Centers for Medicare and Medicaid Services Data Shows Vulnerable Americans Forgoing Mental Health Care During COVID-19 Pandemic

Centers for Medicare and Medicaid Services Data Shows Vulnerable Americans Forgoing Mental Health Care During COVID-19 Pandemic | site |



(Information contained in Centers for Medicare and Medicaid Services press release dated: May 14, 2021)

The Centers for Medicare & Medicaid Services (CMS) released data today highlighting the continued impact the COVID-19 Public Health Emergency (PHE) is having on Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries and utilization of health services. The data show that, from March through October 2020, beneficiaries have foregone millions of primary, preventive, and mental health care visits due to the COVID-19 PHE, compared to the same time period in 2019. Although utilization rates for some treatments have rebounded to pre-pandemic levels, mental health services show the slowest rebound. This decline in utilization is occurring at a time when preliminary evidence shows menta...

U.S. Transportation Secretary Pete Buttigieg Announces $1.69 Billion for Amtrak in Response to COVID-19 | site |



(Information contained in U.S. Department of Transportation's Federal Railroad Administration press release dated: April 27, 2021) Washington - - U.S. Secretary of Transportation Pete Buttigieg today announced that the Department of Transportation’s Federal Railroad Administration (FRA) is making more than $1.69 billion available to the National Railroad Passenger Corporation (Amtrak) to provide relief from the impacts of COVID-19 to the company’s business operations, workforce, and state funding partners. The funding is provided under the American Rescue Plan Act of 2021. “Help is here. The President’s American Rescue Plan is already delivering for workers and the traveling public,” said Secretary Pete Buttigieg. “This new assistance for Amtrak will get employees back to work and restore service on routes across the country, at a time ...

U.S. Department of Health and Human Services Awards $40 Million in American Rescue Plan Funding to Support Emergency Home Visiting Assistance for Families Affected by the COVID-19 Pandemic | site |



(Information contained in U.S. Department of Health and Human Services [HHS] press release dated: May 11, 2021) Today, in recognition of National Women’s Health Week, and thanks to the American Rescue Plan, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded approximately $40 million in emergency home visiting funds to states, territories, and the District of Columbia to support children and families affected by the COVID-19 pandemic. The Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program supports the delivery of coordinated and comprehensive, high quality, voluntary, evidence-based home visiting services to children and families living in communities at risk for...

U.S. Department of Veterans Affairs releases Report detailing Efforts to address COVID-19 Pandemic | site |


(Information contained in U.S. Department of Veterans Affairs [VA] press release dated: May 11, 2021) Washington - - The Department of Veterans Affairs published a second installment report identifying the department’s strategic response from July 1, 2020 to Jan. 1, 2021, to address the COVID-19 pandemic. The results are a continuation of VA’s pledge to share best practices and lessons learned with other government agencies and the private health care system while the country continues to fight COVID-19. The Coronavirus Disease 2019 Response Report Annex A concludes that overall, VA has aligned responsibilities, communicated with stakeholders and employed an operational concept that produced an effective response in support of Veterans and communities around the country. “We created this document so medical professionals can learn from our eff...

Centers for Medicare and Medicaid Services Increases Medicare Payment for COVID-19 Monoclonal Antibody Infusions | site |


New payment policy for at-home administration


(Information contained in Centers for Medicare and Medicaid Services press release dated: May 6, 2021) As part of the ongoing response to address the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) has increased the Medicare payment rate for administering monoclonal antibodies to treat beneficiaries with COVID-19, continuing coverage under the Medicare Part B COVID-19 vaccine benefit. Beneficiaries pay nothing out of pocket, regardless of where the service is furnished – including in a physician’s office, healthcare facility or at home. Effective today, the national average payment rate will increase from $310 to $450 for most health care settings. In support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


(Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential...

U.S. Department of Education Releases "COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs" | site |



(Information contained in U.S. Department Education press release dated: April 9, 2021)

Today, the U.S. Department of Education (Department) released the COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs to provide additional strategies for safely reopening all of America's schools and to promote educational equity by addressing opportunity gaps that have been exacerbated by the pandemic.

Building off of Volume 1: Strategies for Safely Reopening Elementary and Secondary Schools, which focused on health and safety measures that schools can use to successfully implement the Centers for Disease Control and Prevention's (CDC) K-12 Operational Strategy, Volume 2 of the Handbook focuses on research-based strategies to address the social, emotional,...

Centers for Disease Control and Prevention Awards $3 Billion to Expand COVID-19 Vaccine Programs | site |



CDC says Funding can be used for innovative partnerships with community-based organizations to increase vaccine uptake, including in underserved populations


(Information contained in Centers for Disease Control and Prevention press release dated: April 6, 2021)

The Centers for Disease Control and Prevention (CDC) has awarded funding to support local efforts to increase vaccine uptake by expanding COVID-19 vaccine programs and ensuring greater equity and access to vaccine by those disproportionately affected by SARS-CoV-2, the virus that causes COVID-19. The awards are part of $3 billion in funding that CDC has granted to 64 jurisdictions to bolster broad-based vaccine distribution, access, and administration efforts. The funding was made available by the American Rescue Plan and the Coronavirus Response an...

Coronavirus (COVID-19) Update: FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 16, 2021)

The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health

March 16, 2021

Statement From:

Director - CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomati...

Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update: March 12, 2021 | site |



(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: March 12, 2021)

• Today, the FDA issued a Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff and Health Care Providers to alert them that false positive results can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System.

• Today, the FDA issued an Emergency Use Authorization (EUA) for Propofol-Lipuro 1% injectable emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved

...

Biden Administration to Invest $250 Million in Effort to Encourage COVID-19 Safety and Vaccination Among Underserved Populations| site |



HHS Office of Minority Health Will Offer Localities Funding to Partner with Community Organizations to Connect Minority, Underserved Populations with Vital Services, Promote Pandemic Safety Measures (Information contained in U.S. Department of Health and Human Services [HHS] press release dated: March 8, 2021) As part of President Biden's National Strategy for the COVID-19 Response and Pandemic Preparedness today, the Administration is announcing an effort to invest $250 million to encourage COVID-19 safety and vaccination among underserved populations. The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) will offer the funding as health literacy grants to localities, who will partner with community-based organizations, to reach racial and ethnic minority, rural and other vulnerable populati...

Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test | site |




(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. “Today’s authorization further underscores the FDA’s commitment to innovation in test development,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understandi...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |


(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors

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Biden Administration Strengthens Requirements that Plans and Issuers Cover COVID-19 Diagnostic Testing Without Cost Sharing and Ensures Providers are Reimbursed for Administering COVID-19 Vaccines to Uninsured | site |



(Information contained in Centers for Medicare and Medicaid Services press release dated: February 26, 2021)

In accordance with the Executive Order President Biden signed on January 21, 2021, the Centers for Medicare & Medicaid Services (CMS), together with the Department of Labor and the Department of the Treasury, (collectively, the Departments) issued new guidance today removing barriers to COVID-19 diagnostic testing and vaccinations and strengthening requirements that plans and issuers cover diagnostic testing without cost sharing. This guidance makes clear that private group health plans and issuers generally cannot use medical screening criteria to deny coverage for COVID-19 diagnostic tests for individuals with health cove...

Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Issues Authorization for First Molecular Non-Prescription, At-Home Test | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. “The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. �...