures in the FY 2021 IPF PPS final rule.

    Rather, the corrections made through this correction document are intended to ensure that the FY 2021 IPF PPS final rule accurately reflects OMB's determination about its economic significance and major status under the Congressional Review Act (CRA). Executive Order 12866 and CRA determinations are functions of the Office of Management and Budget, not the Department of Health and Human Services, and are not rules as defined by the Administrative Procedure Act (5 U.S. Code 551(4)). We ordinarily provide a 60-day delay in the effective date of final rules after the date they are issued, in accordance with the CRA (5 U.S.C.

    801(a)(3)). However, section 808(2) of the CRA provides that, if an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the rule shall take effect at such time as the agency determines. Even if this were a rulemaking to which the delayed effective date requirement applied, we found, in the FY 2021 IPF PPS Final Rule (85 FR 47043), good cause to waive the 60-day delay in the effective date of the IPF PPS final rule. In the final rule, we explained that, due to CMS prioritizing efforts in support of containing and combatting the COVID-Start Printed Page 5292419 public health emergency by devoting significant resources to that end, the work needed on the IPF PPS final rule was not completed in accordance with our usual rulemaking schedule.

    We noted that it is critical, however, to ensure that the IPF PPS payment policies are effective on the first day of the fiscal year to which they are intended to apply and therefore, it would be contrary to the public interest to not waive the 60-day delay in the effective date. Undertaking further notice and comment procedures to incorporate the corrections in this document into the FY 2021 IPF PPS final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest to ensure that the policies finalized in the FY 2021 IPF PPS are effective as of the first day of the fiscal year to ensure providers and suppliers receive timely and appropriate payments. Further, such procedures would be unnecessary, because we are not altering the payment methodologies or policies. Rather, the correction we are making is only to indicate that the FY 2021 IPF PPS final rule is economically significant and a major rule under the CRA.

    For these reasons, we find we have good cause to waive the notice and comment and effective date requirements. IV. Correction of Errors in the Preamble In FR Doc. 2020-16990, appearing on page 47042 in the Federal Register of Tuesday, August 4, 2020, the following correction is made.

    1. On page 47064, in the 3rd column, under B. Overall Impact, correct starlix reviews the third full paragraph to read as follows. We estimate that the total impact of this final rule is very close to the $100 million threshold.

    The Office of Management and Budget has designated this rule as economically significant under E.O. 12866 and a major rule under the Congressional Review Act (5 U.S.C. 801 et seq.). Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.

    Start Signature Dated. August 24, 2020. Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services.

    End Signature End Supplemental Information [FR Doc. 2020-18902 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PBy Cyndie Shearing @CyndieShearing Americans from all walks of life are struggling to cope with an array of issues related to the COVID-19 pandemic. Fear and anxiety about this new disease and what could happen is sometimes overwhelming and can cause strong emotions in adults and children.

    But long before the pandemic hit the U.S., farmers and ranchers were struggling. Years of falling commodity prices, natural disasters, declining farm income and trade disputes with China hit rural America hard, and not just financially. Farmers’ mental health is at risk, too. Long before the pandemic hit the U.S., farmers and ranchers were struggling.

    Fortunately, America’s food producers have proven to be a resilient bunch. Across the country, they continue to adopt new ways to manage stress and cope with the difficult situations they’re facing. A few examples are below. In Oklahoma, Bryan Vincent and Gary Williams are part of an informal group that meets on a regular basis to share their burdens.

    “It’s way past farming,” said Vincent, a local crop consultant. €œIt’s a chance to meet with like-minded people. It’s a chance for us to let some things out. We laugh, we may cry together, we may be disgusted together.

    We share our emotions, whether good, bad.” Gathering with trusted friends has given them the chance to talk about what’s happening in their lives, both good and bad. €œI would encourage anybody – any group of farmers, friends, whatever – to form a group” to meet regularly, said Williams, a farmer. €œNot just in bad times. I think you should do that regardless, even in good times.

    Share your victories and triumphs with one another, support one another.” James Young Credit. Nocole Zema/Virginia Farm Bureau In Michigan, dairy farmer Ashley Messing Kennedy battled postpartum depression and anxiety while also grieving over a close friend and farm employee who died by suicide. At first she coped by staying busy, fixing farm problems on her own and rarely asking for help. But six months later, she knew something wasn’t right.

    Finding a meaningful activity to do away from the farm was a positive step forward. €œRunning’s been a game-changer for me,” Kennedy said. €œIt’s so important to interact with people, face-to-face, that you don’t normally engage with. Whatever that is for you, do it — take time to get off the farm and walk away for a while.

    It will be there tomorrow.” Rich Baker also farms in Michigan and has found talking with others to be his stress management tactic of choice. €œYou can’t just bottle things up,” Baker said. €œIf you don’t have a built-in network of farmers, go talk to a professional. In some cases that may be even more beneficial because their opinions may be more impartial.” James Young, a beef cattle farmer in Virginia, has found that mental health issues are less stigmatized as a whole today compared to the recent past.

    But there are farmers “who would throw you under the bus pretty fast” if they found out someone was seeking professional mental health, he said. €œIt’s still stigmatized here.” RFD-TV Special on Farm Stress and Farmer Mental HealthAs part of the American Farm Bureau Federation’s ongoing effort to raise awareness, reduce stigma and share resources related to mental health, the organization partnered with RFD-TV to produce a one-hour episode of “Rural America Live” on farm stress and farmer mental health. The episode features AFBF President Zippy Duvall, Farm Credit Council President Todd Van Hoose and National Farmers Union President Rob Larew, as well as two university Extension specialists, a rural pastor and the author of “Stress-Free You!. € The program aired Thursday, Aug.

    27, and will be re-broadcast on Saturday, Aug. 29, at 6 a.m. Eastern/5 a.m. Central.

    Cyndie Shearing is director of communications at the American Farm Bureau Federation. Quotes in this column originally appeared in state Farm Bureau publications and are reprinted with permission. Vincent, Williams (Oklahoma). Kennedy, Baker (Michigan) and Young (Virginia)..

    Start Preamble Centers for buy starlix online usa Medicare http://www.amisdepasteur.fr/how-do-i-get-starlix/ &. Medicaid Services (CMS), HHS. Final rule buy starlix online usa.

    Correction. In the August 4, 2020 issue of the Federal Register, we published a final rule entitled “FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)”. The August 4, 2020 final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include buy starlix online usa psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access hospital.

    In addition, we adopted more recent Office of Management and Budget (OMB) statistical area delineations, and applied a 2-year transition for all providers negatively impacted by wage index changes. This correction document corrects the statement of economic significance in the August 4, 2020 final rule buy starlix online usa. This correction is effective October 1, 2020.

    Start Further Info The IPF Payment Policy mailbox at IPFPaymentPolicy@cms.hhs.gov for general information. Nicolas Brock, (410) 786-5148, for information buy starlix online usa regarding the statement of economic significance. End Further Info End Preamble Start Supplemental Information I.

    Background In buy starlix online usa FR Doc. 2020-16990 (85 FR 47042), the final rule entitled “FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)” (hereinafter referred to as the FY 2021 IPF PPS final rule) there was an error in the statement of economic significance and status as major under the Congressional Review Act (5 U.S.C. 801 et seq.).

    Based on an estimated total impact of $95 million in increased transfers from the federal government to IPF providers, we previously stated that buy starlix online usa the final rule was not economically significant under Executive Order (E.O.) 12866, and that the rule was not a major rule under the Congressional Review Act. However, the Office of Management and Budget designated this rule as economically significant under E.O. 12866 and major buy starlix online usa under the Congressional Review Act.

    We are correcting our previous statement in the August 4, 2020 final rule accordingly. This correction is effective October 1, 2020. II.

    Summary of Errors On page 47064, in the third column, the third full paragraph under B. Overall Impact should be replaced entirely. The entire paragraph stating.

    €œWe estimate that this rulemaking is not economically significant as measured by the $100 million threshold, and hence not a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.” should be replaced with. €œWe estimate that the total impact of this final rule is close to the $100 million threshold.

    The Office of Management and Budget has designated this rule as economically significant under E.O. 12866 and a major rule under the Congressional Review Act (5 U.S.C. 801 et seq.).

    Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.” III. Waiver of Proposed Rulemaking and Delay in Effective Date We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)).

    However, we can waive this notice and comment procedure if the Secretary of the Department of Human Services finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice. This correction document does not constitute a rulemaking that would be subject to these requirements because it corrects only the statement of economic significance included in the FY 2021 IPF PPS final rule. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies and payment methodologies that were adopted and subjected to notice and comment procedures in the FY 2021 IPF PPS final rule.

    Rather, the corrections made through this correction document are intended to ensure that the FY 2021 IPF PPS final rule accurately reflects OMB's determination about its economic significance and major status under the Congressional Review Act (CRA). Executive Order 12866 and CRA determinations are functions of the Office of Management and Budget, not the Department of Health and Human Services, and are not rules as defined by the Administrative Procedure Act (5 U.S. Code 551(4)).

    We ordinarily provide a 60-day delay in the effective date of final rules after the date they are issued, in accordance with the CRA (5 U.S.C. 801(a)(3)). However, section 808(2) of the CRA provides that, if an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the rule shall take effect at such time as the agency determines.

    Even if this were a rulemaking to which the delayed effective date requirement applied, we found, in the FY 2021 IPF PPS Final Rule (85 FR 47043), good cause to waive the 60-day delay in the effective date of the IPF PPS final rule. In the final rule, we explained that, due to CMS prioritizing efforts in support of containing and combatting the COVID-Start Printed Page 5292419 public health emergency by devoting significant resources to that end, the work needed on the IPF PPS final rule was not completed in accordance with our usual rulemaking schedule. We noted that it is critical, however, to ensure that the IPF PPS payment policies are effective on the first day of the fiscal year to which they are intended to apply and therefore, it would be contrary to the public interest to not waive the 60-day delay in the effective date.

    Undertaking further notice and comment procedures to incorporate the corrections in this document into the FY 2021 IPF PPS final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest to ensure that the policies finalized in the FY 2021 IPF PPS are effective as of the first day of the fiscal year to ensure providers and suppliers receive timely and appropriate payments. Further, such procedures would be unnecessary, because we are not altering the payment methodologies or policies. Rather, the correction we are making is only to indicate that the FY 2021 IPF PPS final rule is economically significant and a major rule under the CRA.

    For these reasons, we find we have good cause to waive the notice and comment and effective date requirements. IV. Correction of Errors in the Preamble In FR Doc.

    2020-16990, appearing on page 47042 in the Federal Register of Tuesday, August 4, 2020, the following correction is made. 1. On page 47064, in the 3rd column, under B.

    Overall Impact, correct the third full paragraph http://www.amisdepasteur.fr/how-do-i-get-starlix/ to read as follows. We estimate that the total impact of this final rule is very close to the $100 million threshold. The Office of Management and Budget has designated this rule as economically significant under E.O.

    12866 and a major rule under the Congressional Review Act (5 U.S.C. 801 et seq.). Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.

    Start Signature Dated. August 24, 2020. Wilma M.

    Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18902 Filed 8-26-20.

    8:45 am]BILLING CODE 4120-01-PBy Cyndie Shearing @CyndieShearing Americans from all walks of life are struggling to cope with an array of issues related to the COVID-19 pandemic. Fear and anxiety about this new disease and what could happen is sometimes overwhelming and can cause strong emotions in adults and children. But long before the pandemic hit the U.S., farmers and ranchers were struggling.

    Years of falling commodity prices, natural disasters, declining farm income and trade disputes with China hit rural America hard, and not just financially. Farmers’ mental health is at risk, too. Long before the pandemic hit the U.S., farmers and ranchers were struggling.

    Fortunately, America’s food producers have proven to be a resilient bunch. Across the country, they continue to adopt new ways to manage stress and cope with the difficult situations they’re facing. A few examples are below.

    In Oklahoma, Bryan Vincent and Gary Williams are part of an informal group that meets on a regular basis to share their burdens. “It’s way past farming,” said Vincent, a local crop consultant. €œIt’s a chance to meet with like-minded people.

    It’s a chance for us to let some things out. We laugh, we may cry together, we may be disgusted together. We share our emotions, whether good, bad.” Gathering with trusted friends has given them the chance to talk about what’s happening in their lives, both good and bad.

    €œI would encourage anybody – any group of farmers, friends, whatever – to form a group” to meet regularly, said Williams, a farmer. €œNot just in bad times. I think you should do that regardless, even in good times.

    Share your victories and triumphs with one another, support one another.” James Young Credit. Nocole Zema/Virginia Farm Bureau In Michigan, dairy farmer Ashley Messing Kennedy battled postpartum depression and anxiety while also grieving over a close friend and farm employee who died by suicide. At first she coped by staying busy, fixing farm problems on her own and rarely asking for help.

    But six months later, she knew something wasn’t right. Finding a meaningful activity to do away from the farm was a positive step forward. €œRunning’s been a game-changer for me,” Kennedy said.

    €œIt’s so important to interact with people, face-to-face, that you don’t normally engage with. Whatever that is for you, do it — take time to get off the farm and walk away for a while. It will be there tomorrow.” Rich Baker also farms in Michigan and has found talking with others to be his stress management tactic of choice.

    €œYou can’t just bottle things up,” Baker said. €œIf you don’t have a built-in network of farmers, go talk to a professional. In some cases that may be even more beneficial because their opinions may be more impartial.” James Young, a beef cattle farmer in Virginia, has found that mental health issues are less stigmatized as a whole today compared to the recent past.

    But there are farmers “who would throw you under the bus pretty fast” if they found out someone was seeking professional mental health, he said. €œIt’s still stigmatized here.” RFD-TV Special on Farm Stress and Farmer Mental HealthAs part of the American Farm Bureau Federation’s ongoing effort to raise awareness, reduce stigma and share resources related to mental health, the organization partnered with RFD-TV to produce a one-hour episode of “Rural America Live” on farm stress and farmer mental health. The episode features AFBF President Zippy Duvall, Farm Credit Council President Todd Van Hoose and National Farmers Union President Rob Larew, as well as two university Extension specialists, a rural pastor and the author of “Stress-Free You!.

    € The program aired Thursday, Aug. 27, and will be re-broadcast on Saturday, Aug. 29, at 6 a.m.

    Eastern/5 a.m. Central. Cyndie Shearing is director of communications at the American Farm Bureau Federation.

    Quotes in this column originally appeared in state Farm Bureau publications and are reprinted with permission. Vincent, Williams (Oklahoma). Kennedy, Baker (Michigan) and Young (Virginia)..

    Starlix 120mg tablet

    Elon Musk on Friday unveiled a coin-sized prototype of a brain implant developed by his startup Neuralink to enable people who starlix 120mg tablet are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last summer.In an event live-streamed on YouTube to more than 150,000 viewers, the company staged a demonstration in which it trotted out a pig named Gertrude that was said to have had the company’s device implanted in its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence that the signals — rendered in beeps and bright blue wave patterns on screen — were, in fact, emanating from the starlix 120mg tablet pig’s brain.A pig presented at a Neuralink demonstration was said to have one of the company’s brain implants in its head. YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories.

    €œThe future’s going to be weird.”advertisement Musk said that in July Neuralink received a breakthrough device designation starlix 120mg tablet from the Food and Drug Administration — a regulatory pathway that could allow the company to soon start a clinical trial in people with paraplegia and tetraplegia. The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development. Advertisement Friday’s event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot that could easily have been mistaken for a giant Apple device. Musk described the event as starlix 120mg tablet a “product demo” and said its primary purpose was to recruit potential new employees.

    It was unclear whether the demonstration was taking place at the company’s Fremont, Calif., headquarters or elsewhere. Musk proceeded to reveal the new version of Neuralink’s brain implant, which he said was designed starlix 120mg tablet to fit snugly into the top of the skull. Neuralink’s technological design has changed significantly since its last big update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to starlix 120mg tablet be positioned behind the back of a person’s ear, with several wires stretching to the top of the skull.

    After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone using the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation from the FDA — designed to speed up the starlix 120mg tablet lengthy regulatory process — is a step forward, but it by no means guarantees that a device will receive a green light, either in a short or longer-term time frame. After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roader into space, Musk didn’t hesitate to use the event to cross-promote his electric car company.

    Asked whether the Neuralink chip would allow people to summon starlix 120mg tablet their Tesla telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future. Still, Musk starlix 120mg tablet said. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017.

    At last July’s event, Musk said — without providing evidence — that a monkey had controlled a computer with its brain.At that same July 2019 event, Neuralink released a preprint paper — published a few months later — that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals. Critically, the work did not starlix 120mg tablet show where in the brain the implanted electrodes were recording from, for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress the company reported on Friday fell far short of that. Neuralink’s prototype is ambitious, but it has yet starlix 120mg tablet to show evidence that it can match up to the brain-machine interfaces developed by academic labs and other companies.

    Other groups have shown that they can listen in on neural activity and allow primates and people to control a computer cursor with their brain — so-called “read-out” technology — and have also shown that they can use electrical stimulation to input information, such as a command or the heat of a hot cup of coffee, using “write-in” technology. Neuralink said on Friday that its technology would have both read-out and write-in capabilities.Musk starlix 120mg tablet acknowledged that Neuralink still has a long way to go. In closing the event after more than 70 minutes, Musk said. €œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”.

    Elon Musk on Friday unveiled a coin-sized prototype of a brain implant developed by his startup Neuralink to enable people who are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last buy starlix online usa summer.In an event live-streamed on YouTube to more than 150,000 viewers, the company staged a demonstration in which it trotted out a pig named Gertrude that was said to have had the company’s device implanted in where can i buy starlix over the counter usa its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence that the signals — rendered buy starlix online usa in beeps and bright blue wave patterns on screen — were, in fact, emanating from the pig’s brain.A pig presented at a Neuralink demonstration was said to have one of the company’s brain implants in its head. YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories. €œThe future’s going to be weird.”advertisement Musk said that in July Neuralink received a breakthrough device designation from the Food and Drug Administration — a regulatory pathway that could allow the company to soon start a clinical trial in people with paraplegia and tetraplegia buy starlix online usa.

    The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development. Advertisement Friday’s event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot that could easily have been mistaken for a giant Apple device. Musk described the event as a “product demo” and said buy starlix online usa its primary purpose was to recruit potential new employees. It was unclear whether the demonstration was taking place at the company’s Fremont, Calif., headquarters or elsewhere. Musk proceeded to reveal the new version of Neuralink’s brain implant, which he said was designed to fit snugly into the buy starlix online usa top of the skull.

    Neuralink’s technological design has changed significantly since its last big update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to be positioned behind the back of a person’s ear, with several wires stretching to the buy starlix online usa top of the skull. After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone using the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation buy starlix online usa from the FDA — designed to speed up the what do you need to buy starlix lengthy regulatory process — is a step forward, but it by no means guarantees that a device will receive a green light, either in a short or longer-term time frame.

    After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roader into space, Musk didn’t hesitate to use the event to cross-promote his electric car company. Asked whether the Neuralink chip would allow buy starlix online usa people to summon their Tesla telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future. Still, Musk buy starlix online usa said. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017.

    At last July’s event, Musk said — without providing evidence — that a monkey had controlled a computer with its brain.At that same July 2019 event, Neuralink released a preprint paper — published a few months later — that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals. Critically, the work did not show where in the brain buy starlix online usa the implanted electrodes were recording from, for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress the company reported on Friday fell far short of that. Neuralink’s prototype is ambitious, but it has yet to show evidence that it can match up to the brain-machine interfaces developed by buy starlix online usa academic labs and other companies. Other groups have shown that they can listen in on neural activity and allow primates and people to control a computer cursor with their brain — so-called “read-out” technology — and have also shown that they can use electrical stimulation to input information, such as a command or the heat of a hot cup of coffee, using “write-in” technology.

    Neuralink said on Friday that its technology would have both read-out and write-in capabilities.Musk acknowledged buy starlix online usa that Neuralink still has a long way to go. In closing the event after more than 70 minutes, Musk said. €œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”.

    Starlix diabetes medication

    Start Preamble Centers for why not check here Medicare starlix diabetes medication &. Medicaid Services (CMS), HHS. Extension of starlix diabetes medication timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of starlix diabetes medication August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021.

    Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that starlix diabetes medication addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory starlix diabetes medication Sprint to Coordinated Care.

    In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related starlix diabetes medication services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose starlix diabetes medication financial relationships are governed by the physician self-referral statute and regulations.

    This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant starlix diabetes medication factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in starlix diabetes medication August 2020.

    However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication starlix diabetes medication of the final rule until August 31, 2021. Start Signature Dated. August 24, 2020. Wilma M starlix diabetes medication.

    Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental starlix diabetes medication Information [FR Doc. 2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and starlix diabetes medication amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

    This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further starlix diabetes medication Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882.

    End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

    247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak.

    Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).

    On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

    Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

    Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including.

    Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

    We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate.

    For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved.

    The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule.

    All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

    300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19.

    The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

    15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C.

    247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

    And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

    This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

    The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

    Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

    Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated.

    August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.

    Start Preamble http://www.amisdepasteur.fr/how-do-i-get-starlix/ Centers for buy starlix online usa Medicare &. Medicaid Services (CMS), HHS. Extension of timeline for publication of buy starlix online usa final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, 2020, the timeline for publication of the final rule to buy starlix online usa finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021.

    Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info buy starlix online usa End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' buy starlix online usa (the Department or HHS) Regulatory Sprint to Coordinated Care.

    In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related buy starlix online usa services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by buy starlix online usa the physician self-referral statute and regulations.

    This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences buy starlix online usa in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that buy starlix online usa we would issue the final rule in August 2020.

    However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, 2021 buy starlix online usa. Start Signature Dated. August 24, 2020. Wilma M buy starlix online usa.

    Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End buy starlix online usa Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, buy starlix online usa or threat for which he recommends the administration or use of the Covered Countermeasures.

    This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further Info Robert buy starlix online usa P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882.

    End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

    247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak.

    Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).

    On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

    Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

    Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including.

    Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

    We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such starlix reviews complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate.

    For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved.

    The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule.

    All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

    300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19.

    The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

    15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C.

    247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

    And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

    This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

    The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

    Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

    Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated.

    August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.

    Buy starlix online with free samples

    John Rawls begins a Theory of Justice with the observation that 'Justice is the first virtue of social institutions, as truth is of systems of thought… Each person buy starlix online with free samples possesses an inviolability founded on justice that even the welfare of society as a whole cannot override'1 (p.3). The COVID-19 pandemic has resulted in lock-downs, the restriction of liberties, debate about the right to refuse medical treatment and buy starlix online with free samples many other changes to the everyday behaviour of persons. The justice issues it raises are diverse, profound and will demand our attention for some time. How we can respect the Rawlsian commitment to the inviolability of each person, when the welfare of societies as a whole is under threat goes to the heart of some of the difficult ethical issues we face and are discussed in this issue of the Journal of buy starlix online with free samples Medical Ethics.The debate about ICU triage and COVID-19 is quite well developed and this journal has published several articles that explore aspects of this issue and how different places approach it.2–5 Newdick et al add to the legal analysis of triage decisions and criticise the calls for respecting a narrow conception of a legal right to treatment and more detailed national guidelines for how triage decisions should be made.6They consider scoring systems for clinical frailty, organ failure assessment, and raise some doubts about the fairness of their application to COVID-19 triage situations. Their argument seems to highlight instances of what is called the McNamara fallacy.

    US Secretary of buy starlix online with free samples Defense Robert McNamara used enemy body counts as a measure of military success during the Vietnam war. So, the fallacy occurs when we rely solely on considerations that appear to be quantifiable, to the neglect of vital qualitative, difficult to measure or contestable features.6 Newdick et al point to variation in assessment, subtlety in condition and other factors as reasons why it is misleading to present scoring systems as ‘objective’ tests for triage. In doing so they draw a distinction between buy starlix online with free samples procedural and outcome consistency, which is important, and hints at distinctions Rawls drew between the different forms of procedural fairness. While we might hope to come up with a triage protocol that is procedurally fair and arrives at a fair outcome (what Rawls calls perfect procedural justice, p. 85) there buy starlix online with free samples is little prospect of that.

    As they observe, reasonable people can disagree about the outcomes we should aim for in allocating health resources and ICU triage for COVID-19 is no exception. Instead, we should work toward a transparent and fair process, what Rawls would describe buy starlix online with free samples as imperfect procedural justice (p. 85). His example of this is a criminal trial where we adopt processes that we have reason to believe are our best chance of determining guilt, but which do not guarantee the truth of a verdict, and this is a reason why they must be transparent and consistent (p. 85).

    Their proposal is to triage patients into three broad categories. High, medium and low priority, with the thought that a range of considerations could feed into that evaluation by an appropriately constituted clinical group.Ballantyne et al question another issue that is central to the debate about COVID-19 triage.4 They describe how utility measures such as QALYs, lives saved seem to be in tension with equity. Their central point is that ICU for COVID-19 can be futile, and that is a reason for questioning how much weight should be given to equality of access to ICU for COVID-19. They claim that there is little point admitting someone to ICU when ICU is not in their best interests. Instead, the scope of equity should encompass preventing 'remediable differences among social, economic demographic or geographic groups' and for COVID-19 that means looking beyond access to ICU.

    Their central argument can be summarised as follows.Maximising utility can entrench existing health inequalities.The majority of those ventilated for COVID-19 in ICU will die.Admitting frailer or comorbid patients to ICU is likely to do more harm than good to these groups.Therefore, better access to ICU is unlikely to promote health equity for these groups.Equity for those with health inequalities related to COVID-19 should broadened to include all the services a system might provide.Brown et al argue in favour of COVID-19 immunity passports and the following summarises one of the key arguments in their article.7COVID-19 immunity passports are a way of demonstrating low personal and social risk.Those who are at low personal risk and low social risk from COVID-19 should be permitted more freedoms.Permitting those with immunity passports greater freedoms discriminates against those who do not have passports.Low personal and social risk and preserving health system capacity are relevant reasons to discriminate between those who have immunity and those who do not.Brown et al then consider a number of potential problems with immunity passports, many of which are justice issues. Resentment by those who do not hold an immunity passport along with a loss of social cohesion, which is vital for responding to COVID-19, are possible downsides. There is also the potential to advantage those who are immune, economically, and it could perpetuate existing inequalities. A significant objection, which is a problem for the justice of many policies, is free riding. Some might create fraudulent immunity passports and it might even incentivise intentional exposure to the virus.

    Brown et al suggest that disincentives and punishment are potential solutions and they are in good company as the Rawlsian solution to free riding is for 'law and government to correct the necessary corrections.' (p. 268)Elves and Herring focus on a set of ethical principles intended to guide those making policy and individual level decisions about adult social care delivery impacted by the pandemic.8 They criticize the British government’s framework for being silent about what to do in the face of conflict between principles. They suggest the dominant values in the framework are based on autonomy and individualism and argue that there are good reasons for not making autonomy paramount in policy about COVID-19. These include that information about COVID-19 is incomplete, so no one can be that informed on decisions about their health. The second is one that highlights the importance of viewing our present ethical challenges via the lens of justice or other ethical concepts such as community or solidarity that enable us to frame collective obligations and interests.

    They observe that COVID-19 has demonstrated how health and how we live our lives are linked. That what an individual does can have profound impact on the health of many others.Their view is that appeals to self-determination ring hollow for COVID-19 and their proposed remedy is one that pushes us to reflect on what the liberal commitment to the inviolability of each person means. They explain Dworkin’s account of 'associative obligations' which occur within a group when they acknowledge special rights and responsibilities to each other. These obligations are a way of giving weight to community considerations, without collapsing into full-blown utilitarianism and while still respecting the inviolability of persons.The COVID-19 pandemic is pushing ethical deliberation in new directions and many of them turn on approaching medical ethics with a greater emphasis on justice and related ethical concepts.IntroductionAs COVID-19 spread internationally, healthcare services in many countries became overwhelmed. One of the main manifestations of this was a shortage of intensive care beds, leading to urgent discussion about how to allocate these fairly.

    In the initial debates about allocation of scarce intensive care unit (ICU) resources, there was optimism about the ‘good’ of ICU access. However, rather than being a life-saving intervention, data began to emerge in mid-April showing that most critical patients with COVID-19 who receive access to a ventilator do not survive to discharge. The minority who survive leave the ICU with significant morbidity and a long and uncertain road to recovery. This reality was under-recognised in bioethics debates about ICU triage throughout March and April 2020. Central to these disucssions were two assumptions.

    First, that ICU admission was a valuable but scarce resource in the pandemic context. And second, that both equity and utility considerations were important in determining which patients should have access to ICU. In this paper we explain how scarcity and value were conflated in the early ICU COVID-19 triage literature, leading to undue optimism about the ‘good’ of ICU access, which in turned fuelled equity-based arguments for ICU access. In the process, ethical issues regarding equitable access to end-of-life care more broadly were neglected.Equity requires the prevention of avoidable or remediable differences among social, economic, demographic, or geographic groups.1 How best to apply an equity lens to questions of distribution will depend on the nature of the resource in question. Equitable distribution of ICU beds is significantly more complex than equitable distribution of other goods that might be scarce in a pandemic, such as masks or vaccines.

    ICU (especially that which involves intubation and ventilation i.e. Mechanical ventilation) is a burdensome treatment option that can lead to significant suffering—both short and long term. The degree to which these burdens are justified depends on the probability of benefit, and this depends on the clinical status of the patient. People are rightly concerned about the equity implications of excluding patients from ICU on the grounds of pre-existing comorbidities that directly affect prognosis, especially when these align with and reflect social disadvantage. But this does not mean that aged, frail or comorbid patients should be admitted to ICU on the grounds of equity, when this may not be in their best interests.ICU triage debateThe COVID-19 pandemic generated extraordinary demand for critical care and required hard choices about who will receive presumed life-saving interventions such as ICU admission.

    The debate has focused on whether or not a utilitarian approach aimed at maximising the number of lives (or life-years) saved should be supplemented by equity considerations that attempt to protect the rights and interests of members of marginalised groups. The utilitarian approach uses criteria for access to ICU that focus on capacity to benefit, understood as survival.2 Supplementary equity considerations have been invoked to relax the criteria in order to give a more diverse group of people a chance of entering ICU.3 4Equity-based critiques are grounded in the concern that a utilitarian approach aimed at maximising the number (or length) of lives saved may well exacerbate inequity in survival rates between groups. This potential for discrimination is heightened if triage tools use age as a proxy for capacity to benefit or are heavily reliant on Quality-Adjusted Life-Years (QALYs) which will deprioritise people with disabilities.5 6 Even if these pitfalls are avoided, policies based on maximising lives saved entrench existing heath inequalities because those most likely to benefit from treatment will be people of privilege who come into the pandemic with better health status than less advantaged people. Those from lower socioeconomic groups, and/or some ethnic minorities have high rates of underlying comorbidities, some of which are prognostically relevant in COVID-19 infection. Public health ethics requires that we acknowledge how apparently neutral triage tools reflect and reinforce these disparities, especially where the impact can be lethal.7But the utility versus equity debate is more complex than it first appears.

    Both the utility and equity approach to ICU triage start from the assumption that ICU is a valuable good—the dispute is about how best to allocate it. Casting ICU admission as a scarce good subject to rationing has the (presumably unintended) effect of making access to critical care look highly appealing, triggering cognitive biases. Psychologists and marketers know that scarcity sells.8 People value a commodity more when it is difficult or impossible to obtain.9 When there is competition for scarce resources, people focus less on whether they really need or want the resource. The priority becomes securing access to the resource.Clinicians are not immune to scarcity-related cognitive bias. Clinicians treating patients with COVID-19 are working under conditions of significant information overload but without the high quality clinical research (generated from large data sets and rigorous methodology) usually available for decision-making.

    The combination of overwhelming numbers of patients, high acuity and uncertainty regarding best practice is deeply anxiety provoking. In this context it is unsurprising that, at least in the early stages of the pandemic, they may not have the psychological bandwidth to challenge assumptions about the benefits of ICU admission for patients with severe disease. Zagury-Orly and Schwartzstein have recently argued that the health sector must accept that doctors’ reasoning and decision-making are susceptible to human anxieties and in the “…effort to ‘do good’ for our patients, we may fall prey to cognitive biases and therapeutic errors”.10We suggest the global publicity and panic regarding ICU triage distorted assessments of best interests and decision-making about admittance to ICU and slanted ethical debate. This has the potential to compromise important decisions with regard to care for patients with COVID-19.The emerging reality of ICUIn general, the majority of patients who are ventilated for COVID-19 in ICU will die. Although comparing data from different health systems is challenging due to variation in admission criteria for ICU, clear trends are emerging with regard to those critically unwell and requiring mechanical ventilation.

    Emerging data show case fatality rates of 50%–88% for ventilated patients with COVID-19. In China11 and Italy about half of those with COVID-19 who receive ventilator support have not survived.12 In one small study in Wuhan the ICU mortality rate among those who received invasive mechanical ventilation was 86% (19/22).13 Interestingly, the rate among those who received less intensive non-invasive ventilation (NIV)1 was still 79% (23/29).13 Analysis of 5700 patients in the New York City area showed that the mortality for those receiving mechanical ventilation was 88%.14 In the UK, only 20% of those who have received mechanical ventilation have been discharged alive.15 Hence, the very real possibility of medical futility with regard to ventilation in COVID-19 needs to be considered.It is also important to consider the complications and side effects that occur in an ICU context. These patients are vulnerable to hospital acquired infections such as ventilator associated pneumonias with high mortality rates in their own right,16 neuropathies, myopathies17 and skin damage. Significant long term morbidity (physical, mental and emotional challenges) can also be experienced by people who survive prolonged ventilation in ICU.12 18 Under normal (non-pandemic) circumstances, many ICU patients experience significant muscle atrophy and deconditioning, sleep disorders, severe fatigue,19 post-traumatic stress disorder,20 cognitive deficits,21 depression, anxiety, difficulty with daily activities and loss of employment.22 Although it is too soon to have data on the long term outcomes of ICU survivors in the specific context of COVID-19, the UK Chartered Society of Physiotherapy predicts a ‘tsunami of rehabilitation needs’ as patients with COVID-19 begin to be discharged.23 The indirect effects of carer-burden should also not be underestimated, as research shows that caring for patients who have survived critical illness results in high levels of depressive symptoms for the majority of caregivers.24The emerging mortality data for patients with COVID-19 admitted to ICU—in conjunction with what is already known about the morbidity of ICU survivors—has significant implications for the utility–equity debates about allocating the scarce resource of ICU beds. First, they undermine the utility argument as there seems to be little evidence that ICU admission leads to better outcomes for patients, especially when the long term morbidity of extended ICU admission is included in the balance of burdens and benefits.

    For some patients, perhaps many, the burdens of ICU will not outweigh the limited potential benefits. Second, the poor survival rates challenge the equity-based claim for preferential access to treatment for members of disadvantaged groups. In particular, admitting frailer or comorbid patients to ICU to fulfil equity goals is unlikely to achieve greater survival for these population groups, but will increase their risk of complications and may ultimately exacerbate or prolong their suffering.The high proportions of people who die despite ICU admission make it particularly important to consider what might constitute better or worse experiences of dying with COVID-19, and how ICU admission affects the likelihood of a ‘good’ death. Critical care may compromise the ability of patients to communicate and engage with their families during the terminal phase of their lives—in the context of an intubated, ventilated patient this is unequivocal.Given the high rates of medical futility with patients with COVID-19 in ICU, the very significant risks for further suffering in the short and long term and the compromise of important psychosocial needs—such as communicating with our families—in the terminal phase of life, our ethical scope must be wider than ICU triage. Ho and Tsai argue that, “In considering effective and efficient allocation of healthcare resources as well as physical and psychological harm that can be incurred in prolonging the dying process, there is a critical need to reframe end-of-life care planning in the ICU.”25 We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care.

    This requires attention to minimising barriers to accessing culturally safe care in the following interlinked areas. Palliative care, and communication and decision support and advanced care planning.Palliative careScaling up palliative and hospice care is an essential component of the COVID-19 pandemic response. Avoiding non-beneficial or unwanted high-intensity care is critical when the capacity of the health system is stressed.26 Palliative care focuses on symptom management, quality of life and death, and holistic care of physical, psychological, social and spiritual health.27 Evidence from Italy has prompted recommendations that, “Governments must urgently recognise the essential contribution of hospice and palliative care to the COVID-19 pandemic, and ensure these services are integrated into the healthcare system response.”28 Rapid palliative care policy changes were implemented in response to COVID-19 in Italy, including more support in community settings, change in admission criteria and daily telephone support for families.28 To meet this increased demand, hospice and palliative care staff should be included in personal protective equipment (PPE) allocation and provided with appropriate infection preventon and control training when dealing with patients with COVID-19 or high risk areas.Attention must also be directed to maintaining supply lines for essential medications for pain, distress and sedation. Patients may experience pain due to existing comorbidities, but may also develop pain as a result of excessive coughing or immobility from COVID-19. Such symptoms should be addressed using existing approaches to pain management.27 Supply lines for essential medications for distress and pain management, including fentanyl and midazolam are under threat in the USA and propofol—used in terminal sedation—may also be in short supply.29 The challenges are exacerbated when people who for various reasons eschew or are unable to secure hospital admission decline rapidly at home with COVID-19 (the time frame of recognition that someone is dying may be shorter than that through which hospice at home services usually support people).

    There is growing debate about the fair allocation of novel drugs—sometimes available as part of ongoing clinical trials—to treat COVID-19 with curative intent.2 30 But we must also pay attention to the fair allocation of drugs needed to ease suffering and dying.Communication and end-of-life decision-making supportEnd-of-life planning can be especially challenging because patients, family members and healthcare providers often differ in what they consider most important near the end of life.31 Less than half of ICU physicians—40.6% in high income countries and 46.3% in low–middle income countries—feel comfortable holding end-of-life discussions with patients’ families.25 With ICUs bursting and health providers under extraordinary pressure, their capacity to effectively support end-of-life decisions and to ease dying will be reduced.This suggests a need for specialist COVID-19 communication support teams, analogous to the idea of specialist ICU triage teams to ensure consistency of decision making about ICU admissions/discharges, and to reduce the moral and psychological distress of health providers during the pandemic.32 These support teams could provide up to date information templates for patients and families, support decision-making, the development of advance care plans (ACPs) and act as a liaison between families (prevented from being in the hospital), the patient and the clinical team. Some people with disabilities may require additional communication support to ensure the patients’ needs are communicated to all health providers.33 This will be especially important if carers and visitors are not able to be present.To provide effective and appropriate support in an equitable way, communication teams will need to include those with the appropriate skills for caring for diverse populations including. Interpreters, specialist social workers, disability advocates and cultural support liaison officers for ethnic and religious minorities. Patient groups that already have comparatively poor health outcomes require dedicated resources. These support resources are essential if we wish to truly mitigate equity concerns that arisingduring the pandemic context.

    See Box 1 for examples of specific communication and care strategies to support patients.Box 1 Supporting communication and compassionate care during COVID-19Despite the sometimes overwhelming pressure of the pandemic, health providers continue to invest in communication, compassionate care and end-of-life support. In some places, doctors have taken photos of their faces and taped these to the front of their PPE so that patients can ‘see’ their face.37 In Singapore, patients who test positive for SARS-CoV-2 are quarantined in health facilities until they receive two consecutive negative tests. Patients may be isolated in hospital for several weeks. To help ease this burden on patients, health providers have dubbed themselves the ‘second family’ and gone out of their way to provide care as well as treatment. Elsewhere, medical, nursing and multi-disciplinary teams are utilising internet based devices to enable ‘virtual’ visits and contact between patients and their loved ones.38 Some centres are providing staff with masks with a see-through window panel that shows the wearer’s mouth, to support effective communication with patient with hearing loss who rely on lip reading.39Advance care planningACPs aim to honour decisions made by autonomous patients if and when they lose capacity.

    However, talking to patients and their loved ones about clinical prognosis, ceilings of treatment and potential end-of-life care is challenging even in normal times. During COVID-19 the challenges are exacerbated by uncertainty and urgency, the absence of family support (due to visitor restrictions) and the wearing of PPE by clinicians and carers. Protective equipment can create a formidable barrier between the patient and the provider, often adding to the patient’s sense of isolation and fear. An Australian palliative care researcher with experience working in disaster zones, argues that the “PPE may disguise countenance, restrict normal human touch and create an unfamiliar gulf between you and your patient.”34 The physical and psychological barriers of PPE coupled with the pressure of high clinical loads do not seem conducive to compassionate discussions about patients’ end-of-life preferences. Indeed, a study in Singapore during the 2004 SARS epidemic demonstrated the barrier posed by PPE to compassionate end-of-life care.35Clinicians may struggle to interpret existing ACPs in the context of COVID-19, given the unprecedented nature and scale of the pandemic and emerging clinical knowledge about the aetiology of the disease and (perhaps especially) about prognosis.

    This suggests the need for COVID-19-specific ACPs. Where possible, proactive planning should occur with high-risk patients, the frail, those in residential care and those with significant underlying morbidities. Ideally, ACP conversations should take place prior to illness, involve known health providers and carers, not be hampered by PPE or subject to time constraints imposed by acute care contexts. Of note here, a systematic review found that patients who received advance care planning or palliative care interventions consistently showed a pattern toward decreased ICU admissions and reduced ICU length of stay.36ConclusionHow best to address equity concerns in relation to ICU and end-of-life care for patients with COVID-19 is challenging and complex. Attempts to broaden clinical criteria to give patients with poorer prognoses access to ICU on equity grounds may result in fewer lives saved overall—this may well be justified if access to ICU confers benefit to these ‘equity’ patients.

    But we must avoid tokenistic gestures to equity—admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. ICU admission may exacerbate and prolong suffering rather than ameliorate it, especially for frailer patients. And prolonging life at all costs may ultimately lead to a worse death. The capacity for harm not just the capacity for benefit should be emphasised in any triage tools and related literature. Equity can be addressed more robustly if pandemic responses scale up investment in palliative care services, communication and decision-support services and advanced care planning to meet the needs of all patients with COVID-19.

    Ultimately, however, equity considerations will require us to move even further from a critical care framework as the social and economic impact of the pandemic will disproportionately impact those most vulnerable. Globally, we will need an approach that does not just stop an exponential rise in infections but an exponential rise in inequality.AcknowledgmentsWe would like to thank Tracy Anne Dunbrook and David Tripp for their helpful comments, and NUS Medicine for permission to reproduce the COVID-19 Chronicles strip..

    John Rawls begins buy starlix online usa a Theory of Justice with the observation that 'Justice is the first virtue of social institutions, as truth is of systems of thought… Each person possesses an inviolability founded http://www.amisdepasteur.fr/best-online-starlix/ on justice that even the welfare of society as a whole cannot override'1 (p.3). The COVID-19 pandemic has resulted in lock-downs, the restriction of liberties, debate about the right to buy starlix online usa refuse medical treatment and many other changes to the everyday behaviour of persons. The justice issues it raises are diverse, profound and will demand our attention for some time. How we can respect the Rawlsian commitment to buy starlix online usa the inviolability of each person, when the welfare of societies as a whole is under threat goes to the heart of some of the difficult ethical issues we face and are discussed in this issue of the Journal of Medical Ethics.The debate about ICU triage and COVID-19 is quite well developed and this journal has published several articles that explore aspects of this issue and how different places approach it.2–5 Newdick et al add to the legal analysis of triage decisions and criticise the calls for respecting a narrow conception of a legal right to treatment and more detailed national guidelines for how triage decisions should be made.6They consider scoring systems for clinical frailty, organ failure assessment, and raise some doubts about the fairness of their application to COVID-19 triage situations. Their argument seems to highlight instances of what is called the McNamara fallacy.

    US Secretary of Defense Robert McNamara used buy starlix online usa enemy body counts as a measure of military success during the Vietnam war. So, the fallacy occurs when we rely solely on considerations that appear to be quantifiable, to the neglect of vital qualitative, difficult to measure or contestable features.6 Newdick et al point to variation in assessment, subtlety in condition and other factors as reasons why it is misleading to present scoring systems as ‘objective’ tests for triage. In doing so they draw a buy starlix online usa distinction between procedural and outcome consistency, which is important, and hints at distinctions Rawls drew between the different forms of procedural fairness. While we might hope to come up with a triage protocol that is procedurally fair and arrives at a fair outcome (what Rawls calls perfect procedural justice, p. 85) there buy starlix online usa is little prospect of that.

    As they observe, reasonable people can disagree about the outcomes we should aim for in allocating health resources and ICU triage for COVID-19 is no exception. Instead, we should work toward a transparent and fair process, buy starlix online usa what Rawls would describe as imperfect procedural justice (p. 85). His example of this is a criminal trial where we adopt processes that we have reason to believe are our best chance of determining guilt, but which do not guarantee the truth of a verdict, and this is a reason why they must be transparent and consistent (p. 85).

    Their proposal is to triage patients into three broad categories. High, medium and low priority, with the thought that a range of considerations could feed into that evaluation by an appropriately constituted clinical group.Ballantyne et al question another issue that is central to the debate about COVID-19 triage.4 They describe how utility measures such as QALYs, lives saved seem to be in tension with equity. Their central point is that ICU for COVID-19 can be futile, and that is a reason for questioning how much weight should be given to equality of access to ICU for COVID-19. They claim that there is little point admitting someone to ICU when ICU is not in their best interests. Instead, the scope of equity should encompass preventing 'remediable differences among social, economic demographic or geographic groups' and for COVID-19 that means looking beyond access to ICU.

    Their central argument can be summarised as follows.Maximising utility can entrench existing health inequalities.The majority of those ventilated for COVID-19 in ICU will die.Admitting frailer or comorbid patients to ICU is likely to do more harm than good to these groups.Therefore, better access to ICU is unlikely to promote health equity for these groups.Equity for those with health inequalities related to COVID-19 should broadened to include all the services a system might provide.Brown et al argue in favour of COVID-19 immunity passports and the following summarises one of the key arguments in their article.7COVID-19 immunity passports are a way of demonstrating low personal and social risk.Those who are at low personal risk and low social risk from COVID-19 should be permitted more freedoms.Permitting those with immunity passports greater freedoms discriminates against those who do not have passports.Low personal and social risk and preserving health system capacity are relevant reasons to discriminate between those who have immunity and those who do not.Brown et al then consider a number of potential problems with immunity passports, many of which are justice issues. Resentment by those who do not hold an immunity passport along with a loss of social cohesion, which is vital for responding to COVID-19, are possible downsides. There is also the potential to advantage those who are immune, economically, and it could perpetuate existing inequalities. A significant objection, which is a problem for the justice of many policies, is free riding. Some might create fraudulent immunity passports and it might even incentivise intentional exposure to the virus.

    Brown et al suggest that disincentives and punishment are potential solutions and they are in good company as the Rawlsian solution to free riding is for 'law and government to correct the necessary corrections.' (p. 268)Elves and Herring focus on a set of ethical principles intended to guide those making policy and individual level decisions about adult social care delivery impacted by the pandemic.8 They criticize the British government’s framework for being silent about what to do in the face of conflict between principles. They suggest the dominant values in the framework are based on autonomy and individualism and argue that there are good reasons for not making autonomy paramount in policy about COVID-19. These include that information about COVID-19 is incomplete, so no one can be that informed on decisions about their health. The second is one that highlights the importance of viewing our present ethical challenges via the lens of justice or other ethical concepts such as community or solidarity that enable us to frame collective obligations and interests.

    They observe that COVID-19 has demonstrated how health and how we live our lives are linked. That what an individual does can have profound impact on the health of many others.Their view is that appeals to self-determination ring hollow for COVID-19 and their proposed remedy is one that pushes us to reflect on what the liberal commitment to the inviolability of each person means. They explain Dworkin’s account of 'associative obligations' which occur within a group when they acknowledge special rights and responsibilities to each other. These obligations are a way of giving weight to community considerations, without collapsing into full-blown utilitarianism and while still respecting the inviolability of persons.The COVID-19 pandemic is pushing ethical deliberation in new directions and many of them turn on approaching medical ethics with a greater emphasis on justice and related ethical concepts.IntroductionAs COVID-19 spread internationally, healthcare services in many countries became overwhelmed. One of the main manifestations of this was a shortage of intensive care beds, leading to urgent discussion about how to allocate these fairly.

    In the initial debates about allocation of scarce intensive care unit (ICU) resources, there was optimism about the ‘good’ of ICU access. However, rather than being a life-saving intervention, data began to emerge in mid-April showing that most critical patients with COVID-19 who receive access to a ventilator do not survive to discharge. The minority who survive leave the ICU with significant morbidity and a long and uncertain road to recovery. This reality was under-recognised in bioethics debates about ICU triage throughout March and April 2020. Central to these disucssions were two assumptions.

    First, that ICU admission was a valuable but scarce resource in the pandemic context. And second, that both equity and utility considerations were important in determining which patients should have access to ICU. In this paper we explain how scarcity and value were conflated in the early ICU COVID-19 triage literature, leading to undue optimism about the ‘good’ of ICU access, which in turned fuelled equity-based arguments for ICU access. In the process, ethical issues regarding equitable access to end-of-life care more broadly were neglected.Equity requires the prevention of avoidable or remediable differences among social, economic, demographic, or geographic groups.1 How best to apply an equity lens to questions of distribution will depend on the nature of the resource in question. Equitable distribution of ICU beds is significantly more complex than equitable distribution of other goods that might be scarce in a pandemic, such as masks or vaccines.

    ICU (especially that which involves intubation and ventilation i.e. Mechanical ventilation) is a burdensome treatment option that can lead to significant suffering—both short and long term. The degree to which these burdens are justified depends on the probability of benefit, and this depends on the clinical status of the patient. People are rightly concerned about the equity implications of excluding patients from ICU on the grounds of pre-existing comorbidities that directly affect prognosis, especially when these align with and reflect social disadvantage. But this does not mean that aged, frail or comorbid patients should be admitted to ICU on the grounds of equity, when this may not be in their best interests.ICU triage debateThe COVID-19 pandemic generated extraordinary demand for critical care and required hard choices about who will receive presumed life-saving interventions such as ICU admission.

    The debate has focused on whether or not a utilitarian approach aimed at maximising the number of lives (or life-years) saved should be supplemented by equity considerations that attempt to protect the rights and interests of members of marginalised groups. The utilitarian approach uses criteria for access to ICU that focus on capacity to benefit, understood as survival.2 Supplementary equity considerations have been invoked to relax the criteria in order to give a more diverse group of people a chance of entering ICU.3 4Equity-based critiques are grounded in the concern that a utilitarian approach aimed at maximising the number (or length) of lives saved may well exacerbate inequity in survival rates between groups. This potential for discrimination is heightened if triage tools use age as a proxy for capacity to benefit or are heavily reliant on Quality-Adjusted Life-Years (QALYs) which will deprioritise people with disabilities.5 6 Even if these pitfalls are avoided, policies based on maximising lives saved entrench existing heath inequalities because those most likely to benefit from treatment will be people of privilege who come into the pandemic with better health status than less advantaged people. Those from lower socioeconomic groups, and/or some ethnic minorities have high rates of underlying comorbidities, some of which are prognostically relevant in COVID-19 infection winx starlix. Public health ethics requires that we acknowledge how apparently neutral triage tools reflect and reinforce these disparities, especially where the impact can be lethal.7But the utility versus equity debate is more complex than it first appears.

    Both the utility and equity approach to ICU triage start from the assumption that ICU is a valuable good—the dispute is about how best to allocate it. Casting ICU admission as a scarce good subject to rationing has the (presumably unintended) effect of making access to critical care look highly appealing, triggering cognitive biases. Psychologists and marketers know that scarcity sells.8 People value a commodity more when it is difficult or impossible to obtain.9 When there is competition for scarce resources, people focus less on whether they really need or want the resource. The priority becomes securing access to the resource.Clinicians are not immune to scarcity-related cognitive bias. Clinicians treating patients with COVID-19 are working under conditions of significant information overload but without the high quality clinical research (generated from large data sets and rigorous methodology) usually available for decision-making.

    The combination of overwhelming numbers of patients, high acuity and uncertainty regarding best practice is deeply anxiety provoking. In this context it is unsurprising that, at least in the early stages of the pandemic, they may not have the psychological bandwidth to challenge assumptions about the benefits of ICU admission for patients with severe disease. Zagury-Orly and Schwartzstein have recently argued that the health sector must accept that doctors’ reasoning and decision-making are susceptible to human anxieties and in the “…effort to ‘do good’ for our patients, we may fall prey to cognitive biases and therapeutic errors”.10We suggest the global publicity and panic regarding ICU triage distorted assessments of best interests and decision-making about admittance to ICU and slanted ethical debate. This has the potential to compromise important decisions with regard to care for patients with COVID-19.The emerging reality of ICUIn general, the majority of patients who are ventilated for COVID-19 in ICU will die. Although comparing data from different health systems is challenging due to variation in admission criteria for ICU, clear trends are emerging with regard to those critically unwell and requiring mechanical ventilation.

    Emerging data show case fatality rates of 50%–88% for ventilated patients with COVID-19. In China11 and Italy about half of those with COVID-19 who receive ventilator support have not survived.12 In one small study in Wuhan the ICU mortality rate among those who received invasive mechanical ventilation was 86% (19/22).13 Interestingly, the rate among those who received less intensive non-invasive ventilation (NIV)1 was still 79% (23/29).13 Analysis of 5700 patients in the New York City area showed that the mortality for those receiving mechanical ventilation was 88%.14 In the UK, only 20% of those who have received mechanical ventilation have been discharged alive.15 Hence, the very real possibility of medical futility with regard to ventilation in COVID-19 needs to be considered.It is also important to consider the complications and side effects that occur in an ICU context. These patients are vulnerable to hospital acquired infections such as ventilator associated pneumonias with high mortality rates in their own right,16 neuropathies, myopathies17 and skin damage. Significant long term morbidity (physical, mental and emotional challenges) can also be experienced by people who survive prolonged ventilation in ICU.12 18 Under normal (non-pandemic) circumstances, many ICU patients experience significant muscle atrophy and deconditioning, sleep disorders, severe fatigue,19 post-traumatic stress disorder,20 cognitive deficits,21 depression, anxiety, difficulty with daily activities and loss of employment.22 Although it is too soon to have data on the long term outcomes of ICU survivors in the specific context of COVID-19, the UK Chartered Society of Physiotherapy predicts a ‘tsunami of rehabilitation needs’ as patients with COVID-19 begin to be discharged.23 The indirect effects of carer-burden should also not be underestimated, as research shows that caring for patients who have survived critical illness results in high levels of depressive symptoms for the majority of caregivers.24The emerging mortality data for patients with COVID-19 admitted to ICU—in conjunction with what is already known about the morbidity of ICU survivors—has significant implications for the utility–equity debates about allocating the scarce resource of ICU beds. First, they undermine the utility argument as there seems to be little evidence that ICU admission leads to better outcomes for patients, especially when the long term morbidity of extended ICU admission is included in the balance of burdens and benefits.

    For some patients, perhaps many, the burdens of ICU will not outweigh the limited potential benefits. Second, the poor survival rates challenge the equity-based claim for preferential access to treatment for members of disadvantaged groups. In particular, admitting frailer or comorbid patients to ICU to fulfil equity goals is unlikely to achieve greater survival for these population groups, but will increase their risk of complications and may ultimately exacerbate or prolong their suffering.The high proportions of people who die despite ICU admission make it particularly important to consider what might constitute better or worse experiences of dying with COVID-19, and how ICU admission affects the likelihood of a ‘good’ death. Critical care may compromise the ability of patients to communicate and engage with their families during the terminal phase of their lives—in the context of an intubated, ventilated patient this is unequivocal.Given the high rates of medical futility with patients with COVID-19 in ICU, the very significant risks for further suffering in the short and long term and the compromise of important psychosocial needs—such as communicating with our families—in the terminal phase of life, our ethical scope must be wider than ICU triage. Ho and Tsai argue that, “In considering effective and efficient allocation of healthcare resources as well as physical and psychological harm that can be incurred in prolonging the dying process, there is a critical need to reframe end-of-life care planning in the ICU.”25 We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care.

    This requires attention to minimising barriers to accessing culturally safe care in the following interlinked areas. Palliative care, and communication and decision support and advanced care planning.Palliative careScaling up palliative and hospice care is an essential component of the COVID-19 pandemic response. Avoiding non-beneficial or unwanted high-intensity care is critical when the capacity of the health system is stressed.26 Palliative care focuses on symptom management, quality of life and death, and holistic care of physical, psychological, social and spiritual health.27 Evidence from Italy has prompted recommendations that, “Governments must urgently recognise the essential contribution of hospice and palliative care to the COVID-19 pandemic, and ensure these services are integrated into the healthcare system response.”28 Rapid palliative care policy changes were implemented in response to COVID-19 in Italy, including more support in community settings, change in admission criteria and daily telephone support for families.28 To meet this increased demand, hospice and palliative care staff should be included in personal protective equipment (PPE) allocation and provided with appropriate infection preventon and control training when dealing with patients with COVID-19 or high risk areas.Attention must also be directed to maintaining supply lines for essential medications for pain, distress and sedation. Patients may experience pain due to existing comorbidities, but may also develop pain as a result of excessive coughing or immobility from COVID-19. Such symptoms should be addressed using existing approaches to pain management.27 Supply lines for essential medications for distress and pain management, including fentanyl and midazolam are under threat in the USA and propofol—used in terminal sedation—may also be in short supply.29 The challenges are exacerbated when people who for various reasons eschew or are unable to secure hospital admission decline rapidly at home with COVID-19 (the time frame of recognition that someone is dying may be shorter than that through which hospice at home services usually support people).

    There is growing debate about the fair allocation of novel drugs—sometimes available as part of ongoing clinical trials—to treat COVID-19 with curative intent.2 30 But we must also pay attention to the fair allocation of drugs needed to ease suffering and dying.Communication and end-of-life decision-making supportEnd-of-life planning can be especially challenging because patients, family members and healthcare providers often differ in what they consider most important near the end of life.31 Less than half of ICU physicians—40.6% in high income countries and 46.3% in low–middle income countries—feel comfortable holding end-of-life discussions with patients’ families.25 With ICUs bursting and health providers under extraordinary pressure, their capacity to effectively support end-of-life decisions and to ease dying will be reduced.This suggests a need for specialist COVID-19 communication support teams, analogous to the idea of specialist ICU triage teams to ensure consistency of decision making about ICU admissions/discharges, and to reduce the moral and psychological distress of health providers during the pandemic.32 These support teams could provide up to date information templates for patients and families, support decision-making, the development of advance care plans (ACPs) and act as a liaison between families (prevented from being in the hospital), the patient and the clinical team. Some people with disabilities may require additional communication support to ensure the patients’ needs are communicated to all health providers.33 This will be especially important if carers and visitors are not able to be present.To provide effective and appropriate support in an equitable way, communication teams will need to include those with the appropriate skills for caring for diverse populations including. Interpreters, specialist social workers, disability advocates and cultural support liaison officers for ethnic and religious minorities. Patient groups that already have comparatively poor health outcomes require dedicated resources. These support resources are essential if we wish to truly mitigate equity concerns that arisingduring the pandemic context.

    See Box 1 for examples of specific communication and care strategies to support patients.Box 1 Supporting communication and compassionate care during COVID-19Despite the sometimes overwhelming pressure of the pandemic, health providers continue to invest in communication, compassionate care and end-of-life support. In some places, doctors have taken photos of their faces and taped these to the front of their PPE so that patients can ‘see’ their face.37 In Singapore, patients who test positive for SARS-CoV-2 are quarantined in health facilities until they receive two consecutive negative tests. Patients may be isolated in hospital for several weeks. To help ease this burden on patients, health providers have dubbed themselves the ‘second family’ and gone out of their way to provide care as well as treatment. Elsewhere, medical, nursing and multi-disciplinary teams are utilising internet based devices to enable ‘virtual’ visits and contact between patients and their loved ones.38 Some centres are providing staff with masks with a see-through window panel that shows the wearer’s mouth, to support effective communication with patient with hearing loss who rely on lip reading.39Advance care planningACPs aim to honour decisions made by autonomous patients if and when they lose capacity.

    However, talking to patients and their loved ones about clinical prognosis, ceilings of treatment and potential end-of-life care is challenging even in normal times. During COVID-19 the challenges are exacerbated by uncertainty and urgency, the absence of family support (due to visitor restrictions) and the wearing of PPE by clinicians and carers. Protective equipment can create a formidable barrier between the patient and the provider, often adding to the patient’s sense of isolation and fear. An Australian palliative care researcher with experience working in disaster zones, argues that the “PPE may disguise countenance, restrict normal human touch and create an unfamiliar gulf between you and your patient.”34 The physical and psychological barriers of PPE coupled with the pressure of high clinical loads do not seem conducive to compassionate discussions about patients’ end-of-life preferences. Indeed, a study in Singapore during the 2004 SARS epidemic demonstrated the barrier posed by PPE to compassionate end-of-life care.35Clinicians may struggle to interpret existing ACPs in the context of COVID-19, given the unprecedented nature and scale of the pandemic and emerging clinical knowledge about the aetiology of the disease and (perhaps especially) about prognosis.

    This suggests the need for COVID-19-specific ACPs. Where possible, proactive planning should occur with high-risk patients, the frail, those in residential care and those with significant underlying morbidities. Ideally, ACP conversations should take place prior to illness, involve known health providers and carers, not be hampered by PPE or subject to time constraints imposed by acute care contexts. Of note here, a systematic review found that patients who received advance care planning or palliative care interventions consistently showed a pattern toward decreased ICU admissions and reduced ICU length of stay.36ConclusionHow best to address equity concerns in relation to ICU and end-of-life care for patients with COVID-19 is challenging and complex. Attempts to broaden clinical criteria to give patients with poorer prognoses access to ICU on equity grounds may result in fewer lives saved overall—this may well be justified if access to ICU confers benefit to these ‘equity’ patients.

    But we must avoid tokenistic gestures to equity—admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. ICU admission may exacerbate and prolong suffering rather than ameliorate it, especially for frailer patients. And prolonging life at all costs may ultimately lead to a worse death. The capacity for harm not just the capacity for benefit should be emphasised in any triage tools and related literature. Equity can be addressed more robustly if pandemic responses scale up investment in palliative care services, communication and decision-support services and advanced care planning to meet the needs of all patients with COVID-19.

    Ultimately, however, equity considerations will require us to move even further from a critical care framework as the social and economic impact of the pandemic will disproportionately impact those most vulnerable. Globally, we will need an approach that does not just stop an exponential rise in infections but an exponential rise in inequality.AcknowledgmentsWe would like to thank Tracy Anne Dunbrook and David Tripp for their helpful comments, and NUS Medicine for permission to reproduce the COVID-19 Chronicles strip..

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