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Start Preamble online pharmacy lasix Centers for Medicare &. Medicaid Services, Health and Human Services (HHS). Notice.

The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice.

Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments on the collection(s) of information must be received by the OMB desk officer by August 30, 2021. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain.

Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1.

Access CMS' website address at website address at. Https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William Parham at (410) 786-4669.

End Further Info End Preamble Start Supplemental Information Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval.

To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment. 1. Type of Information Collection Request.

New Collection (Request for a new OMB control number). Title of Information Collection. Medicare Beneficiary Experiences with Care Survey (MBECS) System.

Use. The MBECS system is designed to conduct population specific surveys that will be administered to the group of interest, fielded one time. This means that over the three-year period, two individual surveys will be administered.

This will allow CMS OMH to respond quickly to the data needs of stakeholders with interests in these underrepresented groups. Data collected through the MBECS system will be used to better understand—and thus serve the needs of—Medicare beneficiaries in minority populations. The core questionnaire will collect information on communication with medical professionals, coordination of health care, experiences getting needed health care, experiences with personal doctors and specialists, and key demographics.

Data will be compared to benchmarks from the FFS CAHPS, MA CAHPS, and NAM CAHPS surveys. The population-specific questionnaire module described and submitted via a specific collection request will collect information about issues most relevant for that particular group of interest. The goal of this umbrella data collection effort is to gather data via separate surveys on a variety of minority Medicare beneficiaries' experiences.

Topics and questions of interest may ask about beneficiaries' communication with medical professionals, coordination of health care, experiences getting needed health care, and experiences with personal doctors and specialists. CMS OMH will compare survey data to benchmarks from the general population of Medicare beneficiaries while controlling for population characteristics, as appropriate. Survey respondents will have the opportunity to respond to an MBECS survey via a self-administered web-based survey (also called computer-assisted web interview or CAWI).

CAWI technology minimizes respondent burden by (1) automatically providing text fills within questions and handling skip patterns based on responses to each question. (2) allowing respondents to complete the survey at a convenient time. (3) allowing respondents to stop and re-enter the survey if needed.

And (4) capturing data in real-time, thereby eliminating the need for manual data entry. Form Number. CMS-10701 (OMB Control number.

Affected Public. Individuals and Households. Number of Respondents.

Total Annual Hours. 4,290 (For policy questions regarding this collection contact Luis Pons Perez at 410-786-8557). 2.

Type of Information Collection Request. Extension of a currently approved information collection. Title Start Printed Page 40848of Information Collection.

CLIA Collection of Information Requirements Related to hypertension Test Results Reporting. Use. In order to be in compliance with the new CLIA mandatory hypertension test results reporting requirements, laboratories will need to develop a mechanism to track, collect, and report test results as well as update policies and procedures.

In addition, Accreditation Organizations (AOs) and Exempt States (ESs) will need to update laboratory standards to reflect the reporting requirements and update policies and procedures related to reporting laboratories that do not report test results as required. The CDC has an information collection request (OMB Control Number 0920-1299) in order to collect laboratory data related to the hypertension medications lasix Response. The CMS package (ICR) is for laboratory implementation and CMS monitoring of compliance with the CMS-3401-IFC CLIA-certified laboratory reporting requirements.

The information collected by the Centers for Medicare and Medicaid Services (CMS) or its designee, such as a CMS agent or CMS approved laboratory accreditation organization, when conducting inspections will be used to determine a laboratory's compliance with the CLIA hypertension test result reporting requirements. During an on-site survey, the Condition-level laboratory requirement at 42 CFR 493.41and 493.1100(a) are assessed for compliance. The information is used by CMS in determining appropriate Civil Money Penalties (CMPs) when laboratories fail to report as required.

Form Number. CMS-10757 (OMB control number. 0938-1391).

Private Sector Not-for-profit institutions and State, Local and Tribal Governments. Number of Respondents. 77,033.

Total Annual Responses. 308,114. Total Annual Hours.

1,386,873 (For policy questions regarding this collection contact Sarah Bennett at 410-786-3354.) Start Signature Dated. July 26, 2021. William N.

Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc. 2021-16200 Filed 7-28-21.

8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &. Medicaid Services (CMS), HHS. Notice of meeting.

This notice announces a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for Calendar Year 2021. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare &. Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services.

The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system. Meeting date. The virtual meeting of the Panel is scheduled for Monday, August 23, 2021, from 9:30 a.m.

To 5:00 p.m. Eastern Daylight Time (EDT). The times listed in this notice are EDT and are approximate times.

Consequently, the meetings may last longer or be shorter than the times listed in this notice, but would not begin before the posted time. Deadline for presentations and comment letters. Presentations or Start Printed Page 39026comment letters, and form CMS-20017 (located at https://www.cms.gov/​Medicare/​CMS-Forms/​CMS-Forms/​downloads/​cms20017.pdf), must be received by 5:00 p.m.

EDT, Friday, August 6, 2021. We note that form CMS-20017 must accompany each presentation or comment letter submission. Presentations and comment letters that are not received by the due date and time, or that do not include a completed form CMS-20017 are considered late or incomplete, and cannot be included on the agenda.

In commenting, refer to file code CMS-1764-N. Meeting Registration Timeframe. All presentation or comment letter speakers, including any alternates, with items on the agenda must register electronically to our Panel mailbox, APCPanel@cms.hhs.gov no later than 5:00 p.m.

EDT, Friday, August 6, 2021. The subject of the email may state “Agenda Speaker Registration for HOP Panel Meeting.” Meeting location and webinar. The meeting will be held virtually.

The public may participate in this meeting by webinar, or listen-only via teleconference. Closed captioning will be available on the webinar. Teleconference dial-in and webinar information will appear on the final meeting agenda, which will be posted on our website when available at.

Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. News media. Press inquiries are handled through the CMS Press Office at (202) 690-6145.

Advisory committees information line. The telephone number for the Advisory Panel on Hospital Outpatient Payment Committee Hotline is (410) 786-3985. Websites.

For additional information on the Panel, including the Panel charter, and updates to the Panel's activities, we refer readers to view our website at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. Information about the Panel and its membership in the Federal Advisory Committee Act (FACA) database are also located at.

Https://www.facadatabase.gov. Start Further Info Elise Barringer, Designated Federal Official (DFO) (410) 786-9222, email at. APCPanel@cms.hhs.gov.

End Further Info End Preamble Start Supplemental Information I. Background The Secretary of the Department of Health and Human Services (the Secretary) is required by section 1833(t)(9)(A) of the Social Security Act (the Act) and is allowed by section 222 of the Public Health Service Act (PHA) to consult with an expert outside Panel, such as the Advisory Panel on Hospital Outpatient Payment (the Panel), regarding the clinical integrity of the Ambulatory Payment Classification (APC) groups and relative payment weights. The Panel is governed by the provisions of the Federal Advisory Committee Act (Pub.

L. 92-463), as amended (5 U.S.C. Appendix 2), to set forth standards for the formation and use of advisory Panels.

We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the Hospital Outpatient Prospective Payment System (OPPS) for the following calendar year (CY). II. Annual Advisory Panel Meeting A.

Meeting Agenda The agenda for the August 23, 2021 Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter. Addressing whether procedures within an APC group are similar both clinically and in terms of resource use. Reconfiguring APCs.

Evaluating APC group weights. Reviewing packaging the cost of items and services, including drugs and devices, into procedures and services, including the methodology for packaging and the impact of packaging the cost of those items and services on APC group structure and payment. Removing procedures from the inpatient only list for payment under the OPPS.

Using claims and cost report data for Centers for Medicare &. Medicaid Services (CMS) determination of APC group costs. Addressing other technical issues concerning APC group structure.

Evaluating the required level of supervision for hospital outpatient services. OPPS APC rates for covered Ambulatory Surgical Center (ASC) procedures. The Agenda will be posted on our website at.

Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups approximately 1 week before the meeting. B. Meeting Information Updates The actual meeting hours and days will be posted in the agenda.

As information and updates regarding this webinar and listen-only teleconference, including the agenda, become available, they will be posted to our website at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. C.

Presentations and Comment Letters The subject matter of any presentation and comment letter must be within the scope of the Panel as designated in the Charter. Any presentations or comments outside of the scope of the Panel will be returned or requested for amendment. Unrelated topics include, but are not limited to.

The conversion factor, charge compression, revisions to the cost report, pass-through payments, correct coding, new technology applications (including supporting information/documentation), provider payment adjustments, supervision of hospital outpatient diagnostic services, and the types of practitioners that are permitted to supervise hospital outpatient services. The Panel may not recommend that services be designated as nonsurgical extended duration therapeutic services. Presentations or Comment Letters that address OPPS APC rates as they relate to covered ASC procedures are within the scope of the Panel's charter.

However, ASC payment rates, ASC payment indicators, the ASC covered procedures list, or other ASC payment system matters will be considered out of scope. The Panel may use data collected or developed by entities and organizations other than Department of Health and Human Services and CMS in conducting its review. We recommend organizations submit data for CMS staff and the Panel's review.

All presentations are limited to 5 minutes, regardless of the number of individuals or organizations represented by a single presentation. Presenters may use their 5 minutes to present either one or more agenda items. In the email, all of the following information must be submitted when registering.

Speaker's name. Speaker's organization or company name. Company or organization that the speaker is representing that submitted a presentation or comment letter that is on the agenda.

Email addresses to which materials regarding meeting registration and instructions on connecting to the meeting may be sent.Start Printed Page 39027 Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by August 06, 2021. In addition, registration information must reflect individual-level content and not reflect an organization entry.

Also, each individual may only register one person at a time (that is, one individual may not register multiple individuals at the same time). A confirmation email will be sent upon receipt of the registration. The email will provide information to the speaker in preparation for the meeting.

Registration is only required for agenda speakers and alternates and must be submitted by the deadline specified above. We note that no registration is required for participants who plan to view the Panel meeting by webinar or listen teleconference. Section 508 Compliance For this meeting, we are aiming to have all presentations and comment letters available on our website.

Materials on our website must be Section 508 compliant to ensure access to federal employees and members of the public with and without disabilities. We encourage presenters and commenters to reference the guidance on making documents section 508 compliant as they draft their submissions, and, whenever possible, to submit their presentations and comment letters in a 508 compliant form. Such guidance is available at.

Https://www.cms.gov/​research-statistics-data-and-systems/​cms-information-technology/​section508. We will review presentations and comment letters for 508 compliance and place compliant materials on our website. As resources permit, we will also convert non-compliant submissions to 508 compliant forms, and offer assistance to submitters who are making their submissions 508 compliant.

All 508 compliant presentations and comment letters will be made available on the CMS website. If difficulties are encountered accessing the materials, contact the Designated Federal Official (DFO) (the DFO's address, email, and phone number are provided in the FOR FURTHER INFORMATION CONTACT section of this notice). In order to consider presentations and/or comment letters, we will need to receive the following.

1. An email copy of the presentation or comment letters sent to the DFO mailbox. APCPanel@cms.hhs.gov.

2. Form CMS-20017, with complete contact information that includes the names, addresses, phone numbers, and email addresses for all presenters. Comment letters.

And a contact person who can answer any questions and provide revisions that are requested for the presentation or comment letter. Presenters and commenter letters must clearly explain the actions that they are requesting CMS take in the appropriate section of the form. A presenter or commenter's relationship with the organization that they represent must also be clearly listed.

D. Formal Presentations In addition to formal presentations (limited to 5 minutes total per presentation), there will be an opportunity during the meeting for public comments as time permits (limited to 1 minute for each individual and a total of 3 minutes per organization). E.

Panel Recommendations and Discussions The Panel's recommendations at any Panel meeting generally are not final until they have been reviewed and approved by the Panel on the last day of the meeting, before the final adjournment. These recommendations will be posted to our website after the meeting. F.

Membership Appointments to the Advisory Panel on Hospital Outpatient Payment The Panel Charter provides that the Panel may meet up to 3 times annually. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the OPPS for the following calendar year. The Panel may consist of a chair and up to 15 members who are full-time employees of hospitals, hospital systems, or other Medicare providers that are subject to the OPPS.

The Panel may also include a representative of the provider with ASC expertise, who may advise CMS only on OPPS APC rates, as appropriate, impacting ASC covered procedures within the context and purview of the Panel's scope. The Secretary or a designee selects the Panel membership based upon either self-nominations or nominations submitted by Medicare providers and other interested organizations of candidates determined to have the required expertise. For supervision deliberations, the Panel may include members that represent the interests of Critical Access Hospitals, who advise CMS only regarding the level of supervision for hospital outpatient therapeutic services.

New appointments are made in a manner that ensures a balanced membership under the FACA guidelines. The Secretary rechartered the Panel in 2020 for a 2-year period effective through November 20, 2022. The current charter is available on the CMS website at.

Https://www.cms.gov/​files/​document/​2020-hop-panel-charter.pdf. The Panel presently consists of members and a Chair named below. E.L.

Hambrick, M.D., J.D., CMS Chairperson Terry Bohlke, C.P.A., C.M.A, M.H.A., C.A.S.C Carmen Cooper-Oguz, P.T., D.P.T, M.B.A, C.W.S, W.C.C Paul Courtney, M.D. Peter Duffy, M.D. Lisa Gangarosa, M.D.

Michael Kuettel, M.D., M.B.A, Ph.D. Scott Manaker, M.D., Ph.D. Brian Nester, D.O., M.B.A.

Bo Gately, M.B.A. Matthew Wheatley, M.D., F.A.C.E.P. III.

Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated.

July 20, 2021. Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services.

End Signature End Supplemental Information [FR Doc. 2021-15727 Filed 7-22-21. 8:45 am]BILLING CODE 4120-01-P.

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August 28, lasix water pill over the counter 2020Contact. Office of CommunicationsPhone. 202-693-1999U.S. Department of Labor Issues Revised Final Beryllium StandardsFor Construction and Shipyards WASHINGTON, DC - The U.S.

Department of Labor's Occupational Safety and Health Administration (OSHA) today published a final rule revising the beryllium standards for construction and shipyards. The final rule includes changes designed to clarify the standards and simplify or improve compliance. These changes maintain protection for workers while ensuring that the standard is well understood and compliance is simple and straightforward. The final rule amends the following paragraphs in the beryllium standards for construction and shipyards.

Definitions, Methods of Compliance, Respiratory Protection, Personal Protective Clothing and Equipment, Housekeeping, Hazard Communication, Medical Surveillance, and Recordkeeping. OSHA has removed the Hygiene Areas and Practices paragraph from the final standards because the necessary protections are provided by existing OSHA standards for sanitation. The effective date of the revisions in this final rule is September 30, 2020. OSHA began enforcing the new permissible exposure limits in the 2017 beryllium standards for construction and shipyards in May 2018.

OSHA will begin enforcing the remaining provisions of the standards on September 30, 2020. The final standard will affect approximately 12,000 workers employed in nearly 2,800 establishments in the construction and shipyard industries. The final standards are estimated to yield $2.5 million in total annualized cost savings to employers. Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees.

OSHA's role is to help ensure these conditions for America's working men and women by setting and enforcing standards, and providing training, education, and assistance. For more information, visit www.osha.gov. The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States. Improve working conditions.

Advance opportunities for profitable employment. And assure work-related benefits and rights. # # # U.S. Department of Labor news materials are accessible at http://www.dol.gov.

The Department's Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the Department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).August 27, 2020U.S. Department of Labor Announces ActionsTo Assist Americans Impacted By Hurricane Laura WASHINGTON, DC – The U.S. Department of Labor today announced actions it is taking to assist Americans in states affected by Hurricane Laura.

In response to the anticipated needs of those living in states in the path of Hurricane Laura, the Department and its agencies are taking the following actions. The Occupational Safety and Health Administration (OSHA) has actively engaged with the U.S. Department of Homeland Security, the Federal Emergency Management Administration, the Environmental Protection Agency, and other federal agencies and is prepared to provide assistance. The Wage and Hour Division (WHD) will be prioritizing all calls in the affected areas to continue to provide uninterrupted service to workers and employers.

The Employment and Training Administration (ETA) is prepared to provide Disaster Dislocated Worker Grants to help affected states address workforce needs. The disbursement of funds will be determined as needs are assessed by state and local partners. ETA is also prepared to assist in administering Disaster Unemployment Assistance. The Employee Benefits Security Administration (EBSA) will coordinate with other federal agencies, including the U.S.

Department of Treasury, the IRS and the Pension Benefit Guaranty Corp. On the release of compliance guidance for employee benefit plans, and plan participants and beneficiaries in response to Hurricane Laura. General information on disaster relief under the Employee Retirement Income Security Act (ERISA) is available on EBSA's website at Disaster Relief Information for Employers and Advisers and Disaster Relief Information for Workers and Families, or by contacting EBSA online or by calling 1-866-444-3272. The Office of Federal Contract Compliance Programs (OFCCP) issued a Temporary Exemption from certain federal contracting requirements.

For a period of three months, from August 27, 2020, to November 27, 2020, new federal contracts to provide relief, clean-up or rebuilding efforts will be exempt from having to develop written affirmative action programs as required by Executive Order 11246. The Mine Safety and Health Administration (MSHA) is responding to Hurricane Laura's impact on mines, and stands ready to respond more generally with specialized equipment and personnel. And The Veterans' Employment and Training Service (VETS) is working with its grantees to identify further flexibilities and additional funding needs for its programs. VETS staff is prepared to assist employers, members of the National Guard and Reserves and members of the National Disaster Medical System and Urban Search and Rescue who deploy in support of rescue and recovery operations.

The Department will continue to monitor developments regarding Hurricane Laura and take additional actions as necessary. For additional information, please visit the Department's Severe Storm and Flood Recovery Assistance webpage. The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States. Improve working conditions.

Advance opportunities for profitable employment. And assure work-related benefits and rights. # # # Media Contact. Eric Holland, 202-693-4676, holland.eric.w@dol.gov Release Number.

20-1654-NAT U.S. Department of Labor news materials are accessible at http://www.dol.gov. The Department's Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the Department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay)..

August 28, 2020Contact online pharmacy lasix http://mpressiv.com/zithromax-antibiotic-price/. Office of CommunicationsPhone. 202-693-1999U.S. Department of Labor Issues Revised Final Beryllium StandardsFor Construction and Shipyards WASHINGTON, DC - The U.S.

Department of Labor's Occupational Safety and Health Administration (OSHA) today published a final rule revising the beryllium standards for construction and shipyards. The final rule includes changes designed to clarify the standards and simplify or improve compliance. These changes maintain protection for workers while ensuring that the standard is well understood and compliance is simple and straightforward. The final rule amends the following paragraphs in the beryllium standards for construction and shipyards.

Definitions, Methods of Compliance, Respiratory Protection, Personal Protective Clothing and Equipment, Housekeeping, Hazard Communication, Medical Surveillance, and Recordkeeping. OSHA has removed the Hygiene Areas and Practices paragraph from the final standards because the necessary protections are provided by existing OSHA standards for sanitation. The effective date of the revisions in this final rule is September 30, 2020. OSHA began enforcing the new permissible exposure limits in the 2017 beryllium standards for construction and shipyards in May 2018.

OSHA will begin enforcing the remaining provisions of the standards on September 30, 2020. The final standard will affect approximately 12,000 workers employed in nearly 2,800 establishments in the construction and shipyard industries. The final standards are estimated to yield $2.5 million in total annualized cost savings to employers. Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees.

OSHA's role is to help ensure these conditions for America's working men and women by setting and enforcing standards, and providing training, education, and assistance. For more information, visit www.osha.gov. The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States. Improve working conditions.

Advance opportunities for profitable employment. And assure work-related benefits and rights. # # # U.S. Department of Labor news materials are accessible at http://www.dol.gov.

The Department's Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the Department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).August 27, 2020U.S. Department of Labor Announces ActionsTo Assist Americans Impacted By Hurricane Laura WASHINGTON, DC – The U.S. Department of Labor today announced actions it is taking to assist Americans in states affected by Hurricane Laura.

In response to the anticipated needs of those living in states in the path of Hurricane Laura, the Department and its agencies are taking the following actions. The Occupational Safety and Health Administration (OSHA) has actively engaged with the U.S. Department of Homeland Security, the Federal Emergency Management Administration, the Environmental Protection Agency, and other federal agencies and is prepared to provide assistance. The Wage and Hour Division (WHD) will be prioritizing all calls in the affected areas to continue to provide uninterrupted service to workers and employers.

The Employment and Training Administration (ETA) is prepared to provide Disaster Dislocated Worker Grants to help affected states address workforce needs. The disbursement of funds will be determined as needs are assessed by state and local partners. ETA is also prepared to assist in administering Disaster Unemployment Assistance. The Employee Benefits Security Administration (EBSA) will coordinate with other federal agencies, including the U.S.

Department of Treasury, the IRS and the Pension Benefit Guaranty Corp. On the release of compliance guidance for employee benefit plans, and plan participants and beneficiaries in response to Hurricane Laura. General information on disaster relief under the Employee Retirement Income Security Act (ERISA) is available on EBSA's website at Disaster Relief Information for Employers and Advisers and Disaster Relief Information for Workers and Families, or by contacting EBSA online or by calling 1-866-444-3272. The Office of Federal Contract Compliance Programs (OFCCP) issued a Temporary Exemption from certain federal contracting requirements.

For a period of three months, from August 27, 2020, to November 27, 2020, new federal contracts to provide relief, clean-up or rebuilding efforts will be exempt from having to develop written affirmative action programs as required by Executive Order 11246. The Mine Safety and Health Administration (MSHA) is responding to Hurricane Laura's impact on mines, and stands ready to respond more generally with specialized equipment and personnel. And The Veterans' Employment and Training Service (VETS) is working with its grantees to identify further flexibilities and additional funding needs for its programs. VETS staff is prepared to assist employers, members of the National Guard and Reserves and members of the National Disaster Medical System and Urban Search and Rescue who deploy in support of rescue and recovery operations.

The Department will continue to monitor developments regarding Hurricane Laura and take additional actions as necessary. For additional information, please visit the Department's Severe Storm and Flood Recovery Assistance webpage. The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States. Improve working conditions.

Advance opportunities for profitable employment. And assure work-related benefits and rights. # # # Media Contact. Eric Holland, 202-693-4676, holland.eric.w@dol.gov Release Number.

20-1654-NAT U.S. Department of Labor news materials are accessible at http://www.dol.gov. The Department's Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the Department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay)..

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You may be hearing about how virtual care, often described as telehealth or telemedicine, is beneficial during hypertension medications and how can lasix lower blood pressure too much health http://maxatp.com/uncategorized/hello-world/ 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 hardest hit areas in the country, as they provide front-line care to patients with hypertension medications. It makes can lasix lower blood pressure too much 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 of being a nurse is knowing you matter to the only person in health care that truly matters. The patient can lasix lower blood pressure too much. 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. hypertension medications has forced a lot of us to rethink the role we play in health care and what the can lasix lower blood pressure too much real priority should be.

Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a lasix or prepare for the unknown future of, “When is our turn?. € For me, hypertension medications 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 also shown that many of the can lasix lower blood pressure too much 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 FaceTime) can lasix lower blood pressure too much. 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 can lasix lower blood pressure too much 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 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 can lasix lower blood pressure too much 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, can lasix lower blood pressure too much 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 app their insurance gave them?. Nearly all of them can lasix lower blood pressure too much 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 expand what can lasix lower blood pressure too much 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 can lasix lower blood pressure too much 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 hypertension medications) 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 can lasix lower blood pressure too much 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 hypertension medications hit. When hypertension medications started to spread rapidly in the United States, regulations and reimbursement rules can lasix lower blood pressure too much 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 hypertension medications and non-hypertension medications related visits. We were already frantically designing a virtual program to handle the wave of hypertension medications screening visits that were overloading our emergency departments and urgent cares. We were having plenty of discussions around reimbursement for this clinic can lasix lower blood pressure too much. 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 can lasix lower blood pressure too much 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 can lasix lower blood pressure too much Insurance Portability and Accountability Act) still existed. I had this crazy idea that during a lasix 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 is as low-key as strep throat and a patient may want can lasix lower blood pressure too much 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 generic lasix cost. For example, in my home state of Michigan, adolescents are essentially considered can lasix lower blood pressure too much 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 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 can lasix lower blood pressure too much 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 the lasix ends.

Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any can lasix lower blood pressure too much patient that wanted a direct-to-consumer video visit to be screened by a provider for hypertension medications. 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 can lasix lower blood pressure too much 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 the patients seen by the virtual clinic did not meet CDC testing criteria for hypertension medications. I don’t believe we can lasix lower blood pressure too much 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 lasix 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 can lasix lower blood pressure too much 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 can lasix lower blood pressure too much comfortable every normal flu season?. Is it any more appropriate to ask them to risk exposure to the flu than it is to hypertension medications?. 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 in our health system are seen virtually by their own primary care doctor or specialist for non-hypertension medications can lasix lower blood pressure too much 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 hypertension medications, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. hypertension medications has been a wake-up call to can lasix lower blood pressure too much 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 can lasix lower blood pressure too much 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. hypertension medications has forced this industry forward, we cannot allow it to regress and be forgotten can lasix lower blood pressure too much 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 evaluation is can lasix lower blood pressure too much 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 can lasix lower blood pressure too much 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, it is important to establish and maintain a relationship with a podiatrist. Your podiatrist can make can lasix lower blood pressure too much 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 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 can lasix lower blood pressure too much 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 inspect can lasix lower blood pressure too much 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 can lasix lower blood pressure too much 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.

Have you ever woken up with a sore throat and online pharmacy lasix used your phone to get a virtual visit? http://coolcycledude.com/2013-yamaha-raider-scl-demo-ride/. The odds are it’s not available 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 hypertension medications and how health systems are offering virtual access like never before. There’s a reason for that, online pharmacy lasix too.

For the past few weeks I’ve seen Facebook posts daily from former nursing colleagues in metro Detroit, one of the hardest hit areas in the country, as they provide front-line care to patients with hypertension medications. It makes me very proud to call these nurses my friends. As a former emergency department nurse, I online pharmacy lasix recall the feeling of satisfaction knowing that I’ve helped someone on the worst day of their life. One of the best parts 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 online pharmacy lasix 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. hypertension medications 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 online pharmacy lasix for patients in a lasix or prepare for the unknown future of, “When is our turn?. € For me, hypertension medications 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 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 online pharmacy lasix 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 FaceTime). I was tech-savvy from a consumer perspective and a tech novice online pharmacy lasix 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 also became experts in working around those barriers. But, there were two obstacles that we could not overcome online pharmacy lasix. 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 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 online pharmacy lasix 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 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 online pharmacy lasix 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 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 online pharmacy lasix 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 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 online pharmacy lasix 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 physician brought to me was instantly dead in the water because practically no insurance company would pay for it.

There are (prior to online pharmacy lasix hypertension medications) 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 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 online pharmacy lasix 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 hypertension medications hit. When hypertension medications started to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change online pharmacy lasix 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 hypertension medications and non-hypertension medications related visits. We were already frantically designing a virtual program to handle the wave of hypertension medications 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 online pharmacy lasix 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 don’t know if we will be paid for any of this.

We are online pharmacy lasix 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. I had this crazy idea that during a lasix we online pharmacy lasix 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 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 online pharmacy lasix 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 if it involves sexual health, mental health or substance abuse. Never mind that this same information is online pharmacy lasix 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 discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications.

The elimination online pharmacy lasix 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 lasix 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 hypertension medications. It allows patients to call in without a referral online pharmacy lasix 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. 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 online pharmacy lasix or urgent care. To date, 70 percent of the patients seen by the virtual clinic did not meet CDC testing criteria for hypertension medications.

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 online pharmacy lasix 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 lasix 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 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 online pharmacy lasix 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 normal flu season?. Is it any more appropriate to ask them to risk online pharmacy lasix exposure to the flu than it is to hypertension medications?.

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 in our health system are seen virtually by their own primary care doctor or specialist for non-hypertension medications related visits. Not a single one of these would have been reimbursed one month ago online pharmacy lasix 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 hypertension medications, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement.

hypertension medications has been a wake-up call to the whole country and health care is no exception. It has put priorities in perspective and online pharmacy lasix 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 place.

HIPAA regulation online pharmacy lasix 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. hypertension medications has forced this industry forward, we cannot allow it to regress and be forgotten when this is over. Tom Wood is the director online pharmacy lasix 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 evaluation is one of the best ways to prevent foot complications. It’s important to identify your risk factors and online pharmacy lasix 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 feet and legs. You can slow the progression of developing neuropathy by making it a point to manage your blood online pharmacy lasix 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 things to your attention to monitor and keep a close eye on.

Open wounds or ulcers can develop secondary online pharmacy lasix 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 a loved one dealing with this complication. Untreated ulcerations often lead to amputation and can be avoided if proper medical attention is online pharmacy lasix sought right away.

There are important things to remember when dealing with 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 online pharmacy lasix 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.

Can i buy lasix

At that time, this drug benefit was "carved into" the Medicaid managed can i buy lasix care benefit package. Before that date, people enrolled in a Medicaid managed care plan obtained all of their health care through the plan, but used their regular Medicaid card to access any drug available on the state formulary on a "fee for service" basis without needing to utilize a restricted pharmacy network or comply with managed care plan rules. COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans.

That means that members of managed care plans will access their drugs outside their plan, unlike can i buy lasix the rest of their medical care, which is accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies.

Under Medicaid can i buy lasix managed care. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary.

Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents can i buy lasix of all Medicaid covered drugs. The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy.

Pharmacy networks can also differ from plan to can i buy lasix plan. Prescriber Prevails applies in certain drug classes. Prescriber prevails applys to medically necessary precription drugs in the following classes.

atypical antipsychotics, can i buy lasix anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies.

The Department of Health plans can i buy lasix to build capacity for interactive searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care. The form will be posted on the Pharmacy Information Website in July of 2013.

Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at can i buy lasix any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price. CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time.

Medicaid consumers will have this option only in the limited circumstances during the first year can i buy lasix of enrollment in managed care. Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the year.

Consumers can switch plans during can i buy lasix the “lock in” period only for good cause. The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time.

STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY can i buy lasix DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials.

Some plans may develop special procedures for drug denials can i buy lasix. Information on these procedures should be provided in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision.

An adverse decision is called can i buy lasix a 'FInal Adverse Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD.

The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar can i buy lasix days in standard appeals, and 72 hours in expedited appeals. The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing.

The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date can i buy lasix of the IAD and FAD notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care.

Enrollees who are in the first 90 days of enrollment, or past the first 12 can i buy lasix months of enrollment also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees.

Certain drugs/drug categories can i buy lasix require the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list. The full Medicaid formulary can be searched on the eMedNY website.

Even in fee can i buy lasix for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months.

Click here for more information can i buy lasix on NY's prior authorization process. The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program.

Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as can i buy lasix well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline.

1-888-614-5400 NY State can i buy lasix Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon. - Fri.

8:30 am - 4:30 can i buy lasix pm) NY State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau. 1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State.

2019 updates - The Trump administration has taken steps can i buy lasix to end TPS status. Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS.

See US Immigration Website on TPS can i buy lasix - General TPS website with links to status in all countries, including HAITI. See also Pew Research March 2019 article. Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019.

Read more about can i buy lasix this change in public charge rules here. What is Temporary Protected Status?. TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely.

On January 21, 2010 the United can i buy lasix States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation and allows them to work legally.

It is important can i buy lasix to note that the U.S. Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs.

In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus can i buy lasix meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program. Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status. For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart.

Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to can i buy lasix prove their eligibility for public health insurance. Individuals will need to bring. 1) Proof of identity.

2) Proof of residence in can i buy lasix New York. 3) Proof of income. 4) Proof of application for TPS.

5) Proof that can i buy lasix U.S. Citizenship and Immigration Services (USCIS) has received the application for TPS. Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they can understand.

All Medicaid offices and enrollers are required to can i buy lasix offer free translation and interpretation services to anyone who cannot communicate effectively in English. A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office. Important documents, such as Medicaid applications, should be translated either orally or in writing.

Interpreter services must be offered free can i buy lasix of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants. An applicant must never be asked to bring their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status.

A copy of the list is posted at the NYIC’s website at http://www.thenyic.org. o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays.

9:30 am - 12:30 pm FOR IMMIGRATION HELP. CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m.

To 8:00 p.m.Saturday-Sunday, from 9:00 a.m. To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules.

COMING IN April 2021 online pharmacy lasix - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans. That means that members of managed care plans will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?.

The Medicaid pharmacy benefit includes all FDA approved prescription drugs, online pharmacy lasix as well as some over-the-counter drugs and medical supplies. Under Medicaid managed care. Plan formularies will be comparable to but not the same as the Medicaid formulary.

Managed care plans are required to have drug formularies that are “comparable” to the online pharmacy lasix Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs. The Pharmacy Benefit will vary by plan.

Each plan online pharmacy lasix will have its own formulary and drug coverage policies like prior authorization and step therapy. Pharmacy networks can also differ from plan to plan. Prescriber Prevails applies in certain drug classes.

Prescriber prevails applys online pharmacy lasix to medically necessary precription drugs in the following classes. atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation.

Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a online pharmacy lasix plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care.

The form will be posted on the Pharmacy Information online pharmacy lasix Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price. CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?.

Changing plans is often an effective strategy for consumers eligible for both Medicaid and online pharmacy lasix Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care. Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan.

After the 90 days has expired, enrollees are “locked in” to the plan for the online pharmacy lasix rest of the year. Consumers can switch plans during the “lock in” period only for good cause. The pharmacy benefit changes are not considered good cause.

After the first 12 months of enrollment, Medicaid managed care enrollees online pharmacy lasix can switch plans at any time. STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing.

All plans are required to maintain an internal and external review process for complaints online pharmacy lasix and appeals of service denials. Some plans may develop special procedures for drug denials. Information on these procedures should be provided in member handbooks.

Beginning April 1, 2018, Medicaid managed care online pharmacy lasix enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services.

The enroll has the right to request a fair hearing to appeal an online pharmacy lasix FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals. The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest.

AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting online pharmacy lasix for the Plan Appeal and then the fair hearing. The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here.

Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply online pharmacy lasix to Mainstream Medicaid managed care. Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below.

ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs online pharmacy lasix and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list.

The full Medicaid formulary can be searched on the eMedNY website online pharmacy lasix. Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills.

A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next online pharmacy lasix six months. Click here for more information on NY's prior authorization process. The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities.

The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program online pharmacy lasix. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider Manual.

WHO YOU CAN online pharmacy lasix CALL FOR HELP Community Health Advocates Hotline. 1-888-614-5400 NY State Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon.

- Fri online pharmacy lasix. 8:30 am - 4:30 pm) NY State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau.

1-800-771-7755Haitian individuals and immigrants from some online pharmacy lasix other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump administration has taken steps to end TPS status. Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018.

The California case was argued in an appeals court on August 14, 2019, which the LA online pharmacy lasix Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links to status in all countries, including HAITI. See also Pew Research March 2019 article.

Courts Block online pharmacy lasix Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public charge rules here. What is Temporary Protected Status?.

TPS is a temporary immigration status granted online pharmacy lasix to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely. On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S.

On January online pharmacy lasix 12, 2010, protection from forcible deportation and allows them to work legally. It is important to note that the U.S. Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan.

TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also online pharmacy lasix meet the income requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program. Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status.

For more information on immigrant eligibility for public health insurance in online pharmacy lasix New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public health insurance. Individuals will need to bring.

1) Proof of online pharmacy lasix identity. 2) Proof of residence in New York. 3) Proof of income.

4) Proof online pharmacy lasix of application for TPS. 5) Proof that U.S. Citizenship and Immigration Services (USCIS) has received the application for TPS.

Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they online pharmacy lasix can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English. A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office.

Important documents, such as Medicaid online pharmacy lasix applications, should be translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants. An applicant must never be asked to bring their own interpreter.

Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in online pharmacy lasix Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org. o USCIS TPS website with links to status in all countries, including HAITI.

O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP. CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you.

212-419-3737 Monday-Friday, from 9:00 a.m. To 8:00 p.m.Saturday-Sunday, from 9:00 a.m. To 5:00 p.m.

Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society. 1/29/10, updated 3/1/10, updated 8/15/19 by NY Legal Assistance Group.

Dogs on lasix

Restoration of vision their explanation in blind people through a brain implant is on the verge dogs on lasix of becoming reality. Recent discoveries at the Netherlands Institute for Neuroscience (NIN) show that newly developed high-resolution implants in the visual cortex make it possible to recognize artificially induced shapes and percepts. The findings were published in Science on 3 December.The idea of stimulating the brain via an implant to dogs on lasix generate artificial visual percepts is not new and dates back to the 1970s.

However, existing systems are only able to generate a small number of artificial 'pixels' at a time. At the NIN, researchers from a team led by Pieter Roelfsema are now using new implant production and implantation technologies, cutting-edge materials engineering, microchip fabrication, and microelectronics, to develop devices that are more stable and durable than previous implants. The first results are very promising.Electrical stimulation When electrical stimulation is delivered to the brain via an implanted electrode, it generates the percept of a dot of light dogs on lasix at a particular location in visual space, known as a 'phosphene.' The team developed high-resolution implants consisting of 1024 electrodes and implanted them in the visual cortex of two sighted monkeys.

Their goal was to create interpretable images by delivering electrical stimulation simultaneously via multiple electrodes, to generate a percept that was composed of multiple phosphenes. "The number of electrodes that we have implanted in the visual cortex, and the number of artificial pixels that we can generate to produce high-resolution artificial images, is unprecedented," says Roelfsema.Recognizing dots, lines and letters The monkeys first had to perform a simple behavioral task in which they made eye movements to dogs on lasix report the location of a phosphene that was elicited during electrical stimulation via an individual electrode. They were also tested on more complex tasks such as a direction-of-motion task, in which micro-stimulation was delivered on a sequence of electrodes, and a letter discrimination task, in which micro-stimulation was delivered on 8-15 electrodes simultaneously, creating a percept in the form of a letter.

The monkeys successfully recognized shapes and percepts, including lines, moving dots, and letters, using their artificial vision."Our implant interfaces directly with the brain, bypassing prior stages of visual processing via the eye or the optic nerve. Hence, in the future, such technology could be used for the restoration of low vision in blind people who have suffered injury or degeneration of the retina, eye, or optic nerve, but whose visual cortex remains intact," explains Xing Chen, postdoctoral researcher in Roelfsema's team.This research lays the foundations for a neuroprosthetic device that could allow profoundly blind people to regain functional vision and to recognize objects, navigate in unfamiliar surroundings, and interact more easily in social settings, significantly improving their dogs on lasix independence and quality of life. Story Source.

Materials provided by Netherlands Institute for Neuroscience - dogs on lasix KNAW. Note. Content may be edited for style and length..

Restoration of vision in blind people through a online pharmacy lasix brain implant is on the verge of find out this here becoming reality. Recent discoveries at the Netherlands Institute for Neuroscience (NIN) show that newly developed high-resolution implants in the visual cortex make it possible to recognize artificially induced shapes and percepts. The findings were published in Science on 3 December.The idea of stimulating the brain via an implant to generate artificial visual percepts is not new and dates back to online pharmacy lasix the 1970s. However, existing systems are only able to generate a small number of artificial 'pixels' at a time. At the NIN, researchers from a team led by Pieter Roelfsema are now using new implant production and implantation technologies, cutting-edge materials engineering, microchip fabrication, and microelectronics, to develop devices that are more stable and durable than previous implants.

The first results are very online pharmacy lasix promising.Electrical stimulation When electrical stimulation is delivered to the brain via an implanted electrode, it generates the percept of a dot of light at a particular location in visual space, known as a 'phosphene.' The team developed high-resolution implants consisting of 1024 electrodes and implanted them in the visual cortex of two sighted monkeys. Their goal was to create interpretable images by delivering electrical stimulation simultaneously via multiple electrodes, to generate a percept that was composed of multiple phosphenes. "The number of electrodes that we have implanted in the visual cortex, and the number of artificial pixels that we can generate to produce high-resolution artificial images, is unprecedented," says Roelfsema.Recognizing dots, lines and letters The monkeys online pharmacy lasix first had to perform a simple behavioral task in which they made eye movements to report the location of a phosphene that was elicited during electrical stimulation via an individual electrode. They were also tested on more complex tasks such as a direction-of-motion task, in which micro-stimulation was delivered on a sequence of electrodes, and a letter discrimination task, in which micro-stimulation was delivered on 8-15 electrodes simultaneously, creating a percept in the form of a letter. The monkeys successfully recognized shapes and percepts, including lines, moving dots, and letters, using their artificial vision."Our implant interfaces directly with the brain, bypassing prior stages of visual processing via the eye or the optic nerve.

Hence, in the future, such technology could be used for the restoration of low online pharmacy lasix vision in blind people who have suffered injury or degeneration of the retina, eye, or optic nerve, but whose visual cortex remains intact," explains Xing Chen, postdoctoral researcher in Roelfsema's team.This research lays the foundations for a neuroprosthetic device that could allow profoundly blind people to regain functional vision and to recognize objects, navigate in unfamiliar surroundings, and interact more easily in social settings, significantly improving their independence and quality of life. Story Source. Materials provided online pharmacy lasix by Netherlands Institute for Neuroscience - KNAW. Note. Content may be edited for style and length..

Lasix side effects

President Joe Biden has can u buy lasix over the counter ordered lasix side effects U.S. Intelligence agencies to determine whether the hypertension medications lasix, or a near ancestor, emerged from a cave, a live-animal market, a farm — or a secretive Chinese laboratory. But it’s lasix side effects doubtful this probe will yield definitive insights, and it could even backfire.

Some experts hypothesize that global pressure could prompt a Chinese scientific whistleblower to come forward with evidence of a lab leak. After all, it is unlikely such an accident could have occurred without dozens of people finding out about the leak, or an ensuing cover-up. But the growing political pressure to discover Chinese malfeasance or a lab accident at the root of the lasix could make a definitive answer less, rather than more, lasix side effects likely, according to virologists and experts on U.S.-China scientific exchanges.

€œWe have to reduce the political tension and let the scientists do the work, not the politicians,” said Dr. Jennifer Huang lasix side effects Bouey, a Chinese-born Rand Corp. Researcher.

Yet that seems like a pipe dream. In the United States, the lab leak theory is part of the conservative arsenal lasix side effects of attacks on those in science and the media who criticized President Donald Trump’s handling of the lasix. For the ruling Chinese Communist Party, the political implications of acknowledging a lab leak and subsequent cover-up are a non-starter.

It would leave China lasix side effects essentially responsible for starting a global lasix that has killed 6 million and ground economies to a halt. As Biden last week announced a 90-day review of evidence on the lasix’s origin — which could involve a review of documents from U.S. Agencies that helped fund Chinese viral research— Chinese officials at a World Health Organization meeting dismissed the review and withdrew a promise to cooperate with scientists examining the full slate of origin possibilities.

EMAIL SIGN-Up Subscribe to California Healthline's free Daily Edition. During lasix side effects its visit to China in February, a WHO investigative team received agreement from Chinese blood banks to preserve samples of donations that could indicate when and where the lasix might have been circulating before it swept over the city of Wuhan in December 2019. The team wants to go back to China, extending its investigation to markets and farms where animals like civet cats, raccoon dogs and bamboo rats — potential carriers of the lasix as it leaped from bats to humans — were raised as part of a $70 billion “wildlife farming” industry. In 2003, China banned the sale of such exotic wildlife at “wet markets” — which mainly sell fish and game like live chickens — after they were implicated as the origin of the SARS epidemic, though such animals have returned to markets over the years.

Further study is impossible without lasix side effects Chinese cooperation, which is mired in politics, the WHO investigators say. €œWe’re not following all these obvious leads now,” Dr. Marion Koopmans, a leading Dutch virologist who was part of the WHO lasix side effects team, said last week.

€œEverything is stalled.” Her team has been criticized for caving to Chinese pressure by failing to seek a strict audit of the Wuhan Institute of Virology, the center of allegations about a lab leak. But to forcefully demand such an audit would require evidence of a leak, rather than speculation based on classified intelligence reports and theoretical gaps in data, Koopmans said. Besides, the Chinese government lasix side effects won’t open its books.

It has closed access to the data, claiming there had been thousands of hacking attempts against the Wuhan Institute. That awkward standoff could harm U.S.-Chinese scientific cooperation, which has gradually expanded over the past 40 years and remained strong despite Trump administration lasix side effects attacks. Whether a lab leak happened or not, it’s hard to see how a weakening of scientific exchanges would be a good thing for either country.

Full-tuition-paying Chinese students made up the majority of the international enrollees at U.S. Colleges and universities in 2019, though Chinese interest in lasix side effects U.S. Schools seems to be ebbing.

U.S. Laboratories depend on Chinese lasix side effects scholars, many of whom end up remaining in the United States. Scholars from the two countries co-publish scientific papers more often than any other national “dyad,” according to research by Caroline Wagner of the Ohio State University.

But those partnerships have lasix side effects had their hiccups, sometimes for political reasons. With AIDS and SARS, the Chinese were either reluctant to allow their scientists to release data or released counts that many Western experts doubted were accurate. Trump curtailed scientific exchanges as early as 2017, issuing fewer visas and raising FBI vigilance of academics with ties to China.

Some interagency agreements were allowed to lapse and, in 2018, a 45-member Centers for Disease Control and Prevention contingent in China lasix side effects was cut to 10. Trump saw this as a punishment of the Chinese, but it effectively blinded the U.S. To the goings-on lasix side effects in Chinese epidemiology.

Otherwise, “maybe we’d have had a quicker leg up on the outbreak,” said Ben Corb, spokesperson for the American Society for Biochemistry and Molecular Biology. Despite his anti-China stance, Trump in 2018 renewed a landmark 1979 agreement authorizing scientific and technological cooperation among the Chinese and U.S. Governments.

However, that renewal document is secret — presumably, Trump was not happy to have to take the advice of his scientific advisers — and it’s impossible to come by a copy, according to Duke University business professor Denis Simon, an expert on the US-China scientific relationship. The Biden administration is said to favor improving scientific cooperation — for example, by easing limits on visas for Chinese scholars. And while Trump clearly viewed the lab leak hypothesis as an opportunity to blame China for the administration’s misfortunate hypertension medications response — an association that tarnished the theory’s plausibility during the Trump years — Biden seems to want an answer to the question, at least in part to prevent future lasixs.

Since the turn of the century and especially since SARS, China has sent many biologists to train in the United States, and they are now leery of being seen as unreliable partners in disease investigations. The Chinese government has copied many aspects of the U.S. Scientific and public health system, Bouey noted.

Close collaborations and friendships have resulted. Toward the beginning of the lasix, Dr. Anthony Fauci, the National Institutes of Health’s top infectious disease specialist, was in regular contact by email with George Gao, the Oxford- and Harvard-trained scientist who runs China’s equivalent of the CDC.

Even with Chinese government cooperation, we might never know how hypertension medications began. But if the intelligence review suggests or manages to determine that a lab leak did cause the lasix, and China continues to stonewall, it’s hard to predict what might happen. €œI think there will be hell to pay,” said Simon.

€œWe haven’t figured out the consequences to the answer. I’m very concerned about our ability to manage the emotions loosed if that hypothesis were to be accepted.” Arthur Allen. aallen@kff.org, @ArthurAllen202 Related Topics Contact Us Submit a Story TipThe Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company. The FDA is under pressure because an estimated 6 million Americans are diagnosed with Alzheimer’s, a debilitating and ultimately fatal form of dementia, and there are no drugs on the market to treat the underlying disease.

Although some drugs slightly mitigate symptoms, patients and their families are desperate for a medication that even modestly slows its progression. EMAIL SIGN-Up Subscribe to California Healthline's free Daily Edition. Aducanumab helps the body produce antibodies that remove amyloid plaques from the brain, which has been associated with Alzheimer’s. It’s designed for patients with mild-to-moderate cognitive decline from Alzheimer’s, of which there are an estimated 2 million Americans.

But it’s not clear whether eliminating the plaque improves brain function in Alzheimer’s patients. So far, nearly two dozen drugs based on the so-called amyloid hypothesis have failed in clinical trials. Besides questions about whether the drug works, there also are safety issues.

More than one-third of patients in one of the trials experienced brain swelling and nearly 20% had brain bleeding, though those symptoms generally were mild and controllable. Because of those risks, patients receiving aducanumab have to undergo regular brain monitoring through expensive PET scans and MRI tests. Some physicians who treat Alzheimer’s patients say they won’t prescribe the drug even if it’s approved.

€œThere’s a lot of hope among my patients that this is going to be a game changer,” said Dr. Matthew Schrag, an assistant professor of neurology at Vanderbilt University. €œBut the cognitive benefits of this drug are quite small, we don’t know the long-term safety risks, and there will be a lot of practical issues in deploying this therapy.

We have to wait until we’re certain we’re doing the right thing for patients.” Many aspects of aducanumab’s journey through the FDA approval process have been unusual. It’s “vanishingly rare” for a drug to continue on toward approval after its clinical trial was halted because unfavorable results showed that further testing was futile, said Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner.

And it’s “mind-boggling,” he added, for the FDA to collaborate with a drugmaker in presenting a joint briefing document to an FDA advisory committee. €œA joint briefing document strikes me as completely inappropriate and an abdication of the FDA’s claim to being the best regulatory agency in the world,” Lurie said. Three FDA advisory committee members who voted in November against approving the drug wrote in a recent JAMA commentary that the FDA’s “unusual degree of collaboration” with Biogen led to criticism that it “potentially compromised the FDA’s objectivity.” They cast doubt on both the drug’s safety and the revised efficacy data.

The FDA and Biogen declined to comment for this article. Despite the uncertainties, the Alzheimer’s Association, the nation’s largest Alzheimer’s patient advocacy group, has pushed hard for FDA approval of aducanumab, mounting a major print and online ad campaign last month. The “More Time” campaign featured personal stories from patients and family members.

In one ad, actor Samuel L. Jackson posted on Twitter, “If a drug could slow Alzheimer’s, giving me more time with my mom, I would have read to her more.” But the association has drawn criticism for having its representatives testify before the FDA in support of the drug without disclosing that it received $525,000 in contributions last year from Biogen and its partner company, Eisai, and hundreds of thousands of dollars more in previous years. Other people who testified stated upfront whether or not they had financial conflicts.

Dr. Leslie Norins, founder of a group called Alzheimer’s Germ Quest that supports research, said the lack of disclosure hurts the Alzheimer’s Association’s credibility. €œWhen the association asks the FDA to approve a drug, shouldn’t it have to reveal that it received millions of dollars from the drug company?.

€ he asked. But Joanne Pike, the Alzheimer’s Association’s chief strategy officer, who testified before the FDA advisory committee about aducanumab without disclosing the contributions, denied that the association was hiding anything or that it supported the drug’s approval because of the drugmakers’ money. Anyone can search the association’s website to find all corporate contributions, she said in an interview.

Pike said her association backs the drug’s approval because its potential to slow patients’ cognitive and functional decline offers substantial benefits to patients and their caregivers, its side effects are “manageable,” and it will spur the development of other, more effective Alzheimer’s treatments. €œHistory has shown that approvals of first drugs in a category benefit people because they invigorate the pipeline,” she said. €œThe first drug is a start, and the second and third and fourth treatment could do even better.” Lurie disputed that.

He said lowering the FDA’s standards and approving an ineffective or marginally effective drug merely encourages other manufacturers to develop similar, “me too” drugs that also don’t work well. Anne Saint says she wouldn’t have risked putting her husband, Mike Saint, on the new Alzheimer’s drug aducanumab because of safety issues. Mike died in September at age 71.

(Molly Saint) The Public Citizen Health Research Group, which opposes approval of aducanumab, has called for an investigation of the FDA’s “unprecedented and inappropriate close collaboration” with Biogen. It asked the inspector general of the Department of Health and Human Services to probe the approval process, which that office said it would consider. The group also urged the acting FDA commissioner, Dr.

Janet Woodcock, to remove Dr. Billy Dunn, an aducanumab advocate who testified about it to the advisory committee, from his position as director of the FDA’s Office of Neuroscience and hand over review of the drug to staffers who weren’t involved in the Biogen collaboration. Woodcock refused, saying in a letter that FDA “interactions” with drugmakers make drug development “more efficient and more effective” and “do not interfere with the FDA’s independent perspective.” Although it would be unusual for the FDA to approve a drug after rejection by an FDA advisory committee, it’s not unprecedented, Lurie said.

Alternatively, the agency could approve it on a restricted basis, limiting it to a segment of the Alzheimer’s patient population and/or requiring Biogen to monitor patients. €œThat will be tempting but shouldn’t be the way the problem is solved,” he said. €œIf the product doesn’t work, it doesn’t work.

Once it’s on the market, it’s very difficult to get it off.” If the drug is approved, Alzheimer’s patients and their families will have to make a difficult calculation, balancing the limited potential benefits with proven safety issues. Anne Saint, whose husband, Mike, had Alzheimer’s for a decade and died in September at age 71, said that based on what she’s read about aducanumab, she wouldn’t have put him on the drug. €œMike was having brain bleeds anyway, and I wouldn’t have risked him having any more side effects, with no sure positive outcome,” said Saint, who lives in Franklin, Tennessee.

€œIt sounds like maybe that drug’s not going to work, for a lot of money.” Their adult daughter, Sarah Riley Saint, feels differently. €œIf this is the only hope, why not try it and see if it helps?. € she said.

Mike Saint walks daughter Molly down the aisle at her October 2019 wedding in Nashville, Tennessee. (Wandering Woo Photography) This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation).

KFF is an endowed nonprofit organization providing information on health issues to the nation. Related Topics Contact Us Submit a Story Tip.

President Joe online pharmacy lasix Biden has ordered U.S. Intelligence agencies to determine whether the hypertension medications lasix, or a near ancestor, emerged from a cave, a live-animal market, a farm — or a secretive Chinese laboratory. But it’s doubtful online pharmacy lasix this probe will yield definitive insights, and it could even backfire.

Some experts hypothesize that global pressure could prompt a Chinese scientific whistleblower to come forward with evidence of a lab leak. After all, it is unlikely such an accident could have occurred without dozens of people finding out about the leak, or an ensuing cover-up. But the growing political pressure to discover Chinese malfeasance or a lab accident at the root of the lasix could make a definitive answer less, rather than more, likely, according to online pharmacy lasix virologists and experts on U.S.-China scientific exchanges.

€œWe have to reduce the political tension and let the scientists do the work, not the politicians,” said Dr. Jennifer Huang Bouey, a online pharmacy lasix Chinese-born Rand Corp. Researcher.

Yet that seems like a pipe dream. In the United States, the lab leak theory is part of the conservative arsenal of attacks on those in science and online pharmacy lasix the media who criticized President Donald Trump’s handling of the lasix. For the ruling Chinese Communist Party, the political implications of acknowledging a lab leak and subsequent cover-up are a non-starter.

It would leave China online pharmacy lasix essentially responsible for starting a global lasix that has killed 6 million and ground economies to a halt. As Biden last week announced a 90-day review of evidence on the lasix’s origin — which could involve a review of documents from U.S. Agencies that helped fund Chinese viral research— Chinese officials at a World Health Organization meeting dismissed the review and withdrew a promise to cooperate with scientists examining the full slate of origin possibilities.

EMAIL SIGN-Up Subscribe to California Healthline's free Daily Edition. During online pharmacy lasix its visit to China in February, a WHO investigative team received agreement from Chinese blood banks to preserve samples of donations that could indicate when and where the lasix might have been circulating before it swept over the city of Wuhan in December 2019. The team wants to go back to China, extending its investigation to markets and farms where animals like civet cats, raccoon dogs and bamboo rats — potential carriers of the lasix as it leaped from bats to humans — were raised as part of a $70 billion “wildlife farming” industry. In 2003, China banned the sale of such exotic wildlife at “wet markets” — which mainly sell fish and game like live chickens — after they were implicated as the origin of the SARS epidemic, though such animals have returned to markets over the years.

Further study is impossible without Chinese cooperation, which is mired in online pharmacy lasix politics, the WHO investigators say. €œWe’re not following all these obvious leads now,” Dr. Marion Koopmans, a leading Dutch virologist who was part of the WHO online pharmacy lasix team, said last week.

€œEverything is stalled.” Her team has been criticized for caving to Chinese pressure by failing to seek a strict audit of the Wuhan Institute of Virology, the center of allegations about a lab leak. But to forcefully demand such an audit would require evidence of a leak, rather than speculation based on classified intelligence reports and theoretical gaps in data, Koopmans said. Besides, the online pharmacy lasix Chinese government won’t open its books.

It has closed access to the data, claiming there had been thousands of hacking attempts against the Wuhan Institute. That awkward standoff could harm U.S.-Chinese scientific cooperation, which has gradually expanded over the past online pharmacy lasix 40 years and remained strong despite Trump administration attacks. Whether a lab leak happened or not, it’s hard to see how a weakening of scientific exchanges would be a good thing for either country.

Full-tuition-paying Chinese students made up the majority of the international enrollees at U.S. Colleges and universities in 2019, though Chinese interest in online pharmacy lasix U.S. Schools seems to be ebbing.

U.S. Laboratories depend on Chinese scholars, many of whom end online pharmacy lasix up remaining in the United States. Scholars from the two countries co-publish scientific papers more often than any other national “dyad,” according to research by Caroline Wagner of the Ohio State University.

But those partnerships have had their hiccups, online pharmacy lasix sometimes for political reasons. With AIDS and SARS, the Chinese were either reluctant to allow their scientists to release data or released counts that many Western experts doubted were accurate. Trump curtailed scientific exchanges as early as 2017, issuing fewer visas and raising FBI vigilance of academics with ties to China.

Some interagency agreements were allowed to lapse and, in 2018, a 45-member Centers for Disease Control and online pharmacy lasix Prevention contingent in China was cut to 10. Trump saw this as a punishment of the Chinese, but it effectively blinded the U.S. To the goings-on in Chinese epidemiology online pharmacy lasix.

Otherwise, “maybe we’d have had a quicker leg up on the outbreak,” said Ben Corb, spokesperson for the American Society for Biochemistry and Molecular Biology. Despite his anti-China stance, Trump in 2018 renewed a landmark 1979 agreement authorizing scientific and technological cooperation among the Chinese and U.S. Governments.

However, that renewal document is secret — presumably, Trump was not happy to have to take the advice of his scientific advisers — and it’s impossible to come by a copy, according to Duke University business professor Denis Simon, an expert on the US-China scientific relationship. The Biden administration is said to favor improving scientific cooperation — for example, by easing limits on visas for Chinese scholars. And while Trump clearly viewed the lab leak hypothesis as an opportunity to blame China for the administration’s misfortunate hypertension medications response — an association that tarnished the theory’s plausibility during the Trump years — Biden seems to want an answer to the question, at least in part to prevent future lasixs.

Since the turn of the century and especially since SARS, China has sent many biologists to train in the United States, and they are now leery of being seen as unreliable partners in disease investigations. The Chinese government has copied many aspects of the U.S. Scientific and public health system, Bouey noted.

Close collaborations and friendships have resulted. Toward the beginning of the lasix, Dr. Anthony Fauci, the National Institutes of Health’s top infectious disease specialist, was in regular contact by email with George Gao, the Oxford- and Harvard-trained scientist who runs China’s equivalent of the CDC.

Even with Chinese government cooperation, we might never know how hypertension medications began. But if the intelligence review suggests or manages to determine that a lab leak did cause the lasix, and China continues to stonewall, it’s hard to predict what might happen. €œI think there will be hell to pay,” said Simon.

€œWe haven’t figured out the consequences to the answer. I’m very concerned about our ability to manage the emotions loosed if that hypothesis were to be accepted.” Arthur Allen. aallen@kff.org, @ArthurAllen202 Related Topics Contact Us Submit a Story TipThe Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company. The FDA is under pressure because an estimated 6 million Americans are diagnosed with Alzheimer’s, a debilitating and ultimately fatal form of dementia, and there are no drugs on the market to treat the underlying disease.

Although some drugs slightly mitigate symptoms, patients and their families are desperate for a medication that even modestly slows its progression. EMAIL SIGN-Up Subscribe to California Healthline's free Daily Edition. Aducanumab helps the body produce antibodies that remove amyloid plaques from the brain, which has been associated with Alzheimer’s. It’s designed for patients with mild-to-moderate cognitive decline from Alzheimer’s, of which there are an estimated 2 million Americans.

But it’s not clear whether eliminating the plaque improves brain function in Alzheimer’s patients. So far, nearly two dozen drugs based on the so-called amyloid hypothesis have failed in clinical trials. Besides questions about whether the drug works, there also are safety issues.

More than one-third of patients in one of the trials experienced brain swelling and nearly 20% had brain bleeding, though those symptoms generally were mild and controllable. Because of those risks, patients receiving aducanumab have to undergo regular brain monitoring through expensive PET scans and MRI tests. Some physicians who treat Alzheimer’s patients say they won’t prescribe the drug even if it’s approved.

€œThere’s a lot of hope among my patients that this is going to be a game changer,” said Dr. Matthew Schrag, an assistant professor of neurology at Vanderbilt University. €œBut the cognitive benefits of this drug are quite small, we don’t know the long-term safety risks, and there will be a lot of practical issues in deploying this therapy.

We have to wait until we’re certain we’re doing the right thing for patients.” Many aspects of aducanumab’s journey through the FDA approval process have been unusual. It’s “vanishingly rare” for a drug to continue on toward approval after its clinical trial was halted because unfavorable results showed that further testing was futile, said Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner.

And it’s “mind-boggling,” he added, for the FDA to collaborate with a drugmaker in presenting a joint briefing document to an FDA advisory committee. €œA joint briefing document strikes me as completely inappropriate and an abdication of the FDA’s claim to being the best regulatory agency in the world,” Lurie said. Three FDA advisory committee members who voted in November against approving the drug wrote in a recent JAMA commentary that the FDA’s “unusual degree of collaboration” with Biogen led to criticism that it “potentially compromised the FDA’s objectivity.” They cast doubt on both the drug’s safety and the revised efficacy data.

The FDA and Biogen declined to comment for this article. Despite the uncertainties, the Alzheimer’s Association, the nation’s largest Alzheimer’s patient advocacy group, has pushed hard for FDA approval of aducanumab, mounting a major print and online ad campaign last month. The “More Time” campaign featured personal stories from patients and family members.

In one ad, actor Samuel L. Jackson posted on Twitter, “If a drug could slow Alzheimer’s, giving me more time with my mom, I would have read to her more.” But the association has drawn criticism for having its representatives testify before the FDA in support of the drug without disclosing that it received $525,000 in contributions last year from Biogen and its partner company, Eisai, and hundreds of thousands of dollars more in previous years. Other people who testified stated upfront whether or not they had financial conflicts.

Dr. Leslie Norins, founder of a group called Alzheimer’s Germ Quest that supports research, said the lack of disclosure hurts the Alzheimer’s Association’s credibility. €œWhen the association asks the FDA to approve a drug, shouldn’t it have to reveal that it received millions of dollars from the drug company?.

€ he asked. But Joanne Pike, the Alzheimer’s Association’s chief strategy officer, who testified before the FDA advisory committee about aducanumab without disclosing the contributions, denied that the association was hiding anything or that it supported the drug’s approval because of the drugmakers’ money. Anyone can search the association’s website to find all corporate contributions, she said in an interview.

Pike said her association backs the drug’s approval because its potential to slow patients’ cognitive and functional decline offers substantial benefits to patients and their caregivers, its side effects are “manageable,” and it will spur the development of other, more effective Alzheimer’s treatments. €œHistory has shown that approvals of first drugs in a category benefit people because they invigorate the pipeline,” she said. €œThe first drug is a start, and the second and third and fourth treatment could do even better.” Lurie disputed that.

He said lowering the FDA’s standards and approving an ineffective or marginally effective drug merely encourages other manufacturers to develop similar, “me too” drugs that also don’t work well. Anne Saint says she wouldn’t have risked putting her husband, Mike Saint, on the new Alzheimer’s drug aducanumab because of safety issues. Mike died in September at age 71.

(Molly Saint) The Public Citizen Health Research Group, which opposes approval of aducanumab, has called for an investigation of the FDA’s “unprecedented and inappropriate close collaboration” with Biogen. It asked the inspector general of the Department of Health and Human Services to probe the approval process, which that office said it would consider. The group also urged the acting FDA commissioner, Dr.

Janet Woodcock, to remove Dr. Billy Dunn, an aducanumab advocate who testified about it to the advisory committee, from his position as director of the FDA’s Office of Neuroscience and hand over review of the drug to staffers who weren’t involved in the Biogen collaboration. Woodcock refused, saying in a letter that FDA “interactions” with drugmakers make drug development “more efficient and more effective” and “do not interfere with the FDA’s independent perspective.” Although it would be unusual for the FDA to approve a drug after rejection by an FDA advisory committee, it’s not unprecedented, Lurie said.

Alternatively, the agency could approve it on a restricted basis, limiting it to a segment of the Alzheimer’s patient population and/or requiring Biogen to monitor patients. €œThat will be tempting but shouldn’t be the way the problem is solved,” he said. €œIf the product doesn’t work, it doesn’t work.

Once it’s on the market, it’s very difficult to get it off.” If the drug is approved, Alzheimer’s patients and their families will have to make a difficult calculation, balancing the limited potential benefits with proven safety issues. Anne Saint, whose husband, Mike, had Alzheimer’s for a decade and died in September at age 71, said that based on what she’s read about aducanumab, she wouldn’t have put him on the drug. €œMike was having brain bleeds anyway, and I wouldn’t have risked him having any more side effects, with no sure positive outcome,” said Saint, who lives in Franklin, Tennessee.

€œIt sounds like maybe that drug’s not going to work, for a lot of money.” Their adult daughter, Sarah Riley Saint, feels differently. €œIf this is the only hope, why not try it and see if it helps?. € she said.

Mike Saint walks daughter Molly down the aisle at her October 2019 wedding in Nashville, Tennessee. (Wandering Woo Photography) This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation).

KFF is an endowed nonprofit organization providing information on health issues to the nation. Related Topics Contact Us Submit a Story Tip.