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Latest Top (4) News


States Begin Detailing Specific Use of 150 Million BinaxNOW COVID-19 Tests Distributed by Trump Administration

Washington, DC – Four weeks after the Trump Administration announced it would deploy 150 million state-of-the-art Abbott BinaxNOW COVID-19 tests nationally to assist Governors’ ongoing reopening efforts, states have begun to report back where they are choosing to distribute the rapid, point of care tests. Of the states who have provided preliminary reports, use of the BinaxNOW allocations are largely being deployed to local health departments, K-12 schools and institutes of higher education, nursing homes, hospitals and correctional facilities.

“To protect seniors and to facilitate the continued re-opening of schools, businesses and the economy, the Trump Administration prioritized scaling-up our state and national point of care testing capacity,” said Assistant Secretary for Health Admiral Brett Giroir, MD. “Through strategic deployment of rapid tests to higher-risk individuals, accompanied by Federal surge- testing of individuals where there are outbreaks – as was the case this summer in multiple Sunbelt states – our national plan to provide the right test, at the right time, to the right person is working.”

But Giroir reiterated that testing does not substitute for avoiding crowded indoor spaces, washing one’s hands, or wearing a mask when not able to physically distance. “Combining personal responsibility with smart, targeted testing is a proven formula to prevent outbreaks – but we cannot ‘test our way’ out of this pandemic. Public vigilance in adhering to precautionary measures is required – especially as we clearly see the onset of mitigation fatigue.”

In their initial preliminary feedback, 32 states and the District of Columbia (DC) have shared how they plan to use the massive federal shipment of BinaxNOW tests. Other states, however, have additional priorities: for example, Alaska is sending tests to oil drilling sites; Mississippi and other states to veterans’ homes; Nevada to tribal health clinics; and Colorado to local public health agencies to test homeless populations.

As part of the Trump Administration’s comprehensive national effort to fight the COVID-19 pandemic, HHS purchased 150 million Abbott BinaxNOW rapid tests from Abbott. Of that total, 100 million are being shipped on an ongoing, weekly basis to Governors – who are given the discretion to distribute the BinaxNOW tests as they see fit. The other 50 million tests procured by HHS are being shipped directly to congregate care settings such as nursing homes, assisted living facilities, home health, hospice, the Indian Health Service, and historically black colleges and universities (HBCUs).

To view the allocation of tests to each state and territories click here.

BACKGROUND

The Federal government purchased Abbott BinaxNOW diagnostic tests on August 27, 2020, to ensure equitable distribution of the first 150 million units – one day after an Emergency Use Authorization (EUA) of the test was issued by the Food and Drug Administration (FDA) -- – to ensure that the tests would be expeditiously distributed to vulnerable populations as quickly as possible. The Federal distribution plan helps ensure that the nation’s Governors do not have to compete for the initial BinaxNOW shipments, or waste precious time to set up individual purchasing contracts with the manufacturer.

HHS also provided all CLIA-certified nursing homes over 11 million rapid, point-of-care tests. The tests include the following FDA-authorized antigen diagnostic tests: Abbott BinaxNOW and either a Quidel Sofia 2 or Becton, Dickinson and Company (BD) Veritor™ Plus System instrument(s).



Sun, 25 Oct 2020 14:15:00 -0400


HHS Expands Relief Fund Eligibility and Updates Reporting Requirements

The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is announcing the latest Provider Relief Fund (PRF) application period has been expanded to include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions. On October 1, 2020, HHS announced it would be making up to $20 billion in new Phase 3 General Distribution funding available for providers on the frontlines of the coronavirus pandemic. HHS is also focused on ensuring the safe continuity of all types of health care delivery despite this pandemic. As such, the Administration is committed to providing relief resources in an equitable manner to assist the diverse health care provider community regardless of whether they accept Medicare or Medicaid payments. HHS is also announcing it will be updating its most recent PRF reporting instructions to broaden use of provider relief funds.

"We have worked closely with stakeholders across the healthcare system to ensure that the Provider Relief Fund reaches all American healthcare providers that have been impacted by the pandemic," said HHS Secretary Alex Azar. "Today, we are expanding the pool of eligible providers to include a broader array of practices, such as residential treatment facilities, chiropractors, and vision care providers that may not have already received payments."

Under the Phase 3 General Distribution, which began accepting applicants on October 5, 2020, HHS invited providers that had already received PRF payments to apply for additional funding that considers changes in patient care operating revenue and expenses caused by the coronavirus. HHS also expanded the list of eligible applicants to providers who had not previously received PRF payments, including behavioral health providers known to the Substance Abuse and Mental Health Services Administration (SAMHSA) and certain providers who began practicing in 2020. Still, pandemic related needs across the entirety of the provider community remains high. HHS has designed the PRF program to be agile and responsive to the unique and dynamic challenges this virus presents to the health care ecosystem. Important to this approach is maintaining an open line of communication with providers and provider organizations, members of Congress, and state and local officials. As HHS receives input and feedback on needs caused by the coronavirus pandemic, it has tried to respond.

Newly Eligible Phase 3 General Distribution Providers

Today, HHS is expanding the pool of eligible Phase 3 applicants to include providers across a broad category of practices. Many providers who accept Medicare and Medicaid within these categories have already received a PRF payment, but others have not and HHS is working to ensure even more providers are able to receive Phase 3 funding. The list below includes eligible practices where providers may now apply for Phase 3 funding regardless of whether they accept Medicaid or Medicare.

  • Behavioral Health Providers
  • Allopathic & Osteopathic Physicians
  • Dental Providers
  • Assisted Living Facilities
  • Chiropractors
  • Nursing Service and Related Providers
  • Hospice Providers
  • Respiratory, Developmental, Rehabilitative and Restorative Service Providers
  • Emergency Medical Service Providers
  • Hospital Units
  • Residential Treatment Facilities
  • Laboratories
  • Ambulatory Health Care Facilities
  • Eye and Vision Services Providers
  • Physician Assistants & Advanced Practice Nursing Providers
  • Nursing & Custodial Care Facilities
  • Podiatric Medicine & Surgery Service Providers

(For a detailed description of all eligible Phase 3 General Distribution provider types, visit the PRF website.)

These providers and all Phase 3 applicants will have until 11:59PM EST on November 6, 2020 to submit their applications for payment consideration. Once validated, these providers will receive a baseline payment of approximately 2% of annual revenue from patient care plus an add-on payment that considers changes in operating revenues and expenses from patient care, including expenses incurred related to coronavirus. All payment recipients will be required to attest to receiving the Phase 3 General Distribution payment and accept the associated Terms and Conditions.

Reporting Requirements Update

HHS is committed to distributing PRF funds in a way that is fast, fair, simple and transparent. In September, HHS published final reporting guidance to set expectations for PRF payment recipients. In providing this guidance, HHS also updated its Frequently Asked Questions (FAQs) to clarify that for purposes of relief payments for lost revenues attributable to COVID-19, recipients must submit information showing a negative change in year-over-year net patient care operating income. This definition sought to balance fairness and establish guardrails to restrict some providers from receiving distributions that would make them more profitable than they were before the pandemic.

As providers, provider organizations, and members of Congress familiarized themselves with the reporting requirements, HHS received feedback from many voicing concerns regarding this approach to permissible uses of PRF money. In response to concerns raised, HHS is amending the reporting instructions to increase flexibility around how providers can apply PRF money toward lost revenues attributable to coronavirus. After reimbursing healthcare related expenses attributable to coronavirus that were unreimbursed by other sources, providers may use remaining PRF funds to cover any lost revenue, measured as a negative change in year-over-year actual revenue from patient care related sources.

A policy memorandum on the reporting requirement decision can be found here*.

The amended reporting requirements guidance can be found here.*

For updates and to learn more about the Provider Relief Program, visit: hhs.gov/providerrelief.

*This content is in the process of Section 508 review. If you need immediate assistance accessing this content, please submit a request to digital@hhs.gov.



Thu, 22 Oct 2020 13:15:00 -0400


Trump Administration Marks the Signing of the Geneva Consensus Declaration

On Thursday, October 22, Secretary of State Michael R. Pompeo and HHS Secretary Alex Azar participated in the virtual signing of the Geneva Consensus Declaration, a historic document that further strengthens an ongoing coalition to achieve better health for women, the preservation of human life, support for the family as foundational to a healthy society, and the protection of national sovereignty in global politics.

The document was co-sponsored by the United States, Brazil, Egypt, Hungary, Indonesia, and Uganda, and co-signed by 32 countries in total, representing more than 1.6 billion people.

Secretary Pompeo said in his remarks, “Under President Trump’s leadership, the United States has defended the dignity of human life everywhere and always. He’s done it like no other President in history. We’ve also mounted an unprecedented defense of the unborn abroad. … Today, we’re taking the next step, as we sign the Geneva Consensus Declaration. At its very core, the Declaration protects women’s health, defends the unborn, and reiterates the vital importance of the family as the foundation of society.” 

Secretary Azar said at the event, “The Declaration is much more than a statement of beliefs—it is a critical and useful tool to defend these principles across all United Nations bodies and at every multilateral setting, using language previously agreed to by member states of those bodies. ... Tragically, women around the world unnecessarily suffer health challenges—all too often, deadly health challenges—while too many wealthy nations and international institutions put a myopic focus on a radical agenda that is offensive to many cultures and derails agreement on women’s health priorities. Today, we put down a clear marker: No longer can U.N. agencies reinterpret and misinterpret agreed-upon language without accountability. Member States set the policy for the U.N. to pursue. Not the other way around.”

More information on the event and the Declaration is available at www.hhs.gov/Declaration.

The declaration reads as follows:

On Promoting Women’s Health and Strengthening the Family:

We, ministers and high representatives of Governments,

Having intended to gather on the margins of the 2020 World Health Assembly in Geneva, Switzerland to review progress made and challenges to uphold the right to the highest attainable standards of health for women; to promote women’s essential contribution to health, and strength of the family and of a successful and flourishing society; and to express the essential priority of protecting the right to life, committing to coordinated efforts in multilateral fora; despite our inability to meet in Geneva due to the global COVID-19 pandemic, in solidarity, we

1. Reaffirm “all are equal before the law,” and “human rights of women are an inalienable, integral, and indivisible part of all human rights and fundamental freedoms”;

2. Emphasize “the equal right of men and women to the enjoyment of all civil and political rights,” as well as economic, social, and cultural rights; and the “equal rights, opportunities and access to resources and equal sharing of responsibilities for the family by men and women and a harmonious partnership between them are critical to their well-being and that of their families”; and that “women and girls must enjoy equal access to quality education, economic resources, and political participation as well as equal opportunities with men and boys for employment, leadership and decision-making at all levels;”

3. Reaffirm the inherent “dignity and worth of the human person,” that “every human being has the inherent right to life,” and the commitment “to enable women to go safely through pregnancy and childbirth and provide couples with the best chance of having a healthy infant”;

4. Emphasize that “in no case should abortion be promoted as a method of family planning” and that “any measures or changes related to abortion within the health system can only be determined at the national or local level according to the national legislative process”;  Reaffirm that “the child… needs special safeguards and care… before as well as after birth” and “special measures of protection and assistance should be taken on behalf of all children,” based on the principle of the best interest of the child;

5. Reaffirm that “the family is the natural and fundamental group unit of society and is entitled to protection by society and the State”; that “motherhood and childhood are entitled to special care and assistance,” that “women play a critical role in the family” and women’s “contribution to the welfare of the family and to the development of society”;

6. Recognize that “universal health coverage is fundamental for achieving the Sustainable Development Goals related not only to health and well-being,” with further recognition that “health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” that “the predominant focus of health-care systems on treating illness rather than maintaining optimal health also prevents a holistic approach”; and that there are “needs that exist at different stages in an individual’s lifespan” which together support optimal health across the life course, entailing the provision of the necessary information, skills, and care for achieving the best possible health outcomes and reaching full human potential; and

7. “Reaffirm the importance of national ownership and the primary role and responsibility of governments at all levels to determine their own path towards achieving universal health coverage, in accordance with national contexts and priorities,” preserving human dignity and all the rights and freedoms set forth in the Universal Declaration of Human Rights.

Furthermore, we, the representatives of our sovereign nations do hereby declare in mutual friendship and respect, our commitment to work together to:

  • Ensure the full enjoyment of all human rights and equal opportunity for women at all levels of political, economic, and public life;
  • Improve and secure access to health and development gains for women, including sexual and reproductive health, which must always promote optimal health, the highest attainable standard of health, without including abortion;
  • Reaffirm that there is no international right to abortion, nor any international obligation on the part of States to finance or facilitate abortion, consistent with the long-standing international consensus that each nation has the sovereign right to implement programs and activities consistent with their laws and policies;
  • Build our health system capacity and mobilize resources to implement health and development programs that address the needs of women and children in situations of vulnerability and advance universal health coverage;
  • Advance supportive public health policies for women and girls as well as families, including building our healthcare capacity and mobilizing resources within our own countries, bilaterally, and in multilateral fora;
  • Support the role of the family as foundational to society and as a source of health, support, and care; and
  • Engage across the UN system to realize these universal values, recognizing that individually we are strong, but together we are stronger.

Read Secretary Azar’s remarks here: https://www.hhs.gov/about/leadership/secretary/speeches/2020-speeches/remarks-at-the-geneva-consensus-declaration-signing-ceremony.html



Thu, 22 Oct 2020 11:00:00 -0400


Trump Administration Takes Action to Further Expand Access to Vaccines, COVID-19 Tests

Today, under the leadership of President Trump, the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Health (ASH), issued guidance* under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when made available, and COVID-19 tests, all subject to several requirements. This  guidance clarifies that the pharmacy intern must be authorized by the State or board of pharmacy in the State in which the practical pharmacy internship occurs, but this authorization need not take the form of a license from, or registration with, the State board of pharmacy.

"Pharmacists and their staff are critical to the COVID-19 response," said Assistant Secretary for Health ADM Brett P. Giroir, M.D. "Together with pediatricians and family physicians, they are ensuring that Americans receive the vaccines they need where they need it."

Childhood and COVID-19 Vaccines

On September 3, 2020, the Assistant Secretary for Health issued guidance authorizing state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, to persons ages three or older, COVID-19 vaccinations that have been authorized or licensed by the Food and Drug Administration (FDA), provided that certain conditions are met—thereby making them “covered persons” under the PREP Act with respect to this activity. 

This guidance authorizes both qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist to administer to FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages three or older and to administer FDA-authorized or FDA-licensed ACIP-recommended vaccines to persons ages three through 18 according to ACIP’s standard immunization schedule, if the requirements listed below are satisfied: 

  • The vaccination must be ordered by the supervising qualified pharmacist.
  • The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
  • The vaccine must be FDA-authorized or FDA-licensed.
  • In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).
  • In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
  • The qualified pharmacy technician or State-authorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include a hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
  • The qualified pharmacy technician or State-authorized pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
  • The qualified pharmacy technician must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
  • The supervising qualified pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the State or local immunization information system (vaccine registry).
  • The supervising pharmacist is responsible for complying with requirements related to reporting adverse events.
  • The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern. 
  • The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.
  • The supervising qualified pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

COVID-19 Testing

This guidance also authorizes qualified pharmacy technicians and State-authorized pharmacy interns to administer COVID-19 tests, including serology tests, that the FDA has approved, cleared, or authorized.

Information on the Third Amendment to the PREP Act declaration.

Information on Operation Warp Speed

Clinical resources on vaccines, including continuing education training on best practices

* Persons using assistive technology may not be able to fully access information in this file. For assistance, please contact the Office of the Assistant Secretary for Health at ashmedia@hhs.gov.



Wed, 21 Oct 2020 10:30:00 -0400