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  • American Medical Association Statement on HHS Decision to remove Barriers for Opioid Treatment

    American Medical Association Statement on U.S. Department of Health and Human Services Decision to remove Barriers for Opioid Treatment| site |



    (Information contained in American Medical Association [AMA] press release dated: January 14, 2021)


    The following statement is attributable to:

    Patrice Harris, M.D., M.A. Chair, AMA Opioid Task Force Immediate Past President, American Medical Association “The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder. Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it. The AMA urged HHS to change the regulations last year in order to remove a major barrier to reducing the nationwide epidemic of drug-related overdose and death.
    ...
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  • Statement from HHS Chief of Staff Brian Harrison on Promoting Fairness and Transparency in HHS Civil Enforcement Actions

    Statement from U.S. Department of Health and Human Services Chief of Staff Brian Harrison on Promoting Fairness and Transparency in HHS Civil Enforcement Actions | site |


    (Information contained in U.S. Department of Health and Human Services [HHS] press release: January 13, 2021)

    Today, HHS announced through a policy memorandum - PDF* that its operating and staff divisions will review and revise their procedures related to civil enforcement actions and adjudications to ensure that they promote fairness and transparency. Fairness and transparency foster public trust in administrative procedures and functions, and HHS is committed to acting transparently and fairly with respect to all regulated persons, including parties in administrative enforcement and adjudication proceedings. The policy memorandum directs HHS to provide additional specific protections to regulated parties who are the subject of civil enforcement actions. For example, HHS will
    ...
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  • HHS Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies

    U.S. Department of Health and Human Services Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies | site |
    • System helps doctors and patients find locations for COVID-19 outpatient treatment
    • Use of monoclonal antibody treatments could help reduce need for hospitalization in high-risk patients


    (Information contained in U.S. Department of Health and Human Services press release: January 11, 2021)

    A web-based COVID-19 outpatient treatment locator maintained by the U.S. Department of Health and Human Services (HHS) is now available to assist healthcare providers and patients in finding potential locations for treatment with monoclonal antibody therapeutics. These medicines are authorized for emergency use in treating patients with mild or moderate COVID-19 who are at high risk of developing severe symptoms and requiring hospitalization. "We are focused intently on supporting healthcare providers in their efforts to save liv
    ...
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  • HHS Releases Advisory Opinion Clarifying that 340B Discounts Apply to Contract Pharmacies

    U.S. Department of Health and Human Services Releases Advisory Opinion Clarifying that 340B Discounts Apply to Contract Pharmacies | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 30, 2020) On Wednesday, the HHS Office of the General Counsel released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. The 340B Program requires drug manufacturers (in exchange for coverage of drugs under Medicaid) to offer substantial discounts to "covered entities," which include safety net hospitals, community health centers, and other institutions that serve vulnerable populations. Estimates suggest that discounts in the 340B Program can range between 25 and 50 percent and that approximately $30 billion of drugs are so...
    See more | Go to post

  • HHS Secretary Azar Statement on Executive Order Supporting In-Person Schooling

    HHS Secretary Azar Statement on Executive Order Supporting In-Person Schooling

    U.S. Department of Health and Human Services Secretary Azar Statement on Executive Order Supporting In-Person Schooling | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 28, 2020) On Monday, President Trump signed an executive order directing HHS to allow funds available through the Community Services Block Grant program, administered through the Administration for Children and Families, to be used by grantees and eligible entities to provide emergency learning scholarships to disadvantaged families for their children who lack access to in-person learning. HHS Secretary Alex Azar issued the following statement: “During the COVID-19 pandemic, the Trump Administration has made it a top priority to support safe access to in-person education for American children. President Trump’s executive order will help children and families without access to in-person schooling to secure it with schol...
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  • HHS collaborates with Merck to continue the Development and Large-scale Manufacturing of Investigational COVID-19 Treatment

    U.S. Department of Health and Human Services collaborates with Merck to continue the Development and Large-scale Manufacturing of Investigational COVID-19 Treatment | site |




    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 23, 2020)



    HHS, DOD collaborate with Merck to continue the development and large-scale manufacturing of investigational COVID-19 treatment

    The U.S. Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19. The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive ...
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  • HHS publishes Guidance for National Guard Personnel Regarding COVID-19 Vaccines and Immunity under the PREP Act

    U.S. Department of Health and Human Services publishes Guidance for National Guard Personnel Regarding COVID-19 Vaccines and Immunity under the PREP Act | site |




    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 18, 2020)


    Guidance for National Guard Personnel Regarding COVID-19 Vaccines and Immunity under the PREP Act


    Today, the U.S. Department of Health and Human Services through the Assistant Secretary for Health, extended coverage under the Public Readiness and Emergency Preparedness Act (PREP Act) to qualified National Guardsmen administering COVID-19 vaccinations that have been authorized or licensed by the Food and Drug Administration (FDA). This will allow states and/or territories that wish to fully utilize National Guard health and medical personnel to increase access to COVID-19 vaccinations the flexibility to do so. ...
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  • HHS Increases and Begins Distributing Over 24 Billion Dollars in Phase 3 COVID-19 Provider Relief Funding

    U.S. Department of Health and Human Services Increases and Begins Distributing Over $24 Billion in Phase 3 COVID-19 Provider Relief Funding | site |


    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 16, 2020)

    Today, the Trump Administration, through the Health Resources and Services Administration (HRSA) is announcing it has completed review of Phase 3 applications from the Provider Relief Fund (PRF) program and will distribute $24.5 billion to over 70,000 providers. Up from the $20 billion originally planned, the addition of another $4.5 billion in funding is being used to satisfy close to 90 percent of each applicant’s reported lost revenues and net change in expenses caused by the coronavirus pandemic in the first half of 2020. The U.S. Department of Health and Human Services (HHS) recognizes this pandemic has upended the health care system and caused significant financial hardships.
    ...
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  • HHS Announces that CDC will Award Nearly 227 Million Dollars for COVID-19 Vaccine Preparedness and Response Activities

    U.S. Department of Health and Human Services announces that CDC will Award Nearly $227 million for COVID-19 Vaccine Preparedness and Response Activities | site |


    (Information contained in U.S. Department of Health and Human Services press release: December 15, 2020) The Department of Health and Human Services (HHS) announces that the Centers for Disease Control and Prevention (CDC) will award $140 million for COVID-19 vaccine preparedness and almost $87 million for tracking and testing to 64 jurisdictions, including all 50 states and U.S. territories. “States and other public health jurisdictions are vital partners in the COVID-19 response and especially in the plans for distributing safe and effective COVID-19 vaccines,” said HHS Secretary Alex Azar. “This new round of funding will help these awardees continue to plan for and implement their COVID-19 vaccine programs, in collaboration with CDC, Operation Warp Speed, and the private-sector distribu...
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  • HHS Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test

    U.S. Department of Health and Human Services Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test | site |



    (The following information was contained in U.S. Department of Health and Human Services [HHS] press release: December 15, 2020) On Tuesday, the Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 that does not require a prescription, the Ellume COVID-19 Home Test, which was developed with $30 million in support from the NIH’s RADx Tech program. HHS Secretary Alex Azar issued the following statement: “FDA has authorized the first COVID-19 test that you can purchase over-the-counter, take at home, and get a rapid result, representing a major breakthrough for Americans’ ever-expanding access to convenient COVID-19 testing options. HHS provided support for this new option through NIH’s RADx in...
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  • HHS Proposes Modifications to the HIPAA Privacy Rule

    HHS Proposes Modifications to the HIPAA Privacy Rule

    HHS Proposes Modifications to the HIPAA Privacy Rule to Empower Patients, Improve Coordinated Care, and Reduce Regulatory Burdens| site |



    (Information contained in U.S. Department of Health and Human Services press release: December 10, 2020) Today, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announces proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry. The Notice of Proposed Rulemaking (NPRM) is part of HHS’s Regulatory Sprint to Coordinated Care, initiated under HHS Secretary Alex Azar’s value-based transformation agenda and led by HHS Deputy Secretary Eric Hargan, which seeks to promote value-based health care by examining federal regulations that impede efforts among health care providers and health pl...
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  • HHS Announces False Claims Act Working Group to Enhance Efforts to Combat Fraud and Focus Resources on Bad Actors

    U.S. Department of Health and Human Services Announces False Claims Act Working Group to Enhance Efforts to Combat Fraud and Focus Resources on Bad Actors | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 4, 2020) Today, the Department of Health and Human Services (HHS) announced the creation of a False Claims Act Working Group (Working Group) that enhances its partnership with the Department of Justice (DOJ) and the HHS Office of Inspector General (OIG) to combat fraud and abuse by identifying and focusing resources on those who seek to defraud the American taxpayers. HHS regulates over a third of the United States economy. In 2020, HHS provided over $1.5 trillion in grants and other payments to public and private recipients, including for healthcare items and services. In addition, HHS is one of the largest government contractors, paying over $170 billion in 2020 to thousands of contractors...
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  • Statement from Brian Harrison on HHS Chief of Staff’s Taxpayer Accountability Board

    Statement from Brian Harrison on U.S. Department of Health and Human Services Chief of Staff’s Taxpayer Accountability Board | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 4, 2020) Today, HHS announced that the Department has established the Chief of Staff’s Taxpayer Accountability Board (TAB) to ensure that HHS is a good steward of taxpayer funds and to eliminate excessive spending. The TAB will institutionalize a contract review culture for critical services throughout HHS by implementing a review process to strengthen the management of the acquisition of services at both the strategic and tactical level. HHS Chief of Staff Brian Harrison issued the following statement: “One of the most important responsibilities federal employees have is to be good stewards of the hard-earned taxes Americans send to Washington, and HHS’s Taxpayer Accountability Board will save billions of dollars by ...
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  • HHS Finalizes Good Guidance Practices Rule and Issues Advisory Opinion Regarding Compliance with Notice-and-Comment Obligations

    U.S. Department of Health and Human Services Finalizes Good Guidance Practices Rule and Issues Advisory Opinion Regarding Compliance with Notice-and-Comment Obligations | site |


    (Information contained in U.S. Department of Health and Human Services press release: December 3, 2020)

    Today, the Department of Health and Human Services (HHS) finalized a Good Guidance Practices rule to help ensure that the public receives appropriate notice of new guidance documents and that HHS guidance documents do not impose obligations on regulated parties that are not already reflected in statutes or regulations. This final rule implements Executive Order 13891 and is part of a broader regulatory reform initiative within HHS. The Good Guidance Practices regulation clarifies HHS’s obligations under the Administrative Procedure Act and enhances how HHS issues and maintains guidance documents. The rule requires all guidance documents issued after the rule’s ef
    ...
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  • HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth

    U.S. Department of Health and Human Services Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | site |



    (Information contained in U.S. Department of Health and Human Services press release: December 3, 2020)

    Today, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to criticial countermeasures against COVID-19. “During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” said HHS Secretary Alex Azar. “This new use of the PREP Act will help expand access to important services via telehealth, increase availability of authorized PPE, and make it easier to administer eventual COVID-19 vaccines.” Among other things, ...
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  • Staff Reporter 1
    American Medical Association Statement on HHS Decision to remove Barriers for Opioid Treatment
    by Staff Reporter 1
    American Medical Association Statement on U.S. Department of Health and Human Services Decision to remove Barriers for Opioid Treatment| site |



    (Information contained in American Medical Association [AMA] press release dated: January 14, 2021)


    The following statement is attributable to:

    Patrice Harris, M.D., M.A. Chair, AMA Opioid Task Force Immediate Past President, American Medical Association “The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder. Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it. The AMA urged HHS to change the regulations last year in order to remove a major barrier to reducing the nationwide epidemic of drug-related overdose and death.
    ...
    01-19-2021, 03:34 AM
  • Staff Reporter 1
    Statement from HHS Chief of Staff Brian Harrison on Promoting Fairness and Transparency in HHS Civil Enforcement Actions
    by Staff Reporter 1
    Statement from U.S. Department of Health and Human Services Chief of Staff Brian Harrison on Promoting Fairness and Transparency in HHS Civil Enforcement Actions | site |


    (Information contained in U.S. Department of Health and Human Services [HHS] press release: January 13, 2021)

    Today, HHS announced through a policy memorandum - PDF* that its operating and staff divisions will review and revise their procedures related to civil enforcement actions and adjudications to ensure that they promote fairness and transparency. Fairness and transparency foster public trust in administrative procedures and functions, and HHS is committed to acting transparently and fairly with respect to all regulated persons, including parties in administrative enforcement and adjudication proceedings. The policy memorandum directs HHS to provide additional specific protections to regulated parties who are the subject of civil enforcement actions. For example, HHS will
    ...
    01-14-2021, 03:22 AM
  • Staff Reporter 1
    HHS Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies
    by Staff Reporter 1
    U.S. Department of Health and Human Services Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies | site |
    • System helps doctors and patients find locations for COVID-19 outpatient treatment
    • Use of monoclonal antibody treatments could help reduce need for hospitalization in high-risk patients


    (Information contained in U.S. Department of Health and Human Services press release: January 11, 2021)

    A web-based COVID-19 outpatient treatment locator maintained by the U.S. Department of Health and Human Services (HHS) is now available to assist healthcare providers and patients in finding potential locations for treatment with monoclonal antibody therapeutics. These medicines are authorized for emergency use in treating patients with mild or moderate COVID-19 who are at high risk of developing severe symptoms and requiring hospitalization. "We are focused intently on supporting healthcare providers in their efforts to save liv
    ...
    01-11-2021, 11:44 PM
  • Staff Reporter 1
    HHS Releases Advisory Opinion Clarifying that 340B Discounts Apply to Contract Pharmacies
    by Staff Reporter 1
    U.S. Department of Health and Human Services Releases Advisory Opinion Clarifying that 340B Discounts Apply to Contract Pharmacies | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 30, 2020) On Wednesday, the HHS Office of the General Counsel released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. The 340B Program requires drug manufacturers (in exchange for coverage of drugs under Medicaid) to offer substantial discounts to "covered entities," which include safety net hospitals, community health centers, and other institutions that serve vulnerable populations. Estimates suggest that discounts in the 340B Program can range between 25 and 50 percent and that approximately $30 billion of drugs are so...
    12-30-2020, 10:07 PM
  • Staff Reporter 1
    HHS Secretary Azar Statement on Executive Order Supporting In-Person Schooling
    by Staff Reporter 1
    U.S. Department of Health and Human Services Secretary Azar Statement on Executive Order Supporting In-Person Schooling | site |



    (Information contained in U.S. Department of Health and Human Services [HHS] press release: December 28, 2020) On Monday, President Trump signed an executive order directing HHS to allow funds available through the Community Services Block Grant program, administered through the Administration for Children and Families, to be used by grantees and eligible entities to provide emergency learning scholarships to disadvantaged families for their children who lack access to in-person learning. HHS Secretary Alex Azar issued the following statement: “During the COVID-19 pandemic, the Trump Administration has made it a top priority to support safe access to in-person education for American children. President Trump’s executive order will help children and families without access to in-person schooling to secure it with schol...
    12-29-2020, 12:11 PM

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