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  • OCR Resolves Religious Discrimination Complaints, Patients Can Receive Safe Religious Visitations During COVID-19

    Office for Civil Rights Resolves Religious Discrimination Complaints after Maryland and Virginia Hospitals Ensure Patients Can Receive Safe Religious Visitations During COVID-19 | site |



    (October 20, 2020) - - The U.S. Department of Health and Human Services published today, October 20, 2020, the following information: Today, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) announces the resolution of two religious discrimination complaints ensuring clergy access to patients for religious purposes during the COVID-19 pandemic, one involving MedStar’s Southern Maryland Hospital Center (MSMHC) that is part of the MedStar Health System, and the second one involving Mary Washington Healthcare (MWHC) in Virginia. In the first matter, in July 2020, OCR’s Conscience and Religious Freedom Division (CRFD) received a complaint from a mother alleging that after giving birth alone at MSMHC, she was separated from her newb...
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  • NHGRI Researchers Work with Patients, Families and the Scientific Community to Improve the Informed Consent Process

    National Human Genome Research Institute Researchers Work with Patients, Families and the Scientific Community to Improve the Informed Consent Process | site |


    National Institutes of Health says as genome-editing trials become more common, informed consent is changing


    (October 13, 2020) - - Today the National Institutes of Health (NIH) published the following information: As public interest and expanded research in human genome editing grows, many questions remain about ethical, legal and social implications of the technology. People who are seriously ill may overestimate the benefits of early clinical trials while underestimating the risks. This makes properly understanding informed consent, the full knowledge of risks and benefits of treatments, especially important. In response to this emerging need, researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, asked patients, parents and physicians
    ...
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  • CMS Announces Innovative Payment Model to Improve Care, Lower Costs for Cancer Patients

    Centers for Medicare and Medicaid Services Announces Innovative Payment Model to Improve Care, Lower Costs for Cancer Patients | site |



    (September 18, 2020) - - The Centers for Medicare and Medicaid Services published today (September 18, 2020) the following information:

    Today, the Centers for Medicare & Medicaid Services (CMS) finalized a new Innovation Center model expected to improve the quality of care for cancer patients receiving radiotherapy and reduce Medicare expenditures through bundled payments that allow providers to focus on delivering high-quality treatments. The new Radiation Oncology (RO) Model allows this focus on value-based care by creating simpler, more predictable payments that incentivize cost-efficient and clinically effective treatments to improve quality and outcomes. The RO Model, part of a final rule on specialty care models issued by CMS, will begin on January 1, 2021 and is estimated to save Medicare $230 million over...
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  • U.S. Health and Human Services accepts Donations of Medicine to Strategic National Stockpile as Possible Treatments for COVID-19 Patients

    U.S. Health and Human Services accepts Donations of Medicine to Strategic National Stockpile as Possible Treatments for COVID-19 Patients | site |




    FDA issues emergency use authorization for donated hydroxychloroquine sulfate, chloroquine phosphate


    (March 29, 2020) - - Today (March 29, 2020), the U.S. Department of Health and Human Services published the following information:

    The U.S. Department of Health and Human Services (HHS) today accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market. “President Trump is ta
    ...
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  • HHS Provides 100 Million Dollars to Help U.S. Healthcare Systems Prepare For COVID-19 Patients

    HHS Provides $100 Million to Help U.S. Healthcare Systems Prepare For COVID-19 Patients | site |




    (March 24, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information:

    The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS ASPR) today announced it will provide $100 million to aid U.S. healthcare systems in preparing quickly for a surge in COVID-19 patients. The support will directly benefit the National Special Pathogen System, and is authorized in the Coronavirus Preparedness and Response Supplemental Appropriations Act 2020. "We cannot beat the COVID-19 pandemic without getting America's healthcare workers the training and resources they need to respond to this novel threat, and these funds secured from Congress by President Trump will help make that happen," said HHS Secretary Alex Azar. "America's healthcare providers are doing a
    ...
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  • Coronavirus COVID-19 Update - - - FDA Allows Expanded Use of Devices to Monitor Patients’ Vital Signs Remotely

    Coronavirus COVID-19 Update - - - FDA Allows Expanded Use of Devices to Monitor Patients’ Vital Signs Remotely | site |



    (March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.

    “Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” said FDA
    ...
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  • U.S. Food and Drug Administration informs Health Care Providers, Facilities and Patients about Potential Cybersecurity Vulnerabilities

    U.S. Food and Drug Administration informs Health Care Providers, Facilities and Patients about Potential Cybersecurity Vulnerabilities| site |


    Vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers


    (January 23, 2020) - - The U.S. Food and Drug Administration (FDA) published (today, January 23, 2020) the following information:

    Today, the U.S. Food and Drug Administration is issuing a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers. These devices are primarily used in health care facilities for displaying patient information, such as the physiologic status (i.e., temperature, heartbeat, blood pressure, etc.) of a patient, and monitoring patient status from a central location in a facility, such as a nurse’s bay. The cybersecurity
    ...
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  • FDA Approves the first Targeted Therapy to Treat a Rare Mutation in Patients with Gastrointestinal Stromal Tumors

    U.S. Food and Drug Administration Approves the first Targeted Therapy to Treat a Rare Mutation in Patients with Gastrointestinal Stromal Tumors| site |




    (January 9, 2020) - - The U.S. Food and Drug Administration (FDA) published (today) the following information: Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach or small intestine – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keeps the cancer cells from growing. ...
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  • Centers for Medicare and Medicaid Services Sends Clear Message to Plans - - - Stop Hiding Information from Patients

    Centers for Medicare & Medicaid Services Sends Clear Message to Plans: Stop Hiding Information from Patients




    Part of the continued roll-out of American Patients First, CMS sends letter to Part D plans explaining that gag clauses that keep patients from knowing how to get the best deal are completely unacceptable



    (May 17, 2018) - - Today, the Centers for Medicare & Medicaid Services (CMS) sent a letter to companies that provide Medicare prescription drug coverage in Part D explaining that so-called “gag clauses” are unacceptable, as part of the Administration-wide “American Patients First” initiative to lower prescription drug costs. In Part D, Medicare pays prescription drug plans to cover medicines, which beneficiaries buy at a pharmacy. Gag clauses are provisions in contracts that insurance plans and their pharmacy benefit managers enter into with p
    ...
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  • Department of Health and Human Services Sponsors its Largest Exercise for Moving Patients with Highly Infectious Diseases

    Department of Health and Human Services Sponsors its Largest Exercise for Moving Patients with Highly Infectious Diseases





    (April 10, 2018) - - The largest patient movement exercise in U.S. Department of Health and Human Services’ history began today to test the nationwide ability to move patients with highly infectious diseases safely and securely to regional treatment centers.

    “Saving lives during crises requires preparation and training,” explained HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “A tremendous amount of coordination, synchronization, and skill is needed to move patients with highly infectious diseases safely. We have to protect the patients and the healthcare workers caring for those patients. This type of exercise helps ensure that everyone involved is ready for that level of complexity.”



    Dr. Kadle
    ...
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  • New Technique Makes Heart Valve Replacement Safer for some High-risk Patients

    New Technique Makes Heart Valve Replacement Safer for some High-risk Patients




    April 3, 2018




    Bethesda, Maryland - - (April 2, 2018) - - Scientists have developed a novel technique that prevents coronary artery obstruction during transcatheter aortic valve replacement (TAVR), a rare but often fatal complication. The method, called Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA), will increase treatment options for high-risk patients who need heart valve procedures. The findings by researchers at the National Institutes of Health will publish in the Journal of the American College of Cardiology: Cardiovascular Interventions on April 2. TAVR, a procedure used to treat aortic valve stenosis, involves threading a long, thin, flexible tube, called a catheter, through the femoral artery in the leg
    ...
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  • Centers for Medicare and Medicaid Services Issues Proposed Rule to Increase Health Insurance Choices for Patients for 2018

    Centers for Medicare & Medicaid Services Issues Proposed Rule to Increase Patients’ Health Insurance Choices for 2018




    March 1, 2017


    (February 15, 2017) - - The Centers for Medicare & Medicaid Services (CMS) today issued a proposed rule for 2018, which proposes new reforms that are critical to stabilizing the individual and small group health insurance markets to help protect patients. This proposed rule would make changes to special enrollment periods, the annual open enrollment period, guaranteed availability, network adequacy rules, essential community providers, and actuarial value requirements; and announces upcoming changes to the qualified health plan certification timeline. “Americans participating in the individual health insurance markets deserve as many health insurance options as possible,” said Dr. Patrick Conway, Acting Administrator of the Centers for Medicare & Medicaid Services. “This proposal will take steps
    ...
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  • Staff Reporter 1
    OCR Resolves Religious Discrimination Complaints, Patients Can Receive Safe Religious Visitations During COVID-19
    by Staff Reporter 1
    Office for Civil Rights Resolves Religious Discrimination Complaints after Maryland and Virginia Hospitals Ensure Patients Can Receive Safe Religious Visitations During COVID-19 | site |



    (October 20, 2020) - - The U.S. Department of Health and Human Services published today, October 20, 2020, the following information: Today, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) announces the resolution of two religious discrimination complaints ensuring clergy access to patients for religious purposes during the COVID-19 pandemic, one involving MedStar’s Southern Maryland Hospital Center (MSMHC) that is part of the MedStar Health System, and the second one involving Mary Washington Healthcare (MWHC) in Virginia. In the first matter, in July 2020, OCR’s Conscience and Religious Freedom Division (CRFD) received a complaint from a mother alleging that after giving birth alone at MSMHC, she was separated from her newb...
    10-25-2020, 02:38 AM
  • Staff Reporter 1
    NHGRI Researchers Work with Patients, Families and the Scientific Community to Improve the Informed Consent Process
    by Staff Reporter 1
    National Human Genome Research Institute Researchers Work with Patients, Families and the Scientific Community to Improve the Informed Consent Process | site |


    National Institutes of Health says as genome-editing trials become more common, informed consent is changing


    (October 13, 2020) - - Today the National Institutes of Health (NIH) published the following information: As public interest and expanded research in human genome editing grows, many questions remain about ethical, legal and social implications of the technology. People who are seriously ill may overestimate the benefits of early clinical trials while underestimating the risks. This makes properly understanding informed consent, the full knowledge of risks and benefits of treatments, especially important. In response to this emerging need, researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, asked patients, parents and physicians
    ...
    10-13-2020, 07:00 PM
  • Staff Reporter 1
    CMS Announces Innovative Payment Model to Improve Care, Lower Costs for Cancer Patients
    by Staff Reporter 1
    Centers for Medicare and Medicaid Services Announces Innovative Payment Model to Improve Care, Lower Costs for Cancer Patients | site |



    (September 18, 2020) - - The Centers for Medicare and Medicaid Services published today (September 18, 2020) the following information:

    Today, the Centers for Medicare & Medicaid Services (CMS) finalized a new Innovation Center model expected to improve the quality of care for cancer patients receiving radiotherapy and reduce Medicare expenditures through bundled payments that allow providers to focus on delivering high-quality treatments. The new Radiation Oncology (RO) Model allows this focus on value-based care by creating simpler, more predictable payments that incentivize cost-efficient and clinically effective treatments to improve quality and outcomes. The RO Model, part of a final rule on specialty care models issued by CMS, will begin on January 1, 2021 and is estimated to save Medicare $230 million over...
    09-21-2020, 11:16 PM
  • Staff Reporter 1
    U.S. Health and Human Services accepts Donations of Medicine to Strategic National Stockpile as Possible Treatments for COVID-19 Patients
    by Staff Reporter 1
    U.S. Health and Human Services accepts Donations of Medicine to Strategic National Stockpile as Possible Treatments for COVID-19 Patients | site |




    FDA issues emergency use authorization for donated hydroxychloroquine sulfate, chloroquine phosphate


    (March 29, 2020) - - Today (March 29, 2020), the U.S. Department of Health and Human Services published the following information:

    The U.S. Department of Health and Human Services (HHS) today accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market. “President Trump is ta
    ...
    04-01-2020, 01:41 AM
  • Staff Reporter 1
    HHS Provides 100 Million Dollars to Help U.S. Healthcare Systems Prepare For COVID-19 Patients
    by Staff Reporter 1
    HHS Provides $100 Million to Help U.S. Healthcare Systems Prepare For COVID-19 Patients | site |




    (March 24, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information:

    The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS ASPR) today announced it will provide $100 million to aid U.S. healthcare systems in preparing quickly for a surge in COVID-19 patients. The support will directly benefit the National Special Pathogen System, and is authorized in the Coronavirus Preparedness and Response Supplemental Appropriations Act 2020. "We cannot beat the COVID-19 pandemic without getting America's healthcare workers the training and resources they need to respond to this novel threat, and these funds secured from Congress by President Trump will help make that happen," said HHS Secretary Alex Azar. "America's healthcare providers are doing a
    ...
    03-25-2020, 01:23 AM

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